Company Completes Planned Series of ISO Safety Studies Required for Commercialization
FRAMINGHAM, MA -- (Marketwired) -- 03/14/16 -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of the AC5 Surgical Hemostatic Device™ ("AC5™"), has obtained favorable results from a broad panel of preclinical biocompatibility tests that were performed on AC5, which is required prior to the planned filing of a CE Mark application and commercialization of AC5 in Europe. Results from these biocompatibility safety studies indicate that AC5's peptide structure and mechanism of action, which is based on the formation of a local physical-mechanical barrier at the wound site, does not promote toxicity to the overall biological system following exposure to AC5.
Arch Therapeutics President and CEO Terrence Norchi, MD, stated, "This testing of AC5, performed under International Organization for Standardization (ISO) and Good Laboratory Practice (GLP) protocols, represents another step in our progress toward commercialization. Outcomes of the biocompatibility tests can be meaningful predictors of human safety, which enhances our confidence as we continue with our first human trial. Further, they are an important component of a CE Mark application, which we expect to file this summer -- and obtaining a CE Mark is a required critical step for commercialization."
The standardized studies included tests to assess cytotoxicity, implantation, irritation, pyrogenicity, sensitization and systemic toxicity. The testing was conducted on AC5 samples that were produced and sterilized under the same Good Manufacturing Practice (GMP) protocols as used for the product being tested in the Company's human trial that is underway in Western Europe. Testing was conducted under the guidelines provided by the ISO. The studies also complied with GLP, a Federal regulation (21 CFR part 58) governing the conduct of nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the United States Food and Drug Administration (FDA).
In the cytotoxicity test, which is a three-day in vitro cell culture study, a product is assessed for toxicity to cells is and categorized as either non-cytotoxic or cytotoxic. AC5 was categorized as "non-cytotoxic."
In the implantation test, which is a 28-day in vivo study, each of several rabbits is injected subcutaneously with AC5 and with a control product in multiple locations in order to assess biological tissue response. All animals survived and no adverse effects were observed for either AC5 or the control. When assessed at the end of the study, AC5 was no longer present in the injection sites and was not found in the draining lymph nodes.
In the irritation test, which is a three-day in vivo rabbit model study, intracutaneous tissue reactions to test and control materials are graded. AC5 was scored as a "non-irritant."
In the pyrogenicity test, an in vitro assay is used to test a product for the presence of pyrogens, also known as bacterial endotoxins, which are a type of toxin made by bacteria. A product that contained sufficient amounts of pyrogen or other cell toxins could trigger immune responses with the potential for tissue damage and significant harm to patients. AC5 was found to be non-pyrogenic, which is a desirable characteristic.
In the sensitization test, a product is assessed for sensitization or allergenic potential over more than two weeks in an in vivo model using guinea pigs. AC5 was deemed a "non-sensitizer" with no evidence of causing delayed contact sensitization.
In the systemic toxicity test, the acute systemic toxicity potential of a product is assessed in an in vivo rodent model designed to provide general information on the health hazards likely to arise from acute exposure. AC5 was classified as "not toxic."
Dr. Norchi stated further, "We have seen consistently favorable safety outcomes in our preclinical program to date. Strong safety data are critical to a product's potential for use in humans. Next, we look forward to assessing both safety and efficacy in humans."
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 during 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
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Chief Financial Officer
Arch Therapeutics, Inc.
Source: Arch Therapeutics, Inc.