BioCryst Provides Forodesine HCL Update
- Category: Small Molecules
- Published on Sunday, 09 December 2007 17:49
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BioCryst Pharmaceuticals, Inc. today provided an update to the Company's forodesine HCl development program
BIRMINGHAM, AL, USA | December 6, 2007 | BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today provided an update to the Company's forodesine HCl development program
Forodesine HCl Data to be Presented at American Society of Hematology Meeting Madeleine Duvic, M.D., Deputy Chair, Dermatology, The University of Texas M.D. Anderson Cancer Center, is scheduled to present interim data from the Phase I/II clinical study of oral forodesine HCl in the treatment of patients with refractory cutaneous T-cell lymphoma (CTCL) at the annual meeting of the American Society of Hematology (ASH) in Atlanta, Georgia at 4:45 pm on Sunday, December 9.
Dr. Duvic's presentation entitled, "Response to Oral Forodesine in Refractory Cutaneous T-Cell Lymphoma: Interim Results of a Phase I/II Study" will provide additional data and analyses from this ongoing trial to supplement information presented at the 2006 ASH meeting.
BioCryst to Voluntarily Discontinue Clinical Study of Intravenous Forodesine HCl in Patients with T-ALL After review and consultation with Mundipharma, BioCryst has decided to voluntarily and formally discontinue its Phase IIb clinical trial of intravenous (i.v.) forodesine HCl in the treatment of patients with T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL). This was the only current trial using the i.v. formulation. The other clinical trials of forodesine HCl, including the CTCL trials, which are utilizing the oral capsule formulation, are not affected by this action and those trials continue. The decision to discontinue the trial in T-ALL is related to the delays associated with addressing the previously announced stability issue, the limited number of patients with T-ALL eligible to be enrolled in the trial and, the lower-than-expected response rate observed in the previous Phase IIa clinical trial for this indication.
On March 27, 2007 BioCryst announced that as the result of a stability issue, the Company was voluntarily placing its Phase IIb clinical trial of i.v. forodesine HCl in the treatment of patients with T-ALL/LBL on hold pending internal review and discussions with the Company's partner, Mundipharma.
"Through our partnership with Mundipharma, we remain committed to addressing the significant need for novel therapies for the treatment of cancer and are enthusiastic about the potential of forodesine HCl in treating patients with CTCL," said Jon P. Stonehouse, President and CEO of BioCryst. "We believe that by retaining our focus on CTCL we will be able to bring forodesine HCl to market as quickly as possible, providing patients with a needed treatment alternative."
Pivotal Clinical Trial Of Forodesine HCl in Patients with CTCL Currently Enrolling Patients As announced on October 12, 2007, enrollment has been initiated in the multinational, pivotal trial of oral forodesine HCl in the treatment of patients with CTCL.
Designed to evaluate once daily oral forodesine HCl treatment, the study is being conducted in accordance with a Special Protocol Assessment (SPA) agreement between the U.S. Food and Drug Administration (FDA) and BioCryst granted earlier this year.
Eligible patients are those with CTCL of Stages IB through IVA who have disease that is persistent, progressive or recurrent during or after treatment with at least three systemic therapies. The study's primary endpoint is to determine the objective response rate, defined as either complete response or partial cutaneous response that is sustained for at least 28 days. Secondary endpoints include assessing the safety and tolerability of extended daily treatment with oral forodesine HCl, assessment of the time to objective response and the duration of objective response.
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 http://www.biocryst.com.
SOURCE: BIOCRYST PHARMACEUTICALS