PainReform’s New Manufacturing Process Achieves Significant Benefits Including 18-Month Stability of PRF-110 at Room Temperature
01 Agosto 2024 - 2:30PM
PainReform Ltd. (Nasdaq: PRFX) ("
PainReform" or
the "
Company"), a clinical-stage specialty
pharmaceutical company focused on the reformulation of established
therapeutics, announces a major advancement in the development of
its lead asset, PRF-110. The Company's new highly scalable
manufacturing process, for which it recently filed a new patent,
has enabled PRF-110 to achieve full product stability for 18 months
at room temperature. This stability study is ongoing and marks a
significant achievement for PainReform.
Drug stability, or shelf life, is defined as the
ability of a drug substance or product to maintain its original
properties and characteristics within specified limits during
storage. This is crucial for ensuring the drug's safety and
efficacy. The demonstrated stability of PRF-110 at room temperature
is a critical milestone for PainReform as it significantly eases
handling and transportation and reduces associated costs, all of
which are vital for ensuring future market penetration and
wide-scale use.
Ehud Geller, Chairman and interim Chief
Executive Officer of PainReform, commented, "Achieving 18-month
stability for PRF-110 at room temperature is a major accomplishment
for PainReform and a significant validation of our new
manufacturing process. This stability not only simplifies logistics
and reduces costs but also underscores our commitment to ensuring
the highest standards of safety and efficacy for our products. As
we look forward to the top-line results from our Phase 3 trial in
the second half of 2024, we are confident that this new process
will significantly bolster our future commercialization
efforts."
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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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
Grafico Azioni PainReform (NASDAQ:PRFX)
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Da Dic 2024 a Gen 2025
Grafico Azioni PainReform (NASDAQ:PRFX)
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Da Gen 2024 a Gen 2025