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

ctions and infestations, which were observed in 72% of patients on everolimus and 67% of patients on placebo(1).

EXIST-1 enrolled 117 patients in 10 countries, including the US, Poland, Russia, Germany, Belgium, Canada, Australia, Italy, the Netherlands and the UK(1,10).

About the Phase II studyIn this prospective, open-label, single-arm study, 28 patients aged three years and above (median age=11, range 3-34) with evidence of SEGA growth received a median daily dose of 5.29 mg/m2. The median treatment duration was 34.2 months (range 4.7-47.1 months). Of the 28 patients in the initial study, 27 were enrolled in the extension phase and 25 were still receiving everolimus at the extension phase cut-off date (December 31, 2010). No patients discontinued due to disease progression, adverse events or study drug use(5).

During this extension phase, reduction in SEGA volume was maintained over time and no patients required surgery or other therapy for SEGA or hydrocephalus. In the study, 78% of patients (7 of 9) who took everolimus for at least three years and 79% of patients (19 of 24) who took everolimus for at least two years experienced a reduction of 30% or greater in the size of their largest SEGA relative to baseline. Additionally, 56% of patients (5 of 9) who took everolimus for at least three years and 50% of patients (12 of 24) who took everolimus for at least two years experienced a reduction of 50% or greater in the size of their largest SEGA relative to baseline(5). These findings were consistent with those previously recorded at six months relative to baseline(2,5).

The most common AEs (all grades with an incidence of at least 20%) included: stomatitis or mouth sores (86%), upper respiratory tract infection (86%), sinusitis (47%), middle ear infection (36%), diarrhea (32%), fever (32%), cellulitis or acute infection of the deep tissues of skin or muscle (29%), convulsion (29%), gastroenteritis or inflammation of the gastrointest
'/>"/>

