LAS VEGAS, Sept. 3, 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 confirmed stability of its
developmental batch run of JAN101. Working closely with
selected bottling and labeling partner, Eurofins CDMO, the company
is currently on track to initiate GMP production of JAN101 to
support planned Phase 2b trials to
treat peripheral artery disease (PAD). Required clinical
batches of properly bottled and labeled product will also be
available to support immediate start of clinical research to use
JAN101 as a potential treatment for Covid-19 vascular complications
should JanOne gain FDA IND approval. The company is currently
finalizing its Covid-19 vascular treatment investigational new drug
application (IND) for submission to the FDA.
Eurofins CDMO is a world leader in pharmaceutical
development services. Its Canadian facility, Alphora Research
Inc., will work with the JanOne clinical teams and manufacturing
partner to ensure the integrity of all active and placebo bottles
of JAN101. Precise randomized packaging and labeling is
required so patients and caregivers are unaware of whether they are
receiving the placebo or active formulation but also for accurate
participant tracking and clinical data collection.
Business development executive for Eurofins CDMO (Alphora
Research Inc.), Stefan Soderman,
Ph.D. said, "We are very pleased to support JanOne's project to
treat vascular conditions. We are looking forward to a
long-term relationship with the company."
It is expected that the IND for JAN101 as a Covid-19 vascular
complication treatment will be submitted to the FDA in the coming
weeks. Bottling and labeling of clinical trial batches are
expected to begin in early October led by Eurofins CDMO. The
company remains on track for its PAD Phase 2b clinical trials expected to begin in early
2021.
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
About Eurofins CDMO
Eurofins CDMO is a leading
global Contract Development and Manufacturing Organization that
provides clients with Active Pharmaceutical Ingredients
(API's) / Drug Substance and Drug Product development for
small molecules and biologicals. Its service offering encompasses
Drug Substance/API Development, Solid State Research and
Development, Pre-formulation, Formulation and Development,
Analytical Development, GMP Manufacturing and Clinical Packaging
and Logistics. Operating with facilities in Europe, North
America and India, Eurofins
CDMO is accredited through the FDA, EMA, ANSM, ANSES, FAMHP, PMDA,
and Health Canada. For more information:
https://www.eurofins.com/cdmo
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