To: Miljenko Zuanic who wrote (561 ) 12/20/1999 11:17:00 AM From: Arthur Radley Read Replies (2) | Respond to of 626
We have news this morning. CeaVac moved into Phase III. Completes Accrual Goal for Phase II Colorectal Cancer Study of CeaVac Monoclonal Antibody Study Expanded to Phase III Study SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec. 20, 1999 - Titan Pharmaceuticals, Inc. (AMEX: TTP) today announced that it has reached the accrual goal for its randomized, double blind, placebo controlled study of CeaVac(TM) in advanced colorectal cancer. The clinical study is designed to evaluate the safety and efficacy of CeaVac in approximately 200 patients with previously untreated Dukes D colorectal cancer. Based upon the excellent accrual and lack of safety concerns to date, the study is being expanded to a Phase III study. Details of the expanded study protocol are currently being finalized with the FDA. Approximately 260 patients have been enrolled to date in the study, which is comparing the safety and efficacy of standard therapy, consisting of 5FU and Leucovorin, to standard therapy plus CeaVac. The study is being performed at 45 clinical centers in the US and United Kingdom. "We are pleased to be able to meet our initial accrual goals and further expand this clinical study," stated Dr. Louis R. Bucalo, President and CEO of Titan. "CeaVac is among the most advanced, standardized products in development for the active immunotherapy of colorectal cancer, and we look forward to the further progress of this study." In a related event, the Company also announced the recent issuance of United States patent number 5,977,315, covering it's CeaVac product and its use in generating immune responses to carcinoembryonic antigen, which is present on colorectal cancer cells and many other cancer cell types.