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Genitope Corporation Provides Update on Progress of Lead Product Candidate
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) 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(R) 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(R) 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.
About Genitope Corporation
Genitope Corporation is a biotechnology company focused on the research and development of novel immunotherapies for the treatment of cancer. Genitope Corporation's lead product candidate, MyVax(R) Personalized Immunotherapy, is a patient-specific active immunotherapy based on the unique genetic makeup of a patient's tumor and is designed to activate the patient's immune system to identify and attack cancer cells. Genitope Corporation is based in Redwood City, California. For more information about Genitope Corporation, please call 866-GENITOPE or visit www.genitope.com.
Forward Looking Statements
This press release contains "forward-looking" statements. For this purpose, any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including statements about the expected interim analysis of the ongoing Phase 3 trial and plans to move forward with lease negotiations. Words such as "believes," "anticipates," "plans," "expects," "will," "intends" and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Genitope Corporation's results to differ materially from those indicated by these forward-looking statements, including, without limitation, risks related to Genitope Corporation's need for additional funding, the progress, timing and results of the company's clinical trials, including the fact that neither the DSMB determination nor the preliminary immune response testing is indicative of any results of the ongoing Phase 3 trial and that failure can occur at any stage of testing, and other risks detailed in Genitope Corporation's filings with the Securities and Exchange Commission, including the Quarterly Report on Form 10Q for the fiscal quarter ended September 30, 2004. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and Genitope Corporation undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Contact:
John Vuko
Chief Financial Officer
Genitope Corporation
Ph: 650-482-2000
IR@genitope.com
Quelle: Genitope Corporation
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