Interesting MMP news, though biotechs are really tricky...
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Monday September 13, 3:02 am Eastern Time
Company Press Release
Maxamine Treatment Results in Prostate Tumor Regression in Preclinical Model
SAN DIEGO--(BW HealthWire)--Sept. 13, 1999--Maxim Pharmaceuticals (AMEX:MMP, SSE:MAXM) today announced that combination therapy with Maxamine® (histamine) and interleukin-2 (IL-2) resulted in effective killing of cancer cells in rats with established prostate cancer tumors.
The preclinical studies were conducted at the Department of Oncology at the University of Umea in Sweden, and are being reported in the current issue of Anticancer Research (vol. 19, pp. 1961-1970).
The researchers reported that ''A tremendous reduction in tumor epithelium (i.e. prostate cancer cells) and a highly significant increase in apoptotic cell death (of prostate cancer cells) were encountered.'' The authors also conclude that combined treatment with irradiation, Maxamine and IL-2 ''could be of value in increasing the efficacy of local radiotherapy with a most plausible effect on micrometastatic spread.''
The research team at Umea investigated the effect of Maxamine on prostate tumor morphology, including the number of cancer cells within the tumors and the frequency of dead (apoptotic) cancer cells. Non-irradiated tumors treated with Maxamine and IL-2 contained statistically significantly less prostate cancer cells than tumors from untreated control animals, or tumors from animals treated with IL-2 alone.
Further, Maxamine significantly potentiated the effect of local radiotherapy by decreasing the number of cancer cells within the prostate tumors, and by increasing the frequency of apoptotic (dead) tumor cells. Also, treatment of irradiated prostate cancer tumors with the combination of Maxamine and IL-2 induced the most pronounced reduction of prostate cancer cells of any treatment.
''The model used in these experiments is chosen to mimic the growth of prostate cancer in humans, and these new results further support the proposed use of Maxamine and IL-2 therapy in this disease,'' said Kurt R. Gehlsen, Ph.D., Maxim's Chief Technical Officer. ''It is particularly encouraging that treatment with Maxamine and IL-2 not only delayed prostate cancer growth, but also induced effective killing of cancer cells within tumors. Based on these results, new approaches to treating advanced prostate cancer may be possible.''
A previous research report (published in vol. 77, pp. 1213-1219 of the British Journal of Cancer in 1998) demonstrated that the combination of Maxamine and IL-2 significantly delayed tumor growth in male rats with an established prostate adenocarcinoma (Dunning R3327). This research also found that Maxamine and IL-2 strongly potentiated the inhibition of prostate cancer growth induced by local irradiation.
Prostate cancer is the most common form of cancer in men with approximately 350,000 cases in the United States alone. Prostate cancer is normally treated with surgery, hormone therapy, or local irradiation of tumors. Despite advances in the treatment of this common form of cancer, there is a need for improved therapy.
Overview of Maxamine Therapy
In many patients with cancer and chronic infectious diseases, the capacity of the patient's immune system to detect and destroy tumor cells or virally infected cells is compromised. Cytokines, a class of naturally occurring proteins, are potent stimulators of certain key immune cells.
Cytokines such as IL-2 and IFN-(alpha) have been approved for the treatment of certain cancers and infectious diseases, but when used as single-agent therapies they are ineffective in the majority of patients and cause severe toxic side effects.
Maxamine Therapy combines the administration of Maxamine, a drug that protects critical immune cells, with the administration of cytokines and other agents that stimulate these cells. This combination of actions is designed to improve the immune system's ability to identify, disable and destroy malignant or infected cells.
In addition to extending survival, maintaining the quality of a patient's life during treatment is an important objective of Maxamine Therapy. Many current treatments for cancer and some infectious diseases are as harsh as the illnesses themselves, forcing patients to make the difficult choice of whether to continue therapy. Maxamine can be safely self-administered by patients in their own homes.
Company Overview
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 14 countries around the world 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 by mid 2000. Phase II trials of Maxamine Therapy are also underway for the treatment of hepatitis C patients and advanced renal cell carcinoma patients. Maxamine is designed to be safely self-administered by patients in their own homes, and more than 750 patients have been treated in completed and ongoing clinical trials.
The Company is also developing MaxDerm(TM), a Maxamine-related drug 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 Annual Report on Form 10-K/A for the year ended September 30, 1998 and the Company's Registration Statement on Form S-3 File No. 333-84711, 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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