LAS VEGAS, Aug. 28, 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, has chosen its bottling and labeling
partner to support upcoming clinical trials. JanOne is preparing
its investigational new drug (IND) application for FDA submission
for JAN101 as a potential treatment for vascular complications
caused by Covid-19. JAN101 is already planned for use in
Phase 2b trials as a treatment for
Peripheral Artery Disease (PAD) expected to start in the first
quarter of 2021. JanOne's bottling and labeling partner is a
world leader in pharmaceutical testing and will work with the
company's clinical and manufacturing teams to ensure the integrity
of an initial batch of approximately 3,800 active and placebo
bottles of JAN101.
JAN101 is a sodium nitrite based compound that has been shown to
improve blood flow, restore vascular function, mitigate
inflammation and prevent potential tissue damage in major organs
based on results from Phase 1 and Phase 2a studies. There is no
current treatment on the market today for PAD and, as there is a
growing body of evidence that Covid-19 is a vascular disease,
JAN101 has the potential to impact millions of lives.
According to Tony Isaac, JanOne
chief executive officer, "Having world-class partners is essential
to our success and we continue to build our extended team with some
of the most innovative and reputable companies in the world."
JanOne expects to submit the IND for the treatment of Covid-19
vascular complications in the coming weeks. The company continues
to advance plans to scale-up production of JAN101 with GMP
manufacturing expected to begin by the middle of September.
Combining expert formulation and manufacturing with reliable
bottling and labeling capabilities, the company believes it can
ensure immediate availability of clinical product for its Phase
2b PAD study and for clinical studies
as a treatment for Covid-19 vascular complications, pending
submission of the IND application and FDA approval.
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, (iii) when the Phase 2b trials for PAD commence, and (iv) when and
whether the company will submit an IND for the treatment of
Covid-19 vascular complications, and (v) when manufacturing of
JAN101 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