LAS VEGAS, June 22, 2021 /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, today announced its selection of Avania
as its regulatory partner in the upcoming planned Phase
2b trial of lead product candidate
JAN101 for treating Peripheral Artery Disease (PAD). Avania will
manage all regulatory operations associated with trial preparedness
and execution including ensuring compliance with the FDA's
requirements for investigational practices and managing
correspondence with the FDA on JanOne's behalf throughout the
duration of the trial. Avania has recently completed the
filing of the annual report for IND 111703 on behalf of JanOne.
Tony Isaac, President and Chief
Executive Officer of JanOne, commented, "We are pleased with our
selection of Avania as our regulatory partner for our upcoming
planned Phase 2b trial and will rely
on their globally recognized expertise as we prepare to first file
our pre-Phase 2 briefing package this summer and, following our
planned meeting with the FDA, file our new protocol and related
documents. Avania will assist us through each aspect of filing,
including the clinical protocol, the Investigator's Brochure (IB),
the General Investigational Plan, and Chemistry, Manufacturing, and
Control (CMC) updates. We have made great progress year-to-date as
we approach our protocol filing, and once approved by the FDA, we
look forward to the expected initial recruitment of PAD subjects
for this important trial."
Avania is an integrated global, full-service contract research
organization (CRO) with specialized expertise in medical device,
novel technology, and combination products. Avania advances
products from feasibility all the way through post-approval trials
in analytics, clinical trials, consulting, regulatory, and
reimbursement.
JanOne recently announced its completion of Current Good
Manufacturing Practices (CGMP) production of the first batch of
JAN101, an initial step along the path to initiation of the Phase
2b PAD trial.
About JanOne
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 potentially 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 the near future. JanOne is dedicated to funding resources toward
innovation, technology, and education for PAD, associated vascular
conditions, and neuropathic pain. For more information,
visit www.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 the upcoming Phase 2b
trials, and filing of the pre-Phase 2 briefing package and planned
meeting with the FDA. These forward-looking statements can be
identified by terminology such as "will," "aims," "upcoming,"
"may," "expects," "expected," "potential," "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 January 2, 2021 and other SEC filings (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
IR@Janone.com
1 (800) 400-2247
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SOURCE JanOne Inc.