Bradmer Pharmaceuticals Inc. Provides Clinical Trial Update and Announces Evaluation of Strategic Alternatives
TSX: BMR
TORONTO, Feb. 17 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc. (BMR.TSX), provided an update today on the ongoing Phase III GLASS-ART Trial testing Neuradiab(R) in the most advanced form of brain cancer (glioblastoma). Bradmer also announced that its Board of Directors has recommended a review of strategic options in light of performance, market conditions and new projections of site initiation and patient enrollment from the Company's clinical research organization (CRO).
During the second half of 2008, the Phase III GLASS-ART Trial was successfully launched with five clinical trial sites activated and another 15 sites near initiation with regulatory and budgeting processes completed. Bradmer has now also completed a review of the first cohort of patients.
"We have enrolled our first cohort of patients in the trial and documented the appropriateness of dosing and protocol compliance with no reports of any serious adverse events," said Dr. Alan M. Ezrin, President and Chief Executive Officer. "While the efficiency and quality review of the Phase III study to date yielded encouraging protocol adherence and proof of execution, it also revealed significant logistical issues."
The Company's present CRO has indicated that it is unable to meet the targets for site initiation and enrollment of sufficient patients in a timely manner. This has occurred despite Bradmer having secured participation of multiple key centers across the United States. This projected delay in patient enrollment translates into a longer time to reach key clinical milestones that would require additional capital beyond 2009 to complete a planned 60-patient "run-in phase" and full trial enrollment.
The Company has terminated the relationship with the CRO which has agreed to continue through any "transition" or "wind down" phase. Management and the Board of Directors of Bradmer are now examining the ramification of this delay and are evaluating strategic options related to the Bradmer assets and resources. While the cash on hand is not enough to finish the clinical trial, it is substantial enough to warrant careful consideration of proper deployment. It is envisioned that this strategic evaluation process will be reviewed by the Directors in March and recommendations will be forthcoming.
About Glioblastoma Multiforme
Glioblastoma multiforme (GBM) is the most common and most advanced form of brain cancer with approximately 30,000 new cases diagnosed each year in the world's seven largest healthcare markets. Unlike many other solid tumors, GBM tumors do not metastasize, but cause symptoms and often death through invasion of nearby tissues and impairment of brain function. The current standard of care, consisting of surgery, radiation and adjuvant chemotherapy (temozolomide), extended average overall patient survival from 53 to 64 weeks.
About Neuradiab
Neuradiab is a monoclonal antibody, conjugated to radioactive iodine, used to treat glioblastoma multiforme (GBM), the most common and most advanced form of brain cancer. Neuradiab delivers tumor-killing radiation specifically to residual brain tumor cells after surgery, with minimal impact on normal brain tissue. During the course of development at Duke University, over US$60 million in research grants and related support has produced a series of Phase I and Phase II clinical trials on Neuradiab and other closely related technologies. Approximately 200 brain cancer patients, including over 160 with GBM, have been treated with the Neuradiab therapy regimen, and survival benefits have significantly exceeded historical controls in each completed trial. Neuradiab has been formerly referred to in literature as 131-I anti-tenascin monoclonal antibody 81c6.
GBM tumors typically have infiltrating edges that are very difficult to completely remove with surgery. The Neuradiab therapy is delivered directly into the surgical resection cavity in a separate procedure after the initial surgery. Neuradiab delivers a concentrated level of radiation specifically to the remaining cancer cells by targeting tenascin. Tenascin is a protein over-expressed in 99% of GBM cells but absent from normal brain cells.
About Bradmer Pharmaceuticals Inc. (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. Bradmer has initiated enrollment in a Phase III 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.
CONTACT: Bradmer Pharmaceuticals Inc., Brian Brohman, Chief Business
Officer, Phone: (888) 267-0707 x804, E-mail: bbrohman@bradmerpharma.com,
Internet: www.bradmerpharma.com; Investor Relations, Ross Marshall, The
Equicom Group Inc., Phone: (416) 815-0700 (Ext. 238), Fax: (416) 815-0080,
E-mail: rmarshall@equicomgroup.com