Navigation Links
EMD Serono Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States
Date:9/30/2009

ia. Study participants were randomized to one of three different treatment groups consisting of two different dose regimens of cladribine tablets or matching placebo tablets (1:1:1 ratio). Cladribine tablets were given in two or four treatment courses in the first year, with each course consisting of once daily administration for four to five consecutive days, which means study patients took Cladribine tablets for 8 to 20 days during the year. In the second year, two treatment courses were administered to all patient groups. The primary endpoint of the CLARITY study was the qualifying relapse rate at 96 weeks. Secondary endpoints included MRI endpoints, and proportion of subjects qualifying relapse-free and disability progression at 96 weeks. Out of the 1,326 randomized patients, 90% of patients treated with Cladribine tablets completed the study (92% in the lower total dose group and 89% in the higher total dose group) compared to 87% in the placebo group.

About Cladribine Tablets

EMD Serono's oral formulation of cladribine (cladribine tablets) is currently being evaluated in Phase III as a treatment for patients with relapsing forms of multiple sclerosis (MS). Cladribine is a small molecule that may interfere with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS.

The clinical development program for cladribine tablets includes:

  • The CLARITY (CLAdRIbine Tablets Treating MS OrallY) extension study: a two-year placebo-controlled extension of the CLARITY study, designed to provide data on the long-term safety and efficacy of extended administration of cladribine tablets for up to four years.
  • The ORACLE MS (ORAl CLadribine in Early MS) study: a two-year Phase III placebo-controlled trial designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients at risk of develop
    '/>"/>

