• Loading stock data...
PublicWire | Emerging Market Stock News
  •  Home
  • Technology
  • Medical
  • Energy
  • Cannabis
  • Finance
  • Retail
  • General
  • Podcast
  • Videos
  • Services
  •  Home
  • Technology
  • Medical
  • Energy
  • Cannabis
  • Finance
  • Retail
  • General
  • Podcast
  • Videos
  • Services
No Result
View All Result
PublicWire
No Result
View All Result

Home » Medical » Arch Therapeutics Reports Favorable Results in Repeat Dose Testing of AC5™ for Subchronic Systemic Toxicity

Arch Therapeutics Reports Favorable Results in Repeat Dose Testing of AC5™ for Subchronic Systemic Toxicity

Anthony Ramsumiran by Anthony Ramsumiran
April 26, 2019
in Medical
3 min read
28
0

FRAMINGHAM, Mass., Sept. 12, 2017, ARTH, (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.

Notice Regarding Forward-Looking Statements 
This news release contains “forward-looking statements” as that term is defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release that are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, references to novel technologies and methods, our business and product development plans and projections, or market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company, our ability to retain important members of our management team and attract other qualified personnel, our ability to raise the additional funding we will need to continue to pursue our business and product development plans, our ability to obtain required regulatory approvals, our ability to produce commercial quantities of our products within projected timeframes, our ability to develop and commercialize products based on our technology platform, and market conditions. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in the reports and other documents we file with the SEC, available at www.sec.gov.

Contact
ARTH Investor Relations
Toll Free: +1-855-340-ARTH (2784) (US and Canada)
Email: investors@archtherapeutics.com
Website: www.archtherapeutics.com

Tags: AC5Arch TherapeuticsARTHFDAhemostasistestingTopical Gel
Anthony Ramsumiran

Anthony Ramsumiran

Anthony has a very strong background in Economics. He was born and raised in London and is now based in Orlando, Florida. With over 17 years of experience in automotive and technology.

Related Posts

Regeneron buy back shares from Sanofi
Medical

Regeneron to buy back $5 billion shares from Sanofi

May 25, 2020
137
A report reveals that China is deliberately faking the number of COVID-19 cases and deaths.
General

China is underreporting COVID-19 cases, U.S. intelligence community says

April 1, 2020
152
Around the world, the total number of confirmed coronavirus infection went beyond 600,000, with 28,964 fatalities as of the latest report.
Medical

17% of all confirmed COVID-19 cases in the world comes from the US

March 28, 2020
139
President Donald Trump signed a $2 trillion coronavirus relief bill on Friday
General

Trump signs $2 trillion coronavirus relief

March 28, 2020
121
General Motors and Ventec Life Systems are partnering to convert the GM Kokomo, Indiana ERC building for the production of Ventec ventilators in response to the COVID-19 pandemic.
General

GM announces the start of production of critical-care ventilators shortly after Trump’s tweets against CEO

March 27, 2020
135
Rep. Thomas Massie, R-Ky., tried to force a full yes or no vote on the measure, which could have delayed its passage by hours.
Finance

$2 trillion coronavirus stimulus package passed by the House amid efforts to delay voting by Massie

March 27, 2020
123
Currently Playing

Subscribe To Our Newsletter

Ad

PublicWire | Emerging Market Stock News 24/7 | Investor Relations US Stock Market

© Copyright 2020 PublicWire.com

Navigate Site

  • About
  • #96576 (no title)
  • Disclaimer
  • Watch LIVE
  • Privacy Policy
  • Terms and Services
  • Contributors

Follow Us

No Result
View All Result
  • LIVE Investor News Channel
  • Cannabis
  • Energy
  • Finance
  • General
  • Medical
  • Podcasts
  • Retail
  • Technology
  • #370 (no title)

© Copyright 2020 PublicWire.com

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In

Public Wire Logo

Hello please subscribe to our newsletter to get up to date news weekly!

This website uses cookies. By continuing to use this website you are giving consent to cookies being used. Visit our Privacy and Cookie Policy.