LAS VEGAS, Sept. 24, 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, today announced that the Company has
started production of JAN101 under Current Good Manufacturing
Practices (cGMP) for the company's anticipated Phase 2b trials to treat Peripheral Artery Disease
(PAD) and as a potential treatment for Covid-19 vascular
complications.
This development follows the successful completion of the JAN101
prototype and engineering batches and positive stability data. The
initial production batch will be 250,000 sustained release tablets
and matching placebos. The Phase 2b
trial is expected to begin in early 2021. PAD presents a large
market opportunity as there currently are no effective treatments
for the disease.
"The initiation of this batch is a major milestone for the
Company, as it demonstrates that we now have the ability to
economically scale up production of JAN101," said Tony Isaac, President and Chief Executive
Officer of JanOne. "This cGMP batch will help set the stage for our
anticipated Phase 2b PAD trial, as
well as the exploration of JAN101 as a treatment for vascular
complications caused by Covid-19, with additional product available
for collaborations with independent investigators on other
indications."
JAN101 is a patented sustained release form of sodium nitrite
aimed at improving vascular function, reducing neuropathic pain and
other conditions resulting from poor blood flow. It is highly
selective, acting only in damaged tissue. In animal studies, sodium
nitrite has been shown to promote blood vessel growth and function,
prevents tissue inflammation and necrosis, and prevents diabetic
nephropathy, a leading cause of death in diabetics. Additionally,
three human clinical studies have found that sodium nitrite
significantly reduces pain.
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
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, and (iii) if and when the Phase 2b trials for PAD will commence. 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
IR@Janone.com
1 (800) 400-2247
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SOURCE JanOne Inc.