D-Pharm Ltd. (TASE: DPRM) has obtained US Food and Drug Administration (FDA) approval of the terms for its stroke medication study. The special protocol assessment (SPA) is for a Phase III clinical trial of the company's ischemic stroke treatment, Dp-b99.
In late 2009, D-Pharm began recruitment of the 770 patients for the trial. The FDA informed the company that planning and analysis of the trial complied with the requirements for applying for marketing approval of the drug. This means that if the trial is successful, the FDA will accept the results for a marketing application.
D-Pharm held its IPO last summer. The share fell 1.9% by mid-afternoon today to NIS 25.22, giving a market cap of NIS 531 million.
Clal Biotechnology Industries Ltd. (TASE: CBI) owns 46.6% of D-Pharm. Another Clal Biotech company, Thrombotech Ltd. today announce that it has begun a Phase I clinical trial of its peptide-based treatment for ischemic stroke.
Published by Globes [online], Israel business news - www.globes-online.com - on April 15, 2010
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