Andromeda Biotech Ltd. today published interim results for the Phase IIIb clinical trial of its Diapep277 drug for the treatment of type 1 diabetes (childhood onset diabetes). The company said that there was progress, but not significant progress.
The trial, approved by the European Medicines Agency (EMEA), included 400 patients at 40 medical centers. The interim report examined the safety profile of Diapep277 at the dosages needed to demonstrate its effectiveness. An independent committee examined the results on 100 patients who had completed 18 months of therapy and 37 patients who completed 12 months.
Interim results for Phase III trials usually show clear results with 90% or more certainty. This was note the case for Diapep277. The trial found that the drug was safe, but that progress was not significant. The interim report advised continuing the study on a larger group to determine if the results will be more significant. A second interim report is expected in six month.
Andromeda Biotech is a wholly-owned subsidiary of Clal Biotechnology Industries Ltd. (TASE: CBI). Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has an option to invest more than $300 million in Andromeda Biotech, at a maximum company value of $555 million, subject to the company meeting certain milestones. The determining date for exercising the first option is 60 days from receipt of the interim report, at which point Teva can invest $21 million in the company at a company value at $90 million.
Since the interim report is ambiguous, Teva may ask for a postponement for exercising the option until the next interim report.
Published by Globes [online], Israel business news - www.globes-online.com - on June 17, 2008
© Copyright of Globes Publisher Itonut (1983) Ltd. 2008