Navigation Links
Protalix BioTherapeutics Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial

Protalix BioTherapeutics Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial -- CARMIEL, Israel, Nov. 2, 2010 /PRNewswire-FirstCall/ --

Advanced Search Search

  1. Send a release
  2. Member sign in
  3. Become a member
  4. For journalists
  5. Global sites
PR Newswire: news distribution, targeting and monitoring
  1. Products & Services
  2. Knowledge Center
  3. Browse News Releases
  4. Contact PR Newswire
Biotechnology, Health Care & Hospitals, Medical Pharmaceuticals, Pharmaceuticals, Clinical Trials & Medical Discoveries Click to view news release full screen  

Protalix BioTherapeutics Announces Preliminary Top-Line Positive Data from taliglucerase alfa Switchover Trial


CARMIEL, Israel, Nov. 2, 2010 /PRNewswire-FirstCall/ -- Protalix BioTherapeutics, Inc. (NYSE-AMEX: PLX, TASE: PLX), announced today positive preliminary data from the first 15 patients that completed the Company's nine month, worldwide, multi-center, open-label, switchover trial of taliglucerase alfa for the treatment of Gaucher disease under a protocol cleared by the U.S. Food and Drug Administration (FDA).  The data indicate that patients can safely be switched to taliglucerase alfa from imiglucerase (Cerezyme®).  

Patients enrolled in the trial were switched from imiglucerase (doses ranging from 10-60 U/kg every other week) to an equivalent dose using the same number of units of taliglucerase alfa.  The data from the first 15 patients demonstrate that maintenance of efficacy was achieved over a nine month period with no increased safety concerns.  Patients' hemoglobin and platelet counts remained stable demonstrating hematological stability.  As measured by MRI, mean spleen volume and liver volume also remained stable.  There was no evidence of increased safety concerns in patients switched from Cerezyme® to taliglucerase alfa and there were no drug related serious adverse events.  Hypersensitivity reactions were not reported in this patient group.  One patient developed non-neutralizing IgG antibodies to taliglucerase at the end of the study.  Detailed data will be presented at an upcoming medical meeting.

The switchover trial was originally designed and cleared by FDA to enroll 15 patients, however, it was expanded to recruit a total of 30 patients as a result of the shortage of enzyme replacement therapy for Gaucher patients.  Adult enrollment in the study has closed; pediatric enrollment remains open.

"We are pleased with the interim results of the switchover trial to taliglucerase alfa," said Dr. David Aviezer, the Company's President and Chief Executive Officer.  "Through our Phase III pivotal and extension trial, pediatric study in naïve patients, switch–over trial, expanded access and named patient programs, ATU program in France and supply agreement in Brazil, we are generating a robust clinical database for taliglucerase alfa."

Taliglucerase alfa is under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Action (PDUFA) date scheduled for February 25, 2011.

About ProtalixProtalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell based expression system. Protalix's ProCellEx™ presents a proprietary method for the expression of recombinant proteins that Protalix believes will allow for the cost-effective, industrial-scale production of recombinant therapeutic proteins in an environment free of mammalian components and viruses. Protalix is also advancing additional recombinant biopharmaceutical drug development programs. Taliglucerase alfa is an enzyme replacement therapy in development under a Special Protocol Assessment with the FDA for Gaucher disease. The Company's new drug application (NDA) for taliglucerase alfa has been accepted by the U.S. Food and Drug Administration (FDA) and granted a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2011.

Safe Harbor StatementTo 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 material differences include, among others, risks relating to: the successful preclinical development of our product candidates; the completion of our clinical trials; the review process of the FDA, the EMEA, other foreign regulatory bodies and other governmental regulatory bodies, including the FDA's and the EMEA's review of any filings we make in connection with the treatment protocol for taliglucerase alfa and including the risk that regulatory authorities may find that the data from our clinical trials and other studies is insufficient for regulatory approval; delays in the FDA's, the EMEA's or other health regulatory authorities' approval of any applications we file or refusals to approve such filings, including the NDA we filed with the FDA for taliglucerase alfa for the treatment of Gaucher disease; refusals by such regulatory authorities to approve the marketing and sale of a drug product even after acceptance of an application we file for any such drug product; and other factors described in our filings with the Securities and Exchange Commission. Companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced or late-stage clinical trials, even after obtaining promising earlier trial results or in preliminary findings for such clinical trials. Further, even if favorable testing data is generated by clinical trials of drug products, the FDA, EMEA or any other foreign regulatory authority may not accept or approve an NDA filed by a pharmaceutical or biotechnology company for such drug product. Failure to obtain approval from the FDA, EMEA or any other foreign regulatory authority of any of our drug candidates in a timely manner, if at all, will severely undermine our business and results of operations by reducing our potential marketable products and our ability to generate corresponding product revenues. The statements in this release are valid only as of the date hereof and we disclaim any obligation to update this information.Investor ContactMarcy NanusThe Trout Group, LLCTelephone: 646-378-2927Email:

SOURCE Protalix BioTherapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Protalix BioTherapeutics to Present at Two Upcoming Healthcare Conferences
2. Protalix Names Sandra Lauterbach Vice President of Sales and Commercial Affairs
3. Protalix BioTherapeutics Extends Research Agreement With Yissum Based on Promising Acetylcholinesterase Program Results in Animal Study
4. Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD
5. Talecris Biotherapeutics Receives FDA Approval for Gamunex®-C
6. Talecris Biotherapeutics to Report Third Quarter 2010 Financial Results
7. Talecris Biotherapeutics CEO Accepts 2010 Ernst & Young Entrepreneur Of The Year Award on Behalf of Employees and Patients
8. Garnet BioTherapeutics Announces First Patient Treated in Trial of New Therapy for Improvement in Scar Appearance
9. NASDAQ Trading for Oxygen Biotherapeutics, Inc. Shares to Begin January 15, 2010
10. Oxygen Biotherapeutics, Inc. Announces Approval for NASDAQ Listing
11. Oxygen Biotherapeutics, Inc. Expands Board of Directors
Post Your Comments:
(Date:11/26/2015)... WILMINGTON, North Carolina , 26 november ... Laboratories, Inc. (AAIPharma/CML) kondigt de geplande investering ... de uitbreiding van de laboratoria en het ... . De uitbreiding zal resulteren in ... waarmee wordt voldaan aan de groeiende behoeften ...
(Date:11/26/2015)... -- Research and Markets ( ) has announced the ... to 2019 - Rise in Cardiac Disorders and Growing Awareness ... their offering. Boston scientific ... scientific and others. --> The market is ... Boston scientific and others. ...
(Date:11/26/2015)... 2015 ... the  "2016 Future Horizons and Growth ... Testing Market: Supplier Shares, Competitive Intelligence, ... --> ) has ... Future Horizons and Growth Strategies in ...
Breaking Medicine Technology:
(Date:11/26/2015)... (PRWEB) , ... November 26, 2015 , ... ... American Express Travel Representative. As a franchise owner, Somu now offers travelers, value ... cruise, destination wedding packages, private cruise sales, as well as, cabin upgrades and ...
(Date:11/26/2015)... (PRWEB) , ... November 26, 2015 , ... PRMA Plastic ... November 19, 2015, our surgeons performed their 6,000th free flap breast reconstruction surgery! , ... wake up every day excited to rebuild lives and it’s an honor to have ...
(Date:11/26/2015)... Karnataka (PRWEB) , ... November ... ... innovative online platform for mental health and wellness consultation, has collaborated with ... to holistically address their reader’s queries on topics on mental and emotional ...
(Date:11/25/2015)... ... November 25, 2015 , ... As ... Water For Empowerment ™ attracts volunteers together who want to combine talents and ... as key stakeholders in the process. The non-profit launched its first major fundraiser ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... been recognized once again for its stellar workplace culture with the company’s Cincinnati ... , Medical Solutions’ Cincinnati office was named a finalist in Cincinnati Business ...
Breaking Medicine News(10 mins):