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PainReform Announces Appointment of Lotus Clinical Research as CRO for Phase 3 Clinical Trial of PRF-110 Reports steady progress towards start of Phase 3 trial

Key Takeaway: PainReform Announces Appointment of Lotus Clinical Research as CRO for Phase 3 Clinical Trial of PRF-110 Reports steady progress towards start of HERZLIYA, Israel - January 4, 2021 - PainReform Ltd. (NasdaqCM: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty

Full Press Release Details

PainReform Announces Appointment of Lotus
Clinical Research as CRO
for Phase 3 Clinical Trial of PRF-110
Reports steady progress towards start of
HERZLIYA, Israel - January 4, 2021
- PainReform Ltd. (NasdaqCM: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty
pharmaceutical company focused on the reformulation of established pain drugs, today announced the appointment of Lotus Clinical
Research ("LCR") as its clinical research organization ("CRO") to conduct the Company's upcoming
Phase 3 trial of PRF-110 in patients undergoing bunionectomy and hernia repair operations and the entering into an agreement with
Lotus covering such trials.
LCR is a specialty analgesic focused
CRO with a proven track record of conducting successful, full-service analgesic studies from startup through all phases of analgesic
clinical trials. LCR has its own clinical sites that support all phases of clinical trials
for novel analgesics and specifically in the area of post-operative pain, including bunion and hernia. LCR has developed an acute
pain model that offers numerous advantages over traditional models, providing clients with active engagement and recruitment of
study subjects, on-site accessibility of surgical and recovery services, and lowered project costs throughout a study's lifecycle.
LCR has been involved in approximately 350 pain trials that led to over ten approvals.
PainReform has been working with LCR's Chief Scientific Officer,
Dr. Neil Singla, for over two years in planning these trials. Dr. Singla is a nationally recognized key opinion leader in analgesic
protocol design and implementation. He has published extensively and is a frequent lecturer for physicians, pharmaceutical companies,
and medical research institutes throughout the country. For the past several years, the main focus of Dr. Singla's academic endeavors
has been to analyze and understand how the inherent variability in subjective endpoint clinical trials can be minimized. He has
developed novel techniques for patient education designed to minimize variability, reduce placebo response, and increase effect
Ilan Hadar, CEO of PainReform, noted, "We
are delighted to announce the appointment of LCR as our CRO, which marks another important milestone as we prepare to commence
our pivotal Phase 3 trials for PRF-110. LCR brings extensive and unique expertise in conducting analgesic studies, which we believe
will help ensure a swift and efficient trial. Moreover, Dr. Singla is one of the preeminent experts in the world on analgesic protocol
design. We remain highly encouraged by our prior data, which demonstrated a strong safety profile, suggesting a substantial advantage
to using PRF-110 over the local anesthetic, ropivacaine. For this reason, we believe PRF-110 addresses an important unmet need
in the market, especially as an alternative to systemic opioids, which have contributed to the opioid epidemic."
Dr. Neil Singla, Chief Scientific Officer of
LCR, commented, "We are honored to work with PainReform to advance this important study. PRF-110 holds significant potential
as an alternative to systemic opioids and offers numerous advantages over other topical pain relief therapies. PRF-110 demonstrated
pain relief of up to 72 hours in a Phase 2 clinical study in hernia patients. Importantly, opiate abuse and addiction cause 70,000
deaths annually in the US alone and an economic burden of $80 billion per year. We believe the trial is well designed, and we look
forward to supporting the administration of this trial."
As previously reported,
PRF-110 provided substantial pain reduction for up to 72 hours post-operatively the in the Company's prior Phase 2 proof-of-concept
clinical study in herniorrhaphy (hernia repair). A comparison of these results to historical data for ropivacaine alone suggests
a substantial advantage to using PRF-110 over the local anesthetic, ropivacaine, alone. As indicated in the FDA approved drug description
for ropivacaine, such drug provides pain relief for only 2 to 6 hours. The surgeons that participated in the PRF-110 Phase 2 trial
reported that it was easily integrated into the procedure and non-disruptive of existing surgical techniques. Ropivacaine, the
active drug used in PRF-110, is a safe, well-tolerated, and well-characterized local anesthetic, and the other components that
make up the remainder of the PRF-110 formulation are classified as GRAS by the FDA, mitigating many potential safety issues that
are common in drug development.
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 post-operative 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 post-operative 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.
Notice Regarding Forward-Looking Statements
This press release contains certain forward-looking
statements, including statements with regard to PainReform's proposed clinical trials. Words such as "expects,"
"anticipates" and "intends" or similar expressions are intended to identify forward-looking statements.
These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions, and no
assurance can be given that the clinical trials discussed above will be successfully completed. Completion of the proposed clinical
trials are subject to numerous factors, many of which are beyond the control of the Company, including, without limitation, failure
of the clinical trials, and the risk factors and other matters set forth in the Company's recent prospectus included in the
registration statement, in the form last filed with the SEC. PainReform undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Crescendo Communications, LLC
Chief Executive Officer
Tel: +972-54-5331725
Last updated: Jan 4, 2021