JanOne Prepares Clinical Supply of Product Candidate JAN101 for Distribution to Phase 2b Trial Sites
LAS VEGAS, June 23, 2021 / PRNewswire / – JanOne Inc. (Nasdaq: JAN), a company specializing in the development of treatments for conditions that cause severe pain and drugs with non-addictive analgesic properties, today announced that its packaging partner Xerimis Clinic has received the clinical batch vial of JAN101 for the upcoming Phase 2b trial for the treatment of peripheral arterial disease (PAD) and prepares the supply for labeling and distribution to clinical sites across the United States
“We are pleased to announce that our clinical offering of JAN101 is now ready for short-term release at our clinical trial sites scheduled for the upcoming Phase 2 clinical trial,” said Tony isaac, President and CEO of JanOne. “We are fully prepared and look forward to FDA approval of our new protocol.”
JAN101 is intended to reach the 8.5 million Americans who may have PAD. One of the most encouraging results from patients who participated in the first phase 1 and phase 2a trials of JAN101 was a reported reduction in pain associated with PAD. According to a Stanford University According to a research study, up to 24% of patients with PAD are at risk of high opioid use.1 If JAN101 is successful, the potential increase in value to the medical community as a PAD treatment that also relieves associated pain without addictive properties could be significant. The US market opportunity for JAN101 may result in a potential multi-billion dollar revenue stream for JanOne if the product candidate is approved as a new drug by the FDA.
JanOne (Nasdaq: JAN) focuses on developing treatments for conditions that cause severe pain. By relieving pain at the source, JanOne aims to reduce the need for opioid prescriptions to treat pain associated with illness that can lead to opioid abuse. The company is also exploring solutions for non-addictive pain relievers. Its lead candidate, JAN101, is for the potential treatment of peripheral artery disease (“PAD”), a disease that affects more than 8.5 million Americans. JAN101 has demonstrated positive results in a phase 2a clinical trial, and the Company is currently in preparation for phase 2b trials. JanOne is dedicated to funding resources towards innovation, technology and education for PAD, associated vascular conditions and neuropathic pain. For more information, visit www.janone.com.
Forward-looking statements and cautions
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 that law, statements contained herein that are forward-looking and include anything other than historical information, including statements relating to the start of the upcoming phase 2b trials, the number of Americans who could have PAD if JAN101 will benefit the medical community and the potential revenue stream if JAN101 is approved by the FDA. These forward-looking statements may be identified by words such as “will”, “aims”, “future”, “may”, “expects”, “,,,” “plans”, “believes”, “estimates “and similar statements. JanOne may also make written or oral forward-looking statements in its periodic reports to the United States Securities and Exchange Commission (the” SEC “) on Forms 10-K and 10-Q, Current Reports on the Form 8-K, in its annual report to shareholders, 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 correct and there is a number of important factors that could cause actual results to differ materially from those expressed in forward-looking statements made by the company, including, but not limited to, management plans and objectives for future operations or products, 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 January 2. 2021 and other SEC documents at http://www.sec.gov). JanOne assumes no obligation to publicly update or revise any statements contained in this release, whether as a result of new information, future events, or otherwise.
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SOURCE JanOne Inc.