ProCyte Corp. completed its rebound from the 1994 failure of its leaddrug, Iamin gel, on Wednesday with the clearance of the product forwound-care applications.
The gel, a tripeptide complexed with copper, was cleared under510(k) premarket notification regulatory procedures as a Class Imedical device. The Kirkland, Wash., company is bringing on a 15-to 20-person sales team and expects a mid-year launch, said KarenHedine, ProCyte's vice president, business development andadministration. Co-distribution possibilities are being looked at, shesaid.
In addition, Hedine said ProCyte is planning trials of Iamin as awound-healing drug in Europe, and is exploring the possibility ofbringing Iamin back into the clinic in the U.S. for certain indications.Japanese partner Kissei Pharmaceuticals Co. Ltd., of Matsumoto, hasIamin gel in a Phase I study there and is gearing up for Phase II,Hedine said. ProCyte is running a Phase I/II U.S. study of Iamin inulcerative colitis.
The company's stock (NASDAQ:PRCY) gained 60 percentWednesday, or $1.97, to close at $5 in trading of nearly 2.6 millionshares.
"It's a company that has really started turning ship," Hedine said."Up until yesterday we were known as a R & D-based company."We're trying to be a sales and marketing-oriented company that hasbehind it a nice R & D pipeline."
Iamin is the flagship product of what ProCyte hopes will become adiverse wound care business. The company recently acquired rightsto a family of polymer-based wound care products and the underlyingtechnology.
Hedine said the testing of Iamin gel in more than 800 people,establishing solid safety data, together with the underlying science ofthe product, could differentiate Iamin in the large wound-care market.
The company's pipeline includes the peptide-copper compoundTricomin, which is in Phase II studies for male pattern baldness, andantiviral compounds in the research stage. n
-- Jim Shrine
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