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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."
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