PolyMedix has received a phase I grant from the National Cancer Institute division of the National Institutes of Health (NIH) to further explore the profile and properties of its defensin-mimetic compound, brilacidin, in treating oral mucositis.
The NIH grant will provide PolyMedix with $161,000 over six months.
At the 2012 American Society of Clinical Oncology annual meeting, the biotechnology company reported that brilacidin reduced the occurrence of severe ulcerative oral mucositis in animal models by more than 94% compared with placebo.
The NIH grant will support the work to explore various dosing regimens with brilacidin in animal models, study the mechanisms of action underlying its activity, and optimize an oral rinse formulation, according to the company.
Previously, in two animal models where oral mucositis was induced by acute and fractionated radiation, which is designed to mimic the type of radiation therapy commonly used in the treatment of some cancers, brilacidin was administered as an oral topical rinse. The results showed that brilacidin statistically significantly reduced the severity and duration of the mucositis in these studies.
Based on the time course of efficacy seen in these animal models, it is believed that immunomodulatory and/or anti-inflammatory activities of brilacidin may be important underlying mechanisms of action for its efficacy in oral mucositis, the company noted.
In addition to the activities covered by the recently awarded NIH grant, PolyMedix is currently working toward the filing of an investigational new drug application with the U.S. FDA to enable clinical studies in patients with oral mucositis. Depending on the outcome of discussions with regulators and availability of additional funding, a clinical trial in cancer patients could begin during the first half of 2013.