Clal Biotechnology Industries Ltd. (TASE: CBI) portfolio company D Pharm Ltd. has filed an Investigational New Drug (IND) application US Food and Drug Administration (FDA) for the Phase III clinical trial of DP-b99 for the treatment of acute ischemic stroke. The company believes that the application will take about two months to process, and that the trial will begin shortly afterwards.
D-Pharm also applied for an Special Protocol Assessment (SPA), under which the FDA will review the trial protocol, and, insofar as the trial is successful, it confirm that the data will form the primary basis for a claim of efficacy. The company also obtained Scientific Advice from the European Medicines Agency (EMEA) on the development strategy for DP-b99 in Europe.
The trial will be a large one. D-Pharm plans to enroll 770 moderate to severely affected ischemic stroke patients in over 100 clinical sites in North America, Europe, South Africa, and Israel. The trial cost could exceed $10 million, and results may not be available for at least two years.
Currently, there is only one treatment for ischemic stroke, and it involves considerable risks and is only effective if taken within six hours of the event. A new stroke treatment could have billions to tens of billions of dollars in annual sales.
The risk is as great as the potential reward. Ischemic stroke is very difficult to treat or test clinically. The costs of clinical trials are high. Trials of stroke drugs by several leading companies have failed in recent years.
Because of the risk and its effect on pricing, D-Pharm has not yet reached any agreement with a large drug company for the joint development of DP-b99, despite the good results of the Phase II clinical trial, and D-Pharm is conducting the trial independently.
Published by Globes [online], Israel business news - www.globes-online.com - on May 6, 2009
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