PIII trial fails to meet primary endpoint
Maxim Pharmaceuticals has said that its confirmatory Phase III trial of the investigational drug Ceplene (histamine dihydrochloride) in combination with Interleukin-2 (IL-2) for the treatment of advanced malignant melanoma patients with liver metastases failed to demonstrate an improvement in overall patient survival, the primary endpoint.
Maxim Pharmaceuticals has said that its confirmatory Phase III trial of the investigational drug Ceplene (histamine dihydrochloride) in combination with Interleukin-2 (IL-2) for the treatment of advanced malignant melanoma patients with liver metastases failed to demonstrate an improvement in overall patient survival, the primary endpoint.
The combination therapy was generally well tolerated, and safety was consistent with previous clinical experience, and Maxim will continue evaluating the M104 clinical data, its malignant melanoma program, and the related regulatory submissions seeking approval from the FDA and the European Medicines Agency (EMEA).
'We would like to thank the patients and their families, and the dedicated clinicians and nurses, who participated in this study. While this study did not meet its primary endpoint, we remain committed to further studying Ceplene's potential. It is our belief, as supported by the Phase III Acute Myeloid Leukaemia data released this past May, and other clinical and preclinical evidence, that Ceplene still holds promise for the treatment of certain cancers,' commented Larry Stambaugh, Maxim's chief executive officer.
'Moving forward, our dedication to meeting the challenge of improving survival and quality of life for seriously ill cancer patients will remain unchanged. Maxim plans to pursue regulatory submissions to the FDA and EMEA seeking approval of Ceplene to treat AML patients in complete remission, and to continue evaluating the M104 study data. We will also conduct a review of our pipeline, our operations and resources, so that we can focus on efficiently advancing Ceplene and other product candidates towards the market. Additional information will be provided after we further evaluate the melanoma study data and our other programs, and we have met with regulators," added Mr Stambaugh.
AML
AML is the most common form of acute leukaemia in adults. AML patients are typically treated with chemotherapy to achieve disease remission, but the majority of patients will ultimately relapse. The prognosis for AML patients after relapse is poor, with few long-term survivors. The Ceplene therapy treats patients during remission (after chemotherapy) with the goal of increasing their remission period and preventing relapses.
About Ceplene
In patients with cancer, including leukaemias such as AML, the ability of the immune system to destroy cancer cells is frequently compromised. Ceplene therapy is being developed to maintain the integrity of pivotal immune cells, in particular T cells and natural killer (NK) cells, in patients with cancer. Ceplene treatment aims at facilitating immune-mediated destruction of cancer cells, including leukaemic cells, and also at improving the efficiency of T and NK cell-activating agents such as IL-2. Research regarding histamine, the active agent underlying Ceplene, and related clinical results and Ceplene's mechanism of action, including a short animation, is available on the Company's website at www.maxim.com.