By Mary Welch
IntraBiotics Pharmaceuticals Inc., which has shown unwavering faith in Protegrin IB-367 Rinse, took another step toward justification as the topical anti-microbial started Phase III studies for the prevention and treatment of oral mucositis.
The trial is designed to demonstrate whether Protegrin IB-367 Rinse reduces the severity of oral mucositis, a condition characterized by painful mouth ulcers that form as a side effect of cancer therapies. The study will enroll 316 patients at 20 sites in the U.S. and Europe. The study will evaluate the safety and efficacy of Protegrin IB-367 Rinse in patients receiving high doses of chemotherapy, which frequently is responsible for severe oral mucositis.
Protegrin IB-367 successfully completed Phase II trials, but partner Pharmacia Corp. (formerly Pharmacia & Upjohn), of Bridgewater, N.J., opted out of the collaboration. Pharmacia returned the worldwide rights, saying the drug wasn't a good match for its pipeline. The two firms started their collaboration in 1997, with Pharmacia agreeing to pay up to $35 million to develop and commercialize the drug. (See BioWorld Today, Aug. 11, 1999, p. 1., and Oct. 30, 1997, p. 1.)
After its partner dropped the program, IntraBiotics completed the largest private placement in its six-year history, raising $25 million to help advance the Phase III trials of IB-367 and ramoplanin. Ramoplanin is a naturally occurring antibiotic that has shown potent activity against methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus faecium, two multi-drug-resistant pathogens that cause infections. (See BioWorld Today, Nov. 11, 1999, p. 1.)
In order to raise more money for the trials, the Mountain View, Calif.-based company went public in late March, raising $90 million. (See BioWorld Today, March 29, 2000, p. 1.)
Protegrin IB-367 is an analogue of a naturally occurring antibiotic originally purified from white blood cells of pigs. It is a synthetic peptide based on a class of antimicrobial peptides called protegrins.
IntraBiotics' stock (NASDAQ:IBPI) closed Thursday at $12.50, up 50 cents.