RADNOR, Pa., Sept. 19, 2012 (GLOBE NEWSWIRE) -- 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.
About Oral Mucositis
Oral mucositis is a common, potentially severe and debilitating inflammation and ulceration that can occur in the mouth as a side effect of some chemotherapy and radiation therapy treatments for cancer. It afflicts approximately 450,000 cancer patients each year in the United States1, and can affect the course and outcome of cancer therapy. In addition to increasing the risk of infection, patient discomfort, and ability to eat, oral mucositis may also be associated with increased treatment costs of up to $25,000 per patient2. Despite these issues, there are no broadly effective pharmacological therapeutic options for this condition, and treatment today is mostly focused on pain management.
Brilacidin is PolyMedix's lead compound and the first of a new class of antibiotics known as defensin-mimetics. It is a small molecule designed to mimic the activity of human host-defense proteins, the body's natural defense against bacterial infections.Distinct from many other antibiotics which generally have only antibacterial activity, brilacidin has also shown anti-biofilm and anti-inflammatory properties, as well as a broader spectrum of activity. These advantageous characteristics may make possible a broader range of potential applications, such as prevention of oral mucositis, treatment of fungal infections, treatment of parasitic infections such as malaria, and others. In April 2012, PolyMedix announced results of a Phase 2 clinical trial with brilacidin as an intravenous treatment in patients with ABSSSI which demonstrated that brilacidin was safely administered and showed high clinical efficacy across all treatment arms.
About PolyMedix, Inc.
PolyMedix is a clinical stage biotechnology company dedicated to transforming the treatment of infectious diseases. PolyMedix is developing a new class of antibiotics – defensin-mimetics – for the treatment of serious, life-threatening infections which often develop resistance to currently available antibiotics. PolyMedix's compounds are designed to imitate the mechanism of action of host defense proteins, which contribute to natural human immunity. In contrast to existing antibiotics, our lead antibiotic compound, brilacidin (formerly PMX-30063), was designed to exploit a method of bacterial cell killing, via biophysical membrane attack, against which bacteria have not shown development of resistance in multiple preclinical studies. Brilacidin showed efficacy similar to an active control, and was safely administered in a Phase 2 clinical trial in patients with acute bacterial skin and skin structure infections (ABSSSI) caused by Staph aureus bacteria (including methicillin-resistant Staphylococcus aureus (MRSA)). PolyMedix has plans to initiate a Phase 2B dose optimization study with brilacidin in ABSSSI patients and also to develop brilacidin as a topical treatment for oral mucositis, a common and often debilitating complication of cancer treatments.
PolyMedix has internally developed an extensive pipeline of compounds including other defensin-mimetic antimicrobial compounds for other infectious diseases such as Gram-negative pathogens, fungal infections, and malaria; PolyCides®, antimicrobial additives to materials to create self-sterilizing products and surfaces; and delparantag (formerly PMX-60056), an anticoagulant reversing agent. PolyMedix's compounds have been internally discovered using a proprietary drug design technology.
For more information, please visit our website at www.polymedix.com.
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1National Cancer Institute
2Nonzee N. et al. Cancer 113:1446-52, 2008
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause PolyMedix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. PolyMedix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are PolyMedix's need for, and the availability of, substantial capital to fund its operations, planned clinical trials and research and development, and the fact that PolyMedix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in PolyMedix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. PolyMedix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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