Navigation Links
Interim Safety Analysis Supports Continuation of Allos Therapeutics' Pivotal Phase 2 PROPEL Trial of PDX in Patients with Peripheral T-cell Lymphoma
Date:12/27/2007

endpoints include duration of response, progression-free survival and overall survival.

Owen A. O'Connor, MD, PhD, Director, Lymphoid Development & Malignancy Program and Chief, Lymphoma Service, Columbia University, Herbert Irving Comprehensive Cancer Center, New York, is the international study chair.

In accordance with the PROPEL study design, in January 2007, the DMC completed an interim analysis of safety data based on the first 10 patients enrolled to the study who completed at least one cycle of treatment with PDX, and recommended that the trial continue per the protocol. Also in accordance with the study design, in September 2007, an interim analysis of patient response and safety data was conducted based on the first 35 patients enrolled to the study who completed at least one cycle of treatment with PDX. The results of the interim analysis of patient response data exceeded the pre-specified threshold for continuation of the trial, which required a minimum of four responses (complete or partial) out of the first 35 evaluable patients, as determined by independent oncology review. In addition, the DMC identified no major safety concerns and recommended that the trial continue per the protocol.

The PROPEL trial is being conducted under an agreement with the United States Food and Drug Administration (FDA) under its special protocol assessment (SPA) process. The SPA process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of an NDA, and provides an agreement that the study design, including trial size, clinical endpoints and/or data analyses are acceptable to the FDA. The FDA granted orphan drug designation to PDX for the treatment of T-cell lymphoma in July 2006 and granted fast track designation to PDX for the treatment of patients with T-cell lymphoma in September 2006. In April 2007, the Commission of the European Communities, with a favorable opinion of the Comm
'/>"/>

SOURCE Allos Therapeutics, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Genaera Corporation Presents Interim Phase 1 Data for Obesity Compound Trodusquemine (MSI-1436) at IBC Conference
2. Interim Response and Safety Analyses Support Continuation of Allos Therapeutics Pivotal Phase 2 PROPEL Trial of PDX in Patients with Peripheral T-Cell Lymphoma
3. Immtech Announces Interim Analysis in Phase III African Sleeping Sickness Trial
4. Interim Safety Data Favorable for Vicals Phase 2 Trial of DNA Vaccine Against CMV
5. Interim Phase 2 Data for Exelixis XL880 Show Anti-Tumor Activity in Papillary Renal Cell Cancer
6. Leading Physicians Present Interim Results from Multi-Center Studies of VNUS ClosureFAST Catheter at VEITHsymposium
7. Grantees of the Avon Foundation Breast Cancer Prevention Research Initiative Gather in Houston to Report Interim Findings
8. Novavax Announces Favorable Interim Results from Human Clinical Trial for Its Pandemic Influenza Vaccine Program
9. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
10. Lpath Demonstrates Strong Safety Profile of Lead Drug Candidate, Sphingomab(TM), in Non-Human Primates
11. Cypher(R) Sirolimus-Eluting Coronary Stent Demonstrates Sustained Clinical Benefits Compared to Bare Metal Stents in Five-Year Randomized Clinical Trial With No Differences in Long-Term Safety
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , January 15, 2014 Shire plc (LSE: ... the Office of Fair Trading (OFT) approval condition to the announced ... (NASDAQ: VPHM).   As a result of the waiver, ... expects to complete the tender offer on January 24, 2014 following ...
(Date:1/15/2014)... January 15, 2014 BreedIT Corp (OTC: ... worldwide distributor of highly sophisticated agro-breeding solutions for plant ... 2014, the Company,s board of directors appointed chemistry and ... its new member of the board. From ...
(Date:1/15/2014)... an unprecedented effort to curb the spread of "superbugs" such as ... an advanced and portable UV germicidal lamp manufactured by MRSA-UV is ... In order to prevent EMS paramedics and transport patients ... Palm Beach Fire Rescue is the first in the ...
Breaking Medicine Technology:Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 3BreedIT (OTC: BRDT) Appoints Chemistry and Pharmaceutical Industry Expert Dr. Ben-Zion Weiner to Its Board of Directors 2BreedIT (OTC: BRDT) Appoints Chemistry and Pharmaceutical Industry Expert Dr. Ben-Zion Weiner to Its Board of Directors 3Superbugs No Longer Ride In Rescue Vehicles 2
... 2012  Stockell Healthcare Systems is pleased to announce ... healthcare provider headquartered in Boulder, Colorado, has selected ... featuring complete Patient Access, Patient Accounting, and Claims ... also selected the MindLinc behavioral health EMR solution ...
... SAN DIEGO, Jan. 5, 2012  Essentialis, Inc., today announced ... with the life sciences-focused venture capital firm Vivo Ventures, ... for his expertise in business development and economic strategies, ... of Directors for Essentialis, a company focused on the ...
Cached Medicine Technology:Mental Health Partners Selects Stockell Healthcare's InsightCS® Revenue Cycle Information Management System 2Essentialis Appoints Mahendra G. Shah, Ph.D., to Board of Directors 2Essentialis Appoints Mahendra G. Shah, Ph.D., to Board of Directors 3
(Date:7/9/2014)... PROVIDENCE, R.I. Researchers have found that fecal ... difficile in immunocompromised patients. This is the result ... gastroenterologist in the Center for Women,s Gastrointestinal Medicine at ... have been published online in advance of print in ... Clostridium difficile , or C. diff , has ...
(Date:7/9/2014)... personal and subjective, the human brain turns them ... across different senses, situations and even people, reports ... Anderson. , "We discovered that fine-grained patterns of ... of the brain associated with emotional processing, act ... subjective feeling," says Anderson, associate professor of human ...
(Date:7/9/2014)... 8, 2014) Researchers from Montefiore Medical Center ... of Yeshiva University will present new findings at ... 12 July 17 in Copenhagen, Denmark. Data from ... prompt transition from cognitive normality to mild cognitive impairment ... Einstein Aging Study , established in 1980 to examine ...
(Date:7/9/2014)... a reputation for being highly toxic, but when used in ... found to offer potential health benefits in a range of ... new compound (AP39), designed and made at the University of ... delivery of very small amounts of the substance to the ... Exeter have already found that the compound protects mitochondria ...
(Date:7/9/2014)... BOSTON (July 9, 2014) A retrospective study conducted ... and colleagues reports that among adults with intellectual and ... the number of years receiving dental care increased. The ... Care in Dentistry , may help improve interventions designed ... population. , The researchers reviewed the dental records ...
Breaking Medicine News(10 mins):Health News:Women's Medicine Collaborative examines safety of fecal transplant to treat C. difficile 2Health News:Study cracks how the brain processes emotions 2Health News:Investigators from Montefiore and Einstein to present data at 2014 Alzheimer's Association International Conference 2Health News:Investigators from Montefiore and Einstein to present data at 2014 Alzheimer's Association International Conference 3Health News:Rotten egg gas holds key to healthcare therapies 2Health News:Adults with special needs see gains, challenges with long term oral care 2Health News:Adults with special needs see gains, challenges with long term oral care 3
... In ... of Technical Personnel in Ophthalmology (ATPO) proudly launched a new tool for ophthalmic professionals: ... , ... Paul, MN (Vocus) November 10, 2009 -- Compact, informative, and convenient are just a ...
... Darden Food Supplier Eliminates Workers Health and Retirement Benefits ... members from Teamster Local Union 890 presented Darden Restaurant Group, ... a letter today directed to Darden CEO Clarence Otis. In ... workers from Hollister, CA are seeking justice after a key ...
... Pa., Nov. 10 InfoLogix, Inc. (Nasdaq: IFLG ... for the healthcare and commercial industries, today announced that ... to NASDAQ,s stockholder approval requirements, in accordance with NASDAQ ... this exception to complete a proposed plan of restructuring, ...
... Nov. 10 Roxane Laboratories, Inc. announced today the ... Perindopril Erbumine Tablets, 2mg, 4mg and 8mg by the ... available in bottles of 100 for immediate shipment to ... Tablets are AB rated to ACEON® (perindopril erbumine) tablets. ...
... , ... Rounds -- "What I,ve Learned About the Throwing Arm in the Last 30 Years" ... Gulf Breeze, Fla. (Vocus) November ... Andrews Institute will hold its inaugural Grand Rounds presentation on November, 19, 2009 at ...
... of vascular risk can be simplified, researchers say ... gauge blood cholesterol to determine vascular disease risk can ... measures levels of either total or high-density lipoprotein (HDL, ... that help transport cholesterol), without the need to have ...
Cached Medicine News:Health News:JCAHPO/ATPO Pocket Guide Launches for Eye Care Professionals 2Health News:JCAHPO/ATPO Pocket Guide Launches for Eye Care Professionals 3Health News:Teamsters Look to Darden Restaurant Group for Justice 2Health News:InfoLogix Announces Receipt of NASDAQ Waiver for Stockholder Approval of Restructuring and Extension to Stockholder's Equity Requirement 2Health News:InfoLogix Announces Receipt of NASDAQ Waiver for Stockholder Approval of Restructuring and Extension to Stockholder's Equity Requirement 3Health News:InfoLogix Announces Receipt of NASDAQ Waiver for Stockholder Approval of Restructuring and Extension to Stockholder's Equity Requirement 4Health News:InfoLogix Announces Receipt of NASDAQ Waiver for Stockholder Approval of Restructuring and Extension to Stockholder's Equity Requirement 5Health News:Roxane Laboratories, Inc. Announces the Launch of Perindopril Erbumine Tablets 2Health News:Orthopaedic Surgeon and AOSSM President Dr. James Andrews to Discuss Injury Prevention 2Health News:Orthopaedic Surgeon and AOSSM President Dr. James Andrews to Discuss Injury Prevention 3Health News:Cholesterol Measurements May Be Made Easier 2
The WP1000S is a shortened base version of the WellPro that is shortened 5 inches to facilitate fitting into smaller biohazard hoods....
... Wellpro 384, compatible ... automated liquid handling system ... quickly and accurately prepares ... dilutions. The Wellpro ...
... workstations is designed for laboratories with limited ... automation platform for routine sample preparation and ... throughput, process consistency and safety. Windows ... you to control the robotic and liquid ...
... miniGene LD is a reagent dispensing system ... and 1536-well microplates. This dispenser can be ... or wide orifice nozzle heads. Precise plate ... accurate dispensing to a variety of plate ...
Medicine Products: