Navigation Links
Medarex Announces Ipilimumab Program Continues to Move Forward
Date:4/3/2008

24 Phase 3 trial by the Data Monitoring Committee (DMC) indicated that our trial should continue.

Finally, we and our partner, Bristol-Myers Squibb Company, continue to move firmly forward. Our previously-stated guidance remains unchanged and regulatory discussions are pending."

About the Chemotherapy Combination Registrational Trial

Study 024 is a randomized, blinded registrational Phase 3 study designed to evaluate the effect of dacarbazine in combination with 10mg/kg ipilimumab or placebo on progression-free survival and overall survival in 500 patients with previously untreated metastatic melanoma (front-line). Ipilimumab is administered at 10 mg/kg once every three weeks for up to four doses. Subsequently, eligible patients who have not experienced disease progression at week 24 will continue in a maintenance phase where a single dose of ipilimumab or placebo will be administered once every 12 weeks until disease progression. All efficacy analyses, except for overall survival and survival rate at one year, will be conducted when at least 416 events for progression- free survival have been observed in the study and all patients have been followed for at least 12 weeks.

In June 2006, the 024 registrational Phase 3 trial was reviewed by the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) concerning the suitability of the trial design to support regulatory approval. In December 2006, the FDA granted Fast Track status to this program which provides for expedited regulatory review for new drugs that demonstrate the potential to address unmet medical needs for the treatment of serious or life-threatening conditions. Trial enrollment was completed in the first- quarter of 2008.

About Ipilimumab

Ipilimumab is a fully human antibody that binds to CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that plays a critical role in regulating natural immune responses. The absen
'/>"/>

SOURCE Medarex, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Medarex Announces Allowance of Investigational New Drug Applications for Wholly Owned Fully Human Anti-CD19 Antibody, MDX-1342
2. Medarex to Receive Milestone Payment from Amgen
3. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
4. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
5. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
6. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
7. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
8. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
9. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
10. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
11. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... DUBLIN , July 25, 2014 ... the "Global Ophthalmic Diagnostic Devices Market 2014-2018" ... http://photos.prnewswire.com/prnh/20130307/600769 About Ophthalmic Diagnostic Device ... device used to identify a defect or deficiency in ... patients with ophthalmic disorders such as presbyopia, cataracts, glaucoma, ...
(Date:7/25/2014)... BERWYN, Pa. , July 25, 2014  AMETEK, ... appointment of Kurtis L. Goos as Vice ... Engineered Materials, Interconnects and Packaging (EMIP) Division. ... has extensive general management and business development experience, especially ... to make important contributions to the continued growth and ...
(Date:7/25/2014)... Leading events organizer UBM Live announces that CPhI ... São Paulo, Brazil from 5 th ... co-locate with Food Ingredients South America (FiSA), creating ... pharmaceutical industry.      (Logo: http://photos.prnewswire.com/prnh/20130723/629764-a) Three ... exploring the South America market as ...
Breaking Medicine Technology:Global Ophthalmic Diagnostic Devices Market 2014-2018: Key Vendors are Alcon, Carl Zeiss, Haag-Streit and Topcon 2AMETEK Names Kurtis L. Goos, Vice President & General Manager, Engineered Medical Components 2CPhI South America 2014 Launches with Generics Showing Huge Growth 2CPhI South America 2014 Launches with Generics Showing Huge Growth 3CPhI South America 2014 Launches with Generics Showing Huge Growth 4
... SCHWARTZ LED TEAM, Article in Modern,Pathology set for print ... GENE,S ACTIVATION IN MAJORITY OF BREAST,CANCER CASES, WASHINGTON, ... 70% of prostate cancer tumors, the same gene that ... cases, report,scientists at the George Washington University Medical Center ...
... Novexel, a speciality pharmaceutical,company focused on the ... the significant global problem of microbial,resistance, announces that ... posters,at the joint annual meeting of the Interscience ... Disease Society of America (48th,annual ICAAC/IDSA 46th annual ...
Cached Medicine Technology:Gene Found Activated in 70% of Prostate Cancer Cases, George Washington University Medical Center Scientists Report 2Novexel to Present Five Posters at the Joint Annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Disease Society of America (ICAAC/IDSA) Meeting 2
(Date:7/27/2014)... 2014 The report, “Oil Filter & ... & HCVs), Market Type (OE & Aftermarket), Filter Type ... Geography - Industry Trends & Forecast to 2018”, defines ... market with analysis and forecasting of the global volume ... estimated to reach a revenue of $6.1 billion in ...
(Date:7/27/2014)... The report provides market analysis of the "Actuator ... Aviation And Defense Aviation Landing Gear, Flight Control, ... - 2019." The report covers the key market ... during the study period. It also discusses the ... prevailing in the global market. , Browse 52 ...
(Date:7/27/2014)... Although Cigarette and Tobacco Product ... companies, heavy government regulation results in extremely fierce ... “Demand for cigarettes has declined over the past ... anti-smoking campaigns, increasing regulation and higher excise taxes.” ... fall at a compound annual 0.8% over the ...
(Date:7/27/2014)... Ticket Down is a reputable source for ... Miami, FL at the Sun Life Stadium on August 4th. ... In the opening game, Olympiacos from Superleague Greece defeated AC ... early lead in their group. Six other teams will also ... Manchester City, Manchester United, AS Roma, Liverpool FC, Inter Milan, ...
(Date:7/27/2014)... Discount-Dress.com is a leading online supplier ... current and prospective customers. Each of its top quality ... a team of considerate designers; they are now striving ... solutions. , Recently, the firm has announced its ... top it all off, these brand-new and fashionable items ...
Breaking Medicine News(10 mins):Health News:Oil Filter & Fuel Filter Market Worth $18.6 Billion by 2018 - Report by MarketsandMarkets 2Health News:Oil Filter & Fuel Filter Market Worth $18.6 Billion by 2018 - Report by MarketsandMarkets 3Health News:Oil Filter & Fuel Filter Market Worth $18.6 Billion by 2018 - Report by MarketsandMarkets 4Health News:Oil Filter & Fuel Filter Market Worth $18.6 Billion by 2018 - Report by MarketsandMarkets 5Health News:Actuator Systems Market in Aviation Estimated to Reach $3,839.74 Million by 2019 - New Report by MarketsandMarkets 2Health News:Actuator Systems Market in Aviation Estimated to Reach $3,839.74 Million by 2019 - New Report by MarketsandMarkets 3Health News:Actuator Systems Market in Aviation Estimated to Reach $3,839.74 Million by 2019 - New Report by MarketsandMarkets 4Health News:Cigarette and Tobacco Product Manufacturing in Australia Industry Market Research Report Now Updated by IBISWorld 2Health News:Cigarette and Tobacco Product Manufacturing in Australia Industry Market Research Report Now Updated by IBISWorld 3Health News:Cigarette and Tobacco Product Manufacturing in Australia Industry Market Research Report Now Updated by IBISWorld 4Health News:Guinness International Champions Cup Finals Tickets: Ticket Down Slashes Ticket Prices for International Champions Cup Finals in Miami at Sun Life Stadium 2Health News:Guinness International Champions Cup Finals Tickets: Ticket Down Slashes Ticket Prices for International Champions Cup Finals in Miami at Sun Life Stadium 3Health News:New Cocktail Party Dresses From Leading Online Supplier Discount-Dress.com Receive National Attention 2
... proportions”, a study finding which says that hormone replacement therapy ... of heart disease. , The study published in ... replacement therapy or HRT, taken by women in their 50’s ... attacks and other such conditions. , This finding ...
... cancer patients in the U.S. fails to receive the ... study of hospital data from nine states found that ... Hispanic race, or insured by Medicaid, were at greatest ... oncologists, by surgeons who perform few ovarian cancer surgeries, ...
... land. But there too strident voices are being raised in ... to ensure availability of lower-cost copies of biotechnology drugs that ... year. ,Generics are now allowed only for traditional, ... for complex biological drugs such as hormones or antibodies used ...
... hospitals in Mumbai will soon start an integrated trauma ... and trauma care //to patients on way to a ... powerful American Association of Physicians of Indian Origin (AAPI), ... citizens to avail fully equipped ambulances within minutes of ...
... at the Johns Hopkins Urology Robotics Lab report the ... can safely power remote-controlled // robotic medical devices used ... imaging. The motor that drives the devices can be ... and more precise than a human hand. ,"Lots ...
... food industry is estimated to be worth over $200 million and ... Confederation of Indian Industry (CII). ,The growth of the ... the already booming food retail industry, which is currently growing at ... discussed in a two-day international food meet to be held in ...
Cached Medicine News:Health News:Hormone Replacement Therapy- Not A Fallen Angel 2Health News:Many Women Undertreated for Ovarian Cancer 2Health News:Law Emerging in US for Generic Versions of Biotech Medicine 2Health News:Law Emerging in US for Generic Versions of Biotech Medicine 3Health News:Integrated Trauma Care Facility in Mumbai 2Health News:Integrated Trauma Care Facility in Mumbai 3Health News:MRI Robotic Biopsies Simplified by PneuStep 2
... agitators offer a wide range of storage ... drawer storage platform to agitate smoothly, eliminating ... down and squeak. Sturdy, one-piece perforated drawers ... circulation for your platelets., ,i.Series platelet agitators ...
Platelet agitator....
The "s" series shakers are available in orbital, reciprocating and Blood Bank Platelet versions....
The "s" series shakers are available in orbital, reciprocating and Blood Bank Platelet versions....
Medicine Products: