AC5(TM) Quickly Stopped Brisk Bleeding in Livers of Nine Rats; Potential Treatment Option for Patients at Increased Risk of Bleeding Due to Anticoagulant and Potentially Antiplatelet Drugs

WELLESLEY, MA, USA I August 25, 2014 I Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), developer of the AC5 Surgical Hemostatic Device™ for potential use in bleeding during surgery, today announced positive data in an initial preclinical study assessing the use of its AC5 Surgical Hemostatic Device™ in animals receiving an anticoagulant medication (i.e. blood thinner).

In the first preclinical assessment of AC5 in the presence of an anticoagulant, AC5 quickly stopped brisk bleeding from a 4mm diameter biopsy surgical site created in the livers of nine rats that had been treated with a clinically relevant dose of the drug heparin. Heparin is an anticoagulant commonly given to patients to prevent blood clots during and after surgical procedures and in other circumstances. The study demonstrated that application of AC5 in this commonly used animal model of brisk bleeding was able to stop blood loss from the liver in less than 30 seconds and to achieve hemostasis. Time to hemostasis (TTH) after creation of the liver wounds in heparin-treated animals was comparable to TTH after creation of liver wounds in normal, non-anticoagulated animals.

“There is a great need to continue to develop novel hemostatic agents and sealants that are efficacious in surgical and trauma patients,” said Cambridge, MA-based surgeon Steven Schwaitzberg, MD, Professor of Surgery at Harvard Medical School and advisor to Arch Therapeutics. “In particular, the need is greatest in those patients whose underlying coagulation cascade or platelet status is abnormal, whether due to concurrent antithrombotic therapy or an underlying disease. Increasing numbers of patients are on anticoagulant or antiplatelet medications. This can present a challenge to surgeons and other interventionalists when procedures are needed on these patients. These initial findings on the activity of AC5 in this setting are very encouraging and may lead to significant benefit in the future.”

Terrence W. Norchi, MD, President and CEO of Arch Therapeutics, said, “We are excited by the data from this early study. This is the first of several planned preclinical studies intended to assess the utility of AC5 in animals on antiplatelet or anticoagulant therapy, commonly referred to as blood thinners. A significant portion of the population takes blood thinners to prevent a range of life-threatening conditions. Patients on these medications are at increased risk of bleeding and their management during surgical and other procedures requires extra care. We hope to demonstrate that AC5 is effective regardless of a patient’s underlying platelet or bleeding status, whether due to prescribed medications or an underlying condition such as hemophilia, in order to offer surgeons and patients an even better tool to control bleeding.”

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 AC5 Surgical Hemostatic Device ™, is being designed to achieve hemostasis in minimally invasive and open surgical procedures.

SOURCE: Arch Therapeutics