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Three Year Follow-Up Data Show Statistically Significant Improvement in Survival for Patients Treated With Ceplene, IL-2 Combination
The 36-month results demonstrate that the intent-to-treat population of all 305 advanced metastatic melanoma patients randomized into the trial demonstrated a statistically significant improvement in survival for patients treated with the combination of Ceplene and IL-2 (p=0.037, evaluated by comparing Kaplan-Meier survival curves using the log-rank test) compared to patients treated with IL-2 alone. The improvement in three-year survival remained significant in the subpopulation of advanced metastatic melanoma patients with liver metastases (p=0.006).
"We are pleased that the scientific and clinical community continue to recognize the results of our first phase 3 trial in advanced stage IV melanoma. Patients with this rapidly progressive disease today do not have an effective treatment option," said Dr. Kurt R. Gehlsen, Maxim's Chief Scientific Officer. "Our initial phase 3 trial remains the first large randomized clinical trial, for any new treatment, to demonstrate a survival benefit in this patient population."
In May 2004, the Company announced the approval of a treatment protocol in the United States allowing the Company to provide the Ceplene combination therapy to malignant melanoma patients under an expanded access program while the current Phase 3 trial is being completed. The Company expects to complete its current Phase 3 trial in melanoma patients with liver metastases this summer and amend its NDA with the results from the current Phase 3 study in late 2004. A centralized application for marketing of Ceplene therapy in malignant melanoma was filed with the European regulatory authorities in November 2003 and is currently under review.
The Company also recently announced completion of a Phase 3 trial in acute myeloid leukemia, in which the combination of Ceplene plus IL-2 significantly improved leukemia free survival, the primary endpoint. The results for the primary endpoint can be see on the company's website at www.maxim.com.
Source: Maxim Pharmaceuticals