PainReform Ltd. Announces Favorable Wound Healing Data in Human Clinical Trials for PRF-110
05 Agosto 2024 - 3:00PM
PainReform Ltd. (Nasdaq: PRFX) ("
PainReform" or
the "
Company"), a clinical-stage specialty
pharmaceutical company focused on the reformulation of established
therapeutics, announces positive wound healing data from its human
clinical trials investigating the efficacy of PRF-110, the
Company’s lead asset designed to provide extended, non-opiate,
post-surgical pain relief.
Building on extensive preclinical research,
PainReform previously conducted wound healing studies in animal
models which demonstrated that PRF-110 allows for normal wound
healing of surgical incisions comparable to both Naropin®
(ropivacaine) and saline. Importantly, these studies showed no
adverse histological or radiologic effects on soft or bony
tissues.
The recent human clinical trials included
patients undergoing both hard tissue (bunionectomy) and soft tissue
(hernia) surgeries. Results from these trials indicated no
abnormalities in wound healing or scar formation among patients
treated with PRF-110. Wound healing in all patients was complete
and consistent with outcomes expected from surgeries without
PRF-110.
PRF-110's formulation includes approximately 55%
lecithin, which forms liposome-like structures upon contact with
body fluids. This feature is particularly noteworthy as existing
literature suggests that lecithin liposomes enhance wound healing
through in vitro antioxidant activity and in vivo wound-healing
models (J Comp Eff Res. 2019 Nov;8(15):1343). The potential
beneficial effects of PRF-110 on the wound healing process are
further supported by these in vitro, in vivo, and human
studies.
Ehud Geller, Chairman and interim Chief
Executive Officer of PainReform, commented, "We are very encouraged
by the favorable wound healing data from our human clinical trials
for PRF-110. These findings support the potential of PRF-110 not
only to provide effective pain relief but also to promote normal
wound healing and prevent scar formation. We believe PRF-110 could
significantly enhance post-surgical recovery and patient
outcomes."
PainReform continues to advance the development
of PRF-110 and is on track to report top-line results from the
Phase 3 trial in the second half of 2024. These results are
expected to further inform the regulatory submission process and
potential commercialization plans.
About
PainReform
PainReform 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
Statements
This press release contains forward-looking
statements about our expectations, beliefs and intentions including
with respect to objectives, plans and strategies and expected
timing of results. Forward-looking statements can be identified by
the use of forward-looking words such as "believe", "expect",
"intend", "plan", "may", "should", "could", "might", "seek",
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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 ability to continue as a going concern, 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; 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; 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, including due to the
current war between Israel and Hamas. 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
Dr. Ehud GellerChairman and interim Chief
Executive OfficerPainReform Ltd.Tel: +972-54-4236711Email:
egeller@medicavp.com
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