Medical Discoveries Inc. Announces Receipt of Cystic Fibrosis Pre-Clinical Report on MDI-P
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Continuing Pre-IND Research Documents MDI-P Low Toxicity Profile TWIN FALLS, Idaho, May 20 /PRNewswire-FirstCall/ -- Medical Discoveries, Inc. (OTC Bulletin Board: MLSC) announced the receipt of its third in a series of pre-clinical research reports from Dr. Emil Chi, Chairman of the Department of Histopathology at the University of Washington Medical School. This trial, one of several studies on models of disease which mimic human disease, focused on the company's proprietary drug MDI-P as a potential therapeutic agent for the treatment of the symptoms of cystic fibrosis ("CF"). Results from this study showed that, 48 hours after treatment, MDI-P- treated CF-like mice lungs evidenced: a) a 60% reduction in mucus secretion; b) a 49% reduction in white blood cellular infiltration; and c) a 42% reduction in lung edema, as contrasted with untreated CF-like mice. In MDI-P- treated mice, the associated level of lung hemorrhage was reduced by 39%, the level of neutrophil lung infiltration was reduced by 49%, and eosinophil lung infiltration was reduced by 86%, as contrasted with untreated CF-like mice. The 100% MDI-P solution provided a 100% host-sparing effect against this fatal CF-like condition. No overt signs of toxicity were found in the primary organs (lungs, liver, spleen, kidneys, brain) of mice treated with MDI-P. This study and the other pre-clinical studies of MDI-P are required for filing an Investigational New Drug (IND) application later this year with the FDA for the primary target use for MDI-P, which is treating humans with HIV. There is not an animal test relevant to HIV/AIDS in humans, so MDI is required to sponsor testing of MDI-P on other standard animal/mimicking human models, such as the recently-reported asthma results, in order to determine if there is any potentially significant toxicity to humans related to usage of MDI-P. MDI's President and Chief Executive Officer, Judy Robinett, commented: "Because CF is an invariably fatal disease with no curative therapies currently available, MDI-P may prove to be a very beneficial agent exhibiting minimal toxicity for addressing the continuing lung function degeneration with CF patients. This study sets the stage for possible later expansion of MDI-P into additional indications, potentially including CF. When completed, our other pre-clinical reports and our CMC/CGMP data will allow us to file an IND with the FDA for our initial target indication, HIV, and enter clinical trials sometime late in 2004 or early in 2005." TEST OVERVIEW Infection with Pseudomonas aeruginosa, a common bacterium, plays a major role in the pulmonary inflammation and injury associated with cystic fibrosis. Lung inflammation may also lead to more widespread systemic effects on other organs, including the pancreas. CF affects approximately 1 in 2,500 live births and qualifies as an "orphan" indication with the FDA, with some 30,000 new cases reported annually in the U.S. and an estimated 900,000 patients surviving up to age 30. In this study of 48 mice, it was found that MDI-P (100% solution strength) is a useful agent to reduce primary measures of disease in CF, including bacterial infection, mucus secretion, cellular infiltration, lung edema (swelling with excess fluid), lung hemorrhage, and lung infiltration by neutrophils and eosinophils, the principal white blood cells responding to allergic and infectious pathogens. Excessive presence of neutrophils and eosinophils can lead to cell death in surrounding tissues, causing serious health problems from their over-expression. These findings were established in a new mucus overproduction mouse model designed to more closely mimic the CF disease condition found in humans. This mouse model starts with OVA-induced, chronic asthmatic mice, which are then infected intranasally with P. aeruginosa to establish a lung disease state comparable with CF patients. Almost all CF patients evidence P. aeruginosa colonization at some time during the disease process, associated with progressive deterioration of lung function in CF. With mice mimicking human asthma in this model, the airway is filled with mucus occlusion and the airway becomes infected following inoculation with P. aeruginosa. The data provided evidence that MDI-P inhibits P. aeruginosa growth and colonization in this mouse model with airway mucus hypersecretion. Formed in 1991, Medical Discoveries, Inc. is a publicly traded (OTC Bulletin Board as MLSC) development-stage biopharmaceutical research company engaged in the research, development and validation of its patented anti-infective technology. MDI's electrolyzed solution of free radicals represents a novel approach to treating its initial target indication, HIV. Information in this press release relating to the potential of MDI constitutes forward-looking statements. Actual results in future periods may differ materially from the forward-looking statements because of a number of risks and uncertainties set forth in MDI's 2003 Annual Report on Form 10-KSB and other filings with the Securities and Exchange Commission. SOURCE Medical Discoveries, Inc. -0- 05/20/2004 /CONTACT: Medical Discoveries, Inc., +1-208-736-1799/ (MLSC) CO: Medical Discoveries, Inc.; University of Washington Medical School ST: Idaho, Washington IN: MTC OTC SU: SVY
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Medical Discoveries, Inc. Files Patent Application on Asthma
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Positive Preclinical Testing Results Prompt Action TWIN FALLS, Idaho, April 28 /PRNewswire-FirstCall/ -- Medical Discoveries, Inc. (OTC Bulletin Board: MLSC) announced today that it has filed a provisional patent application on asthma for MDI-P, its proprietary drug. The patent application was filed by Mayer, Brown, Rowe & Maw, patent counsel for MDI. A recent pre-clinical research report from Dr. Emil Chi, Chairman of the Department of Histopathology at the University of Washington Medical School, focused on MDI-P as a potential therapeutic agent for the treatment of the symptoms of asthma. In a press release on April 22, 2004 describing the positive test results, Medical Discoveries Inc. speculated that MDI-P may prove to be a very beneficial agent exhibiting minimal toxicity for addressing asthma attacks. Despite the promising research, in order to be qualified as an asthma therapeutic agent, MDI-P would be additionally required to undergo another complete clinical development, through satisfactory Phase III clinical studies; a process which may take many years and require substantial investment. The current pre-clinical studies of MDI-P are required for filing MDI's Investigational New Drug (IND) application later this year with the FDA for the primary target use for MDI-P, which is treating humans with HIV. There is not an animal test relevant to HIV/AIDS in humans, so MDI-P is being tested on other standard animal/mimicking human models in order to determine if there is any potentially significant toxicity to humans related to usage of MDI-P. Formed in 1991, Medical Discoveries, Inc. is a publicly traded (OTC Bulletin Board: MLSC) development-stage biopharmaceutical research company (as defined in SFAS No.7) engaged in the research, development and validation of its patented anti-infective technology. MDI's electrolyzed solution of free radicals represents a novel approach to treating its initial target indication, HIV. Information in this press release relating to the potential of MDI constitutes forward-looking statements. Actual results in future periods may differ materially from the forward-looking statements because of a number of risks and uncertainties. Additional information about these and other factors that could affect MDI's business is set forth in MDI's 2003 Annual Report on Form 10-KSB and other filings with the Securities and Exchange Commission. SOURCE Medical Discoveries, Inc. -0- 04/28/2004 /CONTACT: Medical Discoveries, Inc., +1-208-736-1799 / (MLSC) CO: Medical Discoveries, Inc. ST: Idaho IN: MTC HEA OTC SU: PDT
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Medical Discoveries Inc. Announces Receipt of Asthma Pre-Clinical Report on MDI-P
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Continuing Research Documents MDI-P Low Toxicity Profile TWIN FALLS, Idaho, April 22 /PRNewswire-FirstCall/ -- Medical Discoveries, Inc. (OTC Bulletin Board: MLSC) MDI announced the receipt of its second in a series of pre-clinical reports from Dr. Emil Chi, Chairman of the Department of Histopathology at the University of Washington Medical School. This trial, one of several studies on models of disease which mimic human disease, focused on MDI-P as a potential therapeutic agent for the treatment of the symptoms of asthma. More than 28-million Americans suffer from asthma, a major medical problem requiring medication to open blocked airways and relieve mucus build-up in both acute and chronic asthma attacks. In the late 1990's, Dr. Chi developed a now-standard mouse model to assess asthma therapeutic agents for efficacy and toxicity. This model is believed to have at least an 80% predictive value of results in humans. In the study, 36 female mice were examined in a chronic asthma model, using various doses of MDI-P as a therapeutic agent as measured against saline control. Samples of bronchial lavage lung fluid and tissue were taken from all mice, with assays performed in airway mucus build-up and eosinophil infiltration, a prime blood cell measure of asthmatic attacks. More than 70% of the MDI-P treated mice exhibited no increase in mucus secretions, comparable with saline control animals, with a marked reduction in eosinophil infiltration. Untreated asthmatic mice, in contrast, had more than a nine-fold increase in mucus build-up as compared with saline controls. Further, no toxicity was found in the MDI-P treated mice. MDI's President and Chief Executive Officer, Judy Robinett, commented: "To the best of our knowledge of other published studies in clearing mucus plugs in the same mouse model, there is no product on the market or soon to be released from pharmaceutical pipelines which accomplishes a similar clearing of mucus plugs in the majority of treated chronic asthmatic mice. From this test, we speculate that MDI-P may prove to be a very beneficial agent exhibiting minimal toxicity for addressing asthma attacks." Robinett continued: "This study and the other pre-clinical studies of MDI-P are required for filing our Investigational New Drug (IND) application later this year with the FDA for our primary target use for MDI-P, which is treating humans with HIV. These studies test MDI-P on animal models of diseases which mimic those of humans. There is not an animal test relevant to HIV/AIDS in humans, so we are testing MDI-P on other standard animal/mimicking human models, such as our recently-reported sepsis results, in order to determine if there is any potentially significant toxicity to humans related to usage of MDI-P. This report, in addition to other preclinical reports and our CMC/CGMP data, will allow us to file an IND with the FDA for our initial target indication, HIV, and enter clinical trials sometime late in 2004 or early in 2005, continuing the path to commercialization." Formed in 1991, Medical Discoveries, Inc. is a publicly traded (OTC Bulletin Board: MLSC) development-stage biopharmaceutical research company (as defined in SFAS No.7) engaged in the research, development and validation of its patented anti-infective technology. MDI's electrolyzed solution of free radicals represents a novel approach to treating its initial target indication, HIV. Information in this press release relating to the potential of MDI constitutes forward-looking statements. Actual results in future periods may differ materially from the forward-looking statements because of a number of risks and uncertainties set forth in MDI's 2003 Annual Report on Form 10-KSB and other filings with the Securities and Exchange Commission. SOURCE Medical Discoveries, Inc. -0- 04/22/2004 /CONTACT: Medical Discoveries, Inc., +1-208-736-1799/ (MLSC) CO: Medical Discoveries, Inc. ST: Idaho IN: HEA MTC BIO OTC SU: PDT
