Navigation Links
Phase III Trial of Novartis Drug Afinitor® Met Primary Endpoint of Reducing SEGA Tumor Size in Patients With Tuberous Sclerosis
Date:7/7/2011

EAST HANOVER, N.J., July 8, 2011 /PRNewswire/ -- Novartis Pharmaceuticals Corporation ("Novartis") announced today Phase III trial results that showed more than one-third of patients taking Afinitor® (everolimus) tablets* experienced a 50% or greater reduction in the size of their subependymal giant cell astrocytomas (SEGAs), non-cancerous brain tumors associated with tuberous sclerosis complex (TSC)(1,2,6). This study, the largest prospective clinical trial to date in this patient population, is being presented on Saturday, July 9 at the International TSC Research Conference in Washington, D.C.

Currently, Afinitor is approved in the US for the following indication: to treat patients with SEGA associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical intervention. The effectiveness of everolimus is based on an analysis of change in SEGA volume. Additionally, the indication states, clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been shown(7).

Tuberous sclerosis complex affects approximately 25,000 to 40,000 people in the US and one to two million people worldwide, and is associated with a variety of resulting disorders including seizures, swelling in the brain (hydrocephalus), developmental delays and skin lesions(2,6). Also known as tuberous sclerosis (TS), TSC is a genetic disorder that may cause non-cancerous tumors to form in vital organs and can affect many different parts of the body, most commonly the brain and kidney(6,8). Signs and symptoms of TSC vary depending on which system and which organs are involved(6). SEGAs occur in up to 20% of patients with TSC. In countries where everolimus is not approved, brain surgery is the only treatment option for patients with growing SEGAs(2).

The 117-patient, randomized, placebo-controlled Phase III EXIST-1 (EXamining everolimus In a Study of TSC) trial met its primary endpoin
'/>"/>

SOURCE Novartis Pharmaceuticals Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13

Related medicine technology :

