Maxim Receives Three Additional U.S. Patents for Ceplene Immune Modulator Technology
Drug Candidate Now Encompassed by 16 U.S. Patents
SAN DIEGO--(BW HealthWire)--July 16, 2002--Maxim Pharmaceuticals (Nasdaq\NM:MAXM)(SSE:MAXM) today announced that the United States Patent Office has issued three new patents supporting the Company's Ceplene(TM) (histamine dihydrochloride) technology for the treatment of cancer, viral infections, and other diseases in which oxidative stress plays a key role.
Ceplene is currently being tested in a broad range of life-threatening cancers and diseases of the liver, including Phase 3 clinical trials in malignant melanoma and leukemia, and Phase 2 clinical trials in hepatitis C and renal cell carcinoma. The intellectual property protection surrounding the Ceplene technology now includes 16 U.S. patents and 12 pending U.S. patents applications, with corresponding patents issued or pending, in major international markets, including Europe, Australia and Japan.
The United States Patent Office has issued U.S. Patent 6,305,380 entitled "Method for Treatment of Cancer and Infectious Disease." Among the claims included in this patent is the use of interferon-alpha (IFN-alpha), a stimulator of Natural Killer (NK) cells, in combination with any histamine type-2 receptor agonist, including histamine and over 30 other histamine type-2 receptor agonists specifically named, for the treatment of viral diseases such as hepatitis C and hepatitis B. Hepatitis C is a key component of the Company's development pipeline, and currently underway is a Phase 2 trial of the triple drug combination of Ceplene, pegylated interferon (sustained-release IFN-alpha), and ribavirin in the treatment of nonresponder hepatitis C patients.
Also issued was U.S. Patent 6,375,946 "Enhanced Activation of Natural Killer Cells Using an NK Cell Activator and a Hydrogen Peroxide Scavenger or Inhibitor." This patent encompasses the activation of NK cells using cytokines other than IFN-alpha or interleukine-2, or other agents for activating NK cells, in combination with histamine or other histamine type-2 receptor agonists.
Finally, the United States Patent Office issued U.S. Patent No. 6,407,133, entitled "Treatment and Prevention of Reactive Oxygen Metabolite-Mediated Cellular Damage." This patent encompasses methods for inhibiting and reducing the oxidative damage caused by the release of oxygen free radicals in patients suffering from inflammatory diseases, infectious diseases, neurodegenerative diseases, and other medical conditions, and is relevant to Maxim's development efforts related to chronic liver disease. Research suggests that oxidative stress caused by oxygen free radicals and inflammatory mediators such as tumor necrosis factor-alpha plays a critical role in the pathogenesis of chronic liver disease such as nonalcoholic steatohepatitis (NASH) and alcoholic liver disease. Research has also suggested that Ceplene can prevent the production of free radicals, thus reducing oxidative stress and tissue damage.
"These patents represent a significant expansion of the protection surrounding the Ceplene technology platform relevant to both our later-stage and earlier-stage drug development efforts," said Kurt R. Gehlsen, Ph.D., Maxim's Senior Vice President and Chief Scientific Officer. "Our goal is to continue to expand our patent portfolio so that it keeps pace with the growing database of clinical and scientific data surrounding this discovery and its apparent mechanism of action, particularly the importance of limiting damage associated with oxidative stress."
Ceplene and Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim's research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend survival while maintaining quality of life. Maxim has attracted an experienced international management group and a team of employees dedicated to commercializing life-enhancing product candidates. Joining this motivated team in its mission are world-leading scientific and clinical investigators and major pharmaceutical development partners.
Ceplene, based on the naturally occurring molecule histamine, is designed to prevent or inhibit oxidative stress, thereby reversing immune suppression and protecting critical immune cells. More than 1,300 patients have participated in the Company's completed and ongoing clinical trials in cancer and hepatitis C. Ceplene is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international regulatory agency. Maxim is also developing small-molecule inhibitors and activators of programmed cell death, also known as apoptosis, that may serve as drug candidates for cancer, cardiovascular disease and other degenerative diseases. The Company's third technology platform, MaxDerm(TM), is an investigational drug candidate designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Ceplene, MaxDerm and the apoptosis modulator compounds, and regarding the Company's clinical trials. Such statements are only predictions and the Company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale clinical trials, the risk that the Company will not obtain approval to market its products, and the risk that if the Company fails to secure adequate protection of its intellectual property or the right to use certain intellectual property of others, it may not be able to protect its products and technologies from competitors. These factors and others are more fully discussed in the Company's periodic reports and other filings with the Securities and Exchange Commission.
Note: Ceplene(TM), MaxDerm(TM) and the Maxim logo are trademarks of the Company.
Editor's Note: This release is also available on the Internet at maxim.com.
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Contact:
Maxim Pharmaceuticals, San Diego
Larry G. Stambaugh, 858/453-4040
or
Burns McClellan
Investors:
John Nugent, 212/213-0006
or
Coffin Communications Group
Media:
Sean Collins or Valerie Bent, 818/789-0100 |
