Meeting With FDA Provides Guidance for U.S.-Based Phase 2B Clinical Trial, Including Use of Single-Dose and Three-Day Dosing Regimens
RADNOR, Pa., Nov. 16, 2012 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX), a biotechnology company dedicated to developing novel treatments for infectious diseases with defensin-mimetic antimicrobial agents, today announced that it had a Type B meeting with the Division of Anti-Infective Products of the United States Food and Drug Administration (FDA). As a result of the meeting, PolyMedix has direction with respect to the design and conduct of its planned Phase 2B dose-optimization clinical trial using brilacidin for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by Staphylococcus aureus (including MRSA) and Streptococcus pyogenes.
"We are pleased with the outcome of our meeting with the FDA, and appreciate the Division's assistance and guidance," commented Dr. Daniel Jorgensen, Senior Vice President of Clinical Development and Chief Medical Officer at PolyMedix. "As a result of this meeting, we are encouraged by our planned path to advance the clinical development of brilacidin, including use of single-dose and three-day dosing regimens, in a Phase 2B dose-optimization clinical trial."
In advance of the meeting, PolyMedix provided the FDA with the Phase 2B clinical trial plans for brilacidin. PolyMedix received support for its proposed regimens of one and three day dosing, as well as guidance to enhance the proposed Phase 2B protocol. Subject to the availability of adequate cash resources, PolyMedix plans to initiate the Phase 2B dose-optimization study in early 2013.
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, PolyMedix's 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.
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.
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 for planned trials or 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.