PainReform Ltd. Confirms Sutures Compatibility in Human Clinical Trials for PRF-110
PainReform (Nasdaq: PRFX) has announced positive results regarding the compatibility of sutures in human clinical trials for its lead product, PRF-110. The company conducted in vitro studies to assess the impact of PRF-110 on both non-absorbable and resorbable sutures, specifically PROLENE™ and Vicryl™. The results showed that PRF-110 does not affect the mechanical properties of these sutures, including breaking force and elongation, after 14 days of exposure.
This finding is consistent with the phase III clinical results from the bunionectomy trial and supports the safety and efficacy of PRF-110 in post-surgical pain management. The compatibility of PRF-110 with surgical sutures is a significant advancement in post-operative care, as it allows for extended, non-opiate pain relief without compromising suture integrity.
PainReform (Nasdaq: PRFX) ha annunciato risultati positivi riguardo alla compatibilità dei punti di sutura negli studi clinici umani per il suo prodotto di punta, PRF-110. L'azienda ha condotto studi in vitro per valutare l'impatto di PRF-110 sia sui punti di sutura non riassorbibili che su quelli riassorbibili, in particolare PROLENE™ e Vicryl™. I risultati hanno mostrato che PRF-110 non influisce sulle proprietà meccaniche di questi punti di sutura, inclusi la forza di rottura e l'allungamento, dopo 14 giorni di esposizione.
Questa scoperta è coerente con i risultati clinici di fase III del trial di bunionectomia e supporta la sicurezza e l'efficacia di PRF-110 nella gestione del dolore post-operatorio. La compatibilità di PRF-110 con i punti di sutura chirurgici rappresenta un significativo progresso nella cura post-operatoria, poiché consente un sollievo dal dolore prolungato e non oppiaceo senza compromettere l'integrità dei punti di sutura.
PainReform (Nasdaq: PRFX) ha anunciado resultados positivos respecto a la compatibilidad de los suturas en ensayos clínicos humanos para su producto principal, PRF-110. La empresa llevó a cabo estudios in vitro para evaluar el impacto de PRF-110 tanto en suturas no absorbibles como reabsorbi les, específicamente PROLENE™ y Vicryl™. Los resultados mostraron que PRF-110 no afecta las propiedades mecánicas de estas suturas, incluyendo la fuerza de rotura y la elongación, después de 14 días de exposición.
Este hallazgo es consistente con los resultados clínicos de fase III del ensayo de bunionectomía y apoya la seguridad y eficacia de PRF-110 en el manejo del dolor post-quirúrgico. La compatibilidad de PRF-110 con las suturas quirúrgicas es un avance significativo en el cuidado postoperatorio, ya que permite un alivio prolongado del dolor no opioide sin comprometer la integridad de las suturas.
PainReform (Nasdaq: PRFX)는 주력 제품인 PRF-110에 대한 인간 임상 시험에서 봉합사 호환성에 대한 긍정적인 결과를 발표했습니다. 회사는 PRF-110이 비흡수성 및 흡수성 봉합사, 특히 PROLENE™과 Vicryl™에 미치는 영향을 평가하기 위해 시험관 내 연구를 수행했습니다. 결과는 PRF-110이 14일 동안의 노출 후 이러한 봉합사의 기계적 특성 (파단력과 신장 포함)에 영향을 미치지 않는 것으로 나타났습니다.
이 발견은 bunionectomía 시험의 3상 임상 결과와 일치하며, PRF-110이 수술 후 통증 관리에서 안전성과 효능을 지원합니다. PRF-110과 수술 봉합사의 호환성은 수술 후 관리에서 중요한 진전을 의미하며, 봉합사 무결성을 훼손하지 않고도 장시간의 비오피오이드 통증 완화를 가능하게 합니다.
PainReform (Nasdaq: PRFX) a annoncé des résultats positifs concernant la compatibilité des sutures lors d'essais cliniques humains pour son produit phare, le PRF-110. La société a mené des études in vitro afin d'évaluer l'impact du PRF-110 sur les sutures non résorbables et résorbables, notamment PROLENE™ et Vicryl™. Les résultats ont montré que le PRF-110 n'affecte pas les propriétés mécaniques de ces sutures, y compris la force de rupture et l'élongation, après 14 jours d'exposition.
Cette découverte est cohérente avec les résultats cliniques de phase III de l'essai de bunionectomie et soutient la sécurité et l'efficacité du PRF-110 dans la gestion de la douleur post-chirurgicale. La compatibilité du PRF-110 avec les sutures chirurgicales représente une avancée significative dans les soins postopératoires, car elle permet un soulagement prolongé de la douleur sans opioïdes, sans compromettre l'intégrité des sutures.
PainReform (Nasdaq: PRFX) hat positive Ergebnisse zur Verträglichkeit von Nähten in klinischen Studien an Menschen für sein Hauptprodukt PRF-110 bekannt gegeben. Das Unternehmen führte in vitro Studien durch, um die Auswirkungen von PRF-110 auf sowohl nicht-resorbierbare als auch resorbierbare Nähte, insbesondere PROLENE™ und Vicryl™, zu bewerten. Die Ergebnisse zeigten, dass PRF-110 die mechanischen Eigenschaften dieser Nähte, einschließlich Bruchkraft und Dehnung, nach 14 Tagen Exposition nicht beeinflusst.
Diese Erkenntnis stimmt mit den Phase-III klinischen Ergebnissen aus der Bunionektomie-Studie überein und unterstützt die Sicherheit und Wirksamkeit von PRF-110 im postoperativen Schmerzmanagement. Die Verträglichkeit von PRF-110 mit chirurgischen Nähten stellt einen bedeutenden Fortschritt in der postoperativen Versorgung dar, da sie eine verlängerte, nicht-opioide Schmerzlindung ermöglicht, ohne die Integrität der Nähte zu beeinträchtigen.
- PRF-110 demonstrated compatibility with common surgical sutures in clinical trials
- In vitro studies showed no impact on mechanical properties of PROLENE™ and Vicryl™ sutures after 14 days
- Results are consistent with phase III clinical findings from the bunionectomy trial
- PRF-110 offers extended, non-opiate post-surgical pain relief without compromising suture integrity
- None.
Insights
The compatibility study of PRF-110 with surgical sutures is a crucial milestone in the product's development. This data addresses a critical concern in post-surgical care: ensuring that pain management solutions don't compromise wound closure integrity. The study's focus on both non-absorbable (PROLENE™) and resorbable (Vicryl™) sutures is comprehensive, covering the main types used in surgeries.
The preservation of mechanical properties, including breaking force and elongation, after 14 days of exposure to PRF-110 is particularly noteworthy. This timeframe is relevant as it covers the critical initial healing period post-surgery. The consistency with phase III clinical results from the bunionectomy trial adds weight to the findings, suggesting real-world applicability.
However, it's important to note that while these results are promising, they are still part of ongoing clinical trials. The transition from in vitro to in vivo performance will be a key factor to monitor in future studies.
This announcement potentially enhances PainReform's market position in the post-surgical pain management sector. The compatibility of PRF-110 with common sutures addresses a critical safety concern, potentially reducing barriers to adoption by surgeons and hospitals. This could translate into a competitive advantage in the lucrative pain management market.
However, investors should note that PainReform is still a clinical-stage company without commercialized products. The path to market approval and revenue generation remains uncertain. The company's financial stability and burn rate should be closely monitored, as further clinical trials and regulatory processes will require significant capital.
While this news is positive, it's important to consider it in the context of the overall competitive landscape and PainReform's ability to successfully bring PRF-110 to market. The company's valuation should reflect both the potential of PRF-110 and the risks inherent in drug development and commercialization.
Positive Compatibility Results Reinforce Safety and Efficacy of PRF-110 in Post-Surgical Pain Management
TEL AVIV, Israel, Sept. 11, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced positive findings regarding the compatibility of sutures in human clinical trials of its lead product, PRF-110. PRF-110 is designed to provide extended, non-opiate, post-surgical pain relief.
The Company conducted comprehensive in vitro studies to assess the impact of PRF-110 on both non-absorbable and resorbable sutures. Given that suture materials are often in proximity to the PRF-110 oily solution following surgery, it was critical to evaluate whether PRF-110 would affect the mechanical properties of these sutures. The mechanical integrity, including breaking force and elongation, of PROLENE™ non-absorbable sutures and Vicryl™ resorbable sutures was tested at the outset (time zero) and after 14 days, with comparisons made to a control group.
The results indicated that PRF-110 does not impact the mechanical properties of either PROLENE™ or Vicryl™ sutures. This clearly suggests that the use of PRF-110 in wound closure procedures adjacent to surgical sutures is compatible with suture performance under surgical conditions. These findings are consistent with the phase III clinical results from the bunionectomy trial.
Ehud Geller, Chairman and interim CEO of PainReform, commented, "We are pleased to report that PRF-110 has demonstrated compatibility with common surgical sutures in our clinical trials. This important milestone underscores the safety and efficacy of PRF-110 as we continue to advance our lead product toward commercialization. The ability to deliver extended pain relief without compromising suture integrity represents a significant advancement in post-surgical care."
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", "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 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, LLC
Tel: 212-671-1021
Email: prfx@crescendo-ir.com
Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com
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