Genitope
Corporation (Nasdaq: GTOP) today announced that MyVax(R) personalized
immunotherapy received Fast Track designation from the U.S. Food & Drug
Administration (FDA) for the treatment of follicular non-Hodgkin's Lymphoma
(fNHL).
The FDA grants Fast Track designation to products that may provide a
significant improvement in the safety or effectiveness of the treatment for
a serious or life-threatening disease. Under this designation, the FDA will
take such actions as are appropriate to expedite the development and review
of the MyVax(R) personalized immunotherapy biologics license application
(BLA) for approval. FDA may also begin review of portions of a BLA in
advance of the full submission. Products that receive the designation are
also eligible for priority review, which provides for a six-month review of
the BLA by the FDA.
"Securing Fast Track designation for MyVax(R) personalized
immunotherapy in advance of the Phase 3 study interim analysis this summer
is especially meaningful and puts us one step further down our pathway
toward commercialization," said Dan W. Denney, Jr., Ph.D., chief executive
officer of Genitope Corporation. "We welcome this designation, as we
execute against our commercialization plan, which includes the build-out of
our manufacturing facility, adding senior management and developing our
product pipeline through a robust clinical program."
Genitope Corporation initiated a Phase 3 pivotal trial evaluating
MyVax(R) personalized immunotherapy in Stage III/IV fNHL patients. The
pivotal trial was based upon results from three separate Phase 2 trials,
evaluating the long-term efficacy of this treatment. Results from the
Genitope Phase 2 trial presented at the American Society of Hematology
(ASH) annual meeting in December 2005 showed nine of the 21 patients in
this trial remained progression-free as of their last clinical follow-up at
56 to 78 months post- chemotherapy.
About Genitope Corporation
Genitope Corporation (Redwood City, Calif.) 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. For more information on the company, please log on to
genitope.
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 but not limited to statements about MyVax(R) personalized
immunotherapy, the progress of Genitope Corporation's commercialization
plan, the build-out of Genitope's manufacturing facility, the addition of
senior management and Genitope's development of a product pipeline through
a robust clinical program. 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 and uncertainties relating to the
progress, timing and results of Genitope's clinical trials and other
research and development activities, the manufacturing of MyVax(R)
personalized immunotherapy, Genitope's ability to obtain marketing approval
for MyVax(R) personalized immunotherapy or other product candidates and the
timing of any such approvals and other risks detailed in Genitope
Corporation's filings with the Securities and Exchange Commission,
including its Quarterly Report on Form 10-Q for the quarter ended March 31,
2006 filed by Genitope Corporation with the Securities and Exchange
Commission. 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 Corporation undertakes no obligation to revise or update
any forward-looking statements to reflect events or circumstances after the
date hereof.
Genitope Corporation
genitope