LAS VEGAS, Feb. 6, 2020 /PRNewswire/ -- JanOne Inc.
(NASDAQ: JAN), a company focused on bringing treatments to market
for conditions that cause severe pain and drugs with non-addictive
pain relieving properties, has executed a manufacturing agreement
for the formulation and manufacturing of TV1001SR, a treatment for
Peripheral Artery Disease (PAD). PAD affects over 8.5 million
people in the United States and
there are currently no direct treatments for PAD on the market
today. Research Market Future (MRFR) values the PAD market at
$3.47 billion in the United States by
2023.1"
"CoreRx's extensive clinical development experience and
capabilities made them a natural choice for phase 2b formulation and manufacturing. As we finalize
our clinical protocols for FDA submission and enter the next phase
of trials for what we believe could be an effective PAD treatment,
CoreRx is a proven partner with exceptional quality controls,"
commented Tony Giordano, PhD,
JanOne's chief scientific officer.
Current PAD treatments only mitigate the effect of symptoms
without treating the underlying cause – reduced ischemic tissue
blood flow - which is a lack of blood flow to the extremities, and
often leads to severe pain. As a result, according to a recent
Stanford University study2,
nearly 25% of patients with PAD are at increased risk of high
opioid use. TV1001SR treats the underlying cause of PAD and
associated pain, therefore potentially eliminating the need to
prescribe dangerous opioids.
"JanOne presents a unique opportunity for our company to have an
impact on patients beyond the disease itself with the potential
pain relieving qualities of its PAD formulation," said CoreRx
President and CEO, Todd R. Daviau.
"We share JanOne's vision for bringing to market a drug that can
treat the underlying cause of PAD and that the company believes
also has the potential to reduce the need for opioid prescriptions
to treat associated pain. This emboldens our commitment to help
make TV1001SR a success."
CoreRx is a contract development manufacturing organization
(CDMO) established in 2006. The company operates over 150,000
square feet of cGMP lab and manufacturing facilities, including six
formulation suites, 18 manufacturing suites, and two analytical
labs. The company began by specializing in clinical drug
development and now has established itself as a leading
commercial-scale pharma manufacturer. CoreRx has worked closely
with leading pharma and bioscience players through FDA approval and
commercialization for a wide range of drug formulations affecting
millions of patient lives.
JanOne's CEO, Tony Isaac said,
"We expect the formulation process of TV1001SR to begin this March
and phase 2b clinical trials to begin
Q4 2020. We are confident that CoreRX Pharma will help us to safely
and efficiently work through clinical trials, and for what we hope
will be a future where we obtain FDA approval and full
commercialization."
About JanOne
JanOne is a unique NASDAQ-listed company
that is focused on bringing medications to market to treat diseases
that cause severe pain in an effort to reduce the need for
prescriptions opioids often used to treat disease associated pain.
The company is also exploring solutions for non-addictive pain
medications. The lead candidate is for treating peripheral artery
disease (PAD), a condition that affects over 8.5 million Americans,
with plans currently underway for phase 2b trials. JanOne is currently dedicated to
funding resources toward innovation, technology, and education for
PAD and neuropathic pain. The company continues to operate its
legacy businesses, ARCA Recycling and GeoTraq, under their current
brand names. ARCA Recycling provides turnkey recycling and
replacement services for utilities and other sponsors of energy
efficiency programs. GeoTraq engages in the development, design
and, ultimately, the company expects, sale of Mobile IoT modules.
Please visit www.janone.com for additional information.
About CoreRx, Inc.
CoreRx, a Contract Development
Manufacturing Organization (CDMO) with capabilities to support
clinical – niche commercial manufacturing, offering state of the
art facilities to support your supply chain needs. Our
integrated offerings provide comprehensive services for the
development, manufacturing and testing of solid, liquid and
semi-solid dosage forms. For more detailed information
about the CoreRX Pharma, visit www.corerxpharma.com.
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 whether TV1001SR has the
ability to reduce the need for opioid prescriptions to treat
associated pain, 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.
Media contact:
Mark Rosenberg
mark@trueparallel.com
919-412-7378
1 Market Watch, April 26,
2019, Peripheral Artery Disease (PAD) Market Size 2019 |
Global Industry is expected to reach at $
3.47 billion, at CAGR of 6.5 % By 2023.
2 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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SOURCE JanOne