Elaine Posted October 10, 2004 Share Posted October 10, 2004 Epimmune Preparing Phase 2 Study of Cancer Vaccine Based on Positive Initial Human Results Tuesday September 28, 7:30 am ET SAN DIEGO, Sept. 28 /PRNewswire-FirstCall/ -- Epimmune Inc. (Nasdaq: EPMN - News) today announced plans for a Phase 2 study of its EP-2101 vaccine in patients with late stage non-small cell lung (NSCL) cancer, based on evidence of relevant biological responses in early clinical trials in both NSCL and colorectal cancer. Analysis of the data from patients who completed the initial trials showed that EP-2101: * was immunogenic with approximately 93% of the patients evaluated responding to at least one epitope included in the vaccine; * induced a multi-epitope response with approximately four vaccine epitopes being the average number recognized by the patients evaluated and approximately 53% of the patients evaluated responding to at least five of the nine epitopes included in the vaccine; and * was safe and well tolerated. The goal of the Phase 2 study will be to correlate overall survival and clinical benefit to patients with the immunogenicity demonstrated in the Phase 1 trials. The Phase 2 study will be conducted in stage IIIB/IV NSCL cancer patients with advanced disease as a single dose level, open-label study. The primary endpoints will be overall survival and safety. Secondary endpoints will be progression-free survival and vaccine immunogenicity. The study will be conducted by Epimmune in the United States and is expected to involve between 10 and 12 sites and enroll approximately 84 patients. Enrollment is expected to be complete by the end of 2005 and data from the study is expected to be available beginning in the second half of 2006. http://biz.yahoo.com/prnews/040928/latu005_1.html Quote Link to comment Share on other sites More sharing options...
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