IntraBiotics Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing high-value anti-infectives and oncology therapeutics, announced top-line results of its 545 patient Phase III clinical trial of lead product, iseganan hydrochloride (HCl) oral solution, to treat patients undergoing radiotherapy to prevent or reduce ulcerative oral mucositis (UOM), a debilitating side effect of cancer therapy.
The trial showed no difference between iseganan and placebo in the primary or secondary end-points. The group of patients who received iseganan and the group of patients who received placebo did better than the group of patients who received only standard of care.
The company is still in the process of fully analyzing and evaluating these data and full results will be presented during an oral presentation on May 21st at the 38th Annual Meeting of the American Society for Clinical Oncology (ASCO).
Iseganan hydrochloride (HCl) oral solution is a broad-spectrum, fast-acting antibiotic that functions by a novel mechanism of action, substantially reducing the likelihood that microbial resistance will develop. It is the first in a new class of antibiotic peptide drugs known as protegrins, which are naturally-occurring substances in mammals that form part of the first line of defense against invading bacteria and fungi.
Early stage clinical trials have been completed with iseganan for prevention of ventilator-associated pneumonia (VAP), and for treatment of respiratory infections associated with cystic fibrosis. These indications could significantly expand the market for this product in the future.
"Based on these results, iseganan does not appear to provide clinical benefit for patients undergoing radiotherapy," said Dr. Ernest Mario, chairman and CEO of IntraBiotics. "In the meantime, we are continuing our Phase III study of iseganan in high-dose chemotherapy patients and expect to announce that data by the end of this year. Our previous studies have indicated potential clinical benefit in this patient group, so we remain hopeful about this and other possible future applications for iseganan, including ventilator-assisted pneumonia and cystic fibrosis." We are planning to begin a Phase II trial with iseganan in ventilator-assisted pneumonia in the second half of this year. So while disappointing, these results do not change our plans to develop iseganan and to acquire other products in the future as part of our long-term strategy to commercialize high-value anti-infectives, oncology therapeutics and other products that present attractive opportunities for the company and our shareholders."