LAS VEGAS, June 8, 2021 /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, today announced the successful completion of Current
Good Manufacturing Practices (CGMP) production of the first batch
of JAN101 for its upcoming Phase 2b
trial for treating Peripheral Artery Disease (PAD).
The initial batch, produced by manufacturing partner CoreRX,
contains approximately 200,000 sustained release tablets and
matching placebos of JAN101, a patented sustained-release form of
sodium nitrite aimed at improving vascular function and reducing
neuropathic pain and other conditions resulting from poor blood
flow. JAN101 is highly selective, acting only in damaged
tissue.
"Completion of the CGMP batch is an exciting achievement as we
advance toward our planned Phase 2b
PAD trial for JAN101," said Tony
Isaac, President and Chief Executive Officer of JanOne.
"With CGMP compliance, we've proven our ability to economically
scale-up production of JAN101 while preserving the product's
identity, strength, quality, and purity. We are now focused on
bottling and labeling JAN101 for distribution to clinical test
sites and engaging a contract research organization (CRO) to manage
our Phase 2b trial, including the
recruitment of subjects."
Commenting on potential indications for JAN101, Isaac added,
"Therapeutic options available for patients with PAD are extremely
limited, and we believe our solution has the potential to transform
the standard of care to an easy twice-a-day pill that substantially
improves moderate to severe PAD and minimizes pain associated with
the disease. We are also exploring the potential of JAN101 as a
treatment for other conditions involving vascular complications,
including chronic kidney disease, and, with our initial batch, we
now have additional product available for collaborations with
independent investigators on this and additional indications."
The U.S. Food and Drug Administration (FDA) regulates the
quality of pharmaceuticals through its main standard CGMP.
Completion of CGMP production signifies that JanOne is fully
compliant with the FDA's formal regulations regarding the design,
monitoring, control, and maintenance of
manufacturing processes and facilities for JAN101.
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 potentially 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 the near future. JanOne is dedicated to funding resources toward
innovation, technology, and education for PAD, associated vascular
conditions, and neuropathic pain. For more information,
visit www.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 the commencement of the upcoming Phase 2b trials, whether JAN101 can treat other
conditions involving vascular complications, including chronic
kidney disease. These forward-looking statements can be identified
by terminology such as "will," "aims," "upcoming," "may,"
"expects," "expected," "potential," "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 January 2, 2021 and other SEC filings (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 Inc.