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Medical Discoveries, Inc. Files Patent Application on Sepsis
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MDI Also Signs CMC Contract with Goodwin Laboratories TWIN FALLS, Idaho, April 14 /PRNewswire-FirstCall/ -- Medical Discoveries, Inc. (OTC Bulletin Board: MLSC) announced today that it has filed a provisional patent application on sepsis for MDI-P, its proprietary drug, as of March 17, 2004. The patent application was filed by Mayer, Brown, Rowe & Maw, patent counsel for MDI. Sepsis is a systemic inflammatory response to infection frequently caused by bacteremia, a condition wherein viable bacteria enter the bloodstream. The threat of cross-infection in hospital admissions is high (estimated at up to 30% of admissions), with the more serious cases leading to bacteremia and potentially sepsis. Consequently, where surgeries are proscribed, sepsis is a continuing threat to the more than 40 million surgery cases that occur in the United States each year. The US reports more than 200,000 sepsis deaths annually. In current preclinical trials, MDI-P is being evaluated for use as a surgical prophylactic or therapeutic agent for sepsis, as part of required research for an IND application for MDI's primary target, HIV/AIDS. If a safe, non-toxic therapeutic agent were available, a high percentage of the more than 40 million annual surgery cases (US, 2001 data) would likely receive such a therapeutic capable of preventing sepsis as a standard prophylactic procedure. However, in order to be qualified as a sepsis therapeutic agent, MDI-P would be additionally required to undergo another complete clinical development, through satisfactory Phase III clinical studies; a process which may take many years and require substantial investment. In another development related to the coming IND application, Medical Discoveries also announced the signing of a contract with Goodwin Biotechnology Inc., of Plantation, Florida, for the determination of complete Chemistry, Manufacturing and Control (CMC) documentation on MDI's proprietary electrolysis device, as well as the resultant MDI-P solution. At the end of this project, expected to take several months, MDI should have Current Good Manufacturing Practices (cGMP) qualification for the device and the solution, both of which are required prior to launching clinical studies on humans. The Goodwin work will become an important part of MDI's Investigational New Drug Application for conduct of Phase I clinical studies in HIV at Harvard Medical School. Formed in 1991, Medical Discoveries, Inc. is a publicly traded (OTC Bulletin Board: MLSC) development-stage biopharmaceutical research company (as defined in SFAS No.7) engaged in the research, development and validation of its patented anti-infective technology. MDI's electrolyzed solution of free radicals represents a novel approach to treating its initial target indication, HIV. Information in this press release relating to the potential of MDI constitutes forward-looking statements. Actual results in future periods may differ materially from the forward-looking statements because of a number of risks and uncertainties. Additional information about these and other factors that could affect MDI's business is set forth in MDI's 2003 Annual Report on Form 10-KSB and other filings with the Securities and Exchange Commission. SOURCE Medical Discoveries, Inc. -0- 04/14/2004 /CONTACT: Medical Discoveries, Inc., +1-208-736-1799/ /Web site: www.mdi-p.com / (MLSC) CO: Medical Discoveries, Inc. ST: Idaho IN: MTC HEA BIO OTC SU: PDT CON
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posted
Dog, This is great news! One of my sons has CF and everytime I see breaking news about a new treatment or drug I get very excited. I will be getting into this right away!
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MLSC - MEDICAL DISCOVER (OTCBB) Date Open High Low Last Change Volume % Change 05/20/04 0.1700 0.1700 0.1550 0.1700 unch 96400 unch%
Composite Indicator Trend Spotter (TM) Buy
Short Term Indicators 7 Day Average Directional Indicator Buy 10 - 8 Day Moving Average Hilo Channel Buy 20 Day Moving Average vs Price Buy 20 - 50 Day MACD Oscillator Buy 20 Day Bollinger Bands Hold
Short Term Indicators Average: 80% - Buy 20-Day Average Volume - 50860
Medium Term Indicators 40 Day Commodity Channel Index Buy 50 Day Moving Average vs Price Buy 20 - 100 Day MACD Oscillator Buy 50 Day Parabolic Time/Price Buy
Medium Term Indicators Average: 100% - Buy 50-Day Average Volume - 43596
Long Term Indicators 60 Day Commodity Channel Index Buy 100 Day Moving Average vs Price Buy 50 - 100 Day MACD Oscillator Buy
Long Term Indicators Average: 100% - Buy 100-Day Average Volume - 58567
Overall Average: 96% - Buy
Price Support Pivot Point Resistance
0.17 0.17 0.17 0.17
JUST NEEDS TO GET OVER THE HUMP..........
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I will be a little passionate about this one beacause I am so close to the complications of Cystic Fibrosis. Just some info about the current daily routine and Drugs that my son uses.
Pulmozime ---- $1500.00 per month Advair $100.00 per month zithromax $200.00 per month Albuterol $100.00 Per month
And misc. others which depend on how his condition is from month to month.
On average his prescription are just over 2100.00 pre month. [ Thank the Lord for Insurance]
Some of these drugs are used in many Pulmonary instances, however the drugs that are specific to CF are extremely costly as you can see with Pulmozime [ above ] .
The principal reason for forming Medical Discoveries, Inc. in 1992 was to begin the investigation and development of an effective, rapid-acting, and safe pharmaceutical capable of destroying the HIV virus. In 1994, the Company received the first of a family of patents covering both the novel drug and the device from which it is produced, based upon MDI's proprietary electrolysis technology. This drug bears the code name MDI-P.
MDI-P is a solution-based drug, produced by the electrolysis of saline using a patented instrument with proprietary electrodes. This solution has a significant oxidation reduction potential due to a mixture of oxidative products resulting from electrolysis.
Medical Discoveries, Inc. holds eight (U.S.) patents on its core technologies, covering the proprietary electrolysis equipment, applications of this technology, and the solutions produced from it. The Company has filed foreign patent applications corresponding to the granted United States patents. MDI's intellectual property spans more than a decade of research and development.
Patent Number Description 5,334,383 "Electrically Hydrolyzed Salines As In Vivo Microbicides For Treatment Of Cardiomyopathy And Multiple Sclerosis." [1994] 5,507,932 "Apparatus For Electrolyzing Fluids" [1996] 5,560,816 "Method For Electrolyzing Fluids" [1996] 5,622,848 "Electrically Hydrolyzed Saline Solutions As Microbicides For In Vitro Treatment Of Contaminated Fluids Containing Blood" [1997] 5,674,537 "An Electrolyzed Saline Solution Containing Concentrated Amounts Of Ozone And Chlorine Species" [1997] 5,731,008 "Electrically Hydrolyzed Salines As Microbicides" [1998] 6,007,686 "System For Electrolyzing Fluids For Use As Antimicrobial Agents" [1999] 6,117,285 "System For Carrying Out Sterilization Of Equipment" [2000]
MDI has developed a compound, MDI-P, which appears to have the ability to destroy certain viruses and bacteria, including the HIV virus. MDI-P may also have the ability to kill other infectious agents, possibly including pathogenic fungi. MDI-P may have an application as a sterilizing agent for medical and dental instruments. Additionally, MDI-P may potentially be used to remove or inactivate infectious agents in human and animal blood-derived products such as plasma and gamma globulin.
Based on preliminary research, MDI-P appears to have several important characteristics and benefits to both medical service providers and patients:
MDI-P is very rapid in effect and destroys bacteria, fungi and viruses without destroying human cells.
MDI-P does not appear to produce any endotoxins with potentially harmful effects.
MDI-P appears to be stable, with a shelf life adequate to permit administration to patients.
MDI-P appears to be safe for patients, hospital staff and the environment.
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We've got MUCH needed sources of funding. Check it out...the studies are being conducted at HARVARD and University of Washington Med School! Looks promising.
MEDICAL DISCOVERIES, INC. COMPLETES PRIVATE PLACEMENT Funding Drives Preclinical Research, Pre-IND Tasks
Twin Falls, Idaho, January 21, 2004 - Medical Discoveries, Inc. (OTC BB as MLSC) Medical Discoveries, Inc. (OTC-BB as MLSC) announced today that it has closed a private placement of restricted common stock with gross proceeds to the company of $1.1 million.
The funds will be used primarily to complete the needed preclinical work (in-vivo animal models of infectious diseases) and Chemistry, Manufacturing and Control (CMC) work to support the filing of the Company’s investigational new drug application (IND) for its proprietary therapeutic product, MDI-P, in late 2004. The IND filing and approval will be necessary to initiate Phase I clinical trials in HIV at Harvard Medical School.
The Company has several preclinical studies underway at the University of Washington Medical School, to contribute needed data to the IND. Similarly, a separate CMC/cGMP study for the manufacture of MDI-P will commence shortly at both the Goodwin Biotechnology Laboratories and Charles River Laboratories. Prior to initiating human clinical studies, the US FDA requires the applicant to demonstrate that the therapeutic product under investigation was manufactured in compliance with the FDA’s Chemistry, Manufacturing and Control (CMC) guidelines, including use of current Good Manufacturing Practices (cGMP).
MDI’s President & CEO, Judy Robinett, commented:, “This financing is instrumental in our efforts to deliver on our promise of developing MDI’s patented technology for therapeutic applications. With this funding, we should have the resources necessary to complete preclinical trials. By completing these trials, we hope to successfully move the product further toward commercial approval and continue to drive the intrinsic value of the business.”
