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Friday February 25, 3:03 am Eastern Time
Company Press Release
FDA Grants Orphan Drug Status to Maxamine for the Treatment of Malignant Melanoma
SAN DIEGO--(BW HealthWire)--Feb. 25, 2000--Maxim Pharmaceuticals (AMEX:MMP - news; SSE:MAXM) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug status to Maxamine® as an adjunct to cytokine therapy for the treatment of metastatic malignant melanoma.
Orphan drug status provides for U.S. marketing exclusivity for seven years upon marketing approval by the FDA. The status also provides certain tax benefits and exempts the company from certain FDA application fees.
''We are pleased to receive orphan drug status for advanced malignant melanoma, the first cancer in which we plan to seek marketing approval for Maxamine,'' said Larry G. Stambaugh, Maxim's chairman and chief executive officer. ''This builds upon the receipt last month of orphan drug status for the treatment of acute myelogenous leukemia. In addition to the U.S. benefits, orphan drug status can also be helpful in accelerating regulatory filings in certain countries outside of the United States.''
Malignant melanoma is the most serious form of skin cancer and is one of the most rapidly increasing cancers in the world. There are approximately 90,000 new cases of malignant melanoma and 15,000 deaths from the disease each year in the United States, Europe and Australia.
The company has conducted a series of four Phase II clinical trials evaluating the combination of Maxamine and cytokines in the treatment of malignant melanoma. The results of the three completed Phase II trials showed a more than doubling of survival for patients treated with Maxamine.
The company currently has three Phase III clinical trials of Maxamine underway, the most advanced of which is a 305-patient study based in the United States for the treatment of advanced-stage malignant melanoma. The company expects to complete this trial in the first half of 2000 and plans to file a New Drug Application (NDA) with the FDA in mid 2000.
In November 1999, clinicians from the largest enrolling site in the company's U.S. Phase III melanoma trial submitted an abstract to an upcoming cancer conference describing preliminary survival data from the 40 patients enrolled at their center. The preliminary single-center results demonstrated a statistically significant increase in overall survival for patients treated with Maxamine as compared to the control group.
Maxamine is designed to improve immunotherapy, the use of the body's immune system to fight cancer and certain infectious diseases. Maxamine protects critical immune cells and is administered in combination with cytokines such as interleukin-2 and interferon-alpha, a class of proteins that stimulate these same immune cells.
More than 1,000 patients have been treated in the company's completed and ongoing clinical trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Clinical trial results to date suggest that Maxamine Therapy, the administration of Maxamine in combination with cytokines, is a safe, at-home treatment that can improve patient survival.
Maxim Pharmaceuticals is developing advanced drugs, therapies and vaccines for cancer and infectious diseases. The company's lead drug candidate, Maxamine, is currently being tested in three Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Maxim expects to file its NDA and report results for its U.S. Phase III study of Maxamine in the treatment of malignant melanoma in mid 2000.
Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. Maxamine is designed to be safely administered by patients in their own homes, and more than 1,000 patients have been treated in completed and ongoing clinical trials. The company is also developing MaxDerm(TM), for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions.
The company's third platform technology, MaxVax(TM), now in preclinical development, utilizes a needle-free mucosal vaccine carrier/adjuvant system for a broad range of infectious diseases. The company expects to commercialize its technologies through a combination of in-house development and collaborative agreements with pharmaceutical companies.
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 Maxamine and 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 efficacy in larger-scale clinical trials and the risk that the company will not obtain approval to market its products. These factors and others are more fully discussed under ''Risk Factors'' and elsewhere in the company's periodic and other reports as filed with the Securities and Exchange Commission.
Note: Maxamine®, Maxamine Therapy(TM), MaxDerm(TM), MaxVax(TM), and the Maxim logo are trademarks of the company.
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