Genitope initiates clinical trial to evaluate GTOP-99 following use of Rituxan.

2003 JAN 1 - (NewsRx.com & NewsRx.net) -- Genitope Corp. announced the initiation of a clinical trial to evaluate the use of GTOP-99, a personalized vaccine-like immunotherapy, following treatment with Rituxan (rituximab) for patients previously treated for follicular non-Hodgkin lymphoma (fNHL).

This open-label study, referred to as 2002-09, will involve only patients previously registered in Genitope's ongoing pivotal Phase III clinical trial.

The protocol for Genitope's Phase III clinical trial requires that patients undergo a standard chemotherapy regimen, followed by a 26-week rest period, prior to receiving GTOP-99 or control. Patients who do not demonstrate a partial or complete response to initial chemotherapy, or who progress during the rest period, are not eligible to proceed to the immunization stage of the trial. The 2002-09 clinical trial will now give these patients the opportunity to receive their personalized vaccine, following a treatment regimen with Rituxan.

"Follicular lymphomas typically respond to initial chemotherapy but most patients ultimately relapse, thus requiring further treatment," said Dan W. Denney Jr., PhD, chairman and chief executive officer of Genitope. "Subsequent therapies, which may include monoclonal antibodies such as Rituxan, may provide remissions which are often of short duration. A personalized approach using GTOP-99 following Rituxan may provide better treatment results than previously seen."

Upon enrollment in the 2002-09 clinical trial, study participants will receive a course of Rituxan. Patients who achieve at least a partial response to the Rituxan infusions will receive a series of immunizations of GTOP-99. The personalized vaccine is manufactured from the patient's own tumor cells and is intended to stimulate the patient's immune system to recognize his or her tumor as foreign and in turn attack the cancer cells to prevent relapse. The adjuvant GM-CSF, ...