Navigation Links
Bradmer provides Phase III Neuradiab trial update and guidance
Date:10/15/2007

TSX: BMR

TORONTO, Oct. 15 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc., a biopharmaceutical company dedicated to the development and commercialization of cancer therapies, today announced that it held a pre-Phase III meeting with the U.S. Food and Drug Administration (FDA) at which the FDA concurred with Bradmer's proposed design of the Phase III trial for its lead drug, Neuradiab, a treatment for newly diagnosed glioblastoma multiforme (GBM), the most common form of brain cancer.

At the recent meeting, the FDA responded favorably to the Company's presentation of its full clinical plan which included the trial protocol, standard operating procedures, statistical plan, and related documents.

"We initiated this discussion with the FDA to establish clarity around the appropriate clinical structure of a multicenter trial that would be suitable for the potential registration of Neuradiab," commented Alan M. Ezrin, Ph.D., President and Chief Executive Officer of Bradmer. "We are delighted with the FDA's response to the presentation of our clinical plans, which were developed in conjunction with the FDA, with our collaborators at Duke University and with thought leaders in neurooncology and neurosurgery."

Bradmer and the FDA discussed and agreed to the study trial design which includes an enhanced statistical power calculation of 90% and an added interim efficacy analysis. The agreed design, which will allow for the enrollment of approximately 380 patients in each of the experimental and control arms, has the possibility to actually shorten the study trial duration and to improve the statistical probability of success. Bradmer anticipates a 24-month enrollment period and an interim efficacy analysis on overall survival at approximately month 39 post-trial initiation, or at 470 mortality events. Should an additional efficacy analysis be required, it would occur at 626 events.

Prior to the initiation of the trial, the Company must present a complete chemistry, manufacturing and controls (CMC) update to the FDA for its review and approval. To facilitate this, Bradmer has submitted a request for an additional guidance meeting with the FDA, during which the Company will detail the technology transfer of the production of Neuradiab from the previous manufacturer to a cGMP commercial facility. Management anticipates that the requested CMC meeting will occur in the near future and the enrollment of patients could begin in late 2007 or in early 2008.

About Bradmer Pharmaceuticals Inc. (http://www.bradmerpharma.com)

Bradmer Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of new and innovative cancer therapies. Bradmer's lead clinical candidate, Neuradiab, was developed at Duke University Medical Center as a proprietary therapy for a particularly aggressive form of brain cancer, glioblastoma multiforme. To date, over US$60 million in grants and related support has driven research and development of the licensed treatment, which has been delivered to over 200 patients with promising results and has completed Phase II clinical trials at Duke University. Bradmer is currently in the process of organizing a prospective multi-center clinical trial of the licensed treatment. Neuradiab has been granted Orphan Drug Status by both the U.S. Food and Drug Administration and the European Medicines Agency.

Bradmer Pharmaceuticals Inc.'s common shares have not been registered under the Securities Act of 1933, as amended (the "Securities Act") or any state regulatory agency in the United States. The resale or transfer by a U.S. investor of such common shares of Bradmer Pharmaceuticals Inc. is subject to the requirements of Rule 904 of Regulation S of the Securities Act or such other applicable exemption thereunder, and other applicable state securities laws.

Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.


'/>"/>
SOURCE Bradmer Pharmaceuticals Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Protein provides antioxidant protection to Neurons
2. Acupuncture provides relief
3. Micro-camera provides new breast imaging technique
4. Hormone therapy provides no heart benefit
5. MicroRNA provides new insight into birth defects
6. Drug Spironolactone Provides Renal And Cardioprotection In Diabetic Patients
7. Neurobiology Provides Answers To Block Memory-Related Drug Cravings
8. Cholesterol provides immunity against infection by certain parasites
9. John Hopkins CGHH program provides Global Health education
10. London Hospital Provides Specialized Care For Pregnant Women
11. Hope Lodges provides free stay to cancer patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/2/2016)... ... May 02, 2016 , ... ... of Patient Experience Journal (PXJ), an international, open access, peer-reviewed journal focused ... half the issue representing international (non-US) based authors, the third volume of PXJ ...
(Date:5/2/2016)... ... 02, 2016 , ... Beanfields, PBC, makers of Beanfields Bean ... students at University of Colorado in Boulder to create new advertising campaigns. , ... the School of Journalism, who selected Beanfields as the brand on which to ...
(Date:5/2/2016)... ... May 02, 2016 , ... Amica Life ... better understand life insurance throughout various life stages. , The site launched on ... needs calculator and content specific to the times when life insurance matters most. ...
(Date:5/2/2016)... ... May 02, 2016 , ... ... for the 2016 Main Residency Match® (“the Match”), the system through which U.S. ... teaching institutions. A record-high 30,750 positions were placed in the 2016 Match, and ...
(Date:5/2/2016)... New York, NY (PRWEB) , ... May 02, 2016 , ... ... Highlighting the year’s best in pet gear and toys, leading product review site ... TTPM Pets Paw of Excellence Awards at their Spring Showcase at the Metropolitan ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)... BURLINGAME, Calif. , April 28, 2016 /PRNewswire/ ... first-ever widely accessible breast and ovarian cancer risk ... cancer panel analyzing 30 genes that highly impact ... and women. Available today, the Color Test analyzes ... pancreatic, prostate, stomach, and uterine cancers. The Color ...
(Date:4/28/2016)... 28, 2016 Treato , ... healthcare, announced today that it has been named a ... Vendor in Life Sciences, 2016, Stephen Davies ... report focuses on life-science- oriented analytics, algorithms and smart ... and doctors, confirm medication ingestion, and analyze unstructured information. ...
(Date:4/28/2016)... , April 28, 2016 Oramed Pharmaceuticals ... clinical-stage pharmaceutical company focused on the development of oral drug ... the upcoming PIONEERS 2016 conference, presented by Joseph Gunnar ... in New York . Nadav Kidron ... the conference. Presentation Details:   ...
Breaking Medicine Technology: