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The Leukemia & Lymphoma Society and Memgen Collaborate on CLL Clinical Trial
Date:6/18/2008

WHITE PLAINS, N.Y., June 18 /PRNewswire/ -- The Leukemia & Lymphoma Society (LLS) and Memgen jointly announced an agreement today to collaborate on a new Phase I clinical trial. The trial will use Memgen's ISF35, an active immunotherapy approach for treating chronic lymphocytic leukemia (CLL).

Based on its alliance with LLS, Memgen plans to begin a Phase I clinical trial this year for up to 12 patients who have 17p-, refractory or resistant CLL with limited therapeutic options. Patients will receive three infusions of ISF35, followed by up to three courses of FCR (fludarabine, cyclophosphamide and rituximab). After treatment, the patients will be followed for at least one year to determine the safety and efficacy of the regimen.

Charles Prussak, Ph.D., Pharm.D., one of the founders of Memgen, said, "Memgen is very pleased to be working with The Leukemia & Lymphoma Society. ISF35 has the potential to become a cornerstone in treatments for leukemia and perhaps for lymphoma. In the initial Phase I CLL clinical trial of ISF35, conducted by William Wierda, M.D., Ph.D., at The University of Texas M. D. Anderson Cancer Center, a single infusion of ISF35 resulted in the rapid decline in circulating and lymph node bound leukemic cells, induced long-term immune based responses against these cells and sensitized them to standard chemotherapies, even in several patients with drug resistant disease."

In commenting on Memgen's upcoming clinical trial, Louis J. DeGennaro, Ph.D., LLS's chief scientific officer, said, "There is a clear unmet medical need for new therapies to treat refractory or relapsed CLL, in particular the 17p- patients. Many of these patients do not respond to current conventional therapy and their treatment options are severely limited. Our goal is to bring new treatment options to these patients more quickly. The partnership with Memgen accelerates the clinical testing of an immunotherapy and brings us closer to that goal."

The agreement marks the first immunotherapy clinical trial funded by LLS's Therapy Acceleration Program, an innovative program designed to advance therapies with high prospects of providing near-term benefit to patients suffering from blood cancers.

About Memgen, LLC

Memgen is a biotechnology company with offices in Dallas, TX and San Diego, CA. Memgen was founded four years ago to develop non-toxic and targeted active immunotherapies for the treatment of cancers. Its lead product, ISF35, has demonstrated potent anti-leukemic activity as a single agent while being well tolerated. ISF35 generates none of the immunosuppressive activities associated with standard cancer treatments.

ISF35's results are achieved through its ability to bind to a protein found on leukemic B lymphocytes. This activates a natural immune process that causes malignant cells to become more sensitive to subsequent chemotherapy treatments. This targeted and active approach by ISF35 first makes the leukemias and lymphomas more "visible" to the human immune system. Then, ISF35 activates the immune system so that it can seek out and destroy the cancerous cells.

Memgen is now seeking corporate partners to assist in the development of the ISF35 molecule as it enters advanced stage clinical trials. For more information about Memgen, please visit http://www.memgenbio.com.

About The Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society(R), headquartered in White Plains, NY, with 68 chapters in the United States and Canada, is the world's largest voluntary health organization dedicated to funding blood cancer research and providing education and patient services. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. Since its founding in 1949, LLS has invested more than $600 million in research specifically targeting leukemia, lymphoma and myeloma. Last year alone, LLS made 5.1 million contacts with patients, caregivers and healthcare professionals.

For more information about blood cancer, visit http://www.LLS.org or call the LLS Information Resource Center (IRC), a call center staffed by master's level social workers, nurses and health educators who provide information, support and resources to patients and their families and caregivers. IRC information specialists are available at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. ET


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SOURCE The Leukemia & Lymphoma Society
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