Navigation Links
Shire Presents Positive Efficacy and Safety Data for velaglucerase alfa in Treatment of Naive Patients With Type 1 Gaucher Disease
Date:2/11/2010

an Genetic Therapies (HGT). "Our program is the largest and most comprehensive set of Phase III clinical trials conducted to date for Gaucher disease, and we look forward to presenting the results from the remaining trials at future scientific meetings."

Results from Five-Year Study

Ten of 11 adult patients who completed the Phase I/II study of velaglucerase alfa administered at 60 U/kg every other week, enrolled in a long-term extension study. After month-12, all patients were eligible to receive a step-wise dose reduction from 60 U/kg to 45 U/kg (13 weeks) and then to a 30 U/kg maintenance dose upon the achievement of specific therapeutic goals. All patients met therapeutic goals and their dose was subsequently titrated down to the 30U/kg dose. Seven of 10 patients received home infusions during the extension period. Eight patients (4 male, 4 female) have now received velaglucerase alfa treatment for 60 months.

After 5 years, velaglucerase alfa continued to be generally well tolerated and demonstrated substantial and prolonged increases in hemoglobin concentration and platelet count, and substantial and prolonged decreases in liver and spleen volumes in these patients with Type 1 Gaucher disease.

At 60 months, the mean increase in hemoglobin concentration from baseline was +2.4 g/dL (95% CI: 1.6, 3.2; 21.3% change) and the mean increase in platelet count from baseline was +85.1 x10(9)/L (95% CI: 59.8,110.4; 157% change). At 57 months, mean percent reduction in normalized liver volume from baseline was 39% (95% CI: -49.1%,-28.5%) and mean percent reduction in normalized spleen volume from baseline was 74% (95% CI: -89.3%,-58.6%).

Velaglucerase alfa was found to be generally well tolerated in these 10 patients with no drug-related serious adverse events reported. Treatment-emergent adverse events reported by at least 50% of patients included arthralgia, back pain, pyrexia, upper abdomi
'/>"/>

SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Shire Submits Biologics License Application (BLA) for REPLAGAL(R) With the U.S. Food and Drug Administration (FDA)
2. Shire Expands its Award-Winning ADHD Support Resource, ADHDSupport.com, by Launching an ADHD Twitter(TM) Page
3. Shire and Teva Settle Litigation Concerning Supply of ADDERALL XR Authorized Generic
4. Shire Announces Publication of Open-Label Study on Coadministration of INTUNIV(TM) (guanfacine) Extended-Release Tablets with Stimulants
5. Shire Re-Launches FOCUS, an Online, Personalized Patient Support Program for Adults with ADHD Taking Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII
6. Shire Reports Tolerability and Clinical Effects Results of Daytrana(R) (methylphenidate transdermal system) from Study in Adolescents with ADHD
7. Shire Continues to Deliver Excellent Growth From Core Products
8. Shire to Present Important Study Findings on its ADHD Treatments at a Major Psychiatric Meeting on October 29 and 30
9. Shire Presents Results of Five Lialda(R) (mesalamine) Analyses at ACG 2009 Annual Scientific Meeting
10. Shire Targets Fourth Quarter Filing of BLA for REPLAGAL(R) for Fabry Disease With U.S. FDA
11. Shire and Sandoz Settle all Pending Litigation Concerning ADDERALL XR(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/22/2015)... Research and Markets ( http://www.researchandmarkets.com/research/3rthk2/latest ... "Latest Regulations on Pharmaceutical International Multi-Center Clinical Trials ... This is first time in history, Chinese ... multi-center clinical trials of drugs in ... implemented on March 1, 2015. The guidance provides ...
(Date:5/22/2015)... -- Richmond Pharmacology is a university ... worldwide reputation for excellence in clinical trials. It ... reviewed medical journals. Its officers are engaged with ... about rules for transparency and publication of clinical ... Clinical research is conducted worldwide, therefore ...
(Date:5/21/2015)... 2015 Research and ... addition of the "North American Joint ... Replacement, Elbow Replacement, Hip Replacement, Knee Replacement, ... report to their offering. ,     (Logo: http://photos.prnewswire.com/prnh/20130307/600769) ... valued at $4,470.9 million in 2014 and ...
Breaking Medicine Technology:2015 Regulations on Pharmaceutical International Multi-Center Clinical Trials in China 2North American Joint Reconstruction Market 2015-2019 - Zimmer Holdings, DePuy Synthes Companies, Stryker, Biomet & Smith & Nephew Dominates the $4.4 Billion Market 2
... , CHICAGO , July 30 ... equity firm focused exclusively on health care, announced today ... (MSD).  Headquartered in Stoughton, Massachusetts , MSD ... biomedical services and technology solutions to the growing home ...
... , CATANIA, Italy , July 30 ... European research project today announced details of the ... three-year ENIAC (European Nanoelectronics Initiative Advisory Council) project ... 3D-imaging platforms by focusing on the diagnosis and ...
Cached Medicine Technology:Water Street Healthcare Partners Announces New Investment in Medical Specialties Distributors, LLC 2Water Street Healthcare Partners Announces New Investment in Medical Specialties Distributors, LLC 3Water Street Healthcare Partners Announces New Investment in Medical Specialties Distributors, LLC 4European Research Project Aims to Improve the Diagnosis and Therapy of Brain Diseases 2European Research Project Aims to Improve the Diagnosis and Therapy of Brain Diseases 3
(Date:5/22/2015)... 22, 2015 The dentist ... announces that they are now offering complimentary consultations ... dental treatments. At consultations, patients can discuss their ... what certain treatments can achieve and whether alternative ... this initial appointment. If treatments are chosen, patients ...
(Date:5/22/2015)... 22, 2015 Wimbledon Health Partners, the ... (EKG), echocardiogram and NCV testing , is proud ... respected All American National athlete, to the Wimbledon Athletics ... the high level of testing and information it provides ... their athletic trainers, this way they can focus on ...
(Date:5/22/2015)... In April 2006, Veatch Consulting opened for business ... have concentrated their focus to working with over 300 ... this growth and their goals to better serve their ... Cleveland, Ohio, Houston, Texas and now Dallas, Texas. ... dental start ups, orthodontic practices, pediatric dental practices, endodontic ...
(Date:5/22/2015)... In efforts to offer full and ... particular muscles stretches has been a large focus over ... now complete, Chunk Fitness envisions a mid-June launch of ... and released at a later point in time. The ... http://www.chunkfitness.com/stretches . , About the Company: Chunk Fitness was ...
(Date:5/21/2015)... 2015 World Patent Marketing, a vertically ... Troll Motor Guide, a boat patent that aims to ... recreational boating industry has reached an annual revenue of ... Director of World Patent Marketing , "Americans are ... continued steady growth of seven percent in new sales ...
Breaking Medicine News(10 mins):Health News:West Hollywood Dental Office, Sunset Plaza Dental is Now Offering Complimentary Consultations 2Health News:Wimbledon Athletics Recruits Team USA Athlete 2Health News:Wimbledon Athletics Recruits Team USA Athlete 3Health News:Great Ways To Celebrate On Memorial Day Weekend- Starting With World Patent Marketing's New Boat Patent 2Health News:Great Ways To Celebrate On Memorial Day Weekend- Starting With World Patent Marketing's New Boat Patent 3
... Va., March 9 CEL-SCI Corporation (NYSE Alternext ... into an exclusive licensing agreement with Byron Biopharma ... exclusive license to market and distribute the Company,s ... Africa (the "Territory"). CEL-SCI already has existing ...
... Ky., March 9 VirtualHealth Technologies, Inc. (OTC Bulletin ... Envoii Healthcare, LLC has changed it,s name to Secure ... Security products. According to Jim Renfro, VHGI President "This ... effort to demonstrate our company,s commitment on growing our ...
... nerves, researchers say , , MONDAY, March 9 (HealthDay News) -- ... a safe, effective and less invasive way to relive the ... Small spongy discs normally act as shock absorbers between the ... break, putting pressure on spinal cord nerves. The standard treatments ...
... Savient Pharmaceuticals, Inc. (Nasdaq: SVNT ) ... will be presenting at the upcoming Cowen and Company ... on Tuesday, March 17, 2009 at 8:45 a.m. Eastern ... Marriott Copley Place in Boston, MA, March 16-19, 2009.Individuals ...
... Time Declared ,Vitamin D Day, to Remind Americans to Get ... get ready to change our clocks for Daylight Saving Time, ... Vitamin D Day to raise awareness of the important role ... make our own vitamin D when the ultraviolet rays of ...
... and Easier TreatmentsOTTAWA, March 9 /PRNewswire-FirstCall/ - ... isotopes and radiopharmaceuticals, today announced the launch ... Yttrium-90 Microsphere (Y-90), a targeted internal radiation ... cancer. The enhancements to the administration system ...
Cached Medicine News:Health News:CEL-SCI Announces Exclusive Licensing Agreement for Cancer Drug Multikine(R) for Republic of South Africa 2Health News:Envoii Healthcare, LLC is now Secure eHealth, LLC 2Health News:Envoii Healthcare, LLC is now Secure eHealth, LLC 3Health News:Ozone/Oxygen Shot Helps Heal Herniated Disk 2Health News:Savient Pharmaceuticals to Present at The Cowen and Company 29th Annual Healthcare Conference on March 17, 2009 2Health News:Vitamin D Deficiency Has Emerged as a Silent Epidemic 2Health News:Vitamin D Deficiency Has Emerged as a Silent Epidemic 3Health News:Vitamin D Deficiency Has Emerged as a Silent Epidemic 4Health News:MDS Nordion Launches Improved TheraSphere(R) Administration System for Physicians 2Health News:MDS Nordion Launches Improved TheraSphere(R) Administration System for Physicians 3
... your practice with a practice management system. ... or on paper. Your patient statements can also ... has a combined traditional software and billing services ... any computer from anywhere - multiples offices or ...
... 3 mirrors angled at 76°, 66° and 60°. ... as well as central and peripheral fundus viewing ... accurately angled and spaced 120° apart to eliminate ... portion of the lens also provides direct observation ...
... Volk 3 mirror lenses featuring ultra-clear Volk ... at 76°, 66° and 60°. The ... as well central and peripheral fundus viewing ... accurately angled to eliminate gaps in the ...
... is a direct image lens ... air-filled eye. In addition to ... air-fluid exchange vitrectomy lens, the ... make it well suited for ...
Medicine Products: