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:12/19/2014)... 19, 2014 (HealthDay News) -- The intestinal bacteria that ... ulcerative colitis, may be inherited, researchers report. The ... , could help in efforts to prevent the disease ... colitis, the study authors added. "The intestinal bacteria, ... age can have a big impact on your health ...
(Date:12/19/2014)... -- Potentially illness-causing E. coli bacteria were found on ... to a new study. Researchers checked cilantro, basil ... markets in Los Angeles and Orange counties in California, ... samples tested, 24 percent were positive for E. coli. ... researchers. Both types of bacteria can cause sometimes ...
(Date:12/19/2014)... Dec. 19, 2014 (HealthDay News) -- Dense bunches of bacteria ... cancers, a new study finds. The researchers said ... the colon. The presence of these biofilms may represent ... new way to predict a person,s risk for the disease, ... pond stones, these biofilms may coat the mucus layer of ...
(Date:12/19/2014)... News) -- Older adults who have lost all their teeth ... who still have at least some of their teeth, a ... loss could provide an early warning of increased risk of ... said. However, the findings don,t prove that tooth loss ... more than 3,100 participants 60 and older. People with no ...
(Date:12/19/2014)... December 19, 2014 Diet Doc strives ... current approach to weight loss by combining ... The professionals at the company understand that remaining committed ... effects of eliminating carbohydrates and sugars from the diet ... to abandon their weight loss goals. , For ...
Breaking Medicine News(10 mins):Health News:Crohn's, Colitis May Have Genetic Underpinnings, Study Finds 2Health News:E. Coli Germs Found on Farmers Market Herbs 2Health News:Could Bacteria Play a Role in Colon Cancer? 2Health News:Loss of Teeth Linked to Physical, Mental Decline in Study 2Health News:Diet Doc Incorporates Appetite Zap into their Already Impressive Collection of Diet Products to Jump Start the Metabolism and Burn Fat 4X Faster 2Health News:Diet Doc Incorporates Appetite Zap into their Already Impressive Collection of Diet Products to Jump Start the Metabolism and Burn Fat 4X Faster 3Health News:Diet Doc Incorporates Appetite Zap into their Already Impressive Collection of Diet Products to Jump Start the Metabolism and Burn Fat 4X Faster 4
... Conference on Cell Therapy for Cardiovascular Disease sponsored ... comprehensive program dedicated to the evolving field of ... cardiac and vascular disease, as well as related ... conference will focus on preclinical and clinical studies ...
... The March of Dimes, along with its partners, are giving ... to learn from each other and to work together to ... give more babies a healthy start. U.S. Surgeon ... Prevention Symposium. The symposium will was a forum to share ...
... of researchers has discovered 13 new regions of the genome ... on the biological pathways involved in reproductive lifespan and will ... cancer and heart disease. Menopause is a ... in their early 50s. The timing of menopause can have ...
... Kathleen Doheny HealthDay Reporter , SUNDAY, Jan. ... genomic regions they believe are linked with breast cancer ... disease. All three newly identified areas "contain interesting ... clinical research," said researcher Douglas Easton, a professor of ...
... 2012) Research to Prevent Blindness (RPB) has awarded ... School, a $30,000 Medical Student Eye Research Fellowship. The award ... award will allow Ms. Shah to participate in research under ... Dr. Louis Pasquale in collaboration with Dr. Suzanne Freitag, Director ...
... By Steven Reinberg HealthDay Reporter , FRIDAY, Jan. ... moratorium on controversial research into a modified avian flu virus ... Although the investigators believe their research has a public ... others that the genetically altered virus could escape from labs ...
Cached Medicine News:Health News:Global conference on stem cell therapy for heart disease to be held Jan. 25-27 in NYC 2Health News:Global conference on stem cell therapy for heart disease to be held Jan. 25-27 in NYC 3Health News:March of Dimes launches Prematurity Prevention Network 2Health News:March of Dimes launches Prematurity Prevention Network 3Health News:Genes and timing of menopause 2Health News:New Genetic Clues to Breast Cancer? 2Health News:New Genetic Clues to Breast Cancer? 3Health News:Scientists Agree to Delay Controversial Bird Flu Research 2Health News:Scientists Agree to Delay Controversial Bird Flu Research 3
(Date:12/19/2014)...   Hospira, Inc. (NYSE: HSP ... infusion technologies, today announced that the company will present ... Wednesday, Jan. 14, 2015, in San Francisco.  ... 10:30 a.m. Pacific time on Wednesday, Jan. 14, 2015.  ... a live audiocast accessible via the Investor Relations section ...
(Date:12/19/2014)... HILL, N.C. , Dec. 19, 2014 /PRNewswire/ ... innovative consumer research and marketing communication tools are ... and globally competitive – consequently consumers, desires, preferences, ... In this environment, market research groups across all ... and marketing communication tools. However, the adoption of ...
(Date:12/19/2014)... SAN DIEGO and CARDIFF-BY-THE-SEA, ... Therapeutics, Inc. (NASDAQ: SRNE ;  Sorrento), ... and associated pain, and Conkwest, Inc., a privately-held ... a Natural Killer (NK) cell-line based therapy, announced ... definitive agreement to jointly develop next generation CAR-TNK™ ...
Breaking Medicine Technology:Study Uncovers New Tools and Techniques for Understanding Consumer Decision Making 2Sorrento and Conkwest Announce Exclusive Global Collaboration 2Sorrento and Conkwest Announce Exclusive Global Collaboration 3Sorrento and Conkwest Announce Exclusive Global Collaboration 4Sorrento and Conkwest Announce Exclusive Global Collaboration 5
... BETHESDA, Md., June 26, 2007 /PRNewswire-FirstCall/ -- ... the development of,novel, proprietary antibody-based products for ... study published recently,in the Proceedings of the ... of several other studies that EpCAM (CD326), ...
... LOS ANGELES--(BUSINESS WIRE)--Jun 27, 2007 - CytRx ... and commercialization of human therapeutics, today,announced promising ... completed Phase IIa clinical trial with arimoclomol ... not placebo-controlled,arimoclomol at a 100 mg dose ...
Cached Medicine Technology:Publication Confirms that EpCAM, the Target for Two of Micromet's,Product Candidates, Is Overexpressed on Cancer Stem Cells of,Certain Cancers 2Publication Confirms that EpCAM, the Target for Two of Micromet's,Product Candidates, Is Overexpressed on Cancer Stem Cells of,Certain Cancers 3Publication Confirms that EpCAM, the Target for Two of Micromet's,Product Candidates, Is Overexpressed on Cancer Stem Cells of,Certain Cancers 4CytRx Reports Promising Data from Its Open-Label Extension Clinical,Trial of Arimoclomol in ALS 2CytRx Reports Promising Data from Its Open-Label Extension Clinical,Trial of Arimoclomol in ALS 3CytRx Reports Promising Data from Its Open-Label Extension Clinical,Trial of Arimoclomol in ALS 4CytRx Reports Promising Data from Its Open-Label Extension Clinical,Trial of Arimoclomol in ALS 5
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... 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 ...
... 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 ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: