Imre's Prosorba To Enter Phase III Trial

Following on from encouraging results in its Phase I and II development program, Imre Corporation has announced that the US Food and Drug Administration has given conditional approval for a pivotal trial of its Prosorba column, a new treatment for rheumatoid arthritis. A six-month pilot study revealed a significant response in over 70% of treated patients (Marketletter October 9).

The study will begin in first-quarter 1996, and will include up to 268 patients. The FDA has said that the trial can go ahead, providing Imre submits information from the trial to the agency regularly and agrees to modify the protocol if necessary. The FDA is thought to be somewhat cautious given that Prosorba will be appraised under the medical device approval requirements, which are not as stringent as those for drugs. The planned study would cost around $10 million. The firm is hoping to raise $30 million through an equity offering and strategic alliance to finance this and other projects over the next three years.

Prosorba consists of a blood filtration column, designed to remove autoreactive T lymphocytes. The product is already US-approved for idiopathic thrombocytopenic purpura, and Imre has begun trials of the column in kidney transplant patients. The company says it is seeking corporate partners, and is hoping to raise $30 million through alliances and an equity offering to finance these projects over the next three years.