Arch Therapeutics Reports Topline Results from Skin Sensitization Study of AC5
Study finds no evidence of irritation or allergic reaction in any enrolled subject
FRAMINGHAM, Mass., Sept. 05, 2018 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of liquid, gel and solid hemostatic and wound care devices, today announced topline data for its irritation/sensitization patch test study of AC5™ Topical Gel (AC5)1. The study was designed to address a request by the Food and Drug Administration (FDA or “the Agency”).
These topline results indicate that AC5 is neither an irritant nor a sensitizer. Additionally, no immunogenic response and no serious or other adverse events attributable to the device were reported in any of the enrolled subjects.
The objective of this Study (“Cumulative Irritancy Assay with Delayed Challenge for Allergic Contact Dermatitis Potential of AC5™ Topical Gel (AC5) in Healthy Volunteers”) was to assess irritation and sensitization potential (development of allergic contact dermatitis) of AC5 after repeat applications and then a delayed challenge application of the product to the skin. Products can be studied in this way to determine if a reaction develops immediately upon initial exposure to the skin, in the case of irritation, or when the skin is ‘challenged’ or exposed again at a point in the future, in the case of allergic contact dermatitis.
Terrence W. Norchi, MD, President and CEO of Arch, said, “We are pleased that these topline results provide favorable support for the safety profile of AC5, and we are eager to provide the full report to the FDA. As previously indicated, this study is intended to strengthen and enhance the Company’s 510(k) notification for AC5 Topical Gel, which we expect to file during this third quarter of calendar 2018, as previously disclosed.”
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 AC5™ Topical Gel and AC5™ Surgical Hemostatic Device.
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Source: Arch Therapeutics, Inc.
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1 AC5 is currently an investigational device and is limited by federal law to investigational use.
