Protalix BioTherapeutics, Inc. Receives Approval from the FDA to,Initiate a Phase III Clinical Trial of prGCD ( Phase III clinical trial may commence s...)

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
'"/>

Page: 1 2 3
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:

(Date:6/19/2013)... Eli Lilly and Company (NYSE: ... scams, purportedly using the name of the company and/or ... the public through postal mail solicitations and job-seekers through ... any foreign lottery organizations and do not conduct the ... of the scam. The activities described in these scams ...

(Date:6/19/2013)... NEW YORK , June 19, ... announces that a new market research ... Partnerships, Licensing, Investments ... May 2013 in Pharmaceuticals ... Licensing, Investments and M&A Deals and ...

(Date:6/19/2013)... , June 19, 2013 ... Philips under de kommande tre åren kommer att ... påskynda övergången till cirkulär ekonomi. Efter ... Kingfisher och National Grid, kommer Philips att ansluta ... inom cirkulär ekonomi i sin egen verksamhet och ...

[0] Lilly Issues Alert for Illegal Scams Involving Fraudulent Checks and Online Job Requests [0] Partnerships, Licensing, Investments and M&A Deals and Trends for May 2013 in Pharmaceuticals [0] Ellen MacArthur Foundation presenterar Philips som global partner vid det konstituerande internationella toppmötet om cirkulär ekonomi

... 16, 2010 NeoStem, Inc. (NYSE Amex: ... company with product and service revenues, global research and ... U.S. adult stem cells, China adult stem cells, and ... An underwritten registered offering of 6,337,980 common ...

... CHICAGO, Nov. 16, 2010 New results from ... at the American Heart Association (AHA) Scientific Sessions ... (prasugrel) prior to coronary artery bypass graft surgery ... to patients treated with Plavix® (clopidogrel) (2.3 percent ...

Cached Medicine Technology:NeoStem Announces Pricing of Concurrent Offerings for $19 Million in Gross Proceeds 2 NeoStem Announces Pricing of Concurrent Offerings for $19 Million in Gross Proceeds 3 Mortality Data Presented for Patients Treated with Effient® Who Underwent Isolated Coronary Artery Bypass Surgery 2 Mortality Data Presented for Patients Treated with Effient® Who Underwent Isolated Coronary Artery Bypass Surgery 3 Mortality Data Presented for Patients Treated with Effient® Who Underwent Isolated Coronary Artery Bypass Surgery 4 Mortality Data Presented for Patients Treated with Effient® Who Underwent Isolated Coronary Artery Bypass Surgery 5 Mortality Data Presented for Patients Treated with Effient® Who Underwent Isolated Coronary Artery Bypass Surgery 6

NeoStem Announces Pricing of Concurrent Offerings for $19 Million in Gross Proceeds Mortality Data Presented for Patients Treated with Effient® Who Underwent Isolated Coronary Artery Bypass Surgery

(Date:6/20/2013)... 2013 Millions of Britons are risking ... conditions because they do not brush their teeth every ... toothpaste. , Seven million Britons do not clean their ... brushes, latest data from the British Dental Health Foundation ... by the BDHF also admitted that they forgot to ...

(Date:6/20/2013)... 2013 Michigan-based natural health and ... chemist David R Hamilton which revealed that performing random ... resulted in the release of the feel-good hormone Oxytocin ... is known as the ‘cardio protective’ hormone because it ... for heart health. , “Being kind is something we ...

(Date:6/20/2013)... CT (PRWEB) June 20, 2013 Startups ... to energize their sales or test new markets, and ... U.S. now have a new sales outsourcing ... sustained sales revenue. , Strategy Sales Partners ... professionals. Founded by business owners for business owners, Strategy ...

(Date:6/20/2013)... Omaha, NE (PRWEB) June 20, 2013 ... President’s Higher Education Community Service Honor Roll – the ... for its commitment to volunteering, student- service learning and ... The award, presented by the Corporation for National and ... is the sixth for Creighton. “Our foundation at Creighton ...

(Date:6/19/2013)... With the winter season having begun in Santiago, ... Santiago day trips schedule. Offering a wide ... Santiago this season, expert mountain guides from Chile Montaña ... skiing, challenging rock climbing adventures, and trekking expeditions near ... skiing in Chile , Chile Montaña guides will ...

Breaking Medicine News(10 mins):Health News:Millions Are Risking Gum Disease, Warn Eludril And Elgydium 2 Health News:Millions Are Risking Gum Disease, Warn Eludril And Elgydium 3 Health News:Kindness Can Be Good for The Heart Says BioGirl Health Show 2 Health News:Kindness Can Be Good for The Heart Says BioGirl Health Show 3 Health News:Strategy Sales Partners Launches to Provide Sales Outsourcing Assistance to Businesses 2 Health News:Strategy Sales Partners Launches to Provide Sales Outsourcing Assistance to Businesses 3 Health News:Creighton Again Named to President’s Honor Roll - University Picks Up Sixth Recognition Award for Service 2 Health News:Creighton Again Named to President’s Honor Roll - University Picks Up Sixth Recognition Award for Service 3 Health News:Chile Montaña Announces Winter Season Santiago Day Trips 2 Health News:Chile Montaña Announces Winter Season Santiago Day Trips 3

[0] Millions Are Risking Gum Disease, Warn Eludril And Elgydium [0] Kindness Can Be Good for The Heart Says BioGirl Health Show [0] Strategy Sales Partners Launches to Provide Sales Outsourcing Assistance to Businesses [0] Creighton Again Named to President’s Honor Roll - University Picks Up Sixth Recognition Award for Service [0] Chile Montaña Announces Winter Season Santiago Day Trips

... HealthDay Reporter , WEDNESDAY, Aug. 24 (HealthDay News) ... supply or not available at all has risen dramatically, according ... these are generic drugs given by injection and used in ... cancer. These shortages are putting patients at risk and compromising ...

... researchers at the Stein Institute for Research on Aging at ... and positive quality of life indicators correlate with sexual satisfaction ... August edition of the Journal of the American Geriatric ... life and sexual satisfaction appear to be stable even in ...

... Federal officials on Wednesday urged residents of the U.S. East ... "category 3" storm with winds up to 115 miles per ... Bahamas. The current forecast track places the center of ... and over New England by Monday morning, according to the ...

... , WEDNESDAY, Aug. 24 (HealthDay News) -- ... potentially fatal abnormal heart rhythms and should no longer ... Administration said Wednesday. Doses of Celexa (citalopram hydrobromide) ... in the electrical activity of the heart, which can ...

... HealthDay Reporter , TUESDAY, Aug. 23 (HealthDay News) -- Adding ... lower your cholesterol more than a low-fat diet alone can, ... known cholesterol-reducing properties, and combined with a lower fat diet, ... A low-fat diet alone produced only a 3 percent reduction ...

... 2011 Exercise can be as effective as a ... patients whose condition have not been cured by a ... involved in the investigation, recently published in the Journal ... levels of daily exercise can work as well as ...

Cached Medicine News:Health News:Cancer Drug Shortages Getting Worse, FDA Says 2 Health News:Cancer Drug Shortages Getting Worse, FDA Says 3 Health News:Sexual satisfaction tied to overall 'successful aging' as reported by women age 60 to 89 2 Health News:East Coast Urged to Prepare for Hurricane Irene 2 Health News:Certain Foods Said to Help Lower Bad Cholesterol 2 Health News:Certain Foods Said to Help Lower Bad Cholesterol 3 Health News:Exercise can substitute effectively as second 'medication' for people with depression 2

Cancer Drug Shortages Getting Worse, FDA Says Sexual satisfaction tied to overall 'successful aging' as reported by women age 60 to 89 East Coast Urged to Prepare for Hurricane Irene Antidepressant Tied to Dangerous Heart Rhythm, FDA Says Certain Foods Said to Help Lower Bad Cholesterol Exercise can substitute effectively as second 'medication' for people with depression

... Per-fit™ tubes are a ... replacement of the disposable inner ... is provided in the procedural ... Per-ft™ tubes are available separately. ...

The soft silicone design promotes patient comfort. , ,Bivona® laryngectomy tubes feature a soft compliant silicone design for patient comfort....

... When the all silicone ... adds no distinguishable dimension to ... tube's shaft, yet it can ... for varied airway management needs. ...

... Aire-Cuf® Adjustable Neck Flange Hyperflex™ Tracheostomy ... this tube features the more traditional ... Mid-Range Aire-Cuf® Adjustable Neck Flange Hyperflex™ ... disconnect wedge, and obturator/introducer device., ...

Medicine Products:

Replacement Per-fit™ Percutaneous Tracheostomy Tubes Bivona® Laryngectomy Tubes Bivona® TTS™ Tracheostomy Tubes Bivona® Mid-Range Aire-Cuf® Adjustable Neck Flange Hyperflex™ Tracheostomy Tubes