Navigation Links
Bradmer receives FDA approval to proceed with Phase III clinical trial
Date:6/3/2008

Clinical and Manufacturing Plans Approved for Neuradiab(TM) Multi- center

Clinical Trial

TSX: BMR

TORONTO, June 3 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc., a biopharmaceutical company dedicated to the development and commercialization of cancer therapies, today announced that it has received notification from the United States Food and Drug Administration (FDA) that it may proceed with the launch of its proposed Phase III trial evaluating Neuradiab(TM) as a front-line therapy for glioblastoma multiforme (GBM), the most common and advanced form of primary brain cancer. To support this approval, Bradmer previously submitted the Chemistry, Manufacturing and Control (CMC) dossier, as well as the Clinical Protocol and related trial design and execution documents to the FDA for review. The FDA determined that the CMC dossier and the Clinical Protocol contained the necessary information to support the execution of the Phase III multi-center clinical trial developed by Bradmer.

"With this positive response from the FDA, we are now in a position to begin treating patients with this potentially vital new therapy for glioblastoma multiforme," said Alan M. Ezrin, Ph.D., President and Chief Executive Officer of Bradmer. "This is a major milestone for Bradmer. We will now turn all of our collective efforts to supporting the clinical trial sites for the successful execution of this landmark study and look forward to enrolling patients at our initial centers."

The Phase III trial, named the GLASS-ART Trial, is currently screening for patients and will investigate Neuradiab(TM) as an adjuvant therapy to surgery, external beam radiation and temozolomide in 760 patients with newly diagnosed glioblastoma multiforme. The randomized trial is expected to be conducted at leading brain tumor treatment centers across the United States.

About Neuradiab(TM)

Neuradiab(TM) is
'/>"/>

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

Page: 1 2 3 4

Related medicine news :

