AC5 was comparable to control when dosed 16 times over two months
FRAMINGHAM, Mass., Sept. 12, 2017 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB:ARTH) (“Arch” or the “Company”), developer of novel liquid, gel and solid hemostatic and wound care devices reported that AC5™ Topical Gel (AC5™) was found to be biocompatible in testing designed to investigate subchronic systemic toxicity. The subchronic systemic testing, which involved repeat, frequent dosing over 8 weeks, is one of a panel of biocompatibility evaluation endpoints recommended by US FDA regulatory guidelines for devices such as AC5 to allow use in humans.
This study was designed to provide information on the health hazards that might arise from repeated exposure to AC5. A total of 80 animals (40 male and 40 female) were assigned to either a group dosed with one of three dose levels of AC5 or control. Accordingly, AC5 solutions and control were administered two times per week by intraperitoneal administration for eight weeks (16 doses). Animals were observed for signs of toxicity before and immediately post administration and daily throughout study duration of 90±2 days. At the end of the survival period, standard blood tests, macroscopic exams and target tissue histopathologic evaluations were conducted.
All animals appeared normal over the course of the study and survived to the scheduled end of the study. Clinical observations throughout the study, including weight, food consumption, blood tests, and other observations were comparable among animals receiving AC5 or control. Gross pathology and histopathology differences for AC5 were minimal and not clinically significant.
This test was conducted in compliance with the International Organization for Standardization (ISO) and in full accordance with the Food and Drug Administration’s Good Laboratory Practice (GLP) regulations (21 CFR Part 58).
Arch Therapeutics President and CEO Terrence Norchi, MD, stated, “This is an important study in the battery of biocompatibility tests in animals needed to demonstrate the safety of AC5, because it supports that even with repeat dosing over two months, AC5 was well tolerated and not associated with clinical toxicity. The favorable results demonstrated in this study are consistent with the other safety studies conducted to date, and provide important new safety information pertaining to repeat, long-term exposure to AC5. We continue to be pleased with the data generated.”
In July, Arch submitted a 510(k) to the U.S. FDA for AC5 Topical Gel, which is under active review.
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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