LAS VEGAS, Nov. 25, 2019 /PRNewswire/ -- JanOne Inc.
(NASDAQ: JAN), a company focused on reducing opioid addiction by
finding treatments for conditions accompanied by pain and bringing
to market drugs and therapies with nonaddictive pain-relieving
properties, today announced a licensing agreement for TV1001SR, a
treatment for Peripheral Artery Disease, commonly called PAD. The
agreement with LSU Health Shreveport, UAB Research Foundation, and
TheraVasc, Inc., gives JanOne a worldwide, exclusive license for
TV1001SR along with a portfolio of 30 patents and other
intellectual property relating to the sustained release of sodium
nitrite.
The company anticipates TV1001SR will be a groundbreaking
treatment for those with PAD, an often painful disease affecting
more than 200 million people worldwide and 8.5 million in
the United
States1. There is no known efficacious
single-drug treatment for PAD available2.
Current treatments only mitigate the effects of PAD without
treating the underlying cause – reduced ischemic tissue blood flow,
which is a lack of blood flow to the extremities, and often leads
to significant pain. As a result, according to a recent
Stanford
University3 study, nearly 25% of
patients with PAD are at increased risk of high opioid
use.
TV1001SR was invented by Dr. Christopher
Kevil, Professor of Pathology, Molecular and Cellular
Physiology, and Cell Biology and Anatomy at LSU Health Shreveport.
In initial research studies, the drug effectively restored ischemic
tissue blood flow and was effective in a wide range of pathologies
involving alterations of angiogenesis - development of new blood
vessels - including diabetes, wound healing and tissue necrosis.
Beneficial effects included enhancing angiogenesis, endothelial
cell proliferation, and arteriogenesis.
"In our Phase 2a trials, we saw encouraging results in the
participants. The compound not only improved vascular function, but
patients also reported a significant reduction in their
PAD-associated pain," said Tony
Giordano, Ph.D., former CEO of Theravasc and JanOne
scientific advisory board member. "During the trial, a number of
patients reported that their long-term pain had subsided, which was
a positive and unexpected development."
As a result of TV1001SR's promising clinical trial history,
JanOne will begin planning a Phase 2b
clinical protocol for PAD with an expectation to commence Phase
2b trials by the second half of 2020.
In addition, the company intends to apply for the secondary
indication of PAD-associated pain as part of its Phase 2b trails. To streamline development and FDA
approval, the company expects to pursue FDA 505(b)(2) pathway for
new drug approval, due to an already approved agent associated with
TV1001SR.
"Developing a non-addictive drug to treat a major disease that
causes pain normally managed with opioids is exactly the kind of
imaginative thinking the opioid crisis demands," said Eric Bolling, JanOne's chairman and president.
"By treating PAD, the root cause of the disease, we hope to also be
preventing and treating pain."
"Partnering with JanOne to bring to market this important
treatment for a significant health issue is extremely gratifying,"
said Dr. Kevil. "We know that by treating PAD we can improve
outcomes, increase quality of life, and avoid opioid addiction for
potentially millions of people. I'm excited to work with JanOne and
to continue the ongoing development of this critical
medication."
If the company is ultimately granted FDA market approval, it
believes that TV1001SR would immediately disrupt
the $4.37 billion a year
PAD market in the United
States4.
"We are thrilled to fast-track this drug into Phase 2b clinical trials with the addition of treating
pain associated with PAD. We believe that having a solution to a
major cause of neuropathic pain while eliminating the dependence on
opioids could be an effective game-changer, with even greater
long-term implications," added Bolling.
Forward-Looking Statements
This press release contains statements that are forward-looking
statements as defined within the Private Securities Litigation
Reform Act of 1995, including, but not limited to, statements
relating to the fact that TV1001SR will treat PAD, the timing of
the commencement of clinical trials, that the FDA will permit
approval through a 505(b)(2) pathway, that upon approval TV1001SR
will immediately disrupt the PAD market, and other statements
including words such as "continue", "expect", "intend", "will",
"hope" "should", "would", "may", "potential" and other similar
expressions. Such statements reflect our current views with respect
to future events and are subject to risks and uncertainties and are
necessarily based upon a number of estimates and assumptions that,
while considered reasonable by us, are inherently subject to
significant business, economic, competitive, political and social
uncertainties, and contingencies. Many factors could cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
described in this press release. Such factors could include, among
others, those detailed in the Company's periodic reports filed with
the Securities and Exchange Commission (the "SEC").
Should one or more of these risks or uncertainties materialize,
or should the assumptions set out in the section entitled "Risk
Factors" in our filings with the SEC underlying those
forward-looking statements prove incorrect, actual results may vary
materially from those described herein. These forward-looking
statements are made as of the date of this press release and we do
not intend, and do not assume any obligation, to update these
forward-looking statements, except as required by law. We cannot
assure you that such statements will prove to be accurate as actual
results and future events could differ materially from those
anticipated in such statements. Investors are cautioned that
forward-looking statements are not guarantees of future performance
and accordingly investors are cautioned not to put undue reliance
on forward-looking statements due to the inherent uncertainty
therein.
About JanOne
JanOne is a unique Nasdaq-listed company
offering innovative, actionable solutions that it believes can help
create an end to the opioid crisis. JanOne is dedicated to funding
resources toward innovation, technology, and education to find a
key resolution to the national opioid epidemic, which is one of the
deadliest and widespread in the country's history. The company
continues to operate its legacy businesses – ARCA Recycling and
GeoTraq – under their current brand names. JanOne's subsidiary,
ARCA Recycling, recycles household appliances by providing turnkey
recycling and replacement services for utilities and other sponsors
of energy efficiency programs. JanOne's subsidiary GeoTraq engages
in the development, design and, ultimately, expected sale of Mobile
IoT modules. Please visit www.janone.com for additional
information.
About LSU Health Shreveport
LSU Health Shreveport is
one of two Health Sciences Centers of the Louisiana State University (LSU) System and one of only 154 in the nation
accredited by the Liaison Committee on Medical Education (LCME).
LSU Health Shreveport is home to three professional schools (School
of Medicine, School of Graduate Studies and School of Allied Health
Professions), Graduate Medical Education (GME) and a robust
research enterprise. At any one time, more than 900 students are
enrolled in degree programs, and more than 560 residents and
fellows are being trained at LSUHS partner teaching hospitals in
North Louisiana. The primary
mission of the LSU Health Shreveport is to teach, heal, and
discover, in order to advance the well-being of the region and
beyond. At the heart of LSU Health Shreveport is a strong faculty
that includes a number of nationally and internationally acclaimed
physicians and scientists. More than 600 strong, they lead research
efforts, educate students, train residents and fellows, and provide
primary and specialty care to patients throughout the region. LSU
Health Shreveport has strong community support, fostering a culture
of diversity and inclusion that promotes mutual respect for all.
For more information visit www.lsuhs.edu.
(1)
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Diagnosis and
Management of Peripheral Arterial Disease Debra
Kohlman-Trigoboff, MS, ACNP-BC: 200 million people in the world
suffer from PAD and 8.5 million of them reside in the US
https://www.npjournal.org/article/S1555-4155(18)30645-7/fulltext
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(2)
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https://www.nhlbi.nih.gov/health-topics/peripheral-artery-disease
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(3)
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Dr.
Itoga Department of Surgery Stanford University: 24.7% of
PAD people with PAD are at increased risk of high opioid use
https://www.jvascsurg.org/article/S0741-5214(19)30179-X/fulltext
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(4)
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https://www.ncbi.nlm.nih.gov/pubmed/18687757#
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Contact: Michele Hart Henry;
1-302-463-6167
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SOURCE JanOne