Maxim Pharmaceuticals 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."