Protalix BioTherapeutics Hosting Key Opinion Leader Meeting on PRX‑102 Drug Candidate for the Treatment of Fabry Disease

Protalix BioTherapeutics Hosting Key Opinion Leader Meeting on PRX‑102 Drug Candidate for the Treatment of Fabry Disease

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Protalix BioTherapeutics Hosting Key Opinion Leader Meeting on PRX‑102 Drug Candidate for the Treatment of Fabry Disease
Breakfast meeting scheduled for Monday, December 2 at 8:00 a.m. EST.

CARMIEL, Israel, Nov. 27, 2019 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: 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 it will host a key opinion leader (KOL) meeting on pegunigalsidase alfa, or PRX‑102, the Company's lead drug candidate for the treatment of Fabry Disease, in New York City on Monday, December 2, 2019, at 8:00 a.m. EST.


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The meeting will feature a presentation from KOL David G. Warnock, M.D., University of Alabama at Birmingham, who will discuss the current treatment landscape, as well as the unmet medical need for treating Fabry patients. Dr. Warnock will be available to answer questions at the conclusion of the event.

The Company's management team will provide an update on PRX‑102. PRX‑102 is an investigational, plant cell culture-expressed, and chemically modified stabilized version of, the recombinant alpha-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, PRX‑102 has been observed to have a circulatory half-life of approximately 80 hours. The Company designed pegunigalsidase alfa to potentially address the continued unmet clinical need in Fabry patients of continuous disease progression, infusion reactions and immunogenicity.

David Warnock, M.D. received a BA degree in 1966 from the University of California at Berkeley and received his M.D. degree in 1970 from the University of California, San Francisco. Following a fellowship at the NIH, his positions included Section Chief at the San Francisco VA Medical Center, Director of Nephrology at the University of Alabama at Birmingham (UAB) from 1988 to 2008, and Director of the Office of Human Research at UAB from 2005 to 2008. He served as the Marie K Ingalls Professor of Medicine and the Hilda B. Anderson Endowed Professor in Nephrology at UAB and became an Emeritus Professor of Medicine at UAB in October 2015. Dr. Warnock's focus is on the genetic and environmental factors that contribute to hypertension and chronic kidney disease. The spectrum extends from basic studies of salt and water transport systems to population-based studies of the prevalence of CKD and the association with stroke and heart disease. Another focus is inherited disorders of renal function, with a current emphasis on the renal manifestations of Fabry disease. Additional research interests include acid-base physiology, sodium transport mechanisms, chronic kidney disease, diabetes and kidney disease, and inherited renal diseases. Dr. Warnock has been actively treating Fabry disease since 2001. He started the first US patient on commercial enzyme replacement therapy (Fabrazyme®) in April 2003. He served on the Genzyme/Sanofi North American Fabry Registry Advisory Board as well as their International Advisory Board from 2003 – 2018. Dr. Warnock has been working with the Company as an advisor since 2015. He has published extensively about the diagnosis and management of Fabry disease.

This event is intended for institutional investors, sell-side analysts and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. Members of the media and the public are invited to participate via the live webcast.

Event Details



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®. Protalix was 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. Protalix's unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix's pipeline consists of proprietary, potentially clinically superior versions of recombinant therapeutic proteins that target established pharmaceutical markets.

Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.

Protalix's development pipeline includes the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease, in phase III clinical trials (BALANCE, BRIDGE and BRIGHT studies); OPRX‑106, an orally delivered anti-inflammatory treatment; and alidornase alfa for the treatment of Cystic Fibrosis, both in phase II clinical trials. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

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," "plan," "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 are 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.

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