Vertex in the News | 2007

D-Pharm reports successful Phase IIb trials for stroke drug
Next week, the company is due to meet pharmaceutical representatives at a JP Morgan conference.
Author: Gali Weinreb
Globes, Jan 3, 2007

D-Pharm Ltd. today reported good results in its Phase IIb clinical trial for its stroke treatment, DP-b99. The trials were conducted on 150 patients who suffered from ischemic brain strokes. 75 patients were given the drug and 75 were given a placebo up to 12 hours after the stroke.
Over 90 days, various tests were carried out to examine the extent of the damage. All the tests showed some degree of effectiveness of DP-b99 compared with the placebo. The strongest measures were the number of patients who returned to their pre-stroke condition after being given the drug - double the number of patients who were given the placebo; and the degree of damage in patients with medium to severe strokes, which was almost double in the patients who were given the placebo compared with those who were given the drug.

Interestingly, there was almost no difference between the patients who were given DP-b99 immediately after the stoke and the patients who were given the drug after 12 hours. This means that there is a long window of treatment. This is an important factor, because it allows for the treatment of strokes in patients who reach hospital several hours after the event, and who cannot be treated with current drugs.

Generally, the completion of Phase IIb clinical trials is when most pharmaceutical start-up are acquired or when they sign large licensing contracts to develop their drugs. D-Pharm is not currently in advanced negotiations with anyone regarding DP-b99, but it is in contact with most pharmaceutical companies. Next week, the company is due to meet pharmaceutical representatives at a JP Morgan conference, and things will then begin to move.

Studies indicate that the quality and size of Phase II clinical trials strongly affect the size of any subsequent deal, and D-Pharm’s trial is big enough. The company says that the trial was also of especially high quality. “We carefully designed the trial in a way that very few Israeli companies do, so that we’ll be sure that if it ends as we want then we’ll get commercial advantage from it,” said Ofer Goldberg of Clal Biotechnology Industries Ltd. (CBI), which owns 33% of D-Pharm.

Published by Globes [online], Israel business news - www.globes.co.il - on January 3, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2006

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