WELLESLEY, MA — Nov 7, 2014 – Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), developer of the AC5 Surgical Hemostat Device™, announced that an independent third-party research group has obtained positive data from a preclinical study assessing the use of AC5™ in animals that had been treated with therapeutic doses of the antiplatelet medications Plavix® (clopidogrel) and aspirin alone and in combination. The results of the study are consistent with recent data obtained from two previous preclinical studies, in which AC5 quickly stopped bleeding from surgical wounds created in rats following treatment with clinically relevant doses of the anticoagulant medication heparin. Antiplatelet and anticoagulant medications are commonly referred to as “blood thinners.”
In the present study, performance of AC5 was measured as time to hemostasis (TTH), or cessation of bleeding from surgical wounds created in the livers of rats. The average TTH of groups of rats that had been pre-treated with clinically relevant doses of the commonly prescribed antiplatelet drugs Plavix® and aspirin was compared to the TTH of rats that were not pre-treated. The anticoagulation effect of doses of Plavix® and aspirin was confirmed by measurements of platelet function. Importantly, after AC5 was applied to the bleeding liver wound, the TTH among the groups was comparable, regardless of whether they were pre-treated with the antiplatelet drugs.
In comparison, animals not pre-treated with antiplatelet medications and in which a saline control was used to stop bleeding took more than nine times as long to achieve hemostasis. Furthermore, animals that were administered the antiplatelet medications and in which a saline control was used to stop bleeding in lieu of AC5 took more than thirteen times as long to achieve hemostasis versus those treated with AC5, highlighting that antiplatelet medications do increase the baseline time to hemostasis.
According to Dr. Paresh Shah, Director of General Surgery and Vice Chair of Surgery at NYU Langone Medical Center, “There are an increasing number of patients on long-term therapy with antiplatelet agents and other anticoagulants. We are often required to perform procedures and operations on patients with active antiplatelet and anticoagulation therapy. Hemostasis for bleeding control in these patients is extraordinarily challenging. None of the hemostatic agents available today have demonstrated enhanced efficacy in the setting of antiplatelet therapy. The results described in this study are extremely promising because we surgeons need improved hemostatic control in the setting of antiplatelet therapy, which many of our patients are required to stay on for its cardioprotective effects.”
The study group intends to submit the data for publication. The results of the study support that AC5 can achieve rapid hemostasis in living animals treated with these commonly used and prescribed antiplatelet medications. The research was led by Rudolf Urbanics, MD, PhD, and Domokos Csukas, DVM at Semmelweis University Faculty of Medicine in Budapest, Hungary within the Department of Surgical Research and Techniques and it was sponsored by Arch. Also part of the research team was Dr. Ellis-Behnke, Director of the Nanomedicine Translational Think Tank in the Department of Ophthalmology at the Medical Faculty Mannheim of the University of Heidelberg in Germany. Dr. Ellis-Behnke is also affiliated with three U.S. academic institutions, and he is an advisor to and co-founder of Arch.
Terrence W. Norchi, MD, President and CEO of Arch Therapeutics, said, “Both Plavix® and aspirin are widely prescribed for ongoing use after a heart attack or stroke. Millions of people take aspirin on their own, many of whom do not realize that it increases their underlying tendency to bleed. This additional research highlights an exciting feature of AC5 that should differentiate it from many existing hemostatic products on the market. If AC5 is approved for commercialization, this key finding highlights a potential solution for the millions of people on these medications who might be at risk for excessive bleeding during surgery and after trauma.”
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking (sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology platform to make surgery and interventional care faster and safer for patients. Arch’s flagship development stage product candidate, known as the AC5 Surgical Hemostatic Device™, is being designed to achieve hemostasis in minimally invasive and open surgical procedures.
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On Behalf of the Board,
Terrence W. Norchi, MD
Arch Therapeutics, Inc.
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