Virpax Pharmaceuticals Announces Preliminary Results of ProbudurTM Pilot Study with the U.S. Army Institute of Surgical Research
February 07 2024 - 7:30AM
Business Wire
Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”)
(NASDAQ: VRPX), a company specializing in developing
non-addictive products for pain management, post-traumatic stress
disorder, central nervous system (CNS) disorders and anti-viral
barrier indications, today announced the initial results from the
pilot study for Probudur™ performed by the U.S. Army Institute of
Surgical Research (USAISR) under an existing Cooperative Research
and Development Agreement (CRADA). The USAISR is the U.S.
Department of Defense’s premier research organization for
developing solutions for trauma and critical care challenges in
combat casualties.
This study was designed to determine if Probudur reduces pain
behaviors in a rat model of incisional pain. Two concentrations of
Probudur were injected into the tissue around the incision site as
well as a saline solution for the control group. Both doses of
Probudur showed reduction in incision-induced pain behaviors.
“While the data from these studies will be further analyzed,
these positive results are consistent with what we at Virpax have
previously observed. We are encouraged by these initial findings
and expect that the next step by the USAISR would be a full powered
study comparing Probudur with free bupivacaine and EXPAREL®,”
commented Gerald W. Bruce, CEO of Virpax Pharmaceuticals.
Probudur is being developed by Virpax to significantly reduce or
eliminate the need for opioids after surgery or trauma in approved
indications. In pre-clinical trials, Probudur has shown long
duration pain control for at least 96 hours.
“All of our RX products have CRADAs associated with them,
similar to the USAISR one recently highlighted in a Forbes.com
article. Virpax has developed a core competency in identifying,
applying for, and winning government grants which are an essential
part of our non-dilutive funding strategy. We are continuing to
apply for additional grants to help fund our upcoming clinical
trials. In the interim, we are moving ahead with our remaining
confirmational studies for Probudur and Envelta™ and are still on
target to file Investigational New Drug (IND) Applications in the
second half of this year,” concluded Mr. Bruce.
About Virpax Pharmaceuticals
Virpax is developing branded, non-addictive pain management
products candidates using its proprietary technologies to optimize
and target drug delivery. Virpax is initially seeking FDA approval
for two prescription drug candidates that employ two different
patented drug delivery platforms. Probudur™ is a single injection
liposomal bupivacaine formulation being developed to manage
post-operative pain and Envelta™ is an intranasal molecular
envelope enkephalin formulation being developed to manage acute and
chronic pain, including pain associated with cancer. Virpax is also
using its intranasal Molecular Envelope Technology (MET) to develop
two other product candidates. PES200 is a product candidate being
developed to manage post-traumatic stress disorder (PTSD) and
NobrXiol™ is a product candidate being developed for the nasal
delivery of a pharmaceutical-grade cannabidiol (CBD) for the
management of rare pediatric epilepsy. Virpax recently acquired
global rights to NobrXiol. Virpax has competitive cooperative
research and development agreements (CRADAs) for all three of its
prescription drug candidates, two with the National Institutes of
Health (NIH) and one with the Department of Defense (DOD). Virpax
is also seeking approval of two nonprescription product candidates:
AnQlar, which is being developed to inhibit viral replication
caused by influenza or SARS-CoV-2, and Epoladerm™, which is a
topical diclofenac spray film formulation being developed to manage
pain associated with osteoarthritis. For more information, please
visit virpaxpharma.com and follow us on Twitter, LinkedIn and
YouTube.
Forward-Looking Statements
This press release contains certain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, and Private Securities Litigation Reform Act, as amended,
including those described below. These forward-looking statements
are based on current expectations, estimates, forecasts and
projections about the industry and markets in which we operate and
management's current beliefs and assumptions.
These statements may be identified by the use of forward-looking
expressions, including, but not limited to, "expect," "anticipate,"
"intend," "plan," "believe," "estimate," "potential,” "predict,"
"project," "should," "would" and similar expressions and the
negatives of those terms and include statements regarding the next
step by the USAISR being a full powered study comparing Probudur
with free bupivacaine and EXPAREL, developing Probudur to
significantly reduce or eliminate the need for opioids after
surgery or trauma in approved indications, continuing to apply for
additional grants to help fund upcoming clinical trials, moving
ahead with remaining confirmational studies for Probudur and
Envelta™ and still being on target to file Investigational New Drug
(IND) Applications in the second half of this year. These
statements relate to future events and involve known and unknown
risks, uncertainties, and other factors, including the Company’s
ability to successfully complete research and further development
and commercialization of Company drug candidates in current or
future indications; the Company’s ability to obtain additional
grants to help fund upcoming clinical trials; the Company’s ability
to move ahead with remaining confirmational studies for Probudur
and Envelta™ as planned; the Company’s ability to manage and
successfully complete clinical trials and the research and
development efforts for multiple product candidates at varying
stages of development; the timing, cost and uncertainty of
obtaining regulatory approvals for the Company’s product
candidates; the Company’s ability to protect its intellectual
property; the Company’s ability to obtain capital to meet its
long-term liquidity needs on acceptable terms, or at all, including
the additional capital which will be necessary to complete clinical
trials that the Company plans to initiate; and other factors listed
under "Risk Factors" in our Annual Report on Form 10-K and
Quarterly Reports on Form 10-Q that the Company has filed with the
U.S. Securities and Exchange Commission. Prospective investors are
cautioned not to place undue reliance on such forward-looking
statements, which speak only as of the date of this press release.
The Company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
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