Guest guest Posted March 4, 2006 Report Share Posted March 4, 2006 Greetings, Within is a press release about the new vaccine study for CLL, along with a protocol outline and a link to details. ~ Karl = Genitope Corporation Initiates Clinical Trial to Evaluate MyVax® Personalized Immunotherapy in the Treatment of Chronic Lymphocytic Leukemia REDWOOD CITY, Calif., Feb. 27 /PRNewswire-FirstCall/ -- Genitope Corporation (Nasdaq: GTOP) today announced the initiation of a clinical trial to evaluate the use of MyVax® personalized immunotherapy to treat Chronic Lymphocytic Leukemia (CLL), a type of cancer affecting the blood and bone marrow. MyVax® 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® 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® 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® 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 s Cancer Center at University of California, San Diego. " The goals of this Phase I/II study are to determine whether MyVax® 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 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 http://www.genitope.com. Genitope Protocol 2005-11: Phase 1/2 Study to Evaluate the Feasibility and Tolerability of Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients with Recombinant Idiotype Conjugated to KLH (Id-KLH) Administered with GM-CSF. Protocol outline: Eligible patients will provide a blood sample or tissue sample from which their personalized immunotherapy will be made. Manufacture of Personalized Immunotherapy may take up to 8 months. Patients' disease activity will be observed while their personalized immunotherapy is being made. " Watchful waiting " is the typical standard of care for patients who are eligible for this study. Once the personalized immunotherapy is produced, a series of 16 immunizations with Id-KLH plus GM-CSF will be given over a 1-year time period. The immunizations will be followed by a 1-year observation period during which study visits will occur every 3 months. After that, patients or their treating physicians will be contacted every 6 months to collect information about subsequent anti-leukemia therapy and survival. For details see: http://www.genitope.com/tr2011.html 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® 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 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 efficacy of MyVax® 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® 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® 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. Media Contact: Waters / Jackie Quintanilla P: 310-593-3443 / 310-962-2005, lisa.waters@... jacqueline.quintanilla@... Investor Contact: Vuko Chief Financial Officer, Genitope Corporation, P: 650-482-2000 IR@... Donna Shu Manager of Advocacy Development Genitope Corporation Quote Link to comment Share on other sites More sharing options...
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