STOCKHOLM, Sweden and SAN DIEGO, Nov. 1, 2004 (PRIMEZONE) -- Maxim Pharmaceuticals (Nasdaq:MAXM) (SSE:MAXM) announced today that based upon the negative outcome of it's confirmatory Phase 3 clinical trial (M0104) studying Ceplene(tm) (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(tm) 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 U.S. New Drug Application seeking approval of Ceplene therapy to treat advanced malignant melanoma patients with liver metastases.
Maxim Pharmaceuticals also reported today at the 29th European Society for Medical Oncology Congress in Vienna, Austria, data from the Phase 3 M0104 clinical trial studying Ceplene in combination with IL-2 for the treatment of advanced malignant melanoma patients with liver metastases. The Company previously reported that the trial did not meet its primary endpoint. The combination therapy was generally well tolerated, and safety was consistent with previous clinical experience.
"Our continuing evaluation of the M0104 trial and the previous Phase 3 study has noted differences, including fewer patients entering cycles 3, 4 and 5 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 authorization in acute myeloid leukemia based on our positive Phase 3 trial reported this summer, as well as partnering efforts for both Ceplene and our apoptosis compounds."
About the M0104 Phase 3 Clinical Trial
The M0104 study was conducted under the Special Protocol Assessment procedure of the FDA to confirm results from an earlier Phase 3 trial (M01), which demonstrated statistical significance at 12 months in the subgroup of advanced malignant melanoma patients with liver metastases. The completed M0104 trial was a multi-center, randomized, and controlled Phase 3 study evaluating Ceplene plus IL-2 against IL-2 alone in 230 patients at 35 sites in North America and Europe. IL-2 is an immunotherapeutic agent approved in the U.S., at significantly higher doses than used in M0104, for the treatment of advanced malignant melanoma. The M0104 trial was conducted under the same treatment protocol as the prior M01 study, but enrollment was limited to advanced malignant melanoma patients with liver metastases. The primary endpoint of the trial was duration of patient survival, as assessed by the stratified log-rank test in the intent-to-treat population.
Maxim Overview
Maxim Pharmaceuticals is a global biopharmaceutical company with a diverse pipeline of therapeutic candidates for life-threatening cancers and liver diseases. Maxim's research and development programs are designed to offer hope to patients by developing safe and effective therapeutic candidates that have the potential to extend survival while maintaining quality of life. Ceplene, Maxim's lead drug candidate, is an immune-modulator that reverses immune suppression and protects critical immune cells. Because Ceplene modifies basic immune functions, it has the potential to be used in a range of diseases. Additionally, Maxim is developing small-molecule apoptosis modulators for cancer, cardiovascular disease and degenerative diseases.
Ceplene and the apoptosis compounds are investigational drugs and have not been approved by the U.S. Food and Drug Administration or any international regulatory agency.
This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy, safety and intended utilization of Ceplene, the conduct and results of the Company's clinical trials, and the Company's plans regarding regulatory filings, future research and clinical trials. Such statements are only predictions and the Company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in larger-scale or later clinical trials, the risk that the Company will not obtain approval to market its products, and the risks associated with the Company's reliance on outside financing to meet its capital requirements. These factors and others are more fully discussed in the Company's periodic reports and other filings with the Securities and Exchange Commission.
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