PolyMedix CEO Posts Letter to Shareholders on Its Website
RADNOR, Pa., Feb. 7, 2013 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB: PYMX), a biotechnology company focused on developing innovative therapeutic drugs based on its novel defensin-mimetic technology platform, today announced that Edward Smith, its newly appointed interim Chief Executive Officer, posted to its website a letter to shareholders. This communication can be found here [Copied below].
PolyMedix continues to work with its financial advisors on a financing transaction or other strategic transaction to fund the continued clinical development of brilacidin and its technology platform.
[The] PolyMedix Letter to Shareholders:
PolyMedix is facing exciting and challenging times. We hope this communication will be the first of a series of initiatives aimed at providing insight into the strategic vision and execution plan for realizing the potential of our technology platform at PolyMedix.
We understand that confidence may have been shaken among some of our shareholders and members of the investment community. That said, we assure you the executive leadership of PolyMedix is committed to building back shareholder value and securing the future development of our technologies.
From a scientific and regulatory perspective, we strongly believe our Company has never been better positioned for progressing the clinical development of brilacidin and building out our research platform, and that recent market prices and capitalization do not fully reflect the value of PolyMedix. We stand committed to address this disconnect and drive value for all of our stakeholders.
PERSPECTIVE ON BRILACIDIN AND OUR TECHNOLOGY PLATFORM:
Brilacidin is not just an ABSSSI drug candidate.
We believe there are several feasible clinical and regulatory paths available for brilacidin. ABSSSI (acute bacterial skin and skin structure infections) was selected as the initial clinical indication for brilacidin after careful consideration of clinical feasibility, commercial, regulatory and other factors. Based on our pre-clinical studies, brilacidin also has potential for development as a treatment of other indications, such as endocarditis (heart), bacteremia (blood), pneumonia (lung), prosthetic joint infections, and others.
To be clear, results from our first brilacidin Phase 2 study in ABSSSI exceeded our expectations and support furthering its development. Since announcing top-line data from our first Phase 2 study, and with the help of leading industry experts and thought leaders, further analysis of pharmacokinetic and pharmacodynamic data have been extensively analyzed and were used to guide dose selection for our planned Phase 2B dose-optimization study. Tthat was provided to FDA in advance of our November 2012 meeting. Our meeting and subsequent communications with FDA have resulted in our being poised to proceed with our planned Phase 2B dose optimization study, subject to our need for additional financing. As planned, the study would evaluate short course (1-3 days) regimens for empiric treatment of ABSSSI.
Brilacidin is not just an antibiotic candidate.
Brilacidin is a small molecule compound which is designed to mimic a protein expressed by the human immune system, known as host defense proteins (HDPs). In addition to bacterial killing properties, both HDPs and brilacidin have been implicated in exerting anti-inflammatory and anti-biofilm activities. We hope to exploit this multifactorial mechanism of action and evaluate brilacidin’s use in other disease arenas, including cancer supportive care for radiation and chemotherapy-induced oral mucositis. To that end, we plan to file an Investigational New Drug Application (IND) with the United States FDA for an oral topical formulation of brilacidin in cancer patients this quarter.
Polymedix is not just brilacidin.
While brilacidin is the focus of our current clinical development efforts, with the support of various government grants and contracts, we continue to move our platform in new directions generating promising activity against fungal, parasitic, Gram negative bacterial and other pathogens.
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Our collective leadership, including our executive management, our board of directors, and our scientific founders, are committed to unlocking the potential of our great company. We truly believe that PolyMedix’s greatest moments may be ahead of us and just over the horizon.
Sincerely,
Edward F. Smith
Interim President & CEO
PolyMedix, Inc.
This letter contains forward-looking statements. Important factors, including PolyMedix’s need for substantial financing to fund its operations and research and development, and other factors described in PolyMedix’s filings with the SEC, could cause actual results to differ materially from those in the forward-looking statements. You should not place undue reliance on any forward-looking statements. |
