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Protalix BioTherapeutics to Present Phase I PRX-115 Data in Late-Breaking Poster at ACR Convergence 2024

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Protalix BioTherapeutics (NYSE American:PLX) announced it will present data from its phase I clinical trial of PRX-115, a recombinant PEGylated uricase product candidate for uncontrolled gout treatment, at the ACR Convergence 2024. The presentation, titled 'Prolonged Plasma Urate-Lowering After a Single Intravenous Administration of PRX-115,' will be delivered as a late-breaking poster on November 18, 2024. The study focuses on participants with elevated urate levels, and the results will be presented by Dr. Orit Cohen Barak from Protalix.

Protalix BioTherapeutics (NYSE American:PLX) ha annunciato che presenterà dati dal suo studio clinico di fase I su PRX-115, un candidato terapeutico a base di uricasi PEGilato ricombinante per il trattamento della gotta incontrollata, all'ACR Convergence 2024. La presentazione, intitolata 'Riduzione prolungata dell'urate plasmatica dopo una singola somministrazione endovenosa di PRX-115,' sarà presentata come poster a diffusione tardiva il 18 novembre 2024. Lo studio si concentra su partecipanti con livelli elevati di urato, e i risultati saranno presentati dalla Dr.ssa Orit Cohen Barak di Protalix.

Protalix BioTherapeutics (NYSE American:PLX) anunció que presentará datos de su ensayo clínico de fase I de PRX-115, un candidato a producto de uricasa pegilada recombinante para el tratamiento de la gota no controlada, en el ACR Convergence 2024. La presentación, titulada 'Reducción Prolongada de Ácido Úrico en Plasma Después de una Sola Administración Intravenosa de PRX-115,' será entregada como un cartel de última hora el 18 de noviembre de 2024. El estudio se centra en participantes con niveles elevados de urato, y los resultados serán presentados por la Dra. Orit Cohen Barak de Protalix.

Protalix BioTherapeutics (NYSE American:PLX)PRX-115에 대한 1상 임상시험 데이터를 발표한다고 발표했습니다. PRX-115는 조절되지 않는 통풍 치료를 위한 재조합 PEG화 요산 효소 후보물질입니다. 이 데이터는 2024 ACR Convergence에서 발표될 예정입니다. 발표 제목은 'PRX-115의 단일 정맥 주사 후 혈장 요산 수치 지속적인 감소'이며, 2024년 11월 18일에 느슨한 포스터로 발표될 것입니다. 이 연구는 요산 수치가 높은 참가자들을 대상으로 하며, 결과는 Protalix의 Orit Cohen Barak 박사가 발표할 예정입니다.

Protalix BioTherapeutics (NYSE American:PLX) a annoncé qu'elle présentera des données de son essai clinique de phase I sur PRX-115, un candidat produit à base d'urate PEGylé recombinant pour le traitement de la goutte incontrôlée, lors de la ACR Convergence 2024. La présentation, intitulée 'Diminution Prolongée de l'Urate Plasmatique Après une Administration Intraveineuse Unique de PRX-115,' sera effectuée sous forme de poster exceptionnel le 18 novembre 2024. L'étude se concentre sur des participants ayant des niveaux d'urate élevés, et les résultats seront présentés par Dr. Orit Cohen Barak de Protalix.

Protalix BioTherapeutics (NYSE American:PLX) gab bekannt, dass Daten aus seiner Phase-I-Studie zu PRX-115, einem rekombinanten PEGylierten Urikase-Produktkandidaten zur Behandlung von unbehandeltem Gicht, auf dem ACR Convergence 2024 präsentiert werden. Die Präsentation mit dem Titel 'Verlängerte Plasmasenkung des Harnsäurespiegels nach einmaliger intravenöser Verabreichung von PRX-115' wird als Spät-Poster am 18. November 2024 vorgestellt. Die Studie konzentriert sich auf Teilnehmer mit erhöhten Uratspiegeln, und die Ergebnisse werden von Dr. Orit Cohen Barak von Protalix präsentiert.

Positive
  • Phase I clinical trial data of PRX-115 selected for late-breaking presentation at major medical conference
  • Study results deemed significant enough to warrant late-breaking status at ACR Convergence
Negative
  • None.

CARMIEL, Israel, Oct. 25, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system, today announced that data from the phase I clinical trial of PRX-115, the Company's recombinant PEGylated uricase product candidate in development for the treatment of uncontrolled gout, will be presented in a late-breaking poster at the American College of Rheumatology (ACR) Convergence 2024, being held November 14-19, 2024 at the Walter E. Washington Convention Center in Washington, D.C.

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Details of the presentation are as follows:

ACR Convergence 2024

Title:                           Prolonged Plasma Urate-Lowering After a Single Intravenous Administration
                                   of PRX-115, a Novel PEGylated Uricase, in Participants with Elevated Urate
                                   Levels

Session:                    Late-Breaking Posters (L01-L14)

Session Date/Time:  Monday, November 18, 2024, 10:30 AM – 12:30 PM Eastern Standard Time

Presenting Author:    Orit Cohen Barak, Ph.D. (Protalix Ltd.)

Abstract Number:      L05

The accepted abstract can be accessed on the ACR Convergence 2024 website at https://acrabstracts.org/abstract/prolonged-plasma-urate-lowering-after-a-single-intravenous-administration-of-prx-115-a-novel-pegylated-uricase-in-participants-with-elevated-urate-levels/. A copy of the poster will be made available on the Protalix website.

About Protalix BioTherapeutics, Inc.

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. Protalix's second product, Elfabrio®, was approved by both the FDA and the European Medicines Agency in May 2023.

Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio. Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; PRX–119, a plant cell-expressed long action DNase I for the treatment of NETs–related diseases; and others.

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "may," "plan," "will," "would," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: failure or delay in the commencement or completion of clinical trials which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; inability to monitor patients adequately during or after treatment; and/or lack of sufficient funding to finance our clinical trials; the risk that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; our dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies; potential product liability risks, and risks of securing adequate levels of related insurance coverage; the possible disruption of our operations due to terrorist activities and armed conflict, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors and customers; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.

Investor Contact

Mike Moyer, Managing Director
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com

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SOURCE Protalix BioTherapeutics, Inc.

FAQ

What is Protalix BioTherapeutics (PLX) presenting at ACR Convergence 2024?

Protalix BioTherapeutics is presenting Phase I clinical trial data of PRX-115, their recombinant PEGylated uricase product candidate for uncontrolled gout treatment, in a late-breaking poster session.

When will PLX present their PRX-115 Phase I trial results?

The presentation will take place on Monday, November 18, 2024, from 10:30 AM to 12:30 PM Eastern Standard Time at the ACR Convergence 2024 in Washington, D.C.

What is the focus of PLX's PRX-115 clinical trial?

The trial focuses on studying plasma urate-lowering effects after a single intravenous administration of PRX-115 in participants with elevated urate levels.

Protalix BioTherapeutics, Inc.

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