Navigation Links
Protalix BioTherapeutics, Inc. Receives Approval from the FDA to,Initiate a Phase III Clinical Trial of prGCD

Phase III clinical trial may commence shortly

CARMIEL, Israel, April 18, 2007 /PRNewswire-FirstCall/ --- Protalix BioTherapeutics, Inc. today announced that it has received written notice from the United States Food and Drug Administration (FDA) that it may initiate a Phase III clinical trial in the United States of its lead product candidate, prGCD, a proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD), for the treatment of Gaucher Disease, a lysosomal storage disorder in humans.

The FDA has allowed the Company to directly initiate Phase III based upon the results of the Company's pre clinical and Phase I clinical trials of prGCD. The Company presented the completed data from its Phase I clinical trial at the European Working Group of Gaucher Disease (WEGGD) in Cambridge, United Kingdom in July 2006.

The Company hopes to commence the Phase III clinical trial shortly. The trial will take place in centers in the United States, Israel, where approval from the Israeli Ministry of Health has been received, and other locations worldwide. The study will initially consist of male and female adult patients with Gaucher Disease.

David Aviezer, Ph.D., President and Chief Executive Officer of Protalix BioTherapeutics, commented, "The receipt of the FDA's approval to initiate a Phase III clinical trial of prGCD represents an important milestone in the development of this product, and we are excited about the progress we have made thus far. Following the success of our Phase I trial and our promising pre clinical and biochemical data, we believe that we will continue to see positive results from our patients in Phase III."

Dr. Aviezer continued, "We remain deeply committed to the development of a treatment for Gaucher Disease and are excited by the opportunity to commence the Phase III trial and working with the medical experts and patient community."

About Protalix BioTherapeutics, Inc.

Protalix's proprietary technology is based on its plant cell culture and bioreactor system, which provides an effective and scaleable cell system for industrial production of recombinant biopharmaceuticals. Protalix is pursuing advanced clinical studies for its enzyme therapy for Gaucher Disease and intends to advance additional recombinant biopharmaceutical drug development programs. The Company believes its plant-based expression has significant advantages over more traditional mammalian and bacterial expression technology with respect to patient safety, cost and scalability.

Safe Harbor Statement

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. 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. Factors that might cause such a material difference include, among others, the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; delays in our preparation and filing of applications for regulatory approval; delays in the approval or potential rejection of any applications we file with the FDA, or other health regulatory authorities; lack of progress of our research and development (including the results of clinical trials being conducted by us); obtaining on a timely basis sufficient patient enrollment in our clinical trials; the impact of development of competing therapies and/or technologies by other companies; our ability to obtain additional financings required to fund our research programs; our ability to establish and maintain strategic license, collaboration and distribution arrangements and to manage our relationships with collaborators, distributors and partners; potential product liability risks and risks of securing adequate levels of product liability and clinical trial insurance coverage; the possible disruption of our operations due to terrorist activities and armed conflict, including as a result of the disruption of our subsidiary, our manufacturing facilities, collaborative partners, licensees, and clinical trial sites; and other factors described in our filings with the Securities and Exchange Commission. The statements are accurate only as of the date hereof and we disclaim any obligation to update this information, except as required by law.

CONTACT: Protalix Investor Relations: ,+972-4-988-9488; AMEX IR Alliance for Protalix: Lee Roth, +1-212-896-1209,, or David Burke, +1-212-896-1258, investors@protalix.com lroth@kcsa.com dburke@kcsa.com

Ticker Symbol: (AMEX:PLX)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
2. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
3. Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma
4. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
5. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
6. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
7. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
8. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
9. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
10. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
11. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/24/2017)... Research and Markets has announced the addition of the ... Forecast to 2025" report to their offering. ... The Global Implantable Medical Devices ... over the next decade to reach approximately $54.28 billion by 2025 ... witnessing include 3D medical printing is expected to develop and find ...
(Date:1/24/2017)... , and GAITHERSBURG, Md. , Jan. ... XON ), a leader in the engineering and industrialization of ... the planet, today announced that it has entered into a ... GNVC ), a clinical-stage company and pioneer in the ... intends to integrate and expand upon GenVec,s expertise in adenoviral ...
(Date:1/24/2017)... 24, 2017   QR Pharma , Inc., ... novel therapies for the treatment of Alzheimer,s, Parkinson,s ... of four world-class key opinion leaders to its ... QR Pharma,s previous roster of impressive advisors in ... support the development of the breakthrough mechanism of ...
Breaking Medicine Technology:
(Date:1/24/2017)... ... January 24, 2017 , ... OMI Industries, ... officially formed a distribution partnership with Byers Scientific & Manufacturing , a ... , Through the agreement, OMI Industries formulated a special version of Ecosorb® for ...
(Date:1/24/2017)... ... January 24, 2017 , ... Providing solutions to critical economic ... the Frank Hawkins Kenan Institute of Private Enterprise at the University ... makers identified concrete solutions at the “What’s Next, America?” conference at the Kenan ...
(Date:1/24/2017)... ... January 24, 2017 , ... Date aired: January 23, ... Kleyne, the nation’s foremost water advocate and host of the nationally syndicated The ... Voice America, once again welcomed one of her favorite guests and colleagues, Dr. ...
(Date:1/24/2017)... ... ... “Speaking With God’s Voice”: a resolute and spirited call for anointed preaching ... A. Miraglia, a born-again believer, who spent his years teaching high school and Sunday-school, ... “There is little doubt that God Himself prepared me for this study, and God’s ...
(Date:1/24/2017)... ... , ... “The Octagon of Spiritual Balances”: a guide for the Christian ... of published author, Pastor Bernard J. Weathers, pastor of Word of Faith Ministries, in ... education and a master degree in theology. , ““The Octagon of Spiritual Balances” exposes ...
Breaking Medicine News(10 mins):