LAS VEGAS, Aug. 26, 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 successfully completed its initial
engineering batch of JAN101. The JAN101 formulation is a patented
sodium nitrite proprietary compound that demonstrated success in
Phase 1 and Phase 2a trials for improving blood flow and vascular
function, necessary in the treatment of Peripheral Artery Disease
(PAD) and potentially for Covid-19 vascular complications that is
believed to be the cause of severe vital organ and tissue
damage.
According to Dr. Tony Giordano,
JanOne's chief scientific officer, "We are very fortunate to have
had the foresight to initiate the manufacturing process this past
February. Should we gain FDA approval for our Covid-19 study,
we will be in a position to start patient trials immediately and
still remain on track for our planned PAD Phase 2b trials to begin in early 2021."
The company expects to submit the investigational new drug (IND)
for the treatment of Covid-19 vascular complications in the coming
weeks and continues to advance plans to scale-up production of
JAN101. The company has secured a partner for bottling and
labeling, GMP batch production, including placebo batches.
The company expects to deliver 250,000 doses within 30 days after
start of manufacturing and have GMP batches of more than 20 million
doses ready next year.
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, (iv) when and whether
the company will submit an IND for the treatment of Covid-19
vascular complications, and (v) how many doses the company will be
able to deliver. 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