GENITOPE CORP.schon vor der Wende? - 500 Beiträge pro Seite

[gerdass]

Genitope Corporation (Genitope, NASDAQ: GTOP) today announced that a summary of the data from its pivotal Phase 3 clinical trial examining the use of MyVax® personalized immunotherapy (MyVax) in previously untreated follicular B-cell non-Hodgkin’s lymphoma (fNHL) patients is available on the Investor Relations section of Genitope’s Web site at http://ir.genitope.com. In December 2007, Genitope obtained data indicating that its pivotal Phase 3 clinical trial did not meet its primary endpoint. The primary analysis demonstrated that there was no statistically significant difference in the progression-free survival (PFS) of patients receiving MyVax compared to patients receiving a non-specific control immunotherapy. However, analysis of a pre-specified endpoint in the group of patients receiving MyVax showed a highly statistically significant difference in PFS between patients who mounted a positive immune response to the tumor-specific target and those who did not.




In early March 2008, Genitope met with the U.S. Food and Drug Administration (FDA) to discuss a potential regulatory path forward for MyVax. The FDA communicated to Genitope during this meeting that, in light of the Phase 3 clinical trial’s failure to meet its primary endpoint, one or more additional Phase 3 clinical trials for MyVax would be required before the FDA would accept a Biologics License Application for FDA review. In light of the FDA’s decision, Genitope suspended the development of MyVax in March 2008.

“We are extremely disappointed in the FDA’s decision and deeply saddened that Genitope is unlikely to be able to make MyVax personalized immunotherapy available to fNHL patients in the U.S.,” said Dan W. Denney, Jr., Ph.D., chairman and chief executive officer of Genitope Corporation.

Dr. Ronald Levy, Professor of Medicine, Stanford University Medical Center, is scheduled to present data from Genitope’s pivotal Phase 3 clinical trial of MyVax at the annual American Association for Cancer Research meeting taking place in San Diego, CA from April 12 – 16, 2008. The presentation will be held on Monday, April 14 at 4:30pm at Hall G-H at the San Diego Convention Center.

About Genitope Corporation

Genitope Corporation (Fremont, Calif.) is a biotechnology company focused on the research and development of novel immunotherapies for the treatment of cancer. Until Genitope recently suspended its development, its lead product candidate was MyVax personalized immunotherapy, a patient-specific active immunotherapy that is 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 is also developing a monoclonal antibody panel that it believes will potentially represent a novel, personalized approach for treating NHL. For more information about Genitope, please log on to http://www.genitope.com.



Media Contact:
Edelman
Courtney Walker
P: 212.704.8102
C: 646.338.9495
[e-mail]
or
Investor Contact:
Genitope Corporation
John Vuko
P: 510-284-3000
[e-mail]

Quelle B.Wire 09.04.2008

[gerdass]

cws was sagst du nun?

[cws]

Antwort auf Beitrag Nr.: 33.997.457 von gerdass am 29.04.08 21:44:28

es klingt gar nicht so schlecht
hat viel luft nach oben.

[gerdass]

Genitope Corporation (NASDAQ:GTOP) today announced that, on May 21, 2008, it received a staff determination letter from The Nasdaq Stock Market (“Nasdaq”) indicating that, as a result of the Company’s failure to timely file its Quarterly Report on Form 10-Q for the quarter ended March 31, 2008, Genitope no longer complied with Nasdaq’s filing requirements for continued listing as set forth in Marketplace Rule 4310(c)(14), and that its securities are, therefore, subject to trading suspension and delisting. That rule requires that each listed issuer to file copies of all reports and other documents required to be filed with the Securities and Exchange Commission (the “SEC”). The letter also stated that, unless the Company requests an appeal of the determination, trading of the Company’s common stock will be suspended at the opening of business on May 30, 2008, and a Form 25-NSE will be filed with the SEC, which will remove the Company’s securities from listing and registration on Nasdaq. On May 28, 2008, Genitope filed with the SEC its Quarterly Report on Form 10-Q for the quarter ended March 31, 2008.




There can be no assurance that Genitope will satisfy Nasdaq's conditions for continued listing, that Genitope will, if required, request a hearing to appeal the staff determination or, if requested, that Genitope will be successful in its appeal or that Genitope's common stock will remain listed on The Nasdaq Global Market or will be listed on another exchange or traded in another market.

About Genitope Corporation

Genitope Corporation (Fremont, Calif.) is a biotechnology company focused on the research and development of novel immunotherapies for the treatment of cancer. Until Genitope recently suspended its development, its lead product candidate was MyVax personalized immunotherapy, a patient-specific active immunotherapy that is 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 is also developing a monoclonal antibody panel that it believes will potentially represent a novel, personalized approach for treating NHL. For more information about Genitope, please log on to http://www.genitope.com.

Forward-Looking Statements

This news 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 forward-looking statements, including statements regarding the potential listing status and potential delisting of Genitope's common stock from The Nasdaq Global Market and statements regarding its possible appeal of the Nasdaq staff determination letter and the potential outcome thereof. There are a number of important factors that could cause Genitope's results to differ materially from those indicated by these forward-looking statements, including without limitation, risks related to Genitope's need for significant additional funding, the Company’s ability to operate as a going concern, the progress, timing and results of Genitope's clinical trials and regulatory approvals and other risks discussed under the heading "Risk Factors" in Genitope's filings with the SEC, including its Quarterly Report on Form 10-Q for the three months ended March 31, 2008. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genitope undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Investor Contact:
Genitope Corporation
John Vuko, 510-284-3000
[e-mail]
or
Media Contact:
Edelman
Courtney Walker, 212.704.8102
[e-mail]