1. Bradmer announces 2008 first quarter operational and financial results
2. Bradmer announces new additions to management team
3. Bradmer announces 2007 fourth quarter and fiscal year operational and financial results
4. Notice of Bradmer Pharmaceuticals Conference Call
5. Bradmer announces Phase II results published in newly diagnosed glioblastoma which demonstrate improved survival and support upcoming Phase III study
6. Bradmer to present at the 10th Annual BIO CEO & Investor Conference
7. Bradmer announces additions to Scientific Advisory Board
8. Bradmer Medical Isotope Supply For Phase III Trial Secure
9. Bradmer to present at Rodman & Renshaw Healthcare Conference
10. Bradmer provides Phase III Neuradiab trial update and guidance
11. Bradmer announces management changes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/16/2014)... Paradigm Physical Therapy is proud to announce ... for their patients. Dry needling is a procedure that ... musculoskeletal problems. , In this invasive procedure, a solid ... and muscle to create a trigger point. Using repeated ... to deactivate and release the trigger point within seconds. ...
(Date:9/16/2014)... Florida (PRWEB) September 16, 2014 These new ... last 3 years to receive up to $10,000 in a ... program, as well as other state and federal programs, are ... to be paid back until you sell or move out ... is a 0% interest loan. There are no monthly payments ...
(Date:9/16/2014)... magnesium sulfate is routinely given to pregnant women at ... won,t provide any long-term benefits for infants. ... pregnant women, researchers in Australia found it had no ... those children when they were assessed at between 6 ... negate the fact that the drug is helpful in ...
(Date:9/16/2014)... able to predict when and how much various treatments ... part to new findings that researchers at Fox Chase ... Oncology,s 56th Annual Meeting on Tuesday, September 16. , ... completed by men diagnosed with prostate cancer, Fox Chase ... following each type of treatment, and by how much. ...
(Date:9/16/2014)... September 16, 2014 This year’s theme ... and Sustainable company Glen Mills, Pennsylvania, September 15, 2014- ... one of the fastest growing companies in the country, ... flower, shrub, and tree health-care by naturally decreasing disease ... development. Today it announced that it will hold its ...
Breaking Medicine News(10 mins):Health News:Paradigm Physical Therapy Introduces Dry Needling 2Health News:New Updated 2014 First Time Home Buyer Programs Available to Florida Residents 2Health News:New Updated 2014 First Time Home Buyer Programs Available to Florida Residents 3Health News:Researchers Don't See Long-Term Benefits From Drug for Preemies 2Health News:Study identifies when and how much various prostate cancer treatments will impact urinary and sexual functioning 2Health News:Study identifies when and how much various prostate cancer treatments will impact urinary and sexual functioning 3Health News:Holganix Holds 3rd Annual Bionutritional Summit in Louisville, Kentucky 2
... Calif., May 27 The Ensign,Group, Inc. (Nasdaq: ... Ensign(TM) group of,skilled nursing, rehabilitative care services and ... in the FBR Capital,Markets 12th Annual Spring Investor ... in New York City. Christopher Christensen, CEO, together ...
... provide the infrastructure for MRF,s collaborative ... ... 27 Collaborative Drug,Discovery, Inc. (CDD) announced today that its ... new drug,candidates, has been selected by the Myelin Repair Foundation ...
... infection following operations for which a "prophylactic" antibiotic is ... than it was just a decade ago, according to ... report their findings in the June 15 issue of ... that have been associated with severe infections, such as ...
... dad is more involved in baby,care than ever before. Whether ... basics, or a new dad to whom the dear wife ... to pack in the "diaper,dude":, The Moms on Call ... pediatric nurse moms, is a guidebook for new dads that ...
... study says , , TUESDAY, May 27 (HealthDay News) -- A ... in nonsmokers, researchers report. , The findings -- that certain ... lung cancer, regardless of whether he or she ever smoked ... said study author Dr. Ping Yang, of the Mayo Clinic. ...
... 27 Somanetics Corporation,(Nasdaq: SMTS ) announced today ... and Drug Administration (FDA) to expand the labeling for ... 510(k) will serve to support our ongoing efforts,in the ... said,Bruce Barrett, Somanetics, president and CEO. "First, the 510(k) ...
Cached Medicine News:Health News:The Ensign Group to Present at the FBR Capital Markets 12th Annual Spring Investor Conference on May 29th 2Health News:The Ensign Group to Present at the FBR Capital Markets 12th Annual Spring Investor Conference on May 29th 3Health News:Collaborative Drug Discovery and Myelin Repair Foundation Announce Partnership 2Health News:Collaborative Drug Discovery and Myelin Repair Foundation Announce Partnership 3Health News:Collaborative Drug Discovery and Myelin Repair Foundation Announce Partnership 4Health News:The balance shifts 2Health News:Father's Day is Almost Here: Two Pediatric Nurses, Moms, Offer Practical Guidebook & DVD for New Dads 2Health News:Common Genetic Variant Tied to Lung Cancer Risk 2Health News:Common Genetic Variant Tied to Lung Cancer Risk 3Health News:Somanetics Receives 510(k) Clearance From the FDA to Expand INVOS System Labeling 2
(Date:9/16/2014)... , Sept. 16, 2014 ... of the "Global Laparoscopy Devices Industry Report ... The Global Laparoscopy Devices Industry Report 2014 ... current state of the global laparoscopic devices. ... the industry including definitions, classifications, applications and industry ...
(Date:9/16/2014)... 16, 2014 The National Association of ... simultaneously released the NAMCP Medical Technologies Dossier Template ... Template © , which provide medical directors and ... medical devices or diagnostics that accounts for evidence-based ... these technology types (instead of having to attempt ...
(Date:9/16/2014)... ORLANDO, Fla. , Sept. 16, 2014   ... standard in the patient experience at hospitals. The myComfort™ ... , Vestagen,s active barrier fabric that is fluid repellant, ... shown to inhibit the growth of bacteria on the ... the role clothing plays in the chain of transmission. ...
Breaking Medicine Technology:Global Laparoscopy Devices Industry Report 2014 2NAMCP Medical Directors Institute releases NAMCP Medical Technologies and Diagnostics Dossier Templates to provide model approach for medical devices or diagnostics 2New Vestagen Patient Garments Aim to Minimize Pathogen Transmission Inside Hospitals 2
... Med, the leading platform for automated revenue and charge ... the App Store for iPhone, iPod touch and iPad. ... company,s presence at the Hospital Information and Management Systems ... users to access the charge and data capture platform ...
... NexBio, Inc. announced the presentation of "Treatment of Parainfluenza ... Stem Cell Transplantation" at the American Society for Blood ... Honolulu, Hawaii.  The data was presented by Dr. Yi-Bin Chen, ... Medical School. Parainfluenza virus (PIV) infection causes ...
Cached Medicine Technology:HIMSS11: Ingenious Med Launches Billing and Data Capture App for iPhone, iPod touch and iPad 2NexBio’s DAS181 (Fludase®*) Improved Symptoms in a Severely Immunocompromised Patient with Parainfluenza Pneumonitis 2NexBio’s DAS181 (Fludase®*) Improved Symptoms in a Severely Immunocompromised Patient with Parainfluenza Pneumonitis 3
Featuring a secure and tamper-evident adhesive closure, computer-generated Smart ScanBand can be simultaneously printed with bar code information and programmed with RFID information....
Safe. Reliable. Baby-friendly. ,The Hugs infant protection system helps to protect your infants and children from the threat of abduction....
VerdaSee Portal ID is a family of solutions that provide automated tracking and tracing of assets as they enter or leave designated areas within a healthcare facility....
... Agility is positioned to support ... to reduce medication and other ... workflow for pharmacy support staff ... blood products, lab specimens and ...
Medicine Products: