Replies to post #93442 on Biotech Values

[mcbio]

PYMX - 4/7/10 Call Re PMX-30063 Phase 1b Results

1. There was mention of no serious adverse events found in the Phase 1b study, although there was some degree of liver elevation and a numbness/tingling side effect. It sounded like the liver elevations were minimal and well below the 3x upper limit threshold that normally gives cause for concern. With respect to the numbness/tingling, it was indicated that the effect was seen out to 10 days post treatment in certain instances. Is that cause for any type of concern? That seems strange that there would still be a numbness/tingling sensation out to 10 days post treatment. Even though this doesn't appear to be a concern now, I wonder if this could be signs of a more worrisome side effect that might occur in a longer duration, or different type of, study. Any thoughts are appreciated here.

2. I have just a general question myself on the MOA for PMX-30063 for Biomaven or any others that closely follow this program. I understand that PMX-30063 is patterned after human defense proteins. How has PMX-30063 been designed to succeed where natural human defense proteins fail? Is it simply a matter of PMX-30063 being many fold more potent than natural human defense proteins or is there some major structural difference that leads PYMX to believe that PMX-30063 can succeed against bacterial infections where natural human defense proteins fail?

3. PYMX is in discussions with pharmaceutical companies with respect to the partnering of PMX-30063. PYMX hopes a decision on whether the drug will be partnered or whether PYMX will go it alone in Phase 3 will be reached by the end of this year.

4. I noted several questions from David Miller around the 44 minute mark of the presentation. David, since I know you read and post here: (1) Were your questions related to safety, among other things, adequately addressed? (2) Any comments on the numbness/tingling out to 10 days? (3) What are your thoughts with respect to PMX-30063 and with PYMX itself generally? Do you like the risk-reward of the stock here?

[mcbio]

PYMX - initiates PMX-30063 Phase 2 trial

http://finance.yahoo.com/news/PolyMedix-Initiates-Phase-2-bw-2798774269.html?x=0&.v=1

PolyMedix Initiates Phase 2 Clinical Trial with Novel Antibiotic, PMX-30063
New Class of Antibiotic to Which Bacterial Resistance is Unlikely to Develop

RADNOR, Pa.--(BUSINESS WIRE)--PolyMedix, Inc. (OTCBB: PYMX - News), an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has initiated a Phase 2 clinical trial in Canada with its novel defensin-mimetic antibiotic, PMX-30063. PMX-30063 represents a new class of antibiotics, and is the first and only systemic antibiotic specifically designed to mimic the activity of human host defense proteins, the body’s natural defense against bacterial infections.

“We appreciate Health Canada granting us approval to initiate this Phase 2 clinical trial and look forward to continuing to work with Health Canada and other regulatory bodies for the clinical development of PMX-30063,” commented Bozena Korczak, Ph.D., Senior Vice President, Drug Development & Chief Development Officer at PolyMedix. “We have incorporated recommendations from Health Canada as well as the recently released FDA draft guidance for development of drugs for the treatment of acute bacterial skin and skin structure infections into the design of this phase 2 clinical trial.”

The randomized, blinded, active controlled Phase 2 clinical trial will be conducted at multiple sites in Canada. The study objective is to evaluate the safety and efficacy of PMX-30063 as an initial treatment for acute bacterial skin and skin structure infections (ABSSSI) caused by Staphylococcus aureus. The trial will enroll up to 200 patients that have ABSSSI presumed to be due to either methicillin susceptible (MSSA) or methicillin resistant (MRSA) S. aureus. Patients will be randomized to receive one of three dosing regimens of PMX-30063 or daptomycin active control, and will have an early treatment assessment at 48 and 72 hours for clinical and microbiologic response. PMX-30063 will be administered once daily as intravenous infusions for five days followed by two days of once daily placebo. Daptomycin will be administered once daily for seven days. Following the treatment assessment, patients will be re-evaluated at day 10 to 15 for test of cure and again for safety at four weeks. An un-blinded interim analysis for safety and efficacy will be conducted after approximately 80 patients have completed treatment. Full study results are anticipated in mid-2011.

“Initiation of this Phase 2 trial represents a significant achievement in the clinical development of PMX-30063,” commented, Nicholas Landekic, PolyMedix’s President and CEO.

“In our completed Phase 1 clinical trials, PMX-30063 was safe and well-tolerated at dose levels which showed bactericidal activity in blood samples drawn from subjects in the trial. This Phase 2 trial is intended to build upon these observations with this study in patients with ABSSSI. We are very proud to be developing the first and only systemic antibiotic drug with this mechanism of action, a defensin-mimetic with less likelihood of resistance than other antibiotics. We look forward to the continued development of PMX-30063 and being able to offer this critically needed new treatment for the major and growing problem of drug-resistant bacterial infections.”

PolyMedix has completed two Phase 1 clinical trials in which a combined total of 77 healthy subjects received PMX-30063. In those clinical trials, PMX-30063 was safely administered in single or multiple doses without serious adverse effects. The only drug-related reactions of clinical importance to date have been paresthesias (abnormal sensations of numbness and tingling), which were mild, transient, non-disabling, and resolved on their own.

About PMX-30063

PolyMedix’s novel antibiotic compound, PMX-30063, is a small-molecule that mimics the activity of human host-defense proteins (HDPs), the body’s natural defense against bacterial infections. Unlike currently available antibiotics, HDPs kill bacteria by directly targeting bacterial membranes and disrupting them. Widespread resistance to this unique mechanism of action has not developed despite millions of years of evolution. With PMX-30063 designed to mimic HDPs, we believe that resistance is also unlikely to evolve to this novel antibiotic, making PMX-30063 a potential addition to the alternatives to combat the growing problem of bacterial resistance to currently available antibiotics. There are many forms of Staph bacteria which are resistant to many antibiotics, including marketed drugs. Studies by PolyMedix against 181 different drug-resistant forms of Staph bacteria have demonstrated the activity of PMX-30063 against all of them, including those strains resistant to marketed drugs. We believe the activity of PMX-30063 against a broad range of many types of Staph bacteria, including those non-responsive to currently marketed drugs such as vancomycin, daptomycin, and linezolid, distinguishes it among available and investigational antibiotic drugs.

About PolyMedix, Inc.

PolyMedix is a publicly traded biotechnology company focused on the development of novel drugs and biomaterials for the treatment of serious acute cardiovascular disorders and infectious diseases. PolyMedix uses a rational drug design approach to create non-peptide small molecule drug candidates and polymers that mimic the activity of proteins. PMX-60056, PolyMedix’s lead heptagonist compound, is being developed to reverse the anticoagulant activity of both heparin and low molecular weight heparins. PolyMedix believes that PMX-60056 could potentially be a safer and easier to use anticoagulant reversing agent, with broader activity, than the currently approved therapy for reversing heparin. PMX-30063, PolyMedix’s lead antibiotic compound, is a small molecule that mimics human host-defense proteins and has a mechanism of action distinct from those of current antibiotic drugs, a mechanism which is intended to make bacterial resistance unlikely to develop. PolyMedix plans to develop this compound for serious systemic Staphylococcal infections, including methicillin resistant Staphylococcus aureus (MRSA). Both PMX-60056 heptagonist and PMX-30063 antibiotic are undergoing clinical testing. PolyMedix also plans to continue the development of its PolyCides™, polymeric formulations as antimicrobial biomaterials, which can be used as additives to paints, plastics, and textiles to create self-sterilizing products and surfaces. For more information, please visit our website at www.polymedix.com.