By Frances Bishopp

Maxim Pharmaceuticals Inc. has filed an investigational new drug application with the FDA for permission to conduct a Phase III clinical trial of its lead compound, Maxamine, for the treatment of malignant melanoma.

Maxim's proprietary Maxamine therapy is based on the administration of an H2 receptor agonist which, when administered in combination with NK-cell-activating cytokines, such as IL-2 and IFN-Alpha, has the potential of enhancing the treatment of cancer and infectious diseases.

The study will be a multi-center, double-blind, placebo-controlled trial in 10 to 12 U.S. centers and possibly include one to two sites in other countries. At least 125 patients will be recruited with advanced (stage IV) malignant melanoma.

The study is intended to demonstrate the safety and efficacy of Maxamine with various planned primary endpoints: time to disease progression, tumor response, duration of response and overall patient survival. The estimated duration of the trial is approximately 12 months once patient enrollment is complete.

In the study, Maxamine will be coadministered with the cytokine, Interleukin-2 (IL-2). In previous clinical studies, study groups treated with Maxamine have demonstrated survival duration to a mean of more than 15 months, compared to a mean of seven months with existing treatments.

This increase in survival duration was achieved even when low doses of cytokines were coadministered with Maxamine. Using the low cytokine doses reduced their side effects and facilitated self administration of the drugs at home.

The company, Kurt Gehlsen, vice president of development and chief technical officer at Maxim, said, was "reborn" in 1993 and its technology is derived from Sweden primarily and the U.S. Its lead product, the Maxamine technology for cancer, has been in clinical trials in Sweden for a number of years.

"We are now poised to start what we consider a pivotal trial in the U.S. to seek approval of this product, Gehlsen said. "This compound is applicable to many types of cancer so we are not only doing it in melanoma but we have a trial in acute myelogenous leukemia, multiple myeloma, renal cell carcinoma and we anticipate starting a trial for treatment of hepatitis C in Sweden."

"We need to do a definitive trial in the U.S. and this is the first definitive trial under FDA guidelines," Gehlsen said.

Maxim, of San Diego, owns worldwide exclusive rights to the Maxamine technology. The company's second platform technology, MaxVax, now in preclinical development, uses a mucosal vaccine carrier/adjuvant system for a broad range of infectious diseases. *

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