Negative outcome for Maxim

Maxim Pharmaceuticals from San Diego has said that based upon the negative outcome of it's confirmatory Phase 3 clinical trial (M0104) studying Ceplene (histamine dihydrochloride) in combination with Interleukin-2 (IL-2) in advanced malignant melanoma patients with liver metastases, it plans to close the treatment protocol approved by the FDA earlier this year.

The treatment protocol allowed Maxim to provide expanded access of Ceplene therapy to advanced malignant melanoma patients while investigation of the drug continued in the confirmatory M0104 clinical trial.

Any patient currently enrolled in the treatment protocol will be allowed to complete their treatment regimen under a compassionate use program. Maxim also intends to withdraw its pending NDA seeking approval of Ceplene therapy to treat advanced malignant melanoma patients with liver metastases.

President and ceo Larry Stambaugh noted: 'Our continuing evaluation of the M0104 trial and the previous Phase III study has noted differences, including fewer patients entering cycles three, four and five in the M0104 study, and more patients receiving dose reductions in the combination arm compared to previous experience. Although we will continue to try and learn from the melanoma results, our focus has shifted to potential filings for marketing authorisation in acute myeloid leukaemia based on the previous positive Phase III trial, as well as partnering efforts for both Ceplene and our apoptosis compounds.'