SOURCE EMD Serono, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. MJFF and Merck Serono (EMD Serono in North America) Join Forces on $2-Million Initiative to Drive Treatments for PD-Related Cognitive Dysfunction and Mood Disorders
2. Merck Serono Completes Enrollment in the REFLEX Trial of Rebif(R) in Patients at Risk of Developing Multiple Sclerosis
3. Merck Serono Announces Initiation of the ORACLE MS Trial to Evaluate Cladribine Tablets in Patients at Risk of Developing Multiple Sclerosis
4. Merck Seronos Safinamide Significantly Improved Motor Function in Patients With Advanced Parkinsons Disease in a Phase III Pivotal Trial
5. Ambrx and Merck Serono Expand Collaboration Through ARX424 Multiple Sclerosis Drug Development Alliance
6. BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health
7. Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast Cancer
8. Vanda Pharmaceuticals Submits Iloperidone New Drug Application
9. Peregrine Pharmaceuticals Submits Clinical Protocol for New Phase II Trial of Bavituximab in Patients With Metastatic Breast Cancer
10. Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
11. AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... , July 11, 2014 Research and ... "Global and Chinese Medical X-ray Film Industry Report 2014" ... http://photos.prnewswire.com/prnh/20130307/600769 Global And Chinese Medical ... in-depth study on the current state of the Global ... Chinese situation. The report provides a basic overview ...
(Date:7/11/2014)... July 11, 2014  Kindred Hospital Houston Northwest, ... the opening of its new outpatient wound healing ... to people with chronic, hard to heal wounds. ... lead to amputation, lower leg wounds related to ... closure, and traumatic injury wounds which are complex ...
(Date:7/11/2014)... ALBANY, New York , July 11, 2014 /PRNewswire/ ... published by Transparency Market Research "Endoscopy Devices Market (Endoscopes, ... Analysis, Size, Share, Growth, Trends and Forecast, 2013-2019" the ... billion in 2012 and is expected to grow at ... reach an estimated value of USD 36.9 billion in ...
Breaking Medicine Technology:Global and Chinese Medical X-ray Film Industry Report 2014 2Kindred Hospital Houston Northwest, With Wound Care Specialists, Opens Outpatient Wound Healing And Hyperbaric Center 2Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 2Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 3Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 4Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 5Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 6
... 2011 /PRNewswire-iReach/ -- In the world of veterinary ... is a 1 in 9 chance of anesthetic complications and ... cats. It is with great pride that LEI Medical ... history; having never had a single, equipment-related animal death reported. ...
... Medical Inc., a leader in developing minimally invasive medical ... tissue from the gastrointestinal tract, announces today that they ... Covidien.  Covidien is a leading global provider of healthcare ... Covidien will acquire all of the ...
Cached Medicine Technology:LEI Medical Emerges as an Innovator and Leads the Way in Safety 2LEI Medical Emerges as an Innovator and Leads the Way in Safety 3BARRX Medical, Inc. Announces Definitive Agreement to be Acquired by Covidien 2BARRX Medical, Inc. Announces Definitive Agreement to be Acquired by Covidien 3
(Date:7/12/2014)... (PRWEB) July 12, 2014 “Critical ... - New and Late-Stage Four-Factor PCCs and Recombinant ... of the critical care market in the US, ... The report provides an estimation of market size ... It covers critical care indications that are being ...
(Date:7/12/2014)... Lake City, Utah (PRWEB) July 12, 2014 ... spotlighted two types of startups, with awards being bestowed ... new emphasis spotlighted Utah’s outstanding entrepreneur community with recognition ... proving a sustainable model with incoming revenue. , 25 ... from across the state that are under 5 years ...
(Date:7/12/2014)... 2014 Praeclarus Press is ... a valuable new resource for women in need of ... women work away from their children. Today’s mothers receive ... of breastfeeding, but often feel unsupported when it comes ... With its evidence-based insights, and written by Nancy Mohrbacher, ...
(Date:7/12/2014)... Los Angeles, CA (PRWEB) July 12, 2014 ... a buyer power score of 4.1 out of ... the market that have been underpinning buyer negotiation ... to IBISWorld procurement analyst Anna Son, “during the ... along with rising costs associated with new product ...
(Date:7/12/2014)... it doesn't matter what your budget is, the trendy wedding ... affordable gown can visit Discount-Dress.com (a reliable online ... items. Recently, the company has announced its new selection of ... it is also providing great discounts for these unique items. ... this promotion is July 29, 2014. , Discount-Dress.com is ...
Breaking Medicine News(10 mins):Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 2Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 3Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 4Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 5Health News:Critical Care Therapeutics in Major Developed Market is Expected to Grow at a CAGR of 4.7% to $2.5 Billion in 2019 6Health News:SquareHook is Recognized for UVEF 25 Businesses Under 5 Years-Watch Out 2Health News:Praeclarus Press Announces the Release of Working and Breastfeeding Made Simple by Nancy Mohrbacher, A Much Needed Resource For Today's Working Mothers 2Health News:Floor-Grade Instruments Procurement Category Market Research Report from IBISWorld has Been Updated 2Health News:Floor-Grade Instruments Procurement Category Market Research Report from IBISWorld has Been Updated 3Health News:Floor-Grade Instruments Procurement Category Market Research Report from IBISWorld has Been Updated 4Health News:Worldwide Brides-to-be: It Is Time To Show Your Beauty By Wearing A Trendy Summer Short Wedding Dress From Discount-Dress.com 2
... peer pressure to share sexual images via the new phenomenon ... has found. ,Sexting, is the practice of sending and ... study is one of the first academic investigations into ,sexting, ... presented to the 2011 Australasian Sexual Health Conference in Canberra. ...
... -- Unspoken clues -- like behavior and appearance -- ... Researchers from the University of Michigan found subtle, nonverbal ... view their relationship with their doctor, they also affect ... better understand how they make decisions and what underlying ...
... Picky eating is normal in children, but a pediatric feeding ... a child,s physical and mental development, an expert says. ... clinical director of the Pediatric Feeding Disorders Program at the ... reject certain foods but still has a nourishing diet. Children ...
... (Sept. 29, 2011) Six leaders in stem cell ... key presenters at the world,s largest interdisciplinary stem cell ... World Stem Cell Summit, co-sponsored by the Cedars-Sinai Regenerative ... stem cell and regenerative medicine community. The Summit ...
... 29 (HealthDay News) -- Working rotating shifts is not ... to new Canadian research that suggests modern shift patterns ... older, more extreme shift schedules. "Recent research has ... although the biological mechanism responsible for this observation is ...
... J. Stang, Ph.D., editor of the Journal of the ... Jacqueline K. Barton, Ph.D. and Rakesh Agrawal, Ph.D., are ... to receive the nation,s highest honors in science and innovation. ... is guided by a passion for innovation, fearlessness even as ...
Cached Medicine News:Health News:'Sexting' driven by peer pressure 2Health News:Doctors Consider Nonverbal Cues in Medical Decisions 2Health News:Does Your Picky Eater Have a 'Feeding Disorder'? 2Health News:Cedars-Sinai scientists, physicians to be key presenters at World Stem Cell Summit 2Health News:Cedars-Sinai scientists, physicians to be key presenters at World Stem Cell Summit 3Health News:Modern Shift Work Patterns May Be Less Harmful to Health 2Health News:White House honors editor of American Chemical Society journal and 2 ACS members 2
The PC4200h is the largest capacity platelet incubator available. It features a built-in agitator with a capacity of 396 random bags (132 apheresis)....
The PC4200i is the largest capacity platelet incubator available. It features a built-in agitator with a capacity of 396 random bags (132 apheresis)....
... Platelet incubators hold rotators ... Incubator temperature can be set ... from 15C to 40C (59F ... 0.5C from top to bottom. ...
ELISA for detection of Anti-Gliadin IgA....
Medicine Products: