Genitope Corporation Provides Update on Progress of Lead Product Candidate
Tuesday November 16, 6:00 pm ET
Data Safety Monitoring Board Recommends Continuation of Phase 3 Clinical Trial of MyVax(R) Personalized Immunotherapy
REDWOOD CITY, Calif., Nov. 16 /PRNewswire-FirstCall/ -- Genitope Corporation (Nasdaq: GTOP - News) today announced that its independent Data Safety Monitoring Board (DSMB) met on November 15, 2004 to review data from Genitope Corporation's pivotal Phase 3 clinical trial to evaluate the safety and efficacy of the company's lead product candidate, MyVax® Personalized Immunotherapy, in patients with previously untreated follicular non-Hodgkin's lymphoma (f-NHL). After reviewing safety data for the entire Phase 3 trial and blinded, preliminary immune response data for more than 100 of the initial patients immunized in the Phase 3 trial, the DSMB noted no concerns and recommended that the trial continue as planned.
"We are very pleased with the outcome of the DSMB meeting and with the results of the preliminary immune response testing. We are looking forward to the expected initiation of the first interim analysis of the data in the pivotal Phase 3 trial in the second quarter of 2005," said Dan W. Denney, Jr. Ph.D., chairman and chief executive officer of Genitope Corporation.
The goal of the company's Phase 3 clinical trial is to compare the progression-free survival time of those treated with MyVax® Personalized Immunotherapy to the control group.
Additionally, following a meeting of the company's Board of Directors on November 15, 2004, the company is moving forward with lease negotiations for buildings identified as potential sites for Genitope Corporation's commercial manufacturing facility |
