Genitope starts clinical trial to evaluate lymphocytic leukemia drug MyVax

By Elaine Rigoli

Tampa, Fla., Feb. 27 - Genitope Corp. announced Monday the launch of a phase 1/2 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 genetic makeup of a patient's own tumor and is designed to activate the patient's immune system to fight cancer, according to a company news release.

The goals of the study are to determine whether MyVax can induce antitumor immune responses that can eradicate or block the progression of leukemia and to determine the tolerability of this approach as a therapy for CLL, the release said.

"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, in a statement.

"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 about 70 patients in the trial. Men and women 18 years of age or older who have been diagnosed with CLL Rai stage 0, 1 and 2, and who are untreated may be eligible for the study, the release said.

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, MD, Ph.D, in the release.

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.

Genitope said CLL, which is incurable, affects about 70,000 patients in the United States.

Redwood City, Calif.-based Genitope is a biotechnology company focused on the research and development of immunotherapies for the treatment of cancer.

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