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FAVRILLE COMPLETES PHASE II NON-HODGKIN'S ENROLLMENT.

Favrille, Inc., San Diego, Calif., has completed enrollment for its current Phase II clinical trial (FavId-04) with the company's lead investigational agent, FavId(tm). This agent is under clinical development for the treatment of follicular B-cell lymphomas following cytoreductive therapy with Rituxan(r), the leading biopharmaceutical approved for the treatment of this disease.

The FavId-04 trial includes 90 evaluable patients with follicular non-Hodgkin's lymphoma (fNHL), an incurable form of cancer. The Phase II trial is designed to evaluate the ability of patients to mount an immune response to their tumor and the potential for FavId to enhance the response rate or prolong the time to progression following Rituxan treatment.

"Favrille's technology enables us to develop a new generation of cost-effective treatments specific for individual patients. The FavId-04 trial is the largest study to date combining Rituxan treatment followed by patient-specific immunotherapy. Completing the enrollment for this key Phase II trial, represents a major corporate milestone toward seeking eventual health agency approval of FavId," said John Longenecker, Ph.D., Favrille's president and CEO

At the American Society of Hematology 45th Annual Meeting, Favrille presented interim results from the Phase II study demonstrating that following Rituxan treatment, FavId may prolong the time to progression of the disease in study patients who were relapsed or refractory following prior chemotherapy and /or Rituxan treatment. Many of these patients are still being followed and the duration of their responses assessed. The most common side effects were temporary redness and soreness at the injection site. Additional data in newly diagnosed, treatment-naive patients will be available in the second quarter of 2004.

The company plans to initiate a Phase III clinical trial in the second quarter of 2004.

About fNHL

According to the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) statistics, non-Hodgkin's Lymphomas are the sixth most common cancer, with approximately 300,000 cases in the U.S., and the sixth most common cause of cancer death. While several therapies exist for patients with fNHL, most patients will eventually have their tumor return, and long-term survival rates remain low.

About Favrille, Inc.

Favrille, Inc., a privately held biotechnology company, has developed a proprietary technology platform that utilizes the unique characteristics of each patient's disease to generate patient-specific therapeutics for the treatment of cancer and autoimmune disease. The company has completed enrollment in two PII clinical studies to assess the utility of its products in treating fNHL. Favrille maintains it's corporate and R&D headquarters in San Diego, California.

For more information, call 858/526-8035 or visit http://www.favrille.com.
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Publication:Biotech Business
Geographic Code:1USA
Date:Feb 1, 2004
Words:425
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