Data Presented at 2007 ASH Meeting Demonstrate Activity of Forodesine HCl as a Single Agent or in Combination With Bendamustine in Certain Types of Leukemia and Lymphoma
Friday December 14, 7:00 am ET
BIRMINGHAM, Ala., Dec. 14 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX - News) today reported clinical trial and in vitro data evaluating forodesine HCl, the Company's lead anti-cancer compound, in the treatment of certain types of leukemias and lymphomas.
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Madeline Duvic, M.D., Deputy Chair, Dermatology, The University of Texas M.D. Anderson Cancer Center presented interim data from the Phase I/II clinical study of oral forodesine HCl in the treatment of subjects with refractory cutaneous T-cell lymphoma (CTCL). The open-label, multi-center, dose-escalation trial further evaluated oral forodesine HCl at the optimal biologic dose in 36 subjects with refractory CTCL. The overall response rate for these subjects was 39%, including 2 subjects with complete response (6%) and 12 subjects with partial response (33%). For those patients with erythroderma at baseline, 65% of patients had significant improvement in erythroderma. These data concluded that in addition to a good safety profile, forodesine HCl demonstrated clinical activity as a single oral agent in patients with advanced refractory CTCL. These data supplement information previously presented at the 2006 ASH meeting. BioCryst is currently enrolling subjects in a pivotal trial of forodesine HCl for the treatment of CTCL.
Additionally, Roberto Alonso Gil, Ph.D., Hematopathology Unit, Clinic Hospital of Barcelona presented a poster detailing the in vitro activity of forodesine HCl and the synergistic in vitro activity of forodesine HCl with bendamustine in primary cells from 29 patients with chronic lymphocytic leukemia (CLL). Forodesine HCl alone induced apoptosis regardless of the ZAP-70 and p53 status. In addition, a significant synergistic effect was observed with the combination of forodesine HCl and bendamustine in these in vitro experiments.
"We believe the encouraging clinical data presented by Dr. Duvic support the further development of forodesine HCl as a single agent and further validate our ongoing pivotal trial in patients with CTCL," said Jon P. Stonehouse, President and CEO of BioCryst. "Additionally, the data from Dr. Gil's laboratory suggest a therapeutic potential for forodesine HCl as a single agent as well as in combination with bendamustine as potentially effective therapeutic options in the treatment of CLL."
About BioCryst
BioCryst Pharmaceuticals, Inc. is a leader in the use of crystallography and structure-based drug design for the development of novel therapeutics to treat cancer, cardiovascular diseases, autoimmune diseases, and viral infections. The company is advancing multiple internal programs toward potential commercialization including forodesine HCl in oncology, BCX-4208 in transplantation and autoimmune diseases and peramivir in seasonal and life- threatening influenza. BioCryst has a worldwide partnership with Roche for the development and commercialization of BCX-4208, and is collaborating with Mundipharma for the development and commercialization of forodesine HCl in markets across Europe, Asia, Australia and certain neighboring countries. In January, 2007 the U.S. Department of Health and Human Services (DHHS) awarded a $102.6 million, four-year contract to BioCryst for advanced development of peramivir to treat seasonal and life-threatening influenza. In February 2007 BioCryst established a partnership with Shionogi & Co., to develop and commercialize peramivir in Japan. For more information about BioCryst, please visit the company's web site at biocryst.com |
