Navigation Links
Genzyme Completes Enrollment in Pivotal, Phase 2 Clinical Trial of Clofarabine in Adult AML
Date:12/5/2007

CAMBRIDGE, Mass, Dec. 5 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ) announced today that the company has completed enrollment of a phase 2 clinical trial examining the safety and effectiveness of Clolar(R) (clofarabine) in previously untreated, older adult patients with acute myelogenous leukemia (AML) who are unlikely to benefit from standard induction therapy. Data from this study are expected to provide substantial evidence for expanding the current product label into adult AML.

"We are very pleased to have reached this milestone and to have done so in a timeframe that we expect will allow us to present preliminary data at ASCO next spring," stated Mark Enyedy, president of Genzyme Oncology. "The completion of patient enrollment in this clinical study is another important step in our plan to broaden the Clolar label to benefit a larger patient population and address multiple lines of adult AML."

Genzyme has held preliminary discussions with the U.S. Food and Drug Administration in advance of submitting a supplemental new drug application (sNDA) for clofarabine as an initial treatment in older adults with AML. The company expects to file this sNDA in the second half of next year.

Significant Unmet Medical Need

The clinical trial, known as CLASSIC II, is designed to address a high unmet medical need among older AML patients who currently have limited treatment options. According to the American Cancer Society, each year approximately 6,500 people over the age of 60 are diagnosed with AML in the U.S. The median survival for those receiving therapy can vary from one to thirteen months, and the five-year survival rate over the past three decades remains at less than 15 percent. Old
'/>"/>

