NO SPLIT. Cellceutix Announces Company Name Change to Innovation Pharmaceuticals Inc.
BEVERLY, Mass., June 7, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), an emerging biopharmaceutical company, is pleased to announce to shareholders, and the public at large, that it is changing its name to Innovation Pharmaceuticals Inc. (IPI) and has received a new Committee on Uniform Securities Identification Procedures (CUSIP) number of 45782D 100.
Innovation Pharmaceuticals more accurately describes the innovative nature of our first-in-class pipeline of mid-stage drug candidates. These changes will have no impact on the marketability of the Company’s securities, or the ability to trade the common stock through brokerage firms. Stockholders of the Company are not required to exchange their stock certificates in connection with the name change.
The Company’s common stock will continue to trade under stock symbol “CTIX” on OTCQB until market close on June 8, 2017. Trading on the OTCQB under the new Innovation Pharmaceuticals name and ticker symbol “IPIX” will begin at market open on June 9, 2017.
The name change will be discussed at the upcoming live shareholder and investor conference call, to be held on Thursday, June 8, 2017, at 11am EDT. Senior Company management will be responding to recently posed questions submitted by email. Live call-in questions will also be addressed.
Below are call-in details for the conference call:
Title: Innovation Pharmaceuticals Shareholder and Investor Conference Call
Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
Effective June 5, 2017, the registrant changed its corporate name from Cellceutix Corporation to Innovation Pharmaceuticals Inc. (the “Company”). In accordance with Section 92A.180 of the Nevada Revised Statutes, stockholder approval of the name change was not required.
In connection with Rule 6490 of the Financial Industry Regulatory Authority (“FINRA”) and Rule 10b-17 of the Securities Exchange Act of 1934, as amended, the Company submitted an issuer company-related action notification form to FINRA notifying FINRA of the name change and FINRA has confirmed that it will process the name change, effective at the open of business on June 9, 2017. In connection with the name change, the CUSIP number for the Company’s Class A common stock will change to 45782D 100. The Company’s Class A common stock will continue to be quoted on the OTCQB market but will trade under a new ticker symbol, “IPIX”.
A copy of the Company’s Articles of Incorporation, as amended, is filed herewith as Exhibit 3.1.
Item 7.01 Regulation FD Disclosure.
On June 7, 2017, the Company issued a press release announcing the name change. The full text of the press release is furnished with this Form 8-K as Exhibit 99.1 and incorporated by reference herein.
The information in this Current Report on Form 8-K under Item 7.01, including the accompanying press release, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by reference to such filing.
AMENDED AND RESTATED ARTICLES OF INCORPORATION OF INNOVATION PHARMACEUTICALS INC.
The name of the corporation (hereinafter referred to as the “Corporation”) is: “Innovation Pharmaceuticals Inc.”
The address of the Corporation’s registered office in the State of Nevada is United Corporate Services, Inc., in the City of Carson City, County of Carson. The name of the Corporation’s registered agent at such address is 202 South Minnesota Street, Carson City, Nevada 89703.
(a) Authorized Capital Stock.
(i) The total number of shares of stock that the Corporation shall have authority to issue is 410,000,000, consisting of
(ii) 300,000,000 shares of Class A Common Stock, par value $0.0001 per share (“Common Stock”) and
(iii) 100,000,000 shares of Class B Common Stock, par value $0.0001 per share (“Common Stock”)
(iv) 10,000,000 shares of Preferred Stock, par value $0.001 per share (“Preferred Stock”).
The holders of shares of the Class A Common Stock shall not have the right to convert their shares of Class A Common Stock into any other securities.
The holders of shares of the Class B Common Stock at their election shall have the right, at any time or from time to time, to convert any or all of their shares of Class B Common Stock into shares of Class A Common Stock, on a one to one basis, by delivery to the Corporation of the certificates representing such shares of Class B Common Stock duly endorsed for such conversion. Any shares of the Class B Common Stock that are transferred will automatically convert into shares of the Class A Common Stock, on a one to one basis, effective as of the date on which certificates representing such shares are presented for transfer on the books of the Corporation.
Subject to the limitations provided by law and subject to any voting rights applicable to shares of the Preferred Stock, the Class A Common Stock and the Class B Common Stock shall have the sole right and power to vote on all matters on which a vote of shareholders is to be taken. In all matters, with respect to actions both by vote and by consent, each holder of shares of the Class A Common Stock shall be entitled to cast one vote in person or by proxy for each share of Class A Common Stock standing in such holder’s name on the transfer books of the Corporation; and each holder of shares of the Class B Common Stock shall be entitled to cast ten votes in person or by proxy for each share of Class B Common Stock standing in such holder’s name on the transfer books of the Corporation. Except as otherwise provided above and subject to the limitations provided by law and subject to any voting rights applicable to shares of the Preferred Stock, the holders of shares of the Class A Common Stock and Class B Common Stock shall vote together as a single class, together with the holders of any shares of the Preferred Stock which are entitled to vote, and not as a separate class.
(b) Preferred Stock. Preferred Stock may be issued from time to time in one or more series. The Board of Directors is hereby authorized to provide for the issuance of shares of Preferred Stock in series and, by filing a certificate pursuant to the Nevada Revised Statutes (“N.R.S.”) (hereinafter, along with any similar designation relating to any other class of stock that may hereafter be authorized, referred to as a “Preferred Stock Designation”), to establish from time to time the number of shares to be included in each such series, and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations and restrictions thereof. The authority of the Board of Directors with respect to each series shall include, but not be limited to, determination of the following:
(i) The designation of the series, which may be by distinguishing number, letter or title;
(ii) The number of shares of the series, which number the Board of Directors may thereafter (except where otherwise provided in the Preferred Stock Designation) increase or decrease (but not below the number of shares thereof then outstanding);
(iii) The amounts payable on, and the preferences, if any, of shares of the series in respect of dividends, and whether such dividends, if any, shall be cumulative or noncumulative;
(iv) Dates on which dividends, if any, shall be payable;
(v) The redemption rights and price or prices, if any, for shares of the series;
(vi) The terms and amount of any sinking fund provided for the purchase or redemption of shares of the series;
(vii) The amounts payable on and the preferences, if any, of shares of the series in the event of any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Corporation;
(viii) Whether the shares of the series shall be convertible into or exchangeable for shares of any other class or series, or any other security, of the Corporation or any other corporation, and, if so, the specification of such other class or series of such other security, the conversion or exchange price or prices or rate or rates, any adjustments thereof, the date or dates at which such shares shall be convertible or exchangeable and all other terms and conditions upon which such conversion or exchange may be made;
(ix) Restrictions on the issuance of shares of the same series or of any other class or series;
(x) The voting rights, if any, of the holders of shares of the series.
(c) Common Stock. The Common Stock shall be subject to the express terms of the Preferred Stock and any series thereof. Each share of Common Stock shall be equal to each other share of Common Stock. Except as may be provided in these Amended Articles of Incorporation or in a Preferred Stock Designation, the holders of shares of Common Stock shall be entitled to one vote for each such share upon all questions presented to the stockholders.
The Board of Directors is hereby authorized to create and issue, whether or not in connection with the issuance and sale of any of stock or other securities or property of the Corporation, rights entitling the holders thereof to purchase from the Corporation shares of stock or other securities of the Corporation or any other corporation. The times at which and the terms upon which such rights are to be issued will be determined by the Board of Directors and set forth in the contracts or instruments that evidence such rights. The authority of the Board of Directors with respect to such rights shall include, but not be limited to, determination of the following:
(a) The initial purchase price per share or other unit of the stock or other securities or property to be purchased upon exercise of such rights.
(b) Provisions relating to the times at which and the circumstances under which such rights may be exercised or sold or otherwise transferred, either together with or separately from, any other stock or other securities of the Corporation.
(c) Provisions that adjust the number or exercise price of such rights or amount or nature of the stock or other securities or property receivable upon exercise of such rights in the event of a combination, split or recapitalization of any stock of the Corporation, a change in ownership of the Corporation’s stock or other securities or a reorganization, merger, consolidation, sale of assets or other occurrence relating to the Corporation or any stock of the Corporation, and provisions restricting the ability of the Corporation to enter into any such transaction absent an assumption by the other party or parties thereto of the obligations of the Corporation under such rights.
(d) Provisions that deny the holder of a specified percentage of the outstanding stock or other securities of the Corporation the right to exercise such rights and/or cause the rights held by such holder to become void.
(e) Provisions that permit the Corporation to redeem or exchange such rights.
(f) The appointment of a rights agent with respect to such rights.
(a) Subject to the rights of the holders of any series of Preferred Stock or any other series or class of stock as set forth in these Amended Articles of Incorporation, to elect additional directors under specified circumstances, the number of directors of the Corporation shall be fixed by the By-laws of the Corporation and may be increased or decreased from time to time in such a manner as may be prescribed by the By-laws.
(b) Unless and except to the extent that the By-laws of the Corporation shall so require, the election of directors of the Corporation need not be by written ballot.
The Corporation may in its By-laws confer powers upon the Board of Directors in addition to the foregoing and in addition to the powers and authorities expressly conferred upon the Board of Directors by applicable law.
(a) Each person who is or was or had agreed to become a director or officer of the Corporation, or each such person who is or was serving or who had agreed to serve at the request of the Board of Directors or an officer of the Corporation as a director, officer or trustee of another corporation, partnership, joint venture, trust or other enterprise (including the heirs, executor, administrators or estate of such person), shall be indemnified by the Corporation, in accordance with the By-laws of the Corporation, to the fullest extent permitted from time to time by the N.R.S. as the same exists or may hereafter be amended (but, in the case of any such amendment, only to the extent that such amendment permits the Corporation to provide broader indemnification rights than said law permitted the Corporation to provide prior to such amendment) or any other applicable laws as presently or hereafter in effect.
(b) The Corporation may, by action of the Board of Directors or through the adoption of By-laws, provide indemnification to employees and agents of the Corporation, and to persons serving as employees or agents of another corporation, partnership, joint venture, trust or other enterprise, at the request of the Corporation, with the same scope and effect as the foregoing indemnification of directors and officers. The Corporation shall be required to indemnify any person seeking indemnification in connection with a proceeding (or part thereof) initiated by such person only if such proceeding (or part thereof) was authorized by the Board of Directors or is a proceeding to enforce such person’s claim to indemnification pursuant to the rights granted by these Amended Articles of Incorporation or otherwise by the Corporation.
(c) The right to indemnification conferred in this Article VII shall be a contract right and shall include the right to be paid by the Corporation the expenses incurred in defending any such proceeding in advance of its final disposition, such advances to be paid by the Corporation within twenty (20) days after the receipt by the Corporation of a statement or statements from the claimant requesting such advance or advances from time to time; provided, however, that if the N.R.S. requires, the payment of such expenses incurred by such a person in his or her capacity as such a director or officer of the Corporation in advance of the final disposition of a proceeding, shall be made only upon delivery to the Corporation of an undertaking by or on behalf of such director or officer, to repay all amounts so advanced if it shall ultimately be determined that such director or officer is not entitled to be indemnified under this Article VII or otherwise.
(d) Without limiting the generality or the effect of the foregoing, the Corporation may enter into one or more agreements with any person that provide for indemnification greater or different than that provided in this Article VII.
(e) Neither any amendment or repeal of any Section of this Article VII, nor the adoption of any provision of these Amended Articles of Incorporation or the By-laws of the Corporation inconsistent with this Article VII, shall adversely affect any right or protection of any director, officer, employee or other agent established pursuant to this Article VII existing at the time of such amendment, repeal or adoption of an inconsistent provision, including without limitation by eliminating or reducing the effect of this Article VII, for or in respect of any act, omission or other matter occurring, or any action or proceeding accruing or arising (or that, but for this Article VII, would accrue or arise), prior to such amendment, repeal or adoption of an inconsistent provision.
(a) The liability of the directors of the Corporation for monetary damages shall be eliminated to the fullest extent permitted by the N.R.S., as now or hereafter in effect. If the N.R.S. is amended to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director of the Corporation shall be eliminated to the fullest extent permitted by the N.R.S., as so amended.
(b) Neither any amendment or repeal of any Section of this Article VIII, nor the adoption of any provision of these Amended Articles of Incorporation or the By-laws of the Corporation inconsistent with this Article VIII, shall adversely affect any right or protection of any director established pursuant to this Article VIII existing at the time of such amendment, repeal or adoption of an inconsistent provision, including without limitation by eliminating or reducing the effect of this Article VIII, for or in respect of any act, omission or other matter occurring, or any action or proceeding accruing or arising (or that, but for this Article VIII, would accrue or arise), prior to such amendment, repeal or adoption of an inconsistent provision.
Except as may be expressly provided in these Amended Articles of Incorporation, the Corporation reserves the right at any time and from time to time to amend, alter, change or repeal any provision contained in these Amended Articles of Incorporation or a Preferred Stock Designation, and any other provisions authorized by the laws of the State of Nevada at the time in force may be added or inserted, in the manner now or thereafter prescribed herein or by applicable law, and all rights, preferences and privileges of whatsoever nature conferred upon stockholders, directors or any other persons whomsoever by and pursuant to these Amended Articles of Incorporation in its present form or as hereafter amended are granted subject to the right reserved in this Article IX; provided, however, that any amendment or repeal of Article VII or Article VIII of these Amended Articles of Incorporation shall not adversely affect any right or protection existing hereunder in respect of any act or omission occurring prior to such amendment or repeal; and provided further that no Preferred Stock Designation shall be amended after the issuance of any shares of the series of Preferred Stock created thereby, except in accordance with the terms of such Preferred Stock Designation and the requirements of applicable law.
Final Patient Completes Treatment in Innovation Pharmaceuticals Phase 2b Study of Oral Prurisol for Psoriasis
BEVERLY, Mass., Nov. 30, 2017 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals Inc., (IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces that the last patient has completed study treatment in the Company’s Phase 2b trial of Prurisol for the treatment of psoriasis. Prurisol is being developed as a novel, nonbiologic, oral psoriasis drug candidate.
A total of 199 patients were enrolled in the clinical trial (see NCT02949388), which includes: a screening period of up to 4 weeks; a treatment period of 12 weeks; and a follow-up visit at 4 weeks, post-treatment. The randomized, double-blind, parallel-group and placebo-controlled study increased the total daily oral dosing of Prurisol from a previous high of 200 mg to include oral Prurisol 300 mg per day, oral Prurisol 400 mg per day, and placebo (3:1:3 randomization).
Primary efficacy is being evaluated using the Psoriasis Area and Severity Index (PASI), enabling a more direct comparison to already approved psoriasis drugs. In addition, multiple secondary endpoints will be studied to provide further insights into the potential benefits of Prurisol compared to marketed therapies, both oral and biologic.
In a previous Phase 2 trial studying Prurisol in mild-to-moderate psoriasis (see NCT02494479), Prurisol demonstrated early efficacy and was shown to be well-tolerated. A summary of these Phase 2 study results, presented at the 14th Annual Discovery on Target Conference, which was held on September 19, 2016, can be accessed at the link below. •“Prurisol: A New Small Molecule Under Investigation for the Treatment of Psoriasis” http://www.ipharminc.com/s/Prurisol-Presentation-for-Med-Derm-RD-Workshop_19Sep2 016-u.pdf
“With all patients having received treatment, we look forward to wrapping up the Phase 2b Prurisol trial,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Only a handful of patient follow-up visits remain to be completed. A novel psoriasis drug, particularly one that is oral, safe and effective, would be well-received by clinical practitioners and patients alike, both looking for newer treatment options to help manage this debilitating skin disease.”
About Psoriasis Affecting an estimated 125 million people worldwide, psoriasis is a chronic immune-mediated skin disorder presenting with varying symptoms and levels of severity. The condition is characterized by raised and inflamed skin, often on the elbows, knees, scalp, hands and feet, causing itching, irritation, stinging and pain. Often feeling socially stigmatized, over 80 percent of people with psoriasis report it negatively impacts the quality of their everyday life. Cases are graded as Mild, Moderate and Severe depending upon extent of body surface area involved as well as other parameters. Up to 30 percent of psoriasis patients will eventually develop psoriatic arthritis (PsA). Psoriasis also is associated with numerous comorbidities. Despite recent advances, there remains a need for orally-delivered psoriasis drugs and other treatment alternatives to biologics, which can be accompanied by side effects that significantly impact activities of daily living, and may lose their effectiveness over time.
About Prurisol Acting through immune modulation and PRINS reduction, Prurisol is a novel dermatology compound currently in mid-stage development as an oral psoriasis treatment utilizing the advantages of the FDA's 505(b)(2) development approach. This regulatory approach helps expedite a drug candidate’s approval as it allows the FDA to rely, in part, on existing clinical data from an already approved drug, in this instance, Ziagen. In laboratory studies, Prurisol was found to be effective against psoriasis in animal models, both in induced psoriasis and in a xenograft model using human psoriatic tissue. In these models, Prurisol eliminated virtually all signs of psoriasis. Innovation Pharmaceuticals has successfully completed a Phase 2 clinical trial of Prurisol in patients with mild-to-moderate chronic plaque psoriasis. Overall analyses showed that the drug candidate appears to be safe, well-tolerated and efficacious in the highest dosing arm across 12 weeks of treatment. Patients with moderate psoriasis saw the greatest clinical improvements. An early dose-dependent response that improved as treatment duration increased was observed. Innovation Pharmaceuticals has initiated a Phase 2b clinical trial of Prurisol in moderate-to-severe psoriasis and will be assessing the drug candidate’s efficacy at higher dosing regimens.
About 505(b)(2) Development Approach Under the FDA’s 505(b)(2) development approach, a drug candidate’s road to market approval can be significantly shortened and conducted at a much-reduced cost. Long-term safety data from a reference drug may be relied upon for approval, and potentially only one pivotal Phase 3 study, enrolling a smaller number of patients than is typical, may be required to establish drug efficacy. For more information about the FDA’s 505(b)(2) development program, please visit: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm079345.pdf
About the Company Headquartered in Beverly, Massachusetts, Innovation Pharmaceuticals Inc. (IPI), formerly Cellceutix Corporation, is publicly-traded under the company symbol “IPIX”. The Company is a clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. The Company believes it has a world-class portfolio of first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. The Company’s Psoriasis drug candidate Prurisol completed a Phase 2 trial and a Phase 2b study is ongoing. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. The Company’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and the Company has commenced a Phase 2 study in Ovarian Cancer. In the laboratory, Kevetrin has been shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Brilacidin, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative Oral Mucositis (OM) by more than 94% compared to placebo. The Company recently completed a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of OM in patients with Head and Neck Cancer and data are being analyzed; interim results have shown a marked reduction in the incidence of severe OM (WHO Grade ≥ 3). The Company’s lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (“superbugs”). Topline results are now available for the Phase 2, open label Proof-of-Concept trial, treating patients with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD). The Company has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACT Innovation Pharmaceuticals Leo Ehrlich email@example.com
B-OM data expected any day. It wasn't a very large trial since the design was just to better nail down the WHO grade.
Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title: Phase 2 Study to Evaluate the Efficacy & Safety of Brilacidin Oral Rinse Administered Daily for 7 Weeks in Attenuating Oral Mucositis in Patients With Head & Neck Cancer Receiving Chemoradiation
Innovation Pharmaceuticals Reports Positive Topline Results from Phase 2 Placebo-Controlled Trial of Brilacidin for the Prevention of Oral Mucositis in Head and Neck Cancer Patients
Company Targets a Therapeutic Leadership Position in Global OM Market
BEVERLY, MA – December 11, 2017 (GLOBE NEWSWIRE) Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today presented successful topline results from the Company's randomized, double-blind, placebo-controlled, Phase 2 clinical trial of Brilacidin (see NCT02324335) for the prevention and control of Oral Mucositis (OM) in patients receiving chemoradiation for treatment of Head and Neck Cancer. Brilacidin-OM is being developed under an FDA Fast Track designation for this indication.
Summary of Topline Results from the Placebo-Controlled Phase 2 Trial
· Brilacidin met primary endpoint of reduced incidence of severe OM experienced by patients during radiation therapy. · Incidence of severe OM in Modified Intent to Treat (mITT) Population: Brilacidin 42.9%, Placebo 60.0%. · Incidence of severe OM in Per Protocol (PP) Population: Brilacidin 36.8%, Placebo 60.0%. · Trial results support continued and expedited development of Brilacidin-OM.
Clinical Trial Background
In this trial, Head and Neck Cancer patients self-administered Brilacidin (45 mg/15 ml oral rinse—“swish and spit”) or placebo three times daily across 7 consecutive weeks (49 days). Of the 61 patients randomized, 46 patients met the cumulative radiation dose criteria of at least 55 Gy—the minimum treatment threshold for inclusion in the efficacy population—and 39 of these patients met more strict criteria for inclusion in the “per protocol” study population. The trial’s primary endpoint was established as reduced incidence of severe OM (defined as Grade ≥ 3 on the WHO Oral Mucositis scale) experienced by patients during radiation therapy.
Topline results reveal a clear reduction in the incidence of severe OM (WHO Grade ≥ 3) in patients treated with Brilacidin-OM as compared to those on placebo. Brilacidin also appeared generally safe and well-tolerated across all treated patients (the safety population).
Primary Efficacy Results: Incidence of severe OM (WHO Grade ≥ 3)
Active (Brilacidin) Control (Placebo)
Modified Intent to Treat 9 of 21 patients (42.9 %) 15 of 25 patients (60.0%) (mITT) Population (n=46) Per Protocol (PP) Population (n=39) 7 of 19 patients (36.8%) 12 of 20 patients (60.0%)
Overall reduction in observed severe Oral Mucositis (WHO Grade ≥ 3) in the Brilacidin-OM treatment group from that seen in the control group ([incidence control - incidence active]/incidence control) was: 28.5% (mITT population) and 38.7% (PP population).
Safety and Tolerability Profile
Brilacidin administered as an oral rinse was generally well-tolerated by patients. Safety findings were typical for patients with Head and Neck Cancer being treated with chemoradiation, with all treated patients reporting at least one Treatment-Emergent Adverse Event (TEAE). Of the TEAEs categorized as serious (SAEs), 13 patients (8 in the Brilacidin group, and 5 in the Placebo group) experienced at least one SAE. No SAEs reported led to death. None of the SAEs were classified by the Investigator as related to Brilacidin.
Additional study endpoint analyses are ongoing, with outputs expected in the coming weeks. These endpoints are important in building a deeper knowledge base around Brilacidin-OM, further informing other aspects of efficacy and helping to plan the next stage of clinical development.
“The completion of the Phase 2 trial of Brilacidin-OM is a major milestone for the Company, particularly given the successful topline study results. In a broader context, these mid-phase study results represent a watershed moment in the management of OM, as there has been negligible prior innovation in safely mitigating the onset of the severest stages of the disease,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “We believe that we now occupy a leadership position with this drug candidate in the prevention and treatment of severe OM in Head and Neck Cancer patients. Considering the global unmet medical need in treating severe OM, we anticipate leveraging these promising data, both in securing potential partnership opportunities and establishing an early competitive market position. In combination with other promising clinical data on Brilacidin, we are building a strong case that our novel defensin-mimetic pipeline can safely address an array of diseases and conditions by showing meaningful clinical responses. We now look forward to discussing our plans with the FDA to best align and prepare for the expedient advancement of the Brilacidin-OM program.”
“Based on these data, we are confident Brilacidin-OM has potential to improve significantly the treatment paradigm for OM,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “To see a clear beneficial clinical response is what clinicians hope for—a viable drug candidate bettering the lives of patients in dire need of newer treatment options. Further, today’s news is added validation of the Brilacidin Franchise, now anchored in three distinct clinical indications—OM, inflammatory bowel disease and serious skin infections. Brilacidin is an extremely unique drug candidate that we look forward to continuing to explore and advance across its many therapeutic applications.”
Brilacidin is Innovation Pharmaceuticals’ lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, the Company is studying Brilacidin’s effect on Oral Mucositis (under Fast Track designation) and on Ulcerative Proctitis / Proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: Atopic Dermatitis, Hidradenitis Suppurativa and Acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and an extra 5 years of United States market exclusivity upon drug approval.
Innovation Pharmaceutical’s first-in-class immunomodulatory drug candidate, Brilacidin, targets the prevention of severe Oral Mucositis (OM)—a common and debilitating side-effect of receiving chemoradiation therapy—in Head and Neck Cancer. Each year, OM affects hundreds of thousands of patients worldwide. Only a limited number of OM treatments are available, most of which are palliative in nature. A Phase 2 randomized, placebo-controlled clinical trial of Brilacidin-OM (see NCT02324335) has been recently completed in which topline results demonstrate a reduced rate of severe OM (WHO Grade >3) in patients treated with Brilacidin-OM compared to those on placebo.
About Oral Mucositis
Oral Mucositis (OM) is a frequent, painful and debilitating complication of chemoradiation. Head and Neck Cancer (HNC) patients—comprising an estimated 65,000 newly diagnosed cases in the U.S. alone in 2017, and an estimated 700,000 worldwide (source: GLOBOCAN)—are at the greatest risk of developing OM (a 90 to 100 percent rate of occurrence). By 2030, the global incidence of HNC cases is expected to exceed 1 million per year. Moreover, between 25 and 60 percent of cancer patients, regardless of cancer type, also will experience OM. Characterized by inflammation and ulceration, patients suffering from OM are often unable to speak and eat (requiring the insertion of a feeding tube) and are more susceptible to infections, with severe cases leading to hospitalization at increased treatment costs of up to $25,000. There currently are no approved medications for the prevention of OM in the HNC population, with only limited palliative care options available. Worldwide, the potential market for OM is expected to exceed $1 billion in the next few years.
This has been completely retail. Not much longer imo. And speaking of retail, just a few articles that have been done over time that still have relevance today. While re-reading them, take a look at the company's corporate overview and see how the projections have kept pace.
Just a little footnote, I'm not sure why the articles are rated as pro, if you have to pay SA to read them I urge not giving them any money. Their site isn't worth it imo. The articles written there are only as good as the reputation/credibility of the authors there and are not vetted in any way. A free for all site imo. I flashed back to these simply because Innovation Pharmaceuticals Inc has maintained their vigilance and goals progressing the pipeline in an exceptional manner with shareholders in mind. With patience I believe we'll be rewarded.
quote:Repost - Doctor-Founder-Billionaire Talks About Biotech Investment, Stocks
Not a lot of biotechnology entrepreneurs go on to count their wealth in billions, build supercomputers or own a significant piece of the Los Angeles Lakers basketball team.
But that’s been the trajectory of Dr. Patrick Soon-Shiong, who launched and sold two biotech startups–together worth nearly $8 billion. He now is heading up a new endeavor featuring artificial intelligence, semiconductors, cloud databases, a supercomputer, nano-optics and fiber-optic cable, all in the name of improving the country’s health-care system.
Dr. Soon-Shiong is also a heavy investor in publicly traded biotech stocks, he said.
The public markets last year welcomed dozens of new entrants from the world of biotech, but many have not been able to sustain the enthusiasm from investors. Many today are trading below their offering price, prompting some to speculate that there could be a biotech bubble.
Dr. Soon-Shiong says that is not the case, and that pressing medical needs will buoy many stocks beyond their initial ups and downs.
And while he stopped short of saying that his new company–Los Angeles-based Nantworks LLC–will definitely file to go public, he said he expects the company to become a powerful standalone player in the high-tech health system that the country is moving toward. He talked to Venture Capital Dispatch about the complex picture for new biotech issues on the public markets.
Q: What is your view of a situation where a lot of companies go public over a short time, and then have a very mixed performance? Is it something people should worry about?
A: No, absolutely not. The evolving tools of science, and their promise, have never been as exciting as right now. There are some real breakthrough drugs out now, particularly in cancer. It’s not a bubble, but people have followed each other [onto the public markets]. There’s been a pent-up demand for growth companies, and there’s capital out there. You will definitely see some of these companies stand the test of time.
As far as the ones that aren’t performing as well, sometimes it’s not the companies, it’s the market. The market is not scientifically driven. People should analyze the fundamentals, not the stock price.
Q: So how does one do that? How can people spot a healthy biotech company, putting aside its stock price?
A: There’s no way to generalize. But you ask: Is the science sound? Is there an unmet need? Has the company built a translational application that is demonstrable in trials? Can you do this at scale? Does the technology improve or impact outcomes for the patient?
If it brings value to the patient, it’s a company of value. We spend $4.3 trillion a year on health-care in the U.S. If the focus of your company is to increase value to the patient, then you will organically grow. A lot of these companies have zero revenue, so the only way to measure them, really, is to ask: Is there forward movement of this technology platform?
Q: What other advice would you give to biotech investors?
A: It’s science. It’s a 10-year horizon. Not everyone wants to invest with a 10-year horizon. There are long lead times, there are trials. If you’re impatient, as an investor, it can be bumpy. Choose wisely, because it takes a decade. It’s never a short-term thing.
When I took American Pharmaceutical Partners public in 1998, it opened at $14 a share. It dropped to $8 a share. Later on, we were so confident of the technology and the business model that we bought $30 million of the stock back. This was eight months after our IPO.
Our drug [a formulation of cancer drug Heparin] came out in 2001, and our stock hit $45 per share. It later split into two companies, and they were both acquired. In 2008, APP was the only safe supplier of Heparin in the country. That’s not a business model. That’s a company focused on benefitting the patient.
Q: So what does the future hold for these biotech stocks?
A: The strong will survive. Not strong as in financial strength, but sustainable value–value to the patient.
Nothing in this post most on this board already know but thought it would be a good generalization for newbies to get them to put IPIX on their watch list or prod them to do their own further in-depth DD.
I hope some can use this to send to friends who may want to put IPIX on a watch list. I realize this is all known to those on this board but it gives a decent description to newbies who might want to watch the stock:
IPIX is at the point where all on this board should have it on a watch list because the rise could(should) be quite dramatic if results on the Psoriasis trial results are good or if a major deal is signed. This applies to both traders and long term holders (long term in the range of a year or so). Am thinking of putting a pretty detailed current report on the Biotech board today for all to be able to share w/ friends (should anyone think they would share same with friends). Just to put in perspective why this could be an extremely dramatic move, if Prurisol is shown to be highly effective against Psoriasis it should become the leading prescribed treatment due to efficacy close to biologics, ease of administering since it is in pill form, much lower cost, and most importantly safety - next to 0 side effects. The Psoriasis market is about $12B/yr and saying they only capture $7B/yr (which I would think is conservative) that brings in a total of over $100B over the life of the patent. Thus, the stock price of IPIX should rise dramatically. Let me know if anyone wants a detailed briefing, otherwise I will pass and just let those that think IPIX is worthwhile to follow to put on their watch list. News should be out any time this month beginning now and certainly coming about before the end of the month.
I will start w/ the negatives of IPIX. First, it is in the biotech field and that is about the riskiest in investing as about 1 in 10K drugs actually make it to commerciality. The company has access to money, no problem, but they issue stock to Aspire Financial when cash needed and at current stock price that is very expensive cash. The only other negative is there is a very, very strong group of folks that have been manipulating the stock price for a couple of years and they will continue to compress the stock price at current levels until we get a major transfusion of cash in due to a deal. As a result, I feel TA is all but useless in the stock at the current time. Extremely positive Prurisol trial results will be a big help, but I believe a major deal with a major BP is the only thing that is firmly going to advance the company in terms of visibility, acceptance by financial institutions, and getting the cabals working against IPIX to finally leave for greener pastures. In all honesty, I cannot think of any more negatives to the company than those listed above. To expand on those mentioned above wanting the stock to fail, they made posts on various blogs about 2 years ago that were nothing but a pack of lies and had an ambulance-chasing law firm that preys upon young firms struggling to succeed file a class action suit against them. These suits usually result with the firm paying off the law firm to drop the suit. IPIX mgt. would have none of that and took them to court and although they were not awarded any monies as punishment, the judge did throw out all charges as pure BS. These same crews have regularly over the last couple of years disparaged both Dr. Menon and Leo's reputations and characters for minor events that were either totally fictitious or were extremely minor and blown totally out of proportion. This was done to try and keep any newcomer from investing in the company. This is indicative of the type of near criminal ploys (or ploys that most reasonable people would say even went over that line) with which mgt has had to contend for the last few years. Thank God they have had the moral fortitude to stand tall against all the slings and arrows that have been pointed at them all this time. Most lesser mgt. types would have packed it in by now.
Now for the upside of the company and though what I am abot to say sounds too good to be true, I believe that I am not exaggerating anything in terms of expectations, numbers, science, etc.
IPIX has en toto somewhere just under 200MM shares so I am using that figure for all share price projections. IPIX has about $70MM debt to insiders so there is no worry about a financial debacle that could bring the company down. The CEO, also the largest shareholder, has said NO, NO, and NO to a possible reverse split so that worry is off the table. I state emphatically that the 3 drugs that IPIX has brought to the end of Phase II trials (Phase I trial is for safety, Phase 2 is for optimum dose and frequency of taking the drug, and Phase 3 is a large population test to make sure no odd side effects prior to gaining FDA approval - Trials normally take about 10 yrs from start to finish. At the end of Phase2 for all our 3 drugs we are looking for BEST IN CLASS for all of them across many applications (each separate application in biotech is referred to as an indication) and EVERY indication is for MULTI-BILLION dollar markets. The one glaring strength of our pipeline is the SAFETY of all our drugs and that fact that we have no bad side effects with any of them for any indication. This is pretty much unheard of in biotech and that is why I am so confident that we will have successful Phase 3's and all drugs will lead to commerciality. It is also why I say that our current pipeline is the strongest pipeline EVER at one time by any startup biotech in history and possibly is the strongest pipeline for new products by any BIG PHARMA in history as our 3 drugs will be addressing markets that total over $100B/yr!! I will get to the science of our drugs in a few moments, but l want to stress that all the areas that make the science moot we also have been blessed in and that is why I believe IPIX at this time is the "Perfect Storm" for being so primed for riches. With no embarrassment, I will state as I have to my family and friends that I believe this is the GOLDEN RING that penny stock players pray for and hope to find once in their life. Our mgt consists of Dr. Krishna Menon, the genius behind formulating the drugs (he already led two projects for E.I. Lily that resulted in 2 current billion dollar cancer drugs), Dr. Bertolino who was head of dermatology for both Pfizer and Novartis and is the new addition to the team and has done wonders in guiding us thru clinical trials and putting us on a respected level when dealing w/ big pharma, and Leo Erhlich, a CPA who is the CEO and manages the company. Leo and Dr. Menon have taken their salary for years in stock rather than cash so as not to drain needed funds, they have lent the company millions, and from acquaintances who know them personally they are said to be of the highest character so in that regard we are blessed. I have already mentioned that IPIX is the rare, rare case where we are not at the mercy of major players being able to bring us into bankruptcy for their own personal gain and that can't be stressed enough. The firm now only has a handful of employees other than mgt as the lab work is done. As for the business plan, Leo has made it clear for years that deals would not be signed until Phase 2s were finished as the value of a drug really rises after P2 since the great portion of failures occur during P1 and P2. He has stated that they see IPIX becoming a franchiser and partnering out our drugs to BPs who will take over the P3 trial costs and then move the drugs into commerciality and do the distributing with IPIX getting regular royalty payments.
Another part of our "Perfect Storm" is that BP at the current time is flush with cash that they want to bring back onshore due to Trump's change to offshore cash and most BPs at the current time have pretty bare pipelines with many top selling drugs coming to the end of their patent protection. Most BPs today prefer to buy drugs in advanced stages of trials (exactly as what IPIX can provide) where the probability of success is much, much higher than taking an idea from scratch and running thru pre-clinical trials and then clinical trials. BP NEEDS NEW DRUGS NOW - IPIX HAS THE GREATEST LINEUP of drugs available - BP HAS THE BIG BUCKS TO SPEND - so it should bode extremely well for IPIX in the very near term. The above are all the incidental areas that can tear a company apart and yet which IPIX has been able to surmount and which now should be working heavily in our favor. That only leaves the science of our products and this is IPIX's greatest strength for our products to date have passed EVERY TRIAL w/ flying colors and spotless safety results.
The first of our drugs is PRURISOL and it was formulated by Dr M from an HIV drug and viewed as a great shot at being able to CURE psoriasis, not take care of the symptoms, but CURE the disease. We ran a P2a trial at dosages of 50, 100, and 200 units and it was found that the 200 dosage showed tremendous improvement in cure rate compared to the 50 and 100. Our current trial, P2b, tested patients with more severe cases of Psoriasis at dosage levels of 300 and 400. Most word I have heard is that we expect the 300 dosage to be the sweet spot and the 400 dosage was done just to make sure there wasn't more to gain from a stronger dose. We finished the actual medication in early Dec '17 and the follow up visits ended the end of Dec '17. We had about 190 patients from 34 various test sites. Upon the end of the trial, the data is all gathered by a firm that specializes in this field and they tabulate all the data and from what I have been told they will also analyze the data (which I expect is so that there can not be said there was any bias by our mgt analyzing the data) and the final primary endpoints are given to mgt. Then months later the secondary endpoints are finished with being analyzed and they are also published and this report as a whole leads to how the Phase 3 trial is to be designed in conjunction w/ FDA approval. We currently expect the primary endpoints ANY DAY now. Excellent results would be great for the company, but if they are not it would certainly be disappointing but not fatal to the company as a drug I will discuss later has already proven itself worth billions in its own right. We are hoping Prurisol does really well in Psoriasis as to curing the disease, but it has already shown in the P2a that it seemed to stop the severe itching of Psoriasis and if all Prurisol does is relieve the itching that would be a tremendous success as I have heard the itching can become so severe it has led to suicides and extremely poor quality of life for many, many thousands of patients. So as one can see, trials are not an all or nothing result. Partial success can lead to very lucrative drugs. The couple anecdotal stories I have heard regarding Prurisol in P2b is that it moistens the skin, stops the itching, and pretty much cures the disease. If this is true, we should have a nearly $10B/yr drug on our hands just for this indication but there is oh so much more just for Prurisol. It's properties (and I am no biological chemist so all what I have read) is that it should have amazing indications in the field of dermatology and even more exciting across the entire range of AUTOIMMUNE diseases (there are about 100 of them to inclue arthritis) and these would be researched by our BP partners down the line with IPIX getting royalties on all indications that prove commercial. The second drug is Brilacidin, a small molecule defensin mimetic (synthetic defensin), that appears to be a damn wonder drug and which some have proclaimed could outdo Humira as the largest drug in history in terms of revenue. It is an antibiotic/antiinflammatory. A protein defensin is the body's first line of defense against viruses and bacterial and B is said to be 100 times as powerful as a natural defensin and 1000 times as selective. You have all heard about the medical crisis with superbugs that defy current antibiotics, well B has already solved that problem because it works in a totally new way against invaders and they cannot develop a resistance to it. In a P2 trial it went up against the best antibiotic available today, daptomyacin, and in one application showed itself as effective as a full weeks application of daptomyacin and it kills everything. Nothing is immune to it in the way of bad viruses. The P3 trial will cost at least $30 MM and involve 4,000 patients and IPIX just doesn't have the money at the current time to put that much money to that indication so it is on hold but ready to proceed immediately and the P3 should be a very short trial as results will be seen in days instead of weeks or months and patients will be found probably within a matter of days. It's most valuable properties seem to be in the antiinflammatory field where it has proven itself to be effective against what many belive will be all IBD (Irritable Bowel Diseases) conditions and solve everything in the entire gastrointestinal (GI) tract and this is a BIG revenue target. It has already worked in tests for Ulcerative Colitis and Supra.... Colitis and would undoubtedly work against Crohn's Disease, it has worked against Oral Mucositis, a condition with no current treatment and is a $1-$2B/ yr target, and it has expected exceptional uses against dermatology conditions (acne, eczema, supra dermititis), eye and ear infections, and some have even said it could become like a one-a-day pill to ward off all infections. It als has the ability to be used in plastics, paints, and textiles to make all these items antimicrobial so indications would be all wound dressings, artifical parts put into the body, hernia stitches, colostomy bags, catheters, etc. In paints and plastics all surfaces in schools and hospitals would be self-ridding of viruses,etc. Brilacidin is also expected to be a monster drug for indications in dermatology in topical cream formulations for acne, eczema, and other more egregious skin indications (Did I say Dr. B was head of dermatology for both Pfizer and Novartis in the past? Nice connections.) There has been much talk that many, many other areas could be targets for Brilacidin that just haven't been recognized yet and that is also one of the major upsides to this drug.
The last drug was the original biggie for the company, Kevetrin, as it is a cancer treatment drug that could be used against about 50% of cancers (per Dr. Menon) and is expected to be such a wonderful complementary drug for all other cancer treatments that it would make all of them much more effective. The wonder of this drug is that it turns back on the p53 gene, the Guardian Angel gene, which in medicine has bee the Holy Grail to fight cancer. It affects no good cells or DNA and in the P1 safety trial which only had Stage 4 terminal patients enrolled they had to quit the trial after about 3 years and the dosage had risen from 10 units to 800 units because they couldn't induce any negative endpoints. People did not get sick because of the drug and these were patienst whose bodies were already at the point of falling apart when they entered the trial. As a complementary drug, this could work with all the big treatment drugs as many of them are getting near the end of their patent and by combining w/ Kevetrin would become patented for another near 20 yr term.
The top nine selling cancer treatment drugs sold about $90B/yr last year. Thus, I feel my call for all to at least put IPIX on your watch list is well warranted. I am not saying to buy now, you can wait until a major deal is done and take away all risk. The stock could rise a couple of dollars and you would still be in at a very attractive entry point. I hate to make projections of where the stock price could go, but I believe from what I posted above that the upside is darn near beyond belief. To make things even better, not only will stockholders make out richly but hundreds of thousands of patients worldwide should benefit from IPIX products.
Pete covers a lot of bases in his "awareness" post. Including partnership potential. Currently waiting for the un-blinding of the prurisol trial which ended in December. Seems like a long time though the protocol was pretty intense and included patient feedback analysis (questionnaires). Even the CEO didn't think it would take as long to get data and while it is possible they don't see it in the next few weeks, they are optimistic it will be out by the end of June. Personally, if you don't have the control to set a timeline, there shouldn't be one at all. Some psoriasis blinded trials have taken a year plus. The technical side is shaping up nicely though on little volume. I took a nice little chunk at .35, my swings on this have been stretching out longer as I think the anticipation is getting more intense.
If anyone's reading this, good luck! Would be nice to see this work out. And soon!
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7781 | From: Virginia | Registered: May 2006
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Innovation Pharmaceuticals Announces Database Lock for Phase 2b Trial of Oral Prurisol for Psoriasis
BEVERLY, MA – June 29, 2018 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces database lock for its Phase 2b clinical trial of oral Prurisol in moderate-to-severe chronic plaque psoriasis. Prurisol is being developed as a novel, nonbiologic, orally-delivered psoriasis drug candidate.
“Locking the database is a key step toward analyzing data from our randomized, placebo-controlled trial of Prurisol, one of the larger studies we’ve conducted to date,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “We are excited to have reached this milestone and will now move to process trial data and report topline study results. Psoriasis is a large market for which new treatments, particularly oral medications, are highly sought after by providers and patients.”
A total of 199 patients were randomized in the clinical trial (see NCT02949388), which included: a screening period of up to 4 weeks; a treatment period of 12 weeks; and a follow-up visit after 4 weeks off-treatment. The randomized, double-blind, parallel-group and placebo-controlled study increased the total daily oral dosing of Prurisol from a previous high of 200 mg, which earlier was shown to be well-tolerated and demonstrated early efficacy, to include oral Prurisol 300 mg per day, oral Prurisol 400 mg per day, and placebo (3:1:3 randomization). Efficacy evaluation includes the Psoriasis Area and Severity Index (PASI) and a Physician Global Assessment.
Innovation Pharmaceuticals Signs Drug Product Manufacturing Contract with CoreRx to Formulate and Package Brilacidin for Oral Mucositis in Sachet Form
BEVERLY, MA – July 17, 2018 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has signed a Drug Product manufacturing contract with CoreRx, a leading Contract Development Manufacturing Organization (CDMO), for formulating Brilacidin into granular form in unit dose sachets. Such drug product packaging in the form of sachets provides patients with a convenient, portable, quick-mixing “instant” Brilacidin oral rinse therapy.
Sachets are planned to be used in the continuing clinical evaluation of Brilacidin for the indication to decrease the incidence of Severe Oral Mucositis (SOM) (WHO Grade ≥ 3) in Head and Neck Cancer (HNC) patients receiving chemoradiation therapy.
The CoreRx agreement for Drug Product production aligns with one signed in April with another leading CDMO to, in parallel, bulk produce a commercial-grade supply of Brilacidin. Both of these manufacturing agreements serve to prepare for, and expedite, Brilacidin’s continued clinical development. Brilacidin is a defensin-mimetic drug candidate with unique immunomodulatory, anti-inflammatory, and antibacterial properties.
The Company signed a non-binding term sheet in August 2018 with a global pharmaceutical company for the licensing/rights to Brilacidin for treating oral mucositis and inflammatory bowel diseases. Initial payments, milestone payments and royalties are being negotiated in accordance with the non-binding term sheet. The pharmaceutical company is now engaged in further due diligence. Management can offer no assurances that the parties will enter into a binding definitive agreement.
I'd say this is a good reason to stay on top of the filings.
The next on could actually a licensing agreement.
Innovation Pharmaceuticals Announces Non-Binding Term Sheet Signed with Global Pharmaceutical Company to Develop and Commercialize Brilacidin for the Treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis
BEVERLY, MA – May 16, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report that the Company has signed a non-binding term sheet with a global pharmaceutical company to develop and commercialize locally-administered Brilacidin (e.g., foam, enema, gel), on a worldwide basis, for the treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis.
The non-binding term sheet also includes a Right of First Refusal for rights to Brilacidin for the treatment of more extensive forms of Inflammatory Bowel Disease, such as Ulcerative Colitis and Crohn’s Disease, and a Right of First Negotiation for rights to Brilacidin in other Gastrointestinal (GI) indications.
Completion of the transaction, as specified in the non-binding term sheet, is subject to further negotiation and execution of a definitive agreement. If the definitive agreement is reached and signed, the Company anticipates that it would receive an upfront payment, plus potential additional regulatory and commercial milestone payments, as well as royalties.
Innovation Pharmaceuticals Announces License Agreement with Alfasigma S.p.A. for the Development and Commercialization of Brilacidin in Ulcerative Proctitis/Ulcerative Proctosigmoiditis
· Over $24M in initial and milestone-based payments
BEVERLY, MA – July 22, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report that the Company has executed a license agreement with Alfasigma S.p.A (“Alfasigma”) to develop and commercialize locally-administered Brilacidin (e.g., foam, enema, gel), on a worldwide basis, for the treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS).
The Company will receive from Alfasigma an initial payment, plus be eligible for additional payments based on certain milestones, totaling over $24 million, and receive a 6 percent royalty (net sales) based on the successful marketing of Brilacidin for UP/UPS. The agreement also includes a Right of First Refusal for Brilacidin for the treatment of more extensive forms of Inflammatory Bowel Disease (IBD), such as Ulcerative Colitis and Crohn’s Disease, and a Right of First Negotiation for Brilacidin in other Gastrointestinal indications.
“This licensing agreement with Alfasigma is a major milestone for the Company,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Alfasigma is a first-class global pharmaceutical company with proven IBD expertise, marketing products like Xifaxan for Irritable Bowel Syndrome, which makes them an attractive partner to advance Brilacidin in UP/UPS. We are confident that Brilacidin for UP/UPS is in good hands, as Alfasigma works to potentially commercialize the drug. At the same time, we’re excited to be underway with our own Brilacidin oral formulation efforts to treat more extensive forms of IBD. We currently are utilizing sophisticated, controlled-release tablet technology to enable targeted delivery of oral Brilacidin in the colon, with in-human testing anticipated to start as soon as year-end. Millions of patients continue to suffer from hard-to-treat GI diseases, with recent deal-making in the pharmaceutical industry revealing significant premiums being paid for promising oral IBD drugs. As such, we are committed to advancing Brilacidin across multiple IBD indications, and also in other key franchise therapeutic areas, like our Phase 3-ready oral rinse Brilacidin program in Oral Mucositis.”
“We are thrilled to forge this partnership with Innovation Pharmaceuticals,” said Pier Vincenzo Colli, Chief Executive Officer at Alfasigma. “The Phase 2 Brilacidin clinical study results in UP/UPS look promising and reflective of Brilacidin’s unique drug properties and treatment potential. Alfasigma plans to dedicate considerable internal resources, including formulation and IP expertise, and to make a substantial investment to advance Brilacidin, with the objective to offer patients a safe and effective new treatment option in the management of UP/UPS. We will also closely follow Innovation’s progress in developing oral Brilacidin, as we remain highly interested in novel oral IBD treatments. This agreement is a further step in strengthening our pipeline.”
About Brilacidin for IBD
Inflammatory Bowel Disease (IBD) is a hard-to-treat, chronic, autoimmune condition that affects approximately 10 million people worldwide, including 3 million people in the U.S., with 70,000 newly diagnosed cases each year. The overall GI market sector is estimated to grow from $35.7 billion in 2015 to $48.4 billion by 2022. Brilacidin is being developed as a novel, non-corticosteroid, non-biologic treatment, with formulation plans including oral tablets for Ulcerative Colitis and Crohn’s Disease, and enema, foam and/or gel for mild-to-moderate Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of IBD. As released previously, a majority of patients treated with Brilacidin administered via retention enema achieved Clinical Remission (Modified Mayo scoring) in a Phase 2, open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin for UP/UPS. In addition, mucosal healing was evidenced by endoscopic review, an increasingly important measure toward establishing a drug’s efficacy. In late 2018, the Company presented a scientific poster—Brilacidin for Inflammatory Bowel Disease (available for download here, pdf)—at the inaugural “IBD Innovate 2018” conference, hosted by the Crohn’s & Colitis Foundation. Brilacidin may be particularly beneficial in treating IBD due to: 1) its ability to inhibit Phosphodiesterase 4 (PDE4), which is being pursued as a novel therapeutic avenue in IBD; and 2) its potential to compensate for defensin deficiencies that are implicated in the pathogenesis of IBD.
About Alfasigma Alfasigma is a privately-owned, Italy-based integrated multinational pharmaceutical company with 2018 revenues in excess of €1 billion, 5 manufacturing plants, R&D facilities, and 3,000 employees globally. Outside of its core Italian market, Alfasigma has 16 subsidiaries in Europe, Asia, North and Central America and Africa, and is present in more than 90 countries. More than 44% of Alfasigma turnover comes from internally developed proprietary products, one of which is XIFAXAN. More information is available at the Alfasigma website at: http://www.alfasigma.com/en
Translated... Alfasigma agrees with Innovation Pharmaceuticals for develop and market Brilacidin in the treatment of Ulcerative Proctitis and Ulcerative Proctosigmoiditis • Innovation Pharmaceuticals & Alfasigma announced an agreement for Brilacidin, in the treatment of Ulcerative Proctitis and Ulcerative Proctosigmoiditis • For Alfasigma it is the second agreement in a few weeks that strengthens pipeline and portfolio in the Gastrointestinal field • The agreement starts from a base of 24 million dollars Bologna, July 23, 2019 - Alfasigma Spa and Innovation Pharmaceuticals (OTCQB:IPIX), a biopharmaceutical company based in the United States, have entered into a licensing agreement for which Alfasigma will develop and market worldwide Brilacidin for use local, for the treatment of Ulcerative Proctitis and Ulcerative Proctosigmoiditis (PU / PSU). There Proctitis is an inflammatory disease of the rectum, which when extended also to sigma is called Proctosigmoidite. PU and PSU are therefore attributable to chronic intestinal inflammatory diseases (MICI, also known as IBD - Inflammatory Bowel Disease: together they represent one chronic and autoimmune condition difficult to treat affecting about 10 million people all over the world, including 200,000 people in Italy. Brilacidin will be developed as a new non-corticosteroid, non-biological treatment, administered by different formulations, Alfasigma will initially develop topical formulations such as enema, foams and / or gel for PU / PSU. A few weeks after the announcement for the commercial re-introduction of Zelnorm in the States - used for the treatment of irritable bowel syndrome constipation - this is a further step in strengthening the pipeline in the Gastro-intestinal area.
"Alfasigma is developing, at a global level, a specific focus in the Gastrointestinal field", stated Pier Vincenzo Colli, CEO of Alfasigma. "We are excited to add to the our portfolio, this partnership with Innovation Pharmaceuticals. The results of the study clinical on Phase 2 Brilacidin in PU / PSU seem promising and enhance properties unique of the drug. To advance Brilacidin, we plan to allocate an important one investment, both in terms of internal resources and expertise for formulations and protection of intellectual property. " "We are proud to be able to work to offer patients a new and effective option safe treatment in the management of PU / PSU ", continues Colli" We will also closely follow i next developments of Innovation Pharmaceuticals in the development of oral Brilacidin, why we are also interested in new treatments for mici. This agreement, along with that a few weeks ago on Zelnorm, represents a further enhancement of ours global pipeline ". The agreement also includes a right of first refusal for Brilacidin in the treatment of forms more extensive inflammatory bowel disease (IBD), such as ulcerative colitis and the Crohn's disease and a first negotiation right for Brilacidin in other gastrointestinal indications. In addition to an initial outlay, the agreement provides for a series of additional payments based on certain milestones, for a total of over $ 24 million and royalties of 6% on net sales in the marketing of Brilacidin for PU / PSU.
Information on Alfasigma. Alfasigma is one of the leading Italian pharmaceutical companies: present in over 90 countries, has a workforce of around 3,000 people, Research and Development laboratories, and 5 factories of production. In Italy Alfasigma is a leader in the market for prescription products where, in addition to the strong focus on Gastro-Intestinal, it is present in many primary care therapeutic areas. Produces and it also markets self-medication products, nutraceuticals and food supplements. For more information, visit www.alfasigma.com or send an e-mail to firstname.lastname@example.org.
Information on Innovation Pharmaceuticals Innovation Pharmaceuticals Inc. (IPIX) is a clinical biopharmaceutical company that develops a portfolio of world-class innovative therapies that address multiple users areas of unmet medical needs, including inflammatory diseases, cancer, infectious diseases and dermatological diseases. More information is available on the company website www.IPharmInc.com. Alfasigma Corporate Communications & Media Relations: Biagio Oppi email@example.com +39 3386352349 Innovation Pharmaceuticals Investor & Media Relations: Leo Ehrlich firstname.lastname@example.org
Locust walk TARGETING a deal for Brilacidin for Oral Mucosa.
Innovation Pharmaceuticals Further Engages Locust Walk to Lead Out-Licensing Negotiations for Rights to Phase 3-Ready Oral Mucositis Drug Candidate
GlobeNewswireJanuary 29, 2020
WAKEFIELD, Mass., Jan. 29, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals Inc. (IPIX) (â€śthe Companyâ€ť), a clinical stage biopharmaceutical company, has further engaged Locust Walk, a leading global life sciences transaction firm serving as its strategic advisor, to lead the Companyâ€™s out-licensing negotiations for rights to oral rinse Brilacidin for the treatment of Oral Mucositis (OM).
The Company had previously engaged Locust Walk to assess the value of its clinical assets, which included recently an in-depth assessment of the commercial opportunity of oral rinse Brilacidin-OMâ€”a Phase 3-ready, FDA Fast Track-designated clinical asset in late-stage development targeting a substantial untapped market in supportive cancer care.
This renewed engagement is a continuation of Innovation Pharmaceuticalâ€™s business relationship with Locust Walk toward realizing the market potential of the Companyâ€™s pipeline.
â€˘Objective to further unlock market potential of pipeline and determine the appropriate path forward to enhance shareholder value â€˘Locust Walk is a global life sciences transaction firm with exceptional strategic insights rooted in their deal experience
BEVERLY, Mass., Sept. 30, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (â€śthe Companyâ€ť), a clinical stage biopharmaceutical company, is pleased to inform shareholders that the Company has engaged Locust Walk, a leading global life sciences transaction firm. Locust Walk will seek to assist the Company in maximizing the value of its assets.
â€śIt is an exciting time at Innovation,â€ť commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. â€śOur pipeline is innovative, mature, and diversified, targeting therapeutic areas encompassing significant market opportunitiesâ€”namely, in Inflammatory Bowel Disease, Dermatology, Cancer, and Infectious Disease. With our first global licensing agreement executed in July with Italyâ€™s Alfasigma in Ulcerative Proctitis/Ulcerative Proctosigmoiditis, we continue to diligently work toward completing other transactions that would unlock additional shareholder value. As such, we are thrilled to engage Locust Walkâ€”with their proven track record and global footprint.â€ť
â€śWe are very selective in deciding which companies to work with,â€ť said Chris Ehrlich, Managing Director and Global Head of Biopharma at Locust Walk. â€śWe look forward to working with Innovation Pharmaceuticals to help them determine the market potential and the best path forward to create value.â€ť
There are no specific therapeutics approved by the FDA to treat people with Covid-19. A robust research effort is currently under way to develop a vaccine against Covid-19. Critical to moving the field forward, even in the context of an outbreak, is ensuring that investigational products are evaluated in scientifically and ethically sound studies. Below is a list of the various coronavirus drugs and approaches that biopharmaceutical companies across the world are developing that have the potential to become major coronavirus vaccines or antivirals for treating the contagious coronavirus infection.
Company Drug/ Vaccine Notes
Tonix Pharmaceuticals TNX-1800 The vaccine is a modified horsepox virus developed using Tonixâ€™s proprietary horsepox vaccine platform.
A defensin mimetic drug candidate, as a potential treatment for coronavirus. Brilacidin has shown antibacterial, anti-inflammatory and immunomodulatory properties in several clinical trials
Inovio Pharmaceuticals and Beijing Advaccine Biotechnology INO-4800
The company has started pre-clinical testing for clinical product manufacturing.
The vaccine development is supported by a $9m grant from the Coalition for Epidemic Preparedness Innovations (CEPI). Inovio aims to progress the vaccine through phase one human testing in the US to test safety and efficacy. A phase one clinical trial is planned to be conducted in parallel in China, by Beijing Advaccine.
Clover Biopharmaceuticals Recombinant subunit vaccine The company is developing the vaccine based on the trimeric S protein (S-Trimer) of the 2019-nCoV virus, which is responsible for binding with the host cell and causing a viral infection. Vaxart Coronavirus vaccine The company plans to develop vaccines based on the published genome of 2019-nCOV to be tested in pre-clinical models for mucosal and systemic immune responses.
Leronlimab (PRO 140) is a CCR5 antagonist.
The drug is already being investigated in phase two clinical trials as a treatment for HIV and has been awarded fast-track approval status by the FDA.
Applied DNA Sciences and Takis Biotech Linear DNA Vaccine The Joint Venture will use Polymerase Chain Reaction (PCR)-based DNA manufacturing technology to develop the vaccine. Bioxytran BXT-25 The Company announced that it is exploring partners to develop its lead drug candidate, BX-25, as a treatment for Acute Respiratory Distress Syndrome (ARDS) in late-stage patients infected with the coronavirus.
Novavax MERS coronavirus vaccine candidate
It is a crucial target for coronavirus vaccine development by the Coalition for Epidemic Preparedness Innovations (CEPI) and is a priority disease for WHO. The candidate is designed to primarily bind to the major surface S-protein and developed using the companyâ€™s recombinant nanoparticle vaccine technology. Tested along with the Novavaxâ€™s proprietary adjuvant Matrix-Mâ„˘, it inhibited infection by inducing immune responses in the laboratory studies.
The investigational DNA immunotherapy, INO-4700 (GLS-5300) is being developed with partner, GeneOne Life Science. It is delivered as vaccine intramuscularly, using the CellectraÂ®delivery device.
Remdesivir (GS-5734) An ebola drug developed by Gilead Sciences that was found to be ineffective is now being tested in phase III randomised clinical trial in partnership with China.
The trials are being performed on 761 patients in a randomised, placebo-controlled, double-blind study at multiple hospitals in Wuhan, the epicentre of the novel coronavirus outbreak. The results from the trials are expected to be available over the next few weeks.
Biocryst Pharma Galidesivir The antiviral drug Galidesivir (BCX4430) has shown broad-spectrum activity against a wide range of pathogens including coronavirus. It is a nucleoside RNA polymerase inhibitor that disrupts the process of viral replication.
The drug has already shown survival benefits in patients against deadly viruses such as Ebola, Zika, Marburg, and Yellow fever.
The combination of neutralizing monoclonal antibodies REGN3048 and REGN3051 is being studied against coronavirus infection in a first-in-human clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The safety and tolerability of the drug will be studied in 48 patients.
Both the antibodies bind to S-protein of MERS coronavirus. The intravenous administration of the drug in the mouse model of MERS resulted in the high-level neutralization of the MERS coronavirus in circulating blood with reduced viral loads in the lungs.
The Company announced that it has identified two monoclonal antibodies that can bind to the virus that causes Covid-19. The antibodies target the spike (S) protein of the virus by entering through the cellular receptor ACE2. The company has formed a partnership with WuXi Biologics on 25 February to commercialise the antibodies identified to treat coronavirus.
The company will utilis\ze its Ii-Key immune system activation technology to produce a Covid-19 peptide for human clinical trials. Moderna mRNA-1273 The first vials of the experimental vaccine have been shipped and will be used in a planned Phase 1 study in the United States.
Serum Institute of India Vaccine Serum Institute of India (SII) is collaborating with Codagenix, a US-based biopharmaceutical company, to develop a coronavirus cure using a vaccine strain similar to the original virus. The vaccine is currently in the pre-clinical testing phase, while human trials are expected to commence in the next six months. SII is expected to launch the vaccine in the market by early 2022.
Zydus Cadila Vaccine Zydus Cadila announced the launch of an accelerated research programme to develop a vaccine for Covid-19 using two novel approaches. The first approach includes the development of a DNA vaccine against the viral membrane protein of the virus, while a live attenuated recombinant measles virus (rMV) vectored vaccine will be developed in the second approach. The rMV-based vaccine works by inducing specific neutralising antibodies, which will provide protection from the coronavirus infection.
NanoViricides NanoViricides, a clinical-stage company, is working on developing a treatment for nCoV-2019 using its nanoviricideÂ® technology. The companyâ€™s technology is used to develop ligands that can bind to the virus in the same way as a cognate receptor and attack various points of the virus.
ImmunoPrecise Antibodies has launched a vaccine and therapeutic antibody program to develop a vaccine as well as antibodies against Covid-19. The company will use its B Cell Selectâ„˘ and DeepDisplayâ„˘ discovery platforms to therapeutic compounds against the coronavirus.
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Type: Defensin mimetic in Phase II development in oral muscositis in Head and Neck Cancer patients
Status: Innovation said March 10 that tests of Brilacidin as a potential COVID-19 treatment were to start the week of March 16 at an undisclosed U.S. Regional Biocontainment Lab. The company said Brilacidin was a compelling candidate due to its unique qualities to mimic the human innate immune system and a mechanism of action that includes disruption of the membrane of pathogens, leading to cell death.
On February 24 Innovation said that it submitted a Material Transfer Agreement with an unidentified “leading U.S.-based virology laboratory” to study Brilacidin for SARS-CoV-2. If lab tests prove successful, Innovation said, it will expedite research and clinical development of Brilacidin “via pharmaceutical partnerships, academic collaborations and government grants.” Innovation has also submitted a preliminary summary of Brilacidin’s potential for treating coronavirus to the Biomedical Advanced Research and Development Authority (BARDA).
Innovation Pharmaceuticals Receives Data Supporting Brilacidinâ€™s Direct Inhibition of SARS-CoV-2, the Novel Coronavirus Responsible for COVID-19
WAKEFIELD, MA â€“ April 1, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (â€śthe Companyâ€ť), a clinical stage biopharmaceutical company, announced today it has received data supporting Brilacidinâ€™s direct inhibition of SARS-CoV-2, the novel coronavirus responsible for COVID-19. The testing of Brilacidin was conducted by researchers at one of the U.S. Regional Biocontainment Laboratories (RBLs). Few compounds have shown activity against SARS-CoV-2, as summarized in the article linked below.
Â· Andersen P, et al. â€śDiscovery and Development of Safe-in-Man Broad-Spectrum Antiviral Agents.â€ť Int J Infect Dis. 2020 Feb 17;93:268-276. doi: 10.1016/j.ijid.2020.02.018.
VERO cells, a monkey kidney cell line commonly used to screen small molecule inhibitors of viruses, were used to test whether Brilacidin inhibits SARS-CoV-2. Cells were pretreated with Brilacidin at increasing concentrations (at 2 ÂµM and at 10 ÂµM) for two hours prior to the infection. Cells treated with the vehicle alone (Dimethyl sulfoxide or DMSO) were maintained alongside, as controls. At 16 hours post-infection (16hpi), researchers observed a dose-dependent reduction in the SARS-CoV-2 infectious viral titers from the Brilacidin treated cells as compared to the vehicle-alone control, as shown below. (The higher number of asterisks denote higher statistical significance compared to control.)
The Company is reviewing data received yesterday and anticipates more data will be forthcoming. Following discussions with researchers at the RBL, the Company will provide additional information and insight into possible joint research plans going forward. It is managementâ€™s understanding that few compounds advance to this next stage of SARS-CoV-2 research.
In a broader context, demonstration of Brilacidinâ€™s direct antiviral activity against the SARS-CoV-2 virus supports the drugâ€™s unique 3-in-1 therapeutic potentialâ€”antiviral, anti-inflammatory, antimicrobialâ€”to treat COVID-19 and its associated complications. Additional data, based on successfully completed Phase 2 clinical studies in other clinical indications, using various modes of administration, show Brilacidinâ€™s ability to inhibit interleukin-6 (IL-6) and other pro-inflammatory cytokines and chemokines, identified as central drivers in the worsening prognoses of COVID-19 patients. Brilacidinâ€™s robust antimicrobial properties might also help fight secondary bacterial infections, which can co-present in patients with COVID-19.