Maxim Ceplene Expanded Access Program To Enroll Up To 1,000 Melanoma Patients
This article was originally published in The Pink Sheet Daily
Executive Summary
The Treatment IND program is directed at Stage IV malignant melanoma patients. Maxim predicts amending its 2000 NDA for histamine dihydrochloride with the confirmatory Phase III results in early 2005.
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Maxim will begin enrolling advanced malignant melanoma patients in a Ceplene expanded access treatment protocol in a "short time," CEO Larry Stambaugh said. The Treatment IND (protocol M0105) will enroll up to 1,000 patients with Stage IV malignant melanoma. It will initially be offered at "approximately ten geographically diverse locations" in the U.S. and then expanded, Maxim said April 14 in announcing FDA approval of the program. All patients in the treatment protocol will receive Ceplene (histamine dihydrochloride) 1 mg twice daily in combination with Proleukin (interleukin-2). Maxim will follow patients for long-term survival. In support of its NDA, Maxim plans to submit results from its 230-patient pivotal Phase III study of Ceplene/IL-2 in malignant melanoma patients with liver metastases in early 2005. The study (protocol M0104) was initiated in January 2002 after the firm received a "not approvable" letter for the drug, originally known as Maxamine , in January 2001. The protocol was reviewed by FDA under the agency's Special Protocol Assessment (SPA) process. Maxim had submitted the NDA in 2000 on the basis of a single 305-patient Phase III trial in advanced malignant melanoma patients. The firm, however, sought approval only for the subgroup of patients with liver metastases, as the study showed a survival advantage for those 129 patients but not the overall intent-to-treat population. FDA appears to have encouraged the Ceplene expanded access program. The treatment protocol was suggested by an office director and division director at the agency, Stambaugh told the conference call. Treatment INDs are "relatively rare programs," Stambaugh said. "Only 11 cancer drugs have been under treatment protocols" since FDA established the program in the late 1980s. Ten of the 11 were subsequently approved, he added. FDA has "approved reimbursement for study medication, which allows Maxim to recover costs," the company stated. "The net cost of making the treatment protocol available to patients will be approximately $1.5 mil. in the current fiscal year," ending Sept. 30. The National Organization of Rare Diseases will collaborate with Maxim "to facilitate treatment for indigent patients." Ceplene has orphan drug status for advanced malignant melanoma. - Bridget Silverman |