TransPharma Medical Ltd. has successfully conducted a Phase IIa preliminary clinical trial for its osteoporosis treatment. The trial was conducted together with Eli Lilly (NYSE: LLY), which also financed it.
TransPharma has developed an innovative method of delivering biological drugs via the skin rather than by injection. It has an agreement with Eli Lilly worth hundreds of millions of dollars altogether, of which it has received $35 million as an initial payment.
TransPharma has not published full details of the trial results, which it plans to present at professional conventions on osteoporosis at the beginning of 2010. However, it reported that the goals for safety and initial efficacy were achieved. Since this is still an early trial, the experimental group is not very large, and there is no obligation to achieve the trial goals with any degree of statistical significance in order to proceed further. Nevertheless, this is an important milestone for the Israeli company.
According to the clinical trials website of the US National Institutes of Health, the trial compared administration of the treatment using TransPharma's product with administration by direct injection. 104 patients participated in the trial, which was conducted over a period of three months.
TransPharma said that the next trial stage, Phase IIb, would take place in 2010. This phase will also be conducted with Eli Lilly, and will involve a larger experimental group. It will determine the recommended dose.
A trial such as this is likely to cost upwards of $10 million. Under the agreement between the two companies, Eli Lilly will bear most of the cost.
Published by Globes [online], Israel business news - www.globes.co.il - on August 31, 2009
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