Genitope
Corporation (Nasdaq: GTOP) today announced the initiation of a clinical trial
to evaluate the use of MyVax(R) personalized immunotherapy to treat Chronic
Lymphocytic Leukemia (CLL), a type of cancer affecting the blood and bone
marrow. MyVax(R) personalized immunotherapy is based on the unique genetic
makeup of a patient's own tumor, and is designed to activate the patient's
immune system to fight cancer.
"Active immunotherapy, sometimes called a cancer vaccine, has shown
considerable promise in treating non-Hodgkin's lymphoma," said Dan W. Denney,
Jr., Ph.D., chief executive officer of Genitope. "The initiation of this trial
marks a key milestone in our efforts to expand the clinical development of
MyVax(R) personalized immunotherapy beyond non-Hodgkin's lymphoma in the hope
of finding an effective treatment for CLL."
Nine leading North American cancer centers will begin registering
approximately 70 patients in a Phase I/II clinical trial to investigate
MyVax(R) personalized immunotherapy for treating CLL. Men and women 18 years
of age or older who have been diagnosed with CLL Rai stage 0, I and II, and
who are untreated may be eligible for the study. Eligible patients will
receive a series of 16 injections of his or her custom-made immunotherapy over
a 52-week period.
"B-cell malignancies are good candidates for active immunotherapy. Unlike
many other types of cancer, B-cell leukemias and lymphomas each have unique
proteins that can distinguish them from one another and from normal cells.
MyVax(R) personalized immunotherapy will help the body target this unique
protein on the cancer cells, while sparing healthy cells," said the study's
lead investigator, Tom Kipps, M.D., Ph.D., Professor of Medicine, Head of the
Hematologic Malignancies Program and Deputy Director for Research at the
Moores Cancer Center at University of California, San Diego. "The goals of
this Phase I/II study are to determine whether MyVax(R) personalized
immunotherapy can induce anti-tumor immune responses that can eradicate or
block the progression of leukemia and to ascertain the tolerability of this
innovative approach as a therapy for CLL."
"The results of early clinical trials at Stanford University Medical
Center suggest that personalized active immunotherapy may induce long-term
remission and improve survival in NHL patients, which leads us to believe this
treatment method may be useful in other B-cell malignancies," said Richard
Furman, M.D., head of CLL and Waldenstrom's Macroglobulinemia program at Weill
Medical College of Cornell University in New York.
CLL is a type of cancer in which the bone marrow makes too many
lymphocytes, a type of white blood cell. It is characterized by an
uncontrolled accumulation of large numbers of lymphocytes in the blood, bone
marrow, lymph nodes and other organs. CLL, which is currently incurable,
affects approximately 70,000 patients in the U.S.
For more information about the trial and a complete list of open trial
sites, patients can call Genitope Corporation at 866-GENITOPE or visit the
company's Web site at genitope.
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 statements
regarding the potential efficacy of MyVax(R) personalized immunotherapy for
the treatment of NHL and CLL and the anticipated timing, scope and potential
outcome of Genitope Corporation's Phase I/II clinical trial of MyVax(R)
personalized immunotherapy for the treatment of CLL. 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 the progress, timing and
results of Genitope Corporation's clinical trials, risks relating to the
manufacturing of MyVax(R) and other risks detailed in Genitope Corporation's
filings with the Securities and Exchange Commission, including under the
heading "Risk Factors" in the prospectus supplement and accompanying
prospectus filed by Genitope Corporation with the Securities and Exchange
Commission on February 8, 2006. 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
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