today announced that its treatment protocol to provide its investigational drug Ceplene(TM), in combination with interleukin-2 (IL-2), for the treatment of patients with advanced malignant melanoma, has been approved by the U.S. Food and Drug Administration (FDA). The treatment protocol allows Maxim to provide expanded access of Ceplene to patients in the United States while investigation of the drug continues in the Company's confirming Phase 3 clinical trial.
Based on earlier clinical findings indicating that the Ceplene/IL-2 investigational therapy may provide a survival benefit to patients with advanced malignant melanoma, the FDA agreed to allow Maxim to provide expanded access of Ceplene to critically ill patients who face limited treatment options. The FDA has also approved reimbursement for study medication, which allows Maxim to recover costs associated with providing qualified patients access to Ceplene therapy. Patients, their families and/or caregivers who wish further information regarding the treatment protocol should call Maxim Pharmaceuticals at 888-562-9465 or visit the Company's website at www.maxim.com.
The FDA specifies four criteria for approval of a treatment protocol. These criteria require that the disease be serious and life threatening, that no satisfactory alternative treatments are available, that the drug is under investigation in a controlled clinical trial under an existing IND and that the sponsor is actively seeking marketing approval.
"We appreciate the guidance provided by the FDA regarding a treatment protocol for the Ceplene/IL-2 combination in advanced metastatic melanoma," commented Larry G. Stambaugh, Maxim's Chief Executive Officer. "We are ready to provide these patients and their caregivers an additional therapeutic option that may enhance their survival with a quality of life. We look forward to implementing this program to provide critically ill patients with the potential clinical benefit that has been observed in our ongoing clinical trials."
The treatment protocol will be available to all eligible patients in the United States and will initially be provided in approximately ten geographically diverse locations. The Company intends to expand the protocol to additional qualified treatment centers over subsequent months. Maxim estimates that the net cost of making the treatment protocol available to patients will be approximately $1.5 million in the current fiscal year. The actual financial impact of the treatment protocol to the Company will depend upon the number of patients enrolled and the rate of reimbursement. The National Organization of Rare Diseases (NORD) has agreed to collaborate with Maxim to facilitate treatment for indigent patients who wish to participate in this treatment protocol.
On September 24, 2003, Maxim announced completion of enrollment for the confirmatory Phase 3 trial (M0104) of its lead drug candidate Ceplene (histamine dihydrochloride) in combination with IL-2 for the treatment of advanced malignant melanoma patients with liver metastases. The multi-national, controlled, and randomized Phase 3 trial includes 230 patients and is designed to compare patient survival of the combination treatment of Ceplene and IL-2 versus IL-2 alone. The Phase 3 trial is expected to conclude in late 2004. In November 2003, Maxim filed an application for market authorization in Europe for approval to market Ceplene for the treatment of advanced malignant melanoma.
Advanced metastatic melanoma is the most deadly form of skin cancer and the fastest-growing cancer in the developed world, and there is no established or proven standard of care for the treatment of this life- threatening disease. Ceplene is an investigational drug and has not been approved by the FDA or any international regulatory agency. Ceplene, which has orphan drug status, has been tested in seven completed or ongoing clinical trials for malignant melanoma in more than 1,000 patients, including the current confirming Phase 3 trial designed to support U.S. FDA registration for marketing approval.