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:7/31/2014)... Continuing Education Company Inc ... Clinical Issues in Primary Care Continuing Medical Education ... the Wailea Beach Marriott Resort and Spa on Maui, ... developed for today's Primary Care practitioners. In 5 days ... Barbara Lyons, VP Education. , The agenda for the ...
(Date:7/30/2014)... Vail and Beaver Creek, Colo., skiers ... with “Blind Skier.” Those skiers and guides are enjoying ... Guides , a non-profit organization founded in 2001 that ... (VIPs) for snow sport opportunities. Visually impaired skiers and ... and pick up an application to participate in the ...
(Date:7/30/2014)... Responding to the call to ... to an increasingly diverse patient population, three leading ... expertise to the publication of a new textbook ... and Cultural Competence in Health Care: A Systems ... a professor in the Management Division at the ...
(Date:7/30/2014)... severe combined immunodeficiency (SCID) can be successfully treated with ... led by Memorial Sloan Kettering,s Richard J. O,Reilly, MD, ... Their review will be published in the July 30 ... . , SCID is a group of inherited disorders ... this breakdown occurs, babies no longer have the ability ...
(Date:7/30/2014)... The Restore My Blood Sugar review recently ... sugar levels can now find an amazingly successful method of ... was created by D. Chao and Andrew Forester who claim ... when it comes to normalizing blood sugar levels. Chao actually ... secret to the cure of diabetes that all patients should ...
Breaking Medicine News(10 mins):Health News:Clinical Issues in Primary Care Continuing Medical Education (CME) Conference - October 13-17, 2014 in Maui, Hawaii - Agenda Released 2Health News:Clinical Issues in Primary Care Continuing Medical Education (CME) Conference - October 13-17, 2014 in Maui, Hawaii - Agenda Released 3Health News:Colorado Non-Profit Foresight Ski Guides Seeking Applications for Blind and Visually Impaired Skiers and Guides for Vail Ski Season 2Health News:NLN CEO Co-Authors Textbook to Advance Diversity and Cultural Competence Across Health Care Professions 2Health News:NLN CEO Co-Authors Textbook to Advance Diversity and Cultural Competence Across Health Care Professions 3Health News:Transplantation shown to be highly effective in treating immune deficiency in children 2Health News:Restore My Blood Sugar Review Reveals Exclusive Ways to Normalize Blood Sugar 2
... hand hygiene knowledge positively correlates with a decreased risk ... elementary school children, according to two studies published in ... Infection Control (AJIC), the official publication of APIC ... Epidemiology. In the first study, conducted by ...
... announced that they were among the first to use artificial-lung ... a device invented by two university faculty members, Dr. Joseph ... patients get oxygen into their blood by transporting blood to ... blood before returning it to the heart, bypassing the lungs ...
... -- U.S. meat processor Cargill announced late Wednesday that it ... involving about 36 million pounds of ground turkey linked to ... experts closer to the source of the outbreak, which the ... one Californian and sickened at least 76 others across 26 ...
... HealthDay Reporter , THURSDAY, Aug. 4 (HealthDay News) ... power of stem cells to help treat, and potentially cure, ... recent issue of the Journal of the American Society ... to morph into other types of kidney cells needed to ...
... , THURSDAY, Aug. 4 (HealthDay News) -- Women with the ... to get pregnant than other women, a new study has ... questionnaires at 12 and 18 weeks of gestation. Of those ... their lives, 199 (1.8 percent) had bulimia, and another 82 ...
... Scientific, Technical, Medical, and Scholarly (STMS) publishing business of John ... partnership with The Hastings Center, to publish the Hastings ... field of bioethics. The partnership aims to broaden the reach ... access to libraries. The self-published Report publishes essays, commentary, ...
Cached Medicine News:Health News:Studies shed light on hand hygiene knowledge and infection risk in hospitals and elementary schools 2Health News:New use of artificial lung device pioneered at University of Kentucky 2Health News:Cargill Begins Massive Recall of Turkey Linked to Salmonella Outbreak 2Health News:Cargill Begins Massive Recall of Turkey Linked to Salmonella Outbreak 3Health News:Stem Cell Therapy Holds Promise for Kidney Disease 2Health News:Stem Cell Therapy Holds Promise for Kidney Disease 3Health News:Eating Disorders Can Harm Women's Fertility 2Health News:Hastings Center Report expands reach through Wiley-Blackwell partnership 2
(Date:7/30/2014)... July 30, 2014 Research and Markets has ... - Forecasts to 2019" report to their offering. ... estimated to grow at a lower CAGR in developed countries; however, ... as China , India , ... The growth of the hematology analyzers and reagents market ...
(Date:7/30/2014)... July 30, 2014 Research and Markets ... and Chinese Aseptic Packaging Industry Report 2014" report ... The Global and Chinese Aseptic Packaging ... the current state of the global Aseptic Packaging industry ... report provides a basic overview of the industry including ...
(Date:7/30/2014)... 30, 2014   Unique Pizza and Subs ... Pink: UPZS), a Delaware Corporation, is pleased to ... Larasan Pharmaceutical Corporation ("Larasan"), a nature-based pharmaceutical company that ... agreement, US-based Larasan will work with Unique to ... through Larasan,s vast distribution network throughout ...
Breaking Medicine Technology:Hematology Analyzers & Reagents Market - Forecasts to 2019 2Global and Chinese Aseptic Packaging Industry Report 2014 2Unique Pizza and Subs Announces Asian Distribution Agreement with Larasan Pharmaceutical Corporation 2Unique Pizza and Subs Announces Asian Distribution Agreement with Larasan Pharmaceutical Corporation 3
... Kaiser Permanente Hawaii has received the inaugural Pharmacy ... Permanente,s achievement of a 5-star rating on the PQA ... Centers for Medicare and Medicaid Services (CMS) Star Rating ... because it uses publicly available quality data from CMS," ...
... June 2, 2011 Mylan Inc. (Nasdaq: ... Inc. has received final approval from the U.S. Food ... Application (ANDA) for Venlafaxine Hydrochloride (HCl) Extended-release (ER) Capsules, ... (base), the generic version of Wyeth,s Effexor XR® Capsules, ...
Cached Medicine Technology:PQA Recognizes Kaiser Permanente Hawaii for Excellence in Medication Safety 2
... Direct has been selling replacement ... 1996, and we are extremely ... guarantee. Check out our catalog ... our discount light bulbs specials. ...
... Bulb Direct has been ... Internet since 1996, and we ... 100% satisfaction guarantee. Check out ... and see our discount light ...
... Direct has been selling replacement ... 1996, and we are extremely ... guarantee. Check out our catalog ... our discount light bulbs specials. ...
... Bulb Direct has been selling ... since 1996, and we are ... satisfaction guarantee. Check out our ... see our discount light bulbs ...
Medicine Products: