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

or the long-term clinical efficacy and safety of velaglucerase alfa," said Pramod Mistry, MD, PhD, FRCP, Professor of Pediatrics & Internal Medicine at Yale University School of Medicine. "The Gaucher community is very fortunate to have velaglucerase alfa as an option for patients."

Results from Study TKT032 in Adults and Children

TKT032 was a 12-month, randomized, double-blind, parallel-group global study in 25 treatment-naive patients aged two years and older that evaluated velaglucerase alfa at 45 U/kg and velaglucerase alfa at 60 U/kg. Patients were eligible to participate in the study if they presented with disease-related anemia and had at least one of the following clinical manifestations of Gaucher disease: thrombocytopenia, moderate splenomegaly or a readily palpable enlarged liver.

The primary endpoint was change in hemoglobin concentrations from baseline at 60 U/kg. Secondary endpoints for both doses were changes in platelet counts, changes in organ volumes, changes in surrogate markers of Gaucher disease, and for the 45 U/kg dose only, change in hemoglobin concentrations from baseline.

At 12 months, in the 60 U/kg group, statistically significant changes in mean hemoglobin concentration increased 23.3%, +2.43+/-0.32 g/dL, P< 0.0001; mean platelet count increased 65.9%, +50.9+/-12.2x10(9)/L, P=0.0016; and mean spleen volume decreased 50%, -1.92+/-0.51% body weight, P=0.0032, from 14.0 multiples of normal [MN] at baseline to 5.75 MN. Mean liver volume decreased 17%, -0.84+/-0.33% body weight, P=0.0282, from 1.46 to 1.22 MN.

Results for 45 U/kg were consistent with those observed with 60 U/kg; however a dose-related effect in favor of velaglucerase alfa at 60 U/kg was observed by platelet count increase and liver volume reduction between the 2 dose groups.

Adverse events
'/>"/>

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:6/30/2015)... SEATTLE , BERKELEY, Kalifornien, und KOPENHAGEN, ... CMC Biologics, Inc. , ein Weltmarktführer der ... und anderen therapeutischen Proteinen, gab heute bekannt, ... Expansionsstrategie der Produktionskapazität den Ausbau der nordamerikanischen ... , mit der Ergänzung  einer Einweg-Anlage Bioreactor ...
(Date:6/30/2015)... 2015  Marken, the leading clinical trial logistics organization ... has been granted permission by the government to deliver ... product in Korea.  This precedent-setting shipment has allowed several ... continue receiving their clinical trial drugs during the outbreak ... emergency was caused by recent partial closures of medical ...
(Date:6/30/2015)... PharmaVentures is pleased to announce ... Oy (CMT) on its divestment of certain assets to ... world leading capabilities in cellular imaging and analysis. ... of successful global deals in the life science research ... Walton , CEO, PharmaVentures, commented: "PharmaVentures is delighted to ...
Breaking Medicine Technology:CMC Biologics baut GMP-Produktionskapazität in den USA aus 2CMC Biologics baut GMP-Produktionskapazität in den USA aus 3Marken Delivers Direct To Patients During MERS Outbreak 2Marken Delivers Direct To Patients During MERS Outbreak 3PharmaVentures Completes M&A Deal for Technology in the Stem Cell & Regenerative Medicine Sector 2
... WORTH, Texas, Aug. 26 Healthpoint today announced,that ... the effectiveness of a,widely prescribed enzymatic debriding agent ... study was prompted, in part, by clinical reports,of ... healing,properties associated with Collagenase SANTYL(R) Ointment.(1,2), "Given ...
... Inc.,(Nasdaq: XTNT ) today announced that the positive ... in the most recent issue of the,peer-reviewed journal, EuroIntervention. ... Stella, M.D., of University Medical Center Utrecht, Utrecht,The Netherlands ... clinical,sites across Europe., The one-year CUSTOM II trial, ...
Cached Medicine Technology:Healthpoint Initiates Randomized, Double-Blind Study to Evaluate Effectiveness of Collagenase SANTYL(R) Ointment on Wound Healing 2Healthpoint Initiates Randomized, Double-Blind Study to Evaluate Effectiveness of Collagenase SANTYL(R) Ointment on Wound Healing 3XTENT Announces CUSTOM II Data Selected for Publication in EuroIntervention 2XTENT Announces CUSTOM II Data Selected for Publication in EuroIntervention 3XTENT Announces CUSTOM II Data Selected for Publication in EuroIntervention 4
(Date:6/30/2015)... York (PRWEB) , ... June 30, 2015 , ... ... http://www.xareltolawsuit2015.com/ ) currently pending in a federal multidistrict litigation now underway in the ... convenes its next monthly Status Conference. According to the Court’s calendar, that conference ...
(Date:6/30/2015)... ... June 30, 2015 , ... Allied Anesthesia physicians ... Fullerton division volunteered to help provide free outpatient procedures to some of Orange ... St. Jude Medical Center. , The event was coordinated by AccessOC, which ...
(Date:6/30/2015)... ... June 30, 2015 , ... Red Hot & Blue Restaurants, Inc. ... at http://scoutology.com/novaburgerwars and was selected as “Best BBQ” in a Texas-based ... Red Hot & Blue President Randy McCann said, “Everyone knows Red Hot & Blue ...
(Date:6/30/2015)... ... June 30, 2015 , ... New Energy Works Timberframers invites ... and 11th 2015. Timber frame post and beam raisings offer a chance to witness ... timber frame is an important and exciting event – it is an ...
(Date:6/30/2015)... ... June 30, 2015 , ... ... response profiling test to help oncologists provide personalized cancer treatment, will be ... assay provides the oncologist with valuable insight on how a specific patient’s ...
Breaking Medicine News(10 mins):Health News:Progress of Federal Xarelto Lawsuits Pending in Multidistrict Litigation to Be Discussed During July 9th Status Conference 2Health News:Progress of Federal Xarelto Lawsuits Pending in Multidistrict Litigation to Be Discussed During July 9th Status Conference 3Health News:Allied Anesthesia Physicians Volunteer to Help Orange County’s Uninsured During Annual Super Surgery Saturday 2Health News:Allied Anesthesia Physicians Volunteer to Help Orange County’s Uninsured During Annual Super Surgery Saturday 3Health News:Red Hot & Blue BBQ Restaurants Voted "Best Burger" in Virginia and "Best Barbecue" in Texas 2Health News:Red Hot & Blue BBQ Restaurants Voted "Best Burger" in Virginia and "Best Barbecue" in Texas 3Health News:Join New Energy Works Timberframers in Raising the Frames in Western New York 2Health News:Join New Energy Works Timberframers in Raising the Frames in Western New York 3Health News:Join New Energy Works Timberframers in Raising the Frames in Western New York 4Health News:Correct Chemo Joins NextGxDx Online Genetic Testing Marketplace 2Health News:Correct Chemo Joins NextGxDx Online Genetic Testing Marketplace 3
... ... from its new upper extremity range, bebionic. Launched at the ISPO World congress in May, ... of approximately 9,000 Euros, or $11,000 USD. , ... (PRWeb UK) July 1, 2010 -- RSLSteeper have announced the pricing for ...
... , ... new manufacturing techniques that provide a higher quality, more fashionable product. Overcoming the knitting ... , ... 17, 2010 --When seeking a non-binding top or diabetic sock you want comfort, ...
... ... Stamen Medical Systems, LLC, a Martinez, GA based provider of the Erec-Tech ... to announce their most recent Medicare Re-Accreditation score of 96. As the ... of compliance and ethics is imperative during these current economic times and ...
... infants at risk of life-threatening conditions ... that are clinically difficult to detect. These include late-onset ... in the blood, and necrotizing enterocolitis, a condition in ... Poon and colleagues, at the The Chinese University of ...
... stem cells have enticed scientists because of the potential to ... targeting the tumor,s most voracious cells. Now, researchers at Children,s ... in a model of the most common form of human ... stem cells may vary from tumor to tumor, depending upon ...
... , THURSDAY, July 1 (HealthDay News) -- Too much Wheel ... for seniors, mental state, new research suggests. Researchers analyzed data ... adults over age 65 spent almost three times more of their ... while the younger folks considered vegging out in front of the ...
Cached Medicine News:Health News:RSLSteeper announces pricing for new bionic hand 2Health News:Diabetic Sock Manufacturing Techniques Improved 2Health News:Stamen Medical Systems Receives Medicare Re-Accreditation and The Exemplary Provider Award 2Health News:JCI online early table of contents: July 1, 2010 2Health News:JCI online early table of contents: July 1, 2010 3Health News:JCI online early table of contents: July 1, 2010 4Health News:JCI online early table of contents: July 1, 2010 5Health News:JCI online early table of contents: July 1, 2010 6Health News:JCI online early table of contents: July 1, 2010 7Health News:Cancer stem cells are not 1 size fits all, lung cancer models show 2Health News:Older Folks Watch More TV, Get Less Out of It 2Health News:Older Folks Watch More TV, Get Less Out of It 3
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: