Engineering batch for JAN101 complete and expectations are for GMP batch production to begin within 30 days
LAS VEGAS, Aug. 26, 2020 /PRNewswire/ -- JanOne Inc. (Nasdaq: JAN), a company focused on developing treatments for conditions that cause severe pain and drugs with non-addictive, pain-relieving properties, has successfully completed its initial engineering batch of JAN101. The JAN101 formulation is a patented sodium nitrite proprietary compound that demonstrated success in Phase 1 and Phase 2a trials for improving blood flow and vascular function, necessary in the treatment of Peripheral Artery Disease (PAD) and potentially for Covid-19 vascular complications that is believed to be the cause of severe vital organ and tissue damage.
According to Dr. Tony Giordano, JanOne's chief scientific officer, "We are very fortunate to have had the foresight to initiate the manufacturing process this past February. Should we gain FDA approval for our Covid-19 study, we will be in a position to start patient trials immediately and still remain on track for our planned PAD Phase 2b trials to begin in early 2021."
The company expects to submit the investigational new drug (IND) for the treatment of Covid-19 vascular complications in the coming weeks and continues to advance plans to scale-up production of JAN101. The company has secured a partner for bottling and labeling, GMP batch production, including placebo batches. The company expects to deliver 250,000 doses within 30 days after start of manufacturing and have GMP batches of more than 20 million doses ready next year.
JanOne (NASDAQ: JAN) is focused on developing treatments for diseases that cause severe pain. By alleviating pain at the source, JanOne aims to reduce the need for opioid prescriptions to treat disease associated pain that can lead to opioid abuse. The company is also exploring solutions for non-addictive pain medications. Its lead candidate JAN101 is for treating peripheral artery disease (PAD), a condition that affects over 8.5 million Americans. JAN101 demonstrated positive results in a Phase 2a clinical trial, and Phase 2b trials are expected to begin in early 2021. JanOne is dedicated to funding resources toward innovation, technology, and education for PAD, associated vascular conditions and neuropathic pain. JanOne continues to operate its legacy businesses under their current brand names which are undergoing review to determine appropriate strategic alternatives. For more information, visit janone.com
Forward-Looking and Cautionary Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. In accordance with the safe harbor provisions of this Act, statements contained herein that look forward in time that include everything other than historical information, including statements relating to (i) whether JAN101 can treat vascular complications in Covid-19 patients, (ii) whether the company can obtain FDA approval for its Covid-19 study, (iii) when the Phase 2b trials for PAD commence, (iv) when and whether the company will submit an IND for the treatment of Covid-19 vascular complications, and (v) how many doses the company will be able to deliver. These forward-looking statements can be identified by terminology such as "will," "aims," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. JanOne may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC") on Forms 10-K and 10-Q, Current Reports on Form 8-K, in its annual report to stockholders, in press releases, and other written materials and in oral statements made by its officers, directors or employees to third parties. There can be no assurance that such statements will prove to be accurate and there are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the company, including, but not limited to, plans and objectives of management for future operations or products, the market acceptance or future success of our products, and our future financial performance. The company cautions that these forward-looking statements are further qualified by other factors including, but not limited to, those set forth in the company's Annual Report on Form 10-K for the fiscal year ended December 28, 2019 (available at http://www.sec.gov). JanOne undertakes no obligation to publicly update or revise any statements in this release, whether as a result of new information, future events, or otherwise.
Investor Relations & Media Contact
1 (800) 400-2247
View original content to download multimedia:http://www.prnewswire.com/news-releases/janone-advances-its-potential-peripheral-artery-disease-and-covid-19-vascular-inflammation-treatment-towards-trial-readiness-301118671.html
Released August 26, 2020