Navigation Links
Bradmer reports progression free survival data from previous Phase II glioblastoma multiforme trials
Date:7/17/2008

but to evaluate such data in a blinded and centrally reviewed manner in order to be able to use the PFS data for additional labeling consideration. As the trial is currently designed, PFS data is being collected as an exploratory secondary endpoint. New regulatory submissions can include secondary endpoint data to support labeling claims for registration purposes if the data are collected in an acceptable manner. In some cases, secondary endpoint data can also provide early insight into patient benefit from an ongoing Phase III trial.

A recent article published in Neuro-Oncology (Lamborn et al, 2008) examined six-month progression free survival as a predictor of overall survival in glioma patients. The article included data from 597 adult patients with recurrent high-grade gliomas that enrolled in Phase II trial protocols collected by the North American Brain Tumor Consortium between 1998 and 2002. The study concluded that progression status at 9, 18, and 26 weeks were strong predictors of survival and that progression free survival is a valid endpoint for trials of therapies for recurrent malignant glioma.

Bradmer's PFS analysis is based on 19 GBM patients in two recent single-arm Phase II trials of Neuradiab with a targeted dose of 44 Gy delivered as an adjunct to the current standard of care consisting of surgery, temozolomide and external radiation therapy (study 01128; n = 21 (Reardon et al., J Neuro-Oncology, Doc. D06-00199, February 20, 2008) (http://neuro-oncology.dukejournals.org) (DOI:10.1215/15228517-2007-053) and study 05018; n = 5).

In addition, Bradmer has reviewed the existing external GBM literature, and in nine of the eleven studies published between 2003 and 2008 by outside parties that the Company analyzed, progression free survival ranged from 4 to 10 months, with two other studies achieving 13 month and 17 month PFS results. The results from the external stu
'/>"/>