SOURCE Genzyme Corp.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Genzyme Announces Second Pivotal Mozobil Trial Meets Primary Endpoint
2. Genzyme and Bayer Schering Pharma AG, Germany Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple Sclerosis
3. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
4. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
5. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
6. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
7. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
8. QuatRx Completes Patient Enrollment in Phase 3 Study of Ophena(TM) in Women with Postmenopausal Vaginal Syndrome
9. CryoCor Completes Enrollment of Pivotal Clinical Study for Atrial Fibrillation
10. Anesiva Completes Enrollment in Phase 3 Clinical Trial of Zingo(TM) to Treat Pain Associated With Venous Access Procedures in Adults
11. Human Genome Sciences Completes Enrollment of First Phase 3 Albuferon(R) Trial Ahead of Schedule
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/1/2014)... , Aug. 1, 2014  PTC Therapeutics, Inc. (NASDAQ: ... 31, 2014 it approved non-statutory stock options to purchase ... to seven new employees. The awards were made pursuant ... of our new hires, employment compensation. The ... July 31, 2014 and are being made as an ...
(Date:8/1/2014)... 1, 2014  With monumental health reform coming into ... second language. Clinical efficacy is no longer the sole ... ACA like PCORI are directing roughly $1 billion a ... entities and environments, the federal healthcare ecosystem is changing, ... of outcomes and managed markets to the right people ...
(Date:8/1/2014)... Quebec and NEW YORK ... (NYSE/TSX: VRX) and Pershing Square Capital Management, L.P. today ... Allergan, Inc. (NYSE: AGN ) in California.  ... Square regarding the tender offer rules.  ... attempt to interfere with shareholders, efforts to call a ...
Breaking Medicine Technology:PTC Therapeutics Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) 2Pharmaceuticals Learning the Language of the New Healthcare Landscape 2Pharmaceuticals Learning the Language of the New Healthcare Landscape 3Valeant Pharmaceuticals And Pershing Square Respond To Frivolous Allergan Lawsuit 2Valeant Pharmaceuticals And Pershing Square Respond To Frivolous Allergan Lawsuit 3Valeant Pharmaceuticals And Pershing Square Respond To Frivolous Allergan Lawsuit 4Valeant Pharmaceuticals And Pershing Square Respond To Frivolous Allergan Lawsuit 5Valeant Pharmaceuticals And Pershing Square Respond To Frivolous Allergan Lawsuit 6
(Date:8/2/2014)... As part of a mission to provide free ... popular TEAS Practice Test to bring the number ... Skills (TEAS) is used in the admissions process of many ... the success of aspiring medical workers. , The current version ... is a computer-based multiple choice exam containing 170 questions and ...
(Date:8/2/2014)... According to the Girl Gets Ring System review recently ... women. The book consists of dating tips and tricks that ... also teaches women how to deal with relationship problems ... review that this book is divided into 10 chapters including:, ... ,     Chapter 2 – How A Traffic Light Can ...
(Date:8/2/2014)... August 02, 2014 According to the ... is a holistic system that has already helped many ... , Vkool reveals in its review that this program ... want to eliminate their foot pain completely in just ... upon ordering this program, people will receive a main ...
(Date:8/2/2014)... August 02, 2014 According to the ... this is comprehensive program for treating leaky gut ... plans that help them improve overall health and say ... , Vkool reveals in its review that ordering this ... of 13 chapters including:,     Chapter 1 ...
(Date:8/2/2014)... Tx (PRWEB) August 02, 2014 ... data orchestration platform simplifying data engineering for big ... Apervi is one of the first Enterprise data ... Apache Spark. Databricks, the company founded by the ... Certification as a means to encourage new development ...
Breaking Medicine News(10 mins):Health News:PracticeQuiz Releases Additional Teas Practice Test Questions for Nursing College Hopefuls 2Health News:Girl Gets Ring System Review Exposes Jonathan Green's Dating Guide For Women – Vkool.com 2Health News:Girl Gets Ring System Review Exposes Jonathan Green's Dating Guide For Women – Vkool.com 3Health News:Plantar Fasciitis System Review Exposes Emma Eccles’ System For Treating Plantar Fasciitis – Vkool.com 2Health News:Plantar Fasciitis System Review Exposes Emma Eccles’ System For Treating Plantar Fasciitis – Vkool.com 3Health News:Leaky Gut Cure Program Review Reveals Karen Brimeyer’s Plan For Treating Leaky Gut Syndrome – Vkool.com 2Health News:Leaky Gut Cure Program Review Reveals Karen Brimeyer’s Plan For Treating Leaky Gut Syndrome – Vkool.com 3Health News:Databricks Certifies Apervi Conflux Director TM on Spark, Supercharging the Data to Insight Journey 2Health News:Databricks Certifies Apervi Conflux Director TM on Spark, Supercharging the Data to Insight Journey 3
... 16 Quantros, Inc., a leading provider of safety ... healthcare industry, announces the creation of a new healthcare ... Michael Tulloch, MBA, as Director of IT Consulting Services. ... office. , "The expansion into IT services is a ...
... procedures in cardiology. The idea of publishing an ESC ... European cardiovascular imagers, is therefore long awaited. The textbook ... a patient rather than technology-based approach, helping clinicians to ... of imaging. The book is divided into ...
... acid typically found in red meats, fish, beans, eggs, ... the risk of developing Alzheimer,s disease, according to a ... findings, titled "Diet-induced hyperhomocysteinemia increases Amyloid-β formation and deposition ... journal Current Alzheimer Research . "When methionine ...
... ... wellness programs have a positive impact on employee presenteeism and bottom line benefits. ... Minneapolis, MN (PRWEB) ... percent of employers have improved employee participation in health and wellness programs by implementing ...
... ... announce that Chris Wepfer and Jackie Kirby have been chosen as the company’s Recruiters ... is the second consecutive year that Chris has received such honors and the first ... ...
... , SCHAFFHAUSEN, Switzerland, Dec. 16 Tyco ... nomination of Michael E. Daniels for election to the Tyco ... March 10, 2010. , Daniels, 55, is Senior Vice ... Machines Corporation. In this role, he has worldwide responsibility for ...
Cached Medicine News:Health News:Safety and Quality Software Developer Quantros, Inc. Launches Healthcare IT Consulting Division 2Health News:The European Society of Cardiology Textbook of Cardiovascular Imaging puts patient at center 2Health News:The European Society of Cardiology Textbook of Cardiovascular Imaging puts patient at center 3Health News:Diet high in methionine could increase risk of Alzheimer's 2Health News:Hallmark Insights' Employer Survey Reveals Cost-Savings Benefits of Health & Wellness Programs 2Health News:Medical Solutions is Proud to Announce Chris Wepfer and Jackie Kirby as the Company's Recruiter of the Year Recipients 2Health News:Medical Solutions is Proud to Announce Chris Wepfer and Jackie Kirby as the Company's Recruiter of the Year Recipients 3Health News:Tyco International Files Preliminary Proxy Proposing Election of New Director 2
... The Specimen Tray accessory fits inside the ... removable working area for tissue sectioning. Specimens ... specimen tray. This is a great option ... an expensive buffer, or wish to utilize the ...
... modular peltier refrigeration system that can be added ... Deluxe bath system as standard which provides for ... The unit will chill the Vibratome bath ... ambient temperature. It will maintain bath temperature ...
Punch set for Advanced Tissue Arrayer, 1.5 mm...
Punch set for Advanced Tissue Arrayer, 1.0 mm...
Medicine Products: