By Debbie Strickland
Right on schedule, Maxim Pharmaceuticals Inc. has initiated the Australian component of an international Phase III trial of its lead drug, Maxamine, for the treatment of advanced-stage malignant melanoma.
Maxamine is a dihydrochloride salt form of histamine designed to be self-administered on an outpatient basis in combination with cytokines such as interluekin-2 and alpha interferon.
The San Diego company is seeking to enroll 200 evaluable patients at more than 20 sites in Sweden and Australia. The primary endpoint is overall patient survival; secondary endpoints include time to progression, tumor response, duration of response and quality of life.
The test group will receive a combination of Maxamine, interleukin-2 and alpha interferon. Patients in the control group will be treated with dacarbazine, the most common chemotherapeutic agent for the treatment of advanced malignant melanoma.
A 200-patient U.S. Phase III trial commenced in June, and a third Phase III study, in acute myelogenous leukemia, will launch in early 1998.
"Our plan is to have three Phase III clinical trials of Maxamine therapy for the treatment of cancer under way by early 1998, any one of which is designed to support regulatory submissions for approval to market Maxamine," said Larry Stambaugh, chairman, president and CEO, in a prepared statement.
The company raised $38 million in a recent international public offering, a substantial portion of which was earmarked for Maxamine development.
In Phase II European studies, Maxamine more than doubled survival and improved quality of life during treatment. In two completed Phase II trials, the mean time for those receiving Maxamine exceeded 14 months, compared to mean survival of seven months for conventional treatments.
In addition, Maxamine in comparison to historical averages has boosted survival fivefold — to 20 months — in patients with liver metastases.
Maxim's shares (AMEX:MMP) closed Tuesday at $14.50, up $0.438. *