The securities issued in MDI’s private placement have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold without a registration statement or exemption from registration. MDI did not grant any registration rights or other rights to the purchasers. Therefore, the restricted common stock may not be sold unless the provisions of Rule 144 are satisfied (including a minimum one-year resale restriction). http://medicaldiscoveries.com/newsandmedia.php
posted
Interesting information regarding their breakthrough drug, MDI-P.
During recent years, the Company has conducted in-vitro (laboratory) testing at a number of university and medical research institutions. Additionally, several human clinical trials have been performed "off-shore," in Mexico and The Cayman Islands. This independent research has demonstrated that MDI-P is effective in destroying the HIV virus. Furthermore, the destruction of the HIV virus by MDI-P does not require any additional combination of drugs. This represents a significant clinical and economic advance, when compared to currently available anti-retroviral drugs.
Research has also shown that MDI-P is a potent antibacterial and anti-fungal agent. Data and results published in June, 2000, in The American Journal of Infection Control by Aldonna Baltch, M.D., of the Stratton V.A. Medical Center and Albany Medical College, Albany, NY, indicate that MDI-P was effective in destroying the fungus Candida albicans and Legionella pneumophillia (Legionaire's Disease) within 60 seconds of exposure, with no evidence of cell toxicity.
All of these tests have demonstrated that MDI-P has broad spectrum anti-viral, anti-fungal and antibacterial characteristics. This means that, in addition to the HIV application, MDI-P possesses clinically significant capabilities in destroying bacteria and fungi.
Medical Discoveries, Inc. is currently engaged in raising capital to fund initial testing and to commence the FDA approval process required to commercialize MDI-P for worldwide treatment of HIV/AIDS, as well as other applications. The company is also studying possible partnering opportunities to develop products aimed at the broad sterilization and purification marketplaces. http://medicaldiscoveries.com/investors.php
You think this thing will spike when they get approval from FDA to begin testing?
Holder Shares Reported HARVEST GROUP L.L.C. 17,116,437 14-Oct-02 WALKER, DAVID R. 403,539 28-Oct-03 DRAKE, STEPHEN R. 33,250 1-Apr-04 HOWARD, RUSTIN R. 100 14-Oct-02
posted
They have done an excellent job resrtucturing their organozation. I will cal them on Friday to discuss the details of their FDA approvals and Timeline for MDI-P. This looks very good!
MEDICAL DISCOVERIES, INC. ANNOUNCES GOALS FOR 2004 Completion Of Preclinical Research, IND Top MDI List
Twin Falls, Idaho, January 14, 2004 - Medical Discoveries, Inc. (OTC BB as MLSC) Medical Discoveries, Inc. (OTC-BB as MLSC) has presented shareholders with management’s milestone goals for the company during 2004. The following information has been published on the company’s website at: www.medicaldiscoveries.com
Your management team believes 2004 will be a pivotal year in our efforts to restart our company, erase ten years of mismanagement and waste, and drive shareholder value. We are confident that we now stand ready to implement that which we have been planning and funding since we joined MDI three years ago and began the restructuring process.
MDI’s promise of novel therapeutic technology for anti-infective applications is much closer now to realization than it was three years ago. Medical Discoveries, Inc. is an early stage biopharmaceutical development company, focused on the advancement of its patented anti-infective technology. MDI’s electrolyzed solution of free radicals represents a novel approach to treating its initial target indication, HIV. MDI plans in the near future to conclude its pre-clinical work and enter the clinic in its initial target indication, and develop this therapy for additional target indications.
Our current team has made progress to date in its efforts to establish a viable therapeutic development program for MDI. We have determined the 2004 milestones with which we will continue pre-qualification for regulatory approvals and drive shareholder value. However, we would first like to begin by giving you a brief overview of our recent past and then move to the strategy for this year and beyond.
Overview of Progress
When we joined MDI in July of 2000, the company was in poor shape; there were no revenues, it was poorly capitalized, it had a failed testing program, and an unmanageable debt overhang. MDI had not filed timely SEC reports for several years and the company had been de-listed from the OTC Bulletin Board and sent to the Pink Sheets. The company had lost momentum by not following up on the expensive testing and research it had performed during the 1990’s, and had lost focus, diverting resources to non-core activities unrelated to the focus of developing anti-infective applications. Several basic patents had been allowed to lapse and there was no apparent business strategy in operation. In short, the company had stalled, and appeared to be “dead in the water”.
Judy Robinett, the current CEO, was brought into this situation and asked to restructure, turnaround or restart MDI. She began by creating a small cadre of dedicated consultants for executive management tasks. Judy focused on clinical research, capital formation, financial reporting, legal compliance, and intellectual property development. Additionally, counsel has been retained for marketing and licensing functions as well as legal, patent strategy, audit and controls, and capital markets interaction. Our legal counsel is Stoel Rives, our patent counsel is Mayer Brown Rowe & Maw, our investment banker is CK Cooper and our audit firm is Balukoff, Lindstrom & Co. This dedicated team has remained with MDI and additional resources have been added. During this time of redirection and reconstruction, Judy has deferred most of her compensation, as have several of the consultants and certain of our counsel, until appropriate full-time employment salaries and fees can be paid.
