In the news release, JanOne Completes Stable Formulation of
JAN101 in Preparation for Its First GMP Manufacturing Batch to
Support Upcoming Clinical Trials, issued 11-Aug-2020 by JanOne over PR Newswire, we are
advised by the company that the 1st paragraph, 1st sentence, should
read "[JAN101...] showed success in Phase 1 and Phase 2a trials
[...]" rather than "[JAN101...] showed success in Phase 1 and Phase
2b trials [...]" as originally issued
inadvertently. The complete, corrected release follows:
JanOne Completes Stable Formulation of JAN101 in Preparation for
Its First GMP Manufacturing Batch to Support Upcoming Clinical
Trials JAN101 formulation ready for Phase
2b peripheral artery disease trials and for
potential treatment of COVID-19 vascular inflammation
LAS VEGAS, Aug. 11, 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, together with its manufacturing partner,
has successfully completed the formulation of JAN101, its potential
treatment for Peripheral Artery Disease (PAD) expected to soon be
in Phase 2b trials. In addition,
JAN101 is planned for use to treat COVID-19 vascular complications
pending approval of the IND submission, expected to be completed in
late August 2020.
JAN101 is one of the few promising treatments for vascular
conditions using sodium nitrite that showed success in Phase 1 and
Phase 2a trials for improving blood flow and vascular function. The
company is preparing its IND packages for FDA submission for
continued development as a treatment of PAD and to extend JAN101 to
potentially mitigate severe organ and tissue damage caused by
COVID-19. The successful formulation of JAN101 will allow the
company to begin its engineering run and GMP manufacturing for
multiple trials expected to begin in early 2021.
"Working with our manufacturing partner, we have been able to
successfully produce JAN101, our sustained release formulation and
expect our engineering batch to begin immediately," said Dr.
Tony Giordano, chief scientific
officer at JanOne. "We believe we will have the initial GMP
batch of 250,000 doses by mid-September
2020. This will provide us with enough tablets to carryout
our proposed Phase 2b PAD trials and
the COVID-19 treatment study IND, which we are confident will gain
approval."
The company will now focus on commercial production capability
of JAN101 and is currently negotiating to purchase 1,000 kilos of
sodium nitrite from a multinational biopharmaceutical company
to support GMP manufacturing batches of more than 20 million doses
of JAN101.
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
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) when
JAN101 will enter Phase 2b trials to
treat PAD, (ii) whether JAN101 can treat vascular complications in
COVID-19 patients, and (v) whether the company is able to negotiate
a sufficient amount of sodium nitrite on terms acceptable to it or
at all. 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