SOURCE Bradmer Pharmaceuticals Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. GeoVax Reports Progress on Its AIDS Vaccine Technology
2. Peregrine Pharmaceuticals Reports Positive Early Results in Phase II Study of Bavituximab in Breast Cancer
3. MAP Pharmaceuticals Reports Positive Pharmacological Response Data for Migraine Product Candidate at the American Headache Society Annual Meeting
4. Alimera Reports Results From the Three-Month Interim Readout of the Human PK Medidur(TM) FA Study
5. Ardea Biosciences Reports Additional Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating Up to 1.9 Log Reduction in Plasma Viral Load with Once-Daily Dosing
6. Victory Pharma, Inc. Reports MGX006 Enters Into Pivotal Development Program
7. Human Genome Sciences Reports Positive Long-Term Data for LymphoStat-B in Patients With Active Systemic Lupus Erythematosus
8. Synvista Therapeutics Reports Results of Three Phase 2 Clinical Trials of SYI-2074 in Diabetic Patients with Cardiovascular Disease
9. Genetic Engineering & Biotechnology News Reports on the Growing Role of Ion-Channel Studies in Global Biotech R&D
10. Semafore Pharmaceuticals Reports Positive Interim Results from a Phase I Study of SF1126, a Targeted Pan-PI3K Inhibitor, in Patients with Advanced Solid Tumors
11. Valor Medical Reports Early Clinical Results of New Technology to Treat Cerebral Aneurysms
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/15/2014)... , Sept. 15, 2014  Patients in today,s ... care more frequently in an outpatient setting versus a ... curve and to ensure that patients continue to receive ... the launch of its new internal medicine residency program. ... more often in office, clinic and even virtual settings. ...
(Date:9/15/2014)... /PRNewswire-iReach/ -- On September 8, 2014, Dr. ... a Citizen Petition to Dr. Margaret Hamburg ... another Black Box Warning to Levaquin, Cipro, and ... a Black Box Warning for the following psychiatric ... or acts, loss of consciousness, delirium, depressed level ...
(Date:9/15/2014)... , Sept. 15, 2014  Decision ... MedTech Physician™ 2014, finds that online information ... for brands to differentiate their offering and ... medical device purchasing decisions rely on websites, ... learning about devices—and these physicians are looking ...
Breaking Medicine Technology:Kaiser Permanente Hawaii Launches New Internal Medicine Residency Program 2Kaiser Permanente Hawaii Launches New Internal Medicine Residency Program 3Quinolone Vigilance Foundation Supports Citizen Petition Requesting Another Black Box Warning for Levaquin, Cipro, Avelox 2Quinolone Vigilance Foundation Supports Citizen Petition Requesting Another Black Box Warning for Levaquin, Cipro, Avelox 3Physician device decision-makers show strong demand for device manufacturer digital content and support 2Physician device decision-makers show strong demand for device manufacturer digital content and support 3
(Date:9/16/2014)... September 16, 2014 Antioch University has ... Arts in Clinical Mental Health Counseling from Antioch ... list of programs offered through Antioch’s online campus. The ... January 2015. , "Antioch University New England’s MA in ... the field and a track record of preparing graduates ...
(Date:9/16/2014)... The rapidly increasing cost of compounded medications has ... PBMs as spending on these specialized drugs has catapulted ... concentrated, patient-specific practice, compounding has become commonplace in the ... Inc. (AIS), “Controlling the Cost of Compounded Medications: ... one leading health insurer and its internal PBM are ...
(Date:9/16/2014)... Madisonville, Louisiana (PRWEB) September 16, 2014 ... packaging for one of its most popular products - ... been designed to educate the general public about the ... weight management and building lean muscle mass. As well ... now detail product benefits, supplement facts, and nutritional information ...
(Date:9/16/2014)... 16, 2014 The Living Ethics lecture ... fall. Reflecting on what it means to live in ... investigates unique and thought-provoking topics. , “The Museum’s job ... to look at their world differently. The Living ... stage for truly enlightening dialogue,” says Richard Conti, Chief ...
(Date:9/16/2014)... September 16, 2014 DiaperBuys, a national ... ‘Healthy Aging’ Month this September. Healthy Aging Month was ... across the nation on the positive aspects of growing ... with conditions or side effects from medications that cause ... Outreach Manager for DiaperBuys.com. “This can seem daunting to ...
Breaking Medicine News(10 mins):Health News:Antioch University Launches Online Master’s Degree Program in Clinical Mental Health Counseling 2Health News:Sept. 25 Webinar to Offer Health Plan, Employer Strategies to Control Compounded Medication Costs 2Health News:BQuick Nutrition Announces Newly Branded BURN Clarinol CLA Powder 2Health News:BQuick Nutrition Announces Newly Branded BURN Clarinol CLA Powder 3Health News:Expanding Community Vision at the Science Museum of Virginia 2Health News:DiaperBuys Honors ‘Healthy Aging’ Month throughout September 2Health News:DiaperBuys Honors ‘Healthy Aging’ Month throughout September 3
... Md., Dec. 4 Nabi,Biopharmaceuticals (Nasdaq: ... completed the,sale of assets constituting its Biologics ... a wholly-owned subsidiary of Biotest,AG, for $185 ... arrangements described,below, Biotest has acquired or will ...
... 4 ConsumerLab.com, LLC claims to,be a leading provider ... and healthcare professionals evaluate health, wellness, and,nutrition products. ... of,Revatrol, a red-wine 100MG resveratrol supplement -- is ... by ConsumerLab.com on red wine,supplements analyzed a formulation ...
... more than one in ten infants in the U.S. is ... problems associated with premature births is brittle bones, or osteopenia ... in the infant, and osteoporosis later in life. , ... that aims to make preemies bones stronger. Dr. Dan Nemet ...
... Florida State University professor will share a $3.3 million ... Vermont to develop an innovative method that will help ... psychology Professor Brad Schmidt and UVM psychology Professor Michael ... each campus -- to participate in the study over ...
... In response to the growing body of research ... for Cancer Research (AACR) announces the launch of a ... submissions of papers. This important new journal is the ... from preclinical research to clinical trials. , In the ...
... that only vertebrates have sophisticated adaptive immune systems that ... being infected by them just once has been revised ... also have a form of immune memory that protects ... encountered. This was just one of the striking discoveries ...
Cached Medicine News:Health News:Nabi Biopharmaceuticals Completes Sale of Nabi Biologics to Biotest AG 2Health News:Nabi Biopharmaceuticals Completes Sale of Nabi Biologics to Biotest AG 3Health News:Renaissance Health Publishing, LLC Asks Key Credibility Questions of ConsumerLab.com 2Health News:Tel Aviv University gives preemies a fighting chance 2Health News:FSU researcher lands $3.3 million grant to help smokers kick habit 2Health News:AACR introduces Cancer Prevention Research 2Health News:AACR introduces Cancer Prevention Research 3Health News:Violent sex acts boost insect's immunity system 2Health News:Violent sex acts boost insect's immunity system 3
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: