LAS VEGAS, July 21, 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 received confirmation from the
Federal Food and Drug Administration (FDA) for the investigational
new drug (IND) sponsorship transfer covering its sodium nitrite
tablets previously held by Soin Neuroscience. The sodium nitrite
sustained release tablet is the clinical candidate TV1001SR,
formulated to treat PAD and other vascular conditions.
Manufacturing of TV1001SR is underway and phase 2b trials for PAD are expected to begin later
this year. There is no current treatment for PAD and over 8.5
million Americans suffer from the disease.
Sodium nitrite has demonstrated positive results on vascular
conditions, such as PAD, diabetic neuropathy and even vascular
decline associated with normal aging. In previous preclinical and
clinical studies, sodium nitrite has shown promise repairing and
restoring vascular function with minimal adverse events. In
addition, in an aged mice study, nitrite administration has been
shown to reduce the production of vascular inflammation and
"The transfer of the IND is significant not only for advancing
JanOne's clinical research for PAD treatment but other indications
as well," remarked Dr. Tony
Giordano, JanOne's chief scientific officer.
The TV1001SR IND was previously held by Soin Neuroscience, whose
founder Dr. Amol Soin, now serves as
JanOne's chief medical officer. Dr. Soin, in collaboration
with Dr. Giordano and JanOne's scientific advisory board chair, Dr.
Christopher Kevil, are the nation's
leading experts on sodium nitrite. This includes its use for
treatment of vascular conditions such as PAD, vascular inflammation
caused by PAD and diabetic neuropathy. The transfer of the
IND from Soin Neuroscience to JanOne was managed by JanOne's
clinical partner, Cato Research, an international regulatory and
clinical contract research organization (CRO) with a proven
track record for cardiovascular pharmaceutical agents.
Tony Isaac, Chief Executive
Officer of JanOne commented, "We would like to thank Cato Research
for their assistance in the IND transfer process. They are
true partners from strategy to approval. We look forward to
moving forward with our clinical trials for PAD and to explore
other possibilities for the application of TV1001SR."
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, but has recently announced both are undergoing a
review to determine appropriate strategic alternatives in an effort
to focus on its biopharma interests. Please visit www.janone.com
for additional information.
Forward-Looking and Cautionary Statements
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 when Phase 2
trials for PAD will begin, involve risks and uncertainties that may
affect the company's actual results. These forward-looking
statements can be identified by terminology such as "will,"
"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
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