1. Ampio Pharmaceuticals Announces Treatment of First Patient in Phase 1b Ampion-In -Knee (AIK) Trial for Osteoarthritis in Australia
2. GlaxoSmithKline Implements Next Phase of New Incentive Compensation Program for U.S. Sales Representatives
3. Ataluren Phase 2 Data in Nonsense Mutation Cystic Fibrosis Published in the European Respiratory Journal
4. Endo Announces Topline Results From Phase 2 Study of Axomadol in Chronic Low Back Pain
5. Phase III Study Shows Once-Daily NVA237 is Superior to Placebo and Similar to Tiotropium in Improving Lung Function in COPD
6. DNA Medicine Institute Awarded Two Phase III SBIR NASA Contracts for Its rHEALTH Sensor
7. Phase I of the Swedish/Issaquah Medical Center Campus to Open in July
8. The Lancet Publishes Data from Protege, MacroGenics Phase 3 Clinical Study of Teplizumab in Type 1 Diabetes Patients
9. Morphotek®, Inc. Announces Initiation of Farletuzumab Phase II Study in First-Line Treatment of Non-Small Cell Lung Cancer
10. Palatin Technologies, Inc. Initiates Enrollment in Phase 2b Trial With Bremelanotide in Women With Female Sexual Dysfunction
11. Cardium Announces Plans to Acquire Transdel Pharmaceuticals Phase 3 Topical Analgesic and Cosmeceutical Business Assets
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2014)... , Aug. 20, 2014 Northstar ... announced that after months of hard work from ... the new Snorenz formulation and package design.  The ... and B-6 back into the product due to ... longer lasting effects.  Snorenz Nighttime will also include ...
(Date:8/20/2014)... LUTHERVILLE, Md. , Aug. 20, 2014 /PRNewswire/ ... today lauded the latest results achieved by the ... known as the National Precursor Log Exchange (NPLEx), ... enforcement officials track down meth offenders and make ... in Indiana blocked the ...
(Date:8/20/2014)... , Aug. 20, 2014  The National ... the latest results achieved by the real-time, pseudoephedrine ... the National Precursor Log Exchange (NPLEx), automatically blocks ... track down meth offenders and make arrests. Data ... Kentucky blocked the sale of ...
Breaking Medicine Technology:Northstar completes the first phase of its new retail strategy and prepares to ship reformulated Snorenz with all new packaging 2Indiana's Stop-Sale System Achieves Significant Results In Battle Against Meth 2Kentucky's Stop-Sale System Achieves Significant Results In Battle Against Meth 2
... , , , ... Exposure of Type I Diabetes Patients to Oramed,s Oral,Insulin and of a First-in-Humans Study With ... Oramed Pharmaceuticals, ... of the,American Diabetes Association currently being held in Orlando, Florida . Dr., Miriam Kidron ...
... WASHINGTON , June 28 Harris Corporation (NYSE: ... Inc., is helping to improve the quality of military patient ... Information Exchange (BHIE) interface.  The exchange is a health enterprise ... the Department of Veterans Affairs (VA) to securely share patient ...
Cached Medicine Technology:Oramed Pharmaceuticals to Present at the 70th Scientific Sessions of the American Diabetes Association 2Oramed Pharmaceuticals to Present at the 70th Scientific Sessions of the American Diabetes Association 3Harris Corporation Leverages CONNECT Solution to Enhance Patient Information Exchange Between DoD and VA 2
(Date:8/20/2014)... 2014 iFitDress.com, the well-known wedding dress ... cheap evening gowns . All items in ... are priced under $100. , iFitDress.com is among ... keeps trying its best to help clients worldwide to ... members are kind and professional. According to its development ...
(Date:8/20/2014)... Top10BestSEOHosting.com is a website dedicated to ... It is headed by a team of experts ... research-based information and factual studies about the newest ... market. , Recently, Top10BestSEOHosting.com has compared many ... and Bluehost are the most recommended suppliers ...
(Date:8/20/2014)... Angeles, CA (PRWEB) August 20, 2014 An ... “How to Keep Skin Looking Young at Every ... all ages maintain healthy skin . These recommendations ... age specific suggestions for women ages 25-45 and beyond. The ... and women of any age and includes using sunscreen religiously, ...
(Date:8/20/2014)... 2014 Park Avenue Dental, a leading ... Sherman, a top graduate of the University of Detroit ... of its website through an ultra-informative blog focused on ... of parkavenuedentalfl.com, the blog page is chock full of ... material, instead concentrating on important dental care tips ...
(Date:8/20/2014)... August 20, 2014 The ... (IBCCES) , an organization recognizing professionals dedicated to ... has announced that with a certificate in ... people on the Autism Spectrum have a way ... quality care. This, in turn, say IBCCES representatives, ...
Breaking Medicine News(10 mins):Health News:iFitDress.com Releases a New Range of Cheap Evening Gowns 2Health News:New Reviews For Linux Web Hosting Suppliers Announced By Top10BestSEOHosting.com 2Health News:Simon Ourian, Kim Kardashian’s Doctor, On Healthy Skin Suggestions for Every Age 2Health News:Park Avenue Dental Provides Dental Care Tips for World Wide Community on New Website Blog 2Health News:Park Avenue Dental Provides Dental Care Tips for World Wide Community on New Website Blog 3Health News:National Autism Certificate Credentialing Board IBCCES Increases Job Placement Opportunities for Those Dedicated to Working Within the Autism Spectrum 2Health News:National Autism Certificate Credentialing Board IBCCES Increases Job Placement Opportunities for Those Dedicated to Working Within the Autism Spectrum 3
... A Pneumonia Report Card released today by the International ... Coalition against Child Pneumonia reveals where urgent efforts are ... life-saving interventions that can prevent, protect against and treat ... leading infectious killer of young children, taking the lives ...
... The November 2010 issue of the Archives of ... American Congress of Rehabilitation Medicine, has published a set ... will accelerate future research in the field by establishing ... is measured and classified, treatment and potential outcomes. It ...
... This release is available in French . ... and depression should receive an additional cardiac test when undergoing ... from Concordia University, the Universit du Qubec Montral and ... study, published in the Journal of Cardiopulmonary Rehabilitation and ...
... By Amanda Gardner HealthDay Reporter , THURSDAY, Nov. ... prescription drug plans will come across some changes as they ... the upcoming open enrollment period, but experts say those differences ... continues through Dec. 31, and any changes will take effect ...
... intensive calculations in the supercomputer MareNostrum at the Barcelona ... Institute for Research in Biomedicine (IRB Barcelona) have presented ... MoDEL, this new database holds more than 1,700 proteins ... MoDEL has been developed to study the basic biology ...
... the body than just damaging the liver. Drinking also can ... the risk of HIV transmission and hinder recovery from burns, ... on such negative effects of alcohol during a meeting Nov. ... at Loyola University Medical Center. , At Loyola, about 50 ...
Cached Medicine News:Health News:Efforts to combat pneumonia among 15 high-burdened countries fall short of recommended targets 2Health News:Efforts to combat pneumonia among 15 high-burdened countries fall short of recommended targets 3Health News:Consensus on TBI and PTSD will accelerate future research and improve patient care 2Health News:Consensus on TBI and PTSD will accelerate future research and improve patient care 3Health News:Consensus on TBI and PTSD will accelerate future research and improve patient care 4Health News:Consensus on TBI and PTSD will accelerate future research and improve patient care 5Health News:Consensus on TBI and PTSD will accelerate future research and improve patient care 6Health News:Additional cardiac testing vital for patients with anxiety and depression 2Health News:Medicare Part D Changes Not Overwhelming, Experts Say 2Health News:Medicare Part D Changes Not Overwhelming, Experts Say 3Health News:Scientists at IRB Barcelona and BSC publish the world's largest video data bank of proteins 2
... electrophoresis system is designed to automate ... classic electrophoresis and immunofixation testing. The ... of electrophoresis from sample application ... destaining and drying. The walkaway nature ...
... FRECHET EXTENDER® is a new device for ... its silicone elastomer strips, it allows a ... tissues, well beyond other devices capacities. Such ... term implant since it is removed before ...
Inquire...
Inquire...
Medicine Products: