PainReform Selected for Poster Presentation at the 13th Congress of the European Pain Federation in Budapest, Hungary
September 07 2023 - 9:00AM
PainReform Ltd. (Nasdaq: PRFX) ("
PainReform" or
the "
Company"), a clinical-stage specialty
pharmaceutical company focused on the reformulation of established
therapeutics, today announced that Company has been selected for a
poster presentation, titled “Pharmacokinetics and Safety Profiles
of PRF-110 in Subjects Following Bunionectomy Surgery,” at the
upcoming 13th Congress of the European Pain Federation (EFIC) being
held September 20-22, 2023 at the HUNGEXPO Exhibition Centre in
Budapest, Hungary. The poster will be presented by Professor Eli
Hazum, Chief Technology Officer of PainReform, on September 20,
2023. The poster will be available on the EFIC website after the
meeting.
The poster presentation will provide further
details regarding the positive safety and pharmacokinetic (PK) data
from the Company’s first part of its two-part Phase 3 clinical
trial of PRF-110, which enrolled 15 bunionectomy patients at two
clinical sites in Texas. PRF-110 was administrated
intra-operatively to validate the formulation's safety and confirm
optimal product instillation in the surgical wound. PRF 110 was
well tolerated, all adverse events (AEs) were mild, and no serious
adverse events (SAEs) were observed.
The Phase 3 trial is a randomized, double-blind,
placebo and active-controlled, multicenter study to evaluate the
analgesic efficacy and safety of intra-operative administration of
PRF-110 following unilateral bunionectomy. PRF-110 is an oil-based,
viscous, clear solution that is deposited directly into the
surgical wound bed before closure to provide localized and extended
postoperative analgesia. The upcoming second part of the trial will
be a double-blind study, randomizing approximately 400 patients at
seven clinical sites in the U.S. and measuring pain reduction by
PRF-110 over 72 hours compared with placebo and plain
ropivacaine.
Ilan Hadar, Chief Executive Officer of
PainReform, stated, “We are honored to announce the acceptance of
our poster for presentation at the highly prestigious EFIC
Congress, detailing the results from the first part of our Phase 3
clinical trial. The analyses of PRF-110 indicate that the drug is
well tolerated and has a favorable PK profile, suggesting a
substantial potential advantage to using PRF-110 over the local
anesthetic, ropivacaine. This data further reinforces the growing
body of clinical evidence supporting our non-opioid, pain-relieving
treatment for postoperative pain. Overall, we remain highly
encouraged by the outlook for the program and we look forward to
proceeding to the second, larger part of the Phase 3 clinical
trial.”
About The European Pain Federation
(EFIC)The European Pain Federation (EFIC) is a non-profit
organization representing healthcare professionals in the fields of
pain management and pain science. 13th Congress of the European
Pain Federation is the main European congress for all healthcare
professionals working in pain management featuring cutting-edge
pain research and hot topics in pain science. For more information,
please visit: https://europeanpainfederation.eu.
About PainReformPainReform is a
clinical-stage specialty pharmaceutical company focused on the
reformulation of established therapeutics. PRF-110, the Company's
lead product is based on the local anesthetic ropivacaine,
targeting the postoperative pain relief market. PRF-110 is an
oil-based, viscous, clear solution that is deposited directly into
the surgical wound bed prior to closure to provide localized and
extended postoperative analgesia. The Company's proprietary
extended-release drug-delivery system is designed to provide an
extended period of post-surgical pain relief without the need for
repeated dose administration while reducing the potential need for
the use of opiates. For more information, please visit
www.painreform.com.
Notice Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements about our expectations, beliefs and intentions.
Forward-looking statements can be identified by the use of
forward-looking words such as "believe", "expect", "intend",
"plan", "may", "should", "could", "might", "seek", "target",
"will", "project", "forecast", "continue" or "anticipate" or their
negatives or variations of these words or other comparable words or
by the fact that these statements do not relate strictly to
historical matters. These forward-looking statements are based on
assumptions and assessments made in light of management's
experience and perception of historical trends, current conditions,
expected future developments and other factors believed to be
appropriate. Forward-looking statements in this press release are
made as of the date of this press release, and we undertake no duty
to update or revise any such statements, whether as a result of new
information, future events or otherwise. Forward-looking statements
are not guarantees of future performance and are subject to risks
and uncertainties, many of which are outside of our control. Many
factors could cause our actual activities or results to differ
materially from the activities and results anticipated in
forward-looking statements, including, but not limited to, the
following: our history of significant losses, our need to raise
additional capital and our ability to obtain additional capital on
acceptable terms, or at all; our dependence on the success of our
initial product candidate, PRF-110; the outcomes of preclinical
studies, clinical trials and other research regarding PRF-110 and
future product candidates; the impact of the COVID-19 pandemic on
our operations; our limited experience managing clinical trials;
our ability to retain key personnel and recruit additional
employees; our reliance on third parties for the conduct of
clinical trials, product manufacturing and development; the impact
of competition and new technologies; our ability to comply with
regulatory requirements relating to the development and marketing
of our product candidates; commercial success and market acceptance
of our product candidates; our ability to establish sales and
marketing capabilities or enter into agreements with third parties
and our reliance on third party distributors and resellers; our
ability to establish and maintain strategic partnerships and other
corporate collaborations; the implementation of our business model
and strategic plans for our business and product candidates; the
scope of protection we are able to establish and maintain for
intellectual property rights and our ability to operate our
business without infringing the intellectual property rights of
others; the overall global economic environment; our ability to
develop an active trading market for our ordinary shares and
whether the market price of our ordinary shares is volatile; and
statements as to the impact of the political and security situation
in Israel on our business. More detailed information about the
risks and uncertainties affecting us is contained under the heading
"Risk Factors" included in the Company's most recent Annual Report
on Form 20-F and in other filings that we have made and may make
with the Securities and Exchange Commission in the
future.
Contact:Crescendo Communications, LLCTel:
212-671-1021Email: prfx@crescendo-ir.com
Ilan HadarChief Executive OfficerPainReform Ltd.Tel:
+972-54-5331725Email: ihadar@painreform.com
PainReform (NASDAQ:PRFX)
Historical Stock Chart
From Apr 2024 to May 2024
PainReform (NASDAQ:PRFX)
Historical Stock Chart
From May 2023 to May 2024