In the more than three years since we came on board, these efforts have largely been successful. We have shut down a failed joint venture, retired a significant portion of the debt, inventoried and characterized the company’s past sponsored research and testing activities, developed a strategy for reaching clinical development of our therapy in our initial target indication, and recovered and secured MDI’s intellectual property portfolio. MDI has resumed regular SEC reporting, recovered its OTC status and is now a fully compliant public corporation. Since 2000, a great deal of executive management’s time has been spent in raising the funds to pay for these accomplishments.
2004 As a Year of Growth For MDI
As 2004 unfolds, we are now well-positioned and have sufficient capitalization to accomplish several important milestones, from both an administrative and development perspective:
Administrative Development Eliminate an additional portion of the current debt overhang – Q1 ‘04 Complete a $1m private placement –Q1 ‘04 Establish a patent strategy for additional new intellectual property – Q1 ‘04 Complete 5 year strategic plan – Q2 ‘04 Complete MDI-P pre-clinical research – Q3 ‘04 Complete MDI-P CMC/CGMP data – Q3 ‘04 Choose additional target indications – Q3 ‘04 File an IND for MDI-P in HIV – Q4 ‘04
As each milestone is achieved, we will issue a press release to help our shareholders continue to track the progress we are making toward testing completion, regulatory approvals and ultimate product sales and profitability.
Therapeutic Product Development Is Risky and Expensive
New therapeutic product development is lengthy, risky, and expensive, as many of our long time shareholders can attest. It is estimated that it currently takes on average 12.5 years for a therapy to be developed from target identification to commercialization. Of 5,000 compounds that enter preclinical development, only 5 may eventually enter human clinical trials and only one may reach the market. The estimated cost associated with developing each commercialized therapy has been estimated at an average of $600 million and may be closer to $800 million, including product failures. The chart below demonstrates typical time required to develop a therapeutic product.
(click on chart above for a larger view)
A majority of therapeutics fails because of toxicity issues. We believe, and hope to prove in clinical research, that our MDI-P product has a higher likelihood of getting to market as a result of the early indication of a low toxicity profile evidenced in pre-clinical development.
In Conclusion
To summarize, we have made significant progress in cleaning up the situation we encountered in 2000. We are poised to accomplish the milestones we have outlined above for 2004. We are confident that Medical Discoveries, Inc. is now well positioned to realistically work toward the promise made in 1991 by a visionary doctor and a group of dedicated supporters: to develop a company that provides novel therapies and focuses on shareholder value – a combination that will take MDI from pre-clinical development, through human testing, to regulatory filing and acceptance and into the fight against infectious disease, to the benefit of humanity.
Formed in 1991, Medical Discoveries, Inc. is a publicly traded (OTC Bulletin Board: MLSC) development-stage biopharmaceutical research company (as defined in SFAS No.7) engaged in the research, development and validation of a new class of drugs, based upon the company's patented and proprietary electrolysis technologies. MDI is developing active anti-viral (HIV/AIDS), anti-bacterial and anti-fungal agents for a variety of applications.
Information in this press release relating to the potential of MDI constitutes forward- looking statements. Actual results in future periods may differ materially from the forward-looking statements because of a number of risks and uncertainties, including but not limited to: MDI's lack of significant operating revenue and lack of profit to date; MDI's need for substantial and immediate additional capital; the fact that MDI may dilute existing shareholders through additional stock issuances; the extensive governmental regulation to which MDI is subject; the fact that MDI's technologies remain unproven; the intense competition MDI faces from other companies and other products; and MDI's reliance upon patents and other intellectual property that may not provide meaningful protection against competitors. Additional information about these and other factors that could affect MDI's business is set forth in MDI's 2002 Annual Report on Form 10-KSB and other filings with the Securities and Exchange Commission.
Press inquiries, please contact: Medical Discoveries, Inc. : 208-736-1799
Top | Home | Products and Technology | News and Media | Investor Relations About Medical Discoveries Inc. | Contact Medical Discoveries Inc. | Site Map
posted
Nice...looks they are on target with that schedule too. Some pre-clinical results released today (mid-2nd quarter), when the pre-clinical was expected to end during 3rd Quarter. Obviously the pre-clinical studies aren't over yet, but this looks very promising. Thanks for calling them needtoretire!
P.S. As a pre-med student at Emory University, home to one of the best Cystic Fibrosis research centers, I can assure you that there is a lot of progress being made.
quote:Originally posted by Smctbone: Nice...looks they are on target with that schedule too. Some pre-clinical results released today (mid-2nd quarter), when the pre-clinical was expected to end during 3rd Quarter. Obviously the pre-clinical studies aren't over yet, but this looks very promising. Thanks for calling them needtoretire!
P.S. As a pre-med student at Emory University, home to one of the best Cystic Fibrosis research centers, I can assure you that there is a lot of progress being made.
You and your son will be in my prayers.
You don't know how much that means to me and my Wife to be in the company of people who will take the time to pray for our son!!
WE live in Grand rapids MI , which has an excellent CF clinic at the DEVOS CHILDRENS HOSPITAL. I will bring this information to our next visit and ask the Doctor about this also. Good luck on your investing ,and keep an eye on this board as I will post what I discover from my call.
Thank you very much and GOD bless !!
[This message has been edited by needtoretire (edited May 21, 2004).]
Ridgeland, MS, MAY 21, 2004 (EventX/Knobias.com via COMTEX) -- The Annual Meeting of Shareholders of Medical Discoveries, Inc. (MLSC) to be held at the Little America Hotel, 500 S. Main Street, Salt Lake City, Utah, on Friday, May 21, 2004, at 1:00 p.m., for the following purposes:
1. To elect three directors of the Company.
2. To ratify the selection of Balukoff Lindstrom & Co., P.A. as independent accountants to audit the financial statements of the Company for the year ending December 31, 2004.
3. To consider a proposal to amend and restate the Articles of Incorporation of the Company to increase the authorized shares of common stock of the Company from 100 million to 250 million and to authorize 50 million shares of undesignated preferred stock of the Company to be designated in the future by the Board of Directors without further action by the shareholders.
4. To approve the Company's 2002 Stock Incentive Plan.
5. To transact such other business as may properly come before the Meeting.
Shareholders of record at the close of business on April 12, 2004 are entitled to notice of and to vote at the Meeting and at any and all adjournments of the Meeting.
Misc Releated Info:
** Original Confirmation
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TWIN FALLS, Idaho, May 26 /PRNewswire-FirstCall/ -- Medical Discoveries, Inc. (OTC Bulletin Board: MLSC) announced the filing of its patent application for MDI-P in treating cystic fibrosis ("CF"). The filing, made by Mayer, Brown, Rowe & Maw, was based upon a recently completed mouse model study mimicking cystic fibrosis, one of several studies on models of diseases that mimic human disease. This study evidenced a 100% host-sparing effect under CF-like conditions in chronic asthmatic mice inoculated with fatal doses of Pseudomonas aeruginosa, a bacterium frequently found to lead to reduced lung function in CF patients. The mouse model focused on MDI-P as a potential therapeutic agent for the treatment of the symptoms of cystic fibrosis ("CF"). MDI filed its patent application not only on MDI-P as a potential therapeutic agent for CF, but also on the use of the mouse model developed by MDI to mimic the disease. Infection with Pseudomonas aeruginosa, a common bacterium, plays a major role in the pulmonary inflammation and injury associated with cystic fibrosis. Lung inflammation may also lead to more widespread systemic effects on other organs, including the pancreas. CF is most frequently autosomal recessive (ie, linked to a non-sex (X/Y) recessive chromosome) discovered in the white population, affecting approximately 1 in 2,500 live births. CF would currently therefore qualify as an orphan indication with the FDA, with some 30,000 new cases reported annually in the U.S. and an estimated 900,000 patients surviving up to age 30. This would make CF an attractive future indication for clinical development by MDI, following suitable progress in the Company's HIV clinical trials. MDI's President and Chief Executive Officer, Judy Robinett, commented: "Because CF is an invariably fatal disease with no curative therapies currently available, MDI-P may prove to be a very beneficial agent exhibiting minimal toxicity for addressing the continuing lung function degeneration with CF patients. This CF patent application continues the process of improving our intellectual property surrounding MDI-P, enhancing both the Company's intrinsic value and commercialization strategy."
Formed in 1991, Medical Discoveries, Inc. is a publicly traded (OTC Bulletin Board: MLSC) development-stage biopharmaceutical research company engaged in the research, development and validation of its patented anti-infective technology. MDI's electrolyzed solution of free radicals represents a novel approach to treating its initial target indication, HIV.
Information in this press release relating to the potential of MDI constitutes forward-looking statements. Actual results in future periods may differ materially from the forward-looking statements because of a number of risks and uncertainties set forth in MDI's 2003 Annual Report on Form 10-KSB and other filings with the Securities and Exchange Commission.
SOURCE Medical Discoveries, Inc. -0- 05/26/2004 /CONTACT: Medical Discoveries, Inc., +1-208-736-1799/ (MLSC)
CO: Medical Discoveries, Inc.; Mayer, Brown, Rowe & Maw ST: Idaho IN: MTC HEA BIO OTC SU: PDT CON
------------------ Due Da Due......But Be Quick About It!!!!!
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No new PR today...but volume picked up 5x the daily average. We've got considerable movement in pps with several patents pending approval. Posts: 372 | From: Belleview, FL, USA | Registered: Apr 2004
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quote:Originally posted by Smctbone: No new PR today...but volume picked up 5x the daily average. We've got considerable movement in pps with several patents pending approval.
I like the looks of this as well! A new High today of .21 this will be a good long hold!
