PolyMedix, Inc. (OTCBB:PYMX), a biotechnology company focused on developing innovative antimicrobial compounds intended to treat a wide range of infectious diseases and other conditions, today announced that it 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. In earlier studies reported at the 2012 American Society of Clinical Oncology (ASCO) annual meeting, brilacidin reduced the occurrence of severe ulcerative oral mucositis in animal models by more than 94% compared to placebo.
This grant will support the work to explore various dosing regimens with brilacidin in animal models, study the mechanism(s) of action underlying its activity, and optimize an oral rinse formulation. The NIH grant will provide PolyMedix with $161,000 over six months.
“Like host defense proteins, brilacidin and related compounds have shown antibacterial, anti-biofilm and anti-inflammatory properties,” commented Richard Scott, Ph.D., Vice President of Research at PolyMedix. ”We believe that the combination of these attributes contribute to the encouraging efficacy of brilacidin demonstrated in these animal studies. We view the results seen with brilacidin as promising and supportive of further development as a new therapeutic agent to address this major unmet medical need. We are grateful to the NIH for providing us with funding to continue this work.”
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. These studies were conducted at Biomodels by Stephen T. Sonis, DMD, DMSc, Chief Medical Officer at Biomodels, Professor of Oral Medicine at Harvard’s School of Dental Medicine, and a member of PolyMedix’s Scientific Advisory Board. 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.
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 (IND) with the Food and Drug Administration (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 commence during the first half of 2013.