Peer-Reviewed Paper Concludes That AC5™ Provided Safe and Effective Hemostasis Regardless of Whether Patients Were Taking or Not Taking Antiplatelet Therapy
Positive data from a
clinical study of patients undergoing dermatologic surgery and treated
with the AC5™ was published in the peer-reviewed journal Dermatologic
Surgery, the official journal of the American Society for Dermatologic
Surgery. The study was sponsored by Arch Therapeutics, Inc. (OTCQB:
ARTH) (“Arch” or the “Company”) and conducted by an independent research
organization in Ireland. The results in the manuscript, titled “First
Safety and Performance Evaluation of T45K, a Self-Assembling Peptide
Barrier Hemostatic Device After Skin Lesion Excision” by Rahmani et al.
show that AC5™ was safe and rapidly achieved hemostasis agnostic to the
presence of antiplatelet medication. SAPB-T45K is a development name for
AC5. The paper has been published as Open Access, and can be accessed
online at the journal website.
Safety assessments in the study included a full battery of laboratory blood tests, assessment of wound healing scores and observation for any systemic reactions. Terrence W. Norchi, MD, President and CEO of Arch Therapeutics, said, “This report represents the first clinical study of both the safety and performance of AC5. The primary purpose of the study was to assess safety. The safety profile of a topical agent is important, and AC5’s safety profile was similar to that of saline and consistent with a normal healing pattern.”
The senior author of the paper and Principle Investigator of the study, Professor Jack Kelly MB MD FRCS(Plast), is a Consultant Plastic Surgeon and Professor of Plastic Surgery at Galway University Hospital, Galway Ireland. Professor Kelly said, “According to a 2015 report, almost half of the patients undergoing elective surgery are taking anticoagulant or antiplatelet medications to prevent potentially life-threatening problems, such as strokes, heart attacks and pulmonary emboli. When these patients require surgery or even a minor procedure, the surgeon often decides to discontinue the drug, weighing the risk of bleeding against the risk of stroke or other event for which the medication was prescribed. The consistent performance of AC5 regardless of the patient’s antiplatelet medication support the potential of AC5 as an important option to control bleeding without having to stop the medication.” In animal studies, AC5 has also demonstrated this consistent performance in the presence of various anticoagulant and antiplatelet medications.
Topline results of the study were previously reported in a press release issued by the Company on August 15, 2016, which can be accessed at the company’s website.
Dr. Norchi further commented, “We continue to develop our exciting technology for wound care and biosurgical applications. As our priority, we are committed to continued collaboration with the FDA and plan to submit a new 510(k) notice for AC5 Topical Gel as soon as possible following further discussion with the agency. We will provide a more detailed update when the plan is finalized.”
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma and interventional care. Arch is developing products based on an innovative self-assembling barrier technology platform with the goal of making care faster and safer for patients. Arch's development stage product candidates include the AC5™ Topical Gel and the AC5™ Surgical Hemostatic Device.
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