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Well this stock looks good I think a good entry would be .1 but not sure if you can get it. O/S about 35 million MLSC -- Medical Discoveries, Inc. (UT) Com (No Par)
Address: 738 Aspenwood Lane Twin Falls ID 83301 USA Phone: 208-736-1799
Officers: Judy M. Robinett, CEO
Shares Outstanding: 35,526,000 as of 2002-05-22
Estimated Market Cap: 5.684M as of 2004-05-28
Current Capital Change: None
Dividends: None
State of Incorporation: UT
Company Notes: Formerly=W.P.I. Pharmaceutical, Inc. to 10-92 Note=12-00 company is in the development stage & has developed a product that appears to have the ability to destroy certain virsuses, bacteria, & fungi
Class Notes: New Issue=2-84 750,000 shs at 2 cents (best efforts-all or none) by the company
Transfer Agents: Colonial Stock Transfer Co., Inc., Salt Lake City, UT 84111
Posts: 795 | From: Brown Deer, WI 53223 | Registered: Feb 2004
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TWIN FALLS, Idaho, Jun 2, 2004 /PRNewswire-FirstCall via COMTEX/ -- Shareholders of Medical Discoveries, Inc. (MLSC) attending the company's annual meeting in Salt Lake City, Utah on Friday, May 21st voted to approve all proposals recommended by the Board of Directors. All proposals received the support of over 98% of the shares voted.
David Walker, MDI's Board Chairman, opened the meeting and Judy Robinett, President & CEO, provided a detailed discussion of the Company's substantial progress in completing its pre-clinical testing and CMC (Chemistry, Manufacturing and Control) milestones, required to submit MDI's first IND for HIV in Q4 of 2004.
Ms. Robinett told shareholders that three of four mouse studies of infectious disease (sepsis, asthma, CF) have been completed with exemplary results in efficacy and toxicity, with the fourth (a toxicity study at 100% strength) to be completed in July. Three new use patents have been applied for as a result of the completed mouse studies. Two additional large mammal studies are nearing completion (sepsis and pharmacokinetics). Ms. Robinett also reported that the CMC studies at Goodwin Laboratories are on track for an expected August completion.
A new Board of Directors was elected, including Larry Anderson, a Salt Lake City businessman with substantial prior business experience, both with entrepreneurial companies and on Wall Street. He was introduced to shareholders, together with continuing Board members David Walker, Chairman, and Judy Robinett, CEO. The Company's lead investment banker at C. K. Cooper, Mikael van Loon, was also introduced to shareholders.
Formed in 1991, Medical Discoveries, Inc. is a publicly traded (MLSC) development-stage biopharmaceutical research company engaged in the research, development and validation of its patented anti-infective technology. MDI's electrolyzed solution of free radicals represents a novel approach to treating its initial target indication, HIV.
Information in this press release relating to the potential of MDI constitutes forward-looking statements. Actual results in future periods may differ materially from the forward-looking statements because of a number of risks and uncertainties set forth in MDI's 2003 Annual Report on Form 10-KSB and other filings with the Securities and Exchange Commission. Posts: 372 | From: Belleview, FL, USA | Registered: Apr 2004
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What do you make of this? I'm not sure If I want to hold this or If I want to get out and see if it will retrace! Thoughts?
Posts: 96 | From: walker, Mi, USA | Registered: Apr 2004
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quote:Originally posted by needtoretire: SmcTbone,
What do you make of this? I'm not sure If I want to hold this or If I want to get out and see if it will retrace! Thoughts?
Not sure...pretty nice profits right now though from where I think you got in. And we do have a while before FDA approval (which is when it will skyrocket). But then again, I have no idea what's causing it to move upward so much right now(besides it having great potential).
quote:Originally posted by Smctbone: Not sure...pretty nice profits right now though from where I think you got in. And we do have a while before FDA approval (which is when it will skyrocket). But then again, I have no idea what's causing it to move upward so much right now(besides it having great potential).
I originally said I was going to hold this thing long ; So I think I will do just that . I would just like to know who is buying this at this price without any news!!
quote:Originally posted by needtoretire: I originally said I was going to hold this thing long ; So I think I will do just that . I would just like to know who is buying this at this price without any news!!
Well, we do have several patent applications that are awaiting approval. Also, remember this from our last PR: "three of four mouse studies of infectious disease (sepsis, asthma, CF) have been completed with exemplary results in efficacy and toxicity, with the fourth (a toxicity study at 100% strength) to be completed in July. Two additional large mammal studies are nearing completion (sepsis and pharmacokinetics)." I would expect announcement soon about the 2 "large mammal studies" and about the fourth mouse study. This buying may be speculation on this news, or some "insiders" know something we don't. Holding long is probably the best bet
quote:Originally posted by Smctbone: Well, we do have several patent applications that are awaiting approval. Also, remember this from our last PR: "three of four mouse studies of infectious disease (sepsis, asthma, CF) have been completed with exemplary results in efficacy and toxicity, with the fourth (a toxicity study at 100% strength) to be completed in July. Two additional large mammal studies are nearing completion (sepsis and pharmacokinetics)." I would expect announcement soon about the 2 "large mammal studies" and about the fourth mouse study. This buying may be speculation on this news, or some "insiders" know something we don't. Holding long is probably the best bet
Yes, I agree completely , and I do think there is some inside trading going on with the volume as high as it's been since I hav been watching this one. I just wish I had bought more than I did!!! Darn it!
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