LAS VEGAS, Aug. 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 entered into an agreement with CATO
SMS, a world-leading, international regulatory and clinical
contract research organization (CRO). CATO SMS will assist JanOne
in expanding its current FDA authorized Investigational New Drug
(IND) for JAN101, an oral, sustained release formulation of sodium
nitrite, to treat vascular complications to potentially restore
endothelial cell function in COVID-19 patients. In addition,
JAN101 is expected to enter Phase 2b
trials in early 2021 to treat Peripheral Artery Disease
(PAD).
A recent study published in the New England Journal of
Medicine3 indicates the possibility that the respiratory
complications from COVID-19 may originate from restrictions and
damage to the vascular system and endothelial cell
dysfunction. The implication is that the endothelial cells
that line the blood vessels are severely compromised and limit the
body's ability to carry oxygen to major organs in the body,
including the lungs. Previous JAN101 clinical studies have
shown promise in repairing and restoring vascular function with
minimal adverse events, which may potentially prove to be
beneficial to COVID-19 patients.
"If COVID-19 is, in fact, a vascular disease that attacks
endothelial cells restricting the ability of cells to deliver
oxygen to vital organs, our sodium nitrite tablets could
potentially offer a safe and effective treatment for that aspect of
the disease," said Tony Giordano,
PhD, JanOne's chief scientific officer. "By mitigating severe organ
and tissue damage, JAN101 can potentially have a significant impact
on the long-term health of these patients."
CATO SMS will work directly with the JanOne leadership team and
scientific advisory board to execute submission of an
investigator-initiated IND for use of JAN101 as a potential
treatment for certain aspects of bodily damage created by COVID–19.
"We have all seen the devastating impacts of COVID-19 and the
severe damage it appears to cause to vital organs that may be a
result from an attack on the vascular system," commented
MerriBeth Adams, Senior Vice
President, Regulatory Affairs at CATO SMS. "We are grateful for the
opportunity to work with JanOne and to do our part to potentially
bring such an important treatment to COVID-19 patients."
In partnership with CATO SMS, JanOne is currently preparing an
investigator-initiated IND package for the FDA, which it expects to
submit in the coming month. If cleared to proceed by the FDA,
clinical management of any ensuing research trials could start
quickly and be conducted by Dr. Amol
Soin, JanOne's chief medical officer. "JAN101 has a
unique approach to treating end organ damage that may result from
COVID-19, which hopefully will help patients. I look forward
to commencing human trials in Dayton,
Ohio in the near future," said Dr. Soin.
JanOne's CEO Tony Isaac said,
"Treatments for COVID-19 complications such as those JAN101 is
looking to address are essential, and we believe our decision to
engage CATO SMS' expertise to guide us through the FDA's regulatory
process is the right choice." In the future, JanOne looks
forward to working with CATO SMS and the FDA to seek an emergency
use authorization for JAN101 in COVID-19 patients.
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)
JAN101's expectation of when it will enter Phase 2b trials to treat PAD, (ii) whether JAN101 is
beneficial to COVID-19 patients, (iii) whether JAN101 can offer a
safe and effective treatment to COVID-19, (iv) whether JAN101 can
treat vascular complications to potentially restore endothelial
cell function in COVID-19 patients, and (v) the timing of the
submission by the company of the IND package for the FDA. 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.
About JanOne
JanOne (NASDAQ: JAN) is focused on
bringing medications to market to treat 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, ARCA Recycling and
GeoTraq, both of which are undergoing review to determine
appropriate strategic alternatives. For more information,
visit janone.com
About CATO SMS
CATO SMS is a provider of specialized
clinical research solutions. The company was formed when CATO
Research LLC and Specialized Medical Services-oncology B.V.
(SMS-oncology) merged in 2019. With more than 30 years of
experience focusing on the needs of small and emerging
biopharmaceutical companies, CATO SMS effectively designs and
executes studies — from strategy to approval — in complex
indications and modalities across a variety of therapeutic areas,
with a proven center of excellence in oncology. CATO SMS'
regulatory, therapeutic, and operational expertise supports
clients with achieving their goals and exceeding their
expectations. Visit CATO-SMS.com for more information.
Investor Relations & Media Contact
IR@Janone.com
1 (800) 400-2247
1 https://pubmed.ncbi.nlm.nih.gov/18508974/
2
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7229726/
3 Pulmonary Vascular Endothelialitis, Thrombosis,
and Angiogenesis in Covid-19, New England Journal of Medicine,
July 9, 2020
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SOURCE JanOne