PainReform Provides PRF-110 Manufacturing Update
PainReform Ltd. (Nasdaq: PRFX) has announced successful improvements in the manufacturing process of its lead product PRF-110, enhancing efficiency and scalability. These advancements include the implementation of terminal filtration, aimed at ensuring high-quality production. The company confirms it is on track to initiate a Phase 3 clinical trial for bunionectomy in November 2022. PainReform focuses on reformulating established therapeutics to provide localized post-operative pain relief, reducing reliance on opiates.
- Improvements in manufacturing process expected to enhance efficiency and scalability.
- Successful implementation of terminal filtration for higher quality production.
- On track to begin Phase 3 clinical trial for bunionectomy in November 2022.
- Dependence on the success of PRF-110 may pose risks for financial stability.
- Potential challenges in obtaining additional capital and managing clinical trials.
Completed tech transfer to CMO resulting in new process improvements
On track to commence Phase 3 clinical trial in bunionectomy in November 2022
TEL AVIV, Israel, Oct. 04, 2022 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today provided an update regarding the added benefits in its PRF-110 manufacturing process. This new process is expected to not only aid the manufacturing of clinical stock for the Phase 3 clinical study about to begin, but also deliver benefits into the future.
Ilan Hadar, Chief Executive Officer of Pain Reform, stated, “The process improvements we achieved will further enhance efficiency, scalability and other aspects of the manufacturing process. Among these improvements was the addition of terminal filtration for PRF-110, which we believe will help ensure the highest quality batch production, as well as support our planned commercial manufacturing. I’m also pleased to report we remain on track to commence our Phase 3 clinical trial in bunionectomy in November 2022 and look forward to providing further updates.”
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 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. 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. 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, LLC
Tel: 212-671-1021
Email: prfx@crescendo-ir.com
Ilan Hadar
Chief Executive Officer
PainReform Ltd.
Tel: +972-54-5331725
Email: ihadar@painreform.com
FAQ
What is the latest update from PainReform Ltd. regarding PRF-110?
When is PainReform set to commence its Phase 3 clinical trial for bunionectomy?
What are the key benefits of PainReform's manufacturing process improvements?
How does PRF-110 work to relieve post-operative pain?