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:9/18/2014)... SAN ANTONIO, Texas , Sept. 18, 2014  Casen ... vessels, skin and muscles to harden.  His case is one ... (GVM) in the world.  The only hospital in ... few in the world, offering treatment with the dual wave-length ... in San Antonio . Using a laser ...
(Date:9/18/2014)... YORK , Sept. 18, 2014 This BCC Research ... share of major players, market growth and size, and opportunities ... trends and revenue through 2018. Patent analysis in the report ... as the U.S., Europe and ... to: - Define and discuss the global medical device technologies ...
(Date:9/18/2014)... and LONDON , ... era for biopharmaceutical companies. Competition for innovation, increasing ... to keep up with the fast-changing environment are ... influence clinical trials, and clinical trial costs continue ... patient recruitment. Studies conducted by industry ...
Breaking Medicine Technology:Methodist Children's Hospital In San Antonio, TX Only Hospital In The U.S. Treating Rare Vascular Condition With Dual Wave-Length Laser 2Medical Devices: Technologies and Global Markets 2Medical Devices: Technologies and Global Markets 3Medical Devices: Technologies and Global Markets 4Patient Recruitment in Asia Biotech and Pharma Companies 2Patient Recruitment in Asia Biotech and Pharma Companies 3
... a leader in pharmacy automation, celebrates its 10th anniversary ... dedicated to providing enterprise-wide medication management across the health ... improved patient safety. Talyst has more than ... The company partners with pharmacies to create the right ...
... TUCSON, Ariz., Feb. 23, 2012 SynCardia Systems, Inc. ... Artificial Heart, announced today that the 1,000th implant of ... CE (Europe) approved Total Artificial Heart was ... Medical Center in Tucson, AZ. Since then, an additional ...
Cached Medicine Technology:1,000th Implant of the World's Only Approved Total Artificial Heart Performed 21,000th Implant of the World's Only Approved Total Artificial Heart Performed 3
(Date:9/18/2014)... September 18, 2014 Thousands of college ... recognizing their shared fundraising impact on 127 member ... , The first-ever Dance Marathon Day will officially kick ... projected to be raised by college and high school ... Donations generated through Dance Marathon campus programs help provide ...
(Date:9/18/2014)... 2014 Stealth Health Revolution co-founders, ... and Frank Davis, founder of Food for Health ... pleased to announce the new recipe book, "The ... nutrition-packed meals using Activz whole-food powders." The ... in the Stealth Health Revolution mission ...
(Date:9/18/2014)... a one-day conference at the Milken Institute School of ... 25, 2014 to discuss the Global Health Security Agenda ... of this event is to invite discussion of proposed ... including action plans to curtail the current deadly Ebola ... international organizations and more than 50 countries have engaged ...
(Date:9/18/2014)... The effect of guidelines recommending that elderly men ... been minimal at best," according to a new study ... published as a research letter online in JAMA ... prostate-specific antigen to test for prostate cancer., ... against the routine screening of elderly men in particular ...
(Date:9/18/2014)... (PRWEB) September 18, 2014 ChopChop ... Bill Yosses and Yonah Kalikow, 10-year-old Massachusetts’s winner of the ... twist on hummus, the classic Middle Eastern bean dip. Watch ... stage how kids can create their own healthy dips at ... at the third annual Let’s Talk About Food Festival ...
Breaking Medicine News(10 mins):Health News:250 Campuses Usher in School Year of Saving Kids’ Lives During First-Ever “Dance Marathon Day” on Sept. 25 2Health News:Montel Williams and Frank Davis Announce New Whole-Food Nutrition Recipe Book, The Simple Scoop, at Natural Products Expo East In Baltimore 2Health News:Montel Williams and Frank Davis Announce New Whole-Food Nutrition Recipe Book, The Simple Scoop, at Natural Products Expo East In Baltimore 3Health News:Non-governmental stakeholders to discuss the Global Health Security Agenda 2Health News:Professional recommendations against routine prostate cancer screening have little effect 2Health News:Award-Winning Cooking Magazine for Kids Challenges Former White House Pastry Chef and 10-Year-Old Chef to Cook Up a Healthy Snack 2Health News:Award-Winning Cooking Magazine for Kids Challenges Former White House Pastry Chef and 10-Year-Old Chef to Cook Up a Healthy Snack 3
... State Board of Education President Kathleen Strauss will join members ... launch a Braille Literacy Campaign Thursday, March 26th at ... Blind persons will kick off an $8 million campaign to ... the Blind of Michigan is joining in a nationwide campaign ...
... Affiliates ("SCA") today announced that it will host ... Time on Tuesday, March 31, 2009, to discuss ... (Logo: http://www.newscom.com/cgi-bin/prnh/20080812/CLTU111LOGO )Please go to SCA,s Intralinks ... for the conference call or contact Kathleen Vojta ...
... DAKAR, Senegal, March 25 The U.S. Agency ... Disaster Assistance (OFDA) is providing more than $3.7 ... and increase food security of families in Senegal.Of ... to improve community-based nutrition efforts and agriculture production ...
... Texas, March 25 The Texas Medical Association (TMA) ... would make using health insurance better and much easier ... not understand their health insurance information and cannot easily ... right to know what,s covered in their insurance," said ...
... standard therapy made the difference, researchers say , , ... with cancer of the larynx who received a ... their larynx than those who received a two-drug ... treatment with a combination of three drugs -- ...
... are main barriers to adoption , , , WEDNESDAY, March 25 ... the United States have comprehensive electronic health record systems currently ... to adopting such systems are costs, which can run as ... of doctors to change their ways, experts say. , "President ...
Cached Medicine News:Health News:Kathleen Strauss to Help Launch Braille Literacy Campaign 2Health News:TMA Physicians and Legislators: 'Patients Have a Right to Know' 2Health News:TMA Physicians and Legislators: 'Patients Have a Right to Know' 3Health News:Drug Combo Helps Larynx Cancer Patients Preserve Voice Box 2Health News:Few Hospitals Embracing Electronic Health Record Systems 2Health News:Few Hospitals Embracing Electronic Health Record Systems 3Health News:Few Hospitals Embracing Electronic Health Record Systems 4
... today operate with either one, eight, or ... use an imaging process to map the ... the individual signals can overlap). The reader ... array containing 96 parallel micro-objectives. The 96 ...
The Columbus microplate strip washer is for individual strips or whole plates.Programming and control are via an alphanumeric display. Up to 30 methods are stored for easy recall....
Easy to use , Allow for a flexible washing , Uniform and efficient , Very robust and reliable , Adjustable to all well shapes , Rack included (not autoclavable) , Autoclavable at 121C , No e...
... with a 25-microplate capacity ... and aspiration and dispense ... On-board software for user ... programs. External vacuum pump ...
Medicine Products: