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 firstname.lastname@example.org
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.