Arch Therapeutics Obtains Favorable Safety Data for AC5 Surgical Hemostatic Device(TM) in Skin Irritation Testing in Humans
AC5(TM) Not Considered an Irritant in a Cumulative Evaluation
FRAMINGHAM, MA -- (Marketwired) -- 03/22/16 -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of the AC5 Surgical Hemostatic Device™ ("AC5™"), reports favorable data from a 21-day repeat exposure skin test to evaluate the irritation potential of AC5 to human skin. This represents the first safety data obtained for AC5 from human testing.
The study was a Cumulative Irritation Evaluation test designed to determine the skin irritation potential of AC5 and controls after each was applied daily for 21 sequential days to the skin of a total of 41 healthy male and female human subjects. Results were obtained by evaluating and comparing the subject's skin in areas where AC5 and the controls were repeatedly applied. Based upon the results, AC5 was not considered an irritant.
Arch Therapeutics President and CEO Terrence Norchi, MD, stated, "The results of this study represent an important step toward demonstrating clinical safety of AC5, and we remain pleased with the safety data generated to date. This irritation test adds to the portfolio of solid results and should enhance the profile of AC5 for hemostasis and other wound care applications."
In addition, blood tests were performed both prior to and 24 hours after the testing period to evaluate any changes from baseline levels. No change was attributed to exposure to AC5 or the controls, indicating that there were no adverse events associated with the absorption or metabolism of AC5.
The Cumulative Irritation Evaluation test is a standard test that provides safety information. AC5's peptide structure and mechanism of action, which is based on the formation of a local physical-mechanical barrier at the wound site, continues to be associated with a favorable safety profile.
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a biotechnology 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 surgical procedures.
Find out more at www.archtherapeutics.com.
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On Behalf of the Board,
Terrence W. Norchi, MD
Arch Therapeutics, Inc.
ARTH Investor Relations
Toll Free: +1-855-340-ARTH (2784) (US and Canada)
Chief Financial Officer
Arch Therapeutics, Inc.
Source: Arch Therapeutics, Inc.