Navigation Links
Clinical Benefits Demonstrated with Low-Dose GATTEX(TM) in Phase 3 Short Bowel Syndrome Study
Date:10/11/2007

Conference Call Today at 9 am ET

BEDMINSTER, N.J., Oct. 11 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) today reported top-line results from the company's Phase 3 study of its investigational drug GATTEX(TM) (teduglutide, recombinant GLP-2) in which 83 patients with short bowel syndrome (SBS) received either a low dose of GATTEX, (0.05 milligrams/kilogram/day), a higher dose (0.10 mg/kg/day) or placebo. The clinical efficacy endpoint of the study was a reduction in parenteral nutrition (PN) of at least 20% comparing baseline to weeks 16 to 24, measured as a graded response to capture reductions up to 100%. In an intent-to-treat analysis, forty-six percent (46%) of patients receiving the lower dose of GATTEX (N=35) responded and achieved a highly statistically significant reduction in PN compared to placebo (p=0.007), with two patients gaining independence from and discontinuing PN by week 20 and a third patient discontinuing PN at the end of treatment. Twenty-five percent (25%) of patients receiving the higher dose of GATTEX (N=32) responded and showed a trend in the difference between the treatment group and placebo, but this did not reach statistical significance (p=0.161). The study's criteria for conducting the statistical analysis of the primary endpoint required that the results for the high-dose group show statistical significance before the results of the low-dose group could be considered. However, given the drug's orphan designation in SBS and the statistically strong (p=0.007) and clinically meaningful findings in the low-dose group, the company intends to meet with the FDA to discuss the path to regulatory approval for GATTEX.

Dr. Stephen O'Keefe, profes
'/>"/>

SOURCE NPS Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Genetic Analysis Systems Enter the Clinical Mainstream
2. Clinical Study Shows Regenecare Relieves Pain and Itching of Skin Rashes Caused by Widely Used Cancer Drugs
3. Large Geographic Differences in EpiPen Prescriptions in the U.S., From the Journal of Allergy and Clinical Immunology
4. Sygnis Pharma AG announces date for presentation of clinical results
5. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
6. Clinical Data Suggest Decreased Bleeding Risk in People With Severe Hemophilia A While Maintaining Factor VIII Levels Above One Percent
7. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
8. Halozyme Therapeutics Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society
9. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
10. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
11. Protox Announces Positive Clinical Data from Prostate Cancer Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... 2014 Does your doctor know what you,re smoking?  ... recommended marijuana to the over 112,000 currently registered patients under ... of the other roughly 20,300+ active physicians listed with the ... it – even though a poll in February 2014 showed ... have tried it. "With marijuana legalization underway, ...
(Date:8/29/2014)... Aug. 29, 2014 Diseases largely eradicated in ... ago are returning. Measles was declared eliminated in 2000, ... as of August 15—the highest incidence in 20 years. ... department declared whooping cough a problem of "epidemic ... sick and dying from these preventable diseases—in part because ...
(Date:8/29/2014)... 29, 2014  Abaxis, Inc. (NasdaqGS: ABAX ... and consumables to the medical, research and veterinary markets, ... Chief Executive Officer, will present at the CL King ... Tuesday, September 9, 2014 at 12:30 p.m. ET. The ... Hotel in New York City . ...
Breaking Medicine Technology:Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 2Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 3Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 4Vaccines at the Crossroads: Outbreaks On the Rise Across America 2Vaccines at the Crossroads: Outbreaks On the Rise Across America 3Abaxis, Inc. to Present at CL King's 12th Annual Best Ideas Conference 2014 2
... Medicare Part D beneficiaries who enter the "donut ... previously subsidized prescription costs, are twice as likely to ... more affordable or generic medications, a new study published ... (Logo: http://photos.prnewswire.com/prnh/20090226/NE75914LOGO) The study conducted by researchers ...
... The National Association of Drug Diversion Investigators ... Responsibly to Ensure Safety) Alliance (SM) have joined Attorney ... issue in Florida – prescription drug abuse. Attorney General ... a statewide Drug Take Back Day. NADDI and the ...
Cached Medicine Technology:CVS Caremark, Harvard and Brigham and Women's Researchers Say Medicare 'Donut Hole' Can Lead to a Decrease in Medication Adherence 2CVS Caremark, Harvard and Brigham and Women's Researchers Say Medicare 'Donut Hole' Can Lead to a Decrease in Medication Adherence 3NADDI and the C.A.R.E.S. Alliance Join Attorney General Bondi in Fight Against Prescription Drug Abuse 2NADDI and the C.A.R.E.S. Alliance Join Attorney General Bondi in Fight Against Prescription Drug Abuse 3
(Date:8/30/2014)... 31 August 2014: A new batteryless cardiac pacemaker ... heart motion was presented at ESC Congress 2014 ... device does not require battery replacement. , Mr ... Group at ARTORG, University of Bern, Switzerland, said: ... implants. Once they reach a critically low energy ...
(Date:8/30/2014)... (PRWEB) August 31, 2014 According to the ... step by step holistic system for skin health. It seems ... already been tried by more than 138,000 patients from all ... Mike Walden, who says that this method will not only ... clear skin. , What makes this program unique among ...
(Date:8/30/2014)... (PRWEB) August 31, 2014 In a world ... dog’ approach, Karma Web Group, LLC launches a game app ... Android the newly launched Ultimate Karma app is a colorful ... new levels of play, the game pulls double-duty by teaching ... same time. , Designed to reward gamers for consistently taking ...
(Date:8/30/2014)... NY (PRWEB) August 31, 2014 This ... and fastest growing union in New York State and ... middle-class healthcare jobs and the best quality of care ... , In recent years, thousands of healthcare workers in ... and their families by becoming members of the healthcare ...
(Date:8/30/2014)... 31, 2014 Atlanta based automotive group ... help raise money and awareness for ALS by participating ... Managers, staff, and even Vice President Jimmy Ellis all ... and can be viewed on their Youtube page; ... challenge, general managers and staff also took the opportunity ...
Breaking Medicine News(10 mins):Health News:Batteryless cardiac pacemaker is based on automatic wristwatch 2Health News:Acne No More Review Reveals Unusual Tip to Eliminate Acne Permanently 2Health News:Newly Launched Ultimate Karma App Elicits Happiness in Players and Encourages Moral Values 2Health News:This Labor Day, 1199SEIU Continues Commitment to Growing Local Economies with Good, Middle-Class Healthcare Jobs 2Health News:This Labor Day, 1199SEIU Continues Commitment to Growing Local Economies with Good, Middle-Class Healthcare Jobs 3Health News:This Labor Day, 1199SEIU Continues Commitment to Growing Local Economies with Good, Middle-Class Healthcare Jobs 4Health News:Jim Ellis Automotive Group Take the ALS Ice Bucket Challenge 2
... Medical Center,s Institute for Regenerative Medicine and colleagues have discovered ... how the human body regulates blood sugar levels. Reporting in ... says the protein may represent a new target for treating ... current thinking about what causes type 1 diabetes," said Bryon ...
... Journal of Clinical Oncology shows that most patients ... surgery recover an average quality of life. However, quality of ... level that remains much lower than the average population in ... that hospitals must be better at identifying this patient group. ...
... clinical research findings in peer-reviewed biomedical journals, Yale School of ... sample of trials primarily or partially funded by the National ... completing the clinical trial. These findings appear in ... which focuses on the topic of unpublished evidence. ...
... Reporter , TUESDAY, Jan. 3 (HealthDay News) -- Obese people ... risk of heart attack, stroke and death, Swedish researchers report. ... metabolic changes that occur after the surgery, such as altered ... "Bariatric surgery is associated with about 30 percent reduction ...
... News) -- Sexual satisfaction increases with age among sexually active ... don,t have sex are satisfied with their sex lives. ... planned community in the San Diego area and whose ... average age was 67 years and 63 percent of them ...
... all wounds Wound healing requires complex interactions between ... As healing progresses, the growth of new blood vessels is ... are cells that come from the bone marrow and are ... that direct their emigration from the bone marrow are unknown. ...
Cached Medicine News:Health News:Researchers discover protein that may represent new target for treating type 1 diabetes 2Health News:Impaired quality of life: A warning signal after oesophageal cancer surgery 2Health News:Many NIH-funded clinical trials go unpublished over 2 years after completion 2Health News:Weight Loss Surgery Linked to Fewer Heart Attacks, Deaths 2Health News:Weight Loss Surgery Linked to Fewer Heart Attacks, Deaths 3Health News:Women's Sexual Satisfaction Often Rises With Age: Study 2Health News:Preview of articles to be published Jan. 3, 2012 2Health News:Preview of articles to be published Jan. 3, 2012 3Health News:Preview of articles to be published Jan. 3, 2012 4Health News:Preview of articles to be published Jan. 3, 2012 5Health News:Preview of articles to be published Jan. 3, 2012 6Health News:Preview of articles to be published Jan. 3, 2012 7Health News:Preview of articles to be published Jan. 3, 2012 8
Instrument necessary for insertion of Ritleng Bicanaliculus systems and of Self-Threading Monoka systems....
... For canalicular laceration or ... silicone and Stainless Steel Probe. ... Tubing securely swaged into malleable ... anchored by punctum plug: no ...
Recommended to insert plug portion of all monocanalicular intubation systems into punctum....
Skin Tone External Eyelid Weights...
Medicine Products: