TORONTO, July 23 /CNW/ - July 23, 2008 - Bradmer Pharmaceuticals Inc.
(TSX: BMR), a biopharmaceutical company dedicated to the development and
commercialization of cancer therapies, today announced that it has initiated
enrollment in the Phase III GLASS-ART Trial evaluating Neuradiab(TM), a
monoclonal antibody conjugated to Iodine-131, as a front-line therapy for
primary glioblastoma multiforme (GBM). The first patient was enrolled at the
Preston Robert Tisch Brain Tumor Center at Duke University under direction of
Dr. David Reardon as Principal Investigator.
"As a physician who has treated innumerable patients with this advanced
form of brain cancer, it is an honor to enroll the first patient in the Phase
III trial for a treatment developed at Duke and previously studied in
approximately 200 patients. This trial culminates the extensive research we
have performed at our institute over the years on Neuradiab, including seven
peer-reviewed publications," said Dr. David Reardon, Lead Principal
Investigator of the GLASS-ART Trial. "We believe broader access to Neuradiab
through the clinical trial will offer new hope for GBM patients and their
families to substantially improve patient outcomes."
"We believe Neuradiab has broad applicability for patients with newly
diagnosed GBM because the molecular target for Neuradiab, a protein called
tenascin, is expressed in almost all GBM tumors," said Dr. Alan M. Ezrin,
President and Chief Executive Officer of Bradmer. "This stands in contrast to
other agents under development for GBM which may only benefit a limited subset
of patients for a variety of reasons. We look forward to bringing this
investigational drug to patients via collaborative efforts with more than 30
U.S. cancer centers that are participating in the GLASS-ART Trial."
About the GLASS-ART Trial (www.glassarttrial.com)
The Phase III GLASS-ART Trial derives its name from its description: GBM
Locoregional Agent Survival Study - Antitenascin Radiolabeled antibody Therapy
Trial. The study is designed to determine the survival benefit derived from,
and safety of, adding Neuradiab(TM) to the current standard of care therapy,
consisting of surgery, radiation and adjuvant chemotherapy (temozolomide), for
patients diagnosed with primary glioblastoma mulitforme. The randomized trial
will enroll up to 760 patients at leading treatment centers across the United
States. Additional information on the trial can be found at
www.glassarttrial.com or at www.clinicaltrials.gov and then by searching the
term "Bradmer" or the study identifier NCT00615186.
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 131I
anti- tenascin monoclonal antibody 81c6.
Each year up to 30,000 new cases of GBM are diagnosed in the world's
seven largest healthcare markets. The current standard of care for GBM
patients is surgical resection followed by radiation and temozolomide. 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. Prior to the Company's inception, over
US$60 million in grants and related support had driven research and
development of the licensed treatment, which has been delivered to over 200
patients with promising results in Phase I and Phase II clinical trials at
Duke University. Bradmer is currently in the process of executing 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
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 risks and
uncertainties, which may include but are not limited to, the receipt of all
regulatory approvals required to conduct the proposed clinical trial of
Neuradiab, 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.
For further information:
For further information: Bradmer Pharmaceuticals Inc., Mr. Brian
Brohman, Chief Business Officer, Phone: (416) 361-6058 (Ext. 804), E-mail:
firstname.lastname@example.org, Internet: www.bradmerpharma.com; Investor
Relations, Ross Marshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext.
238), Fax: (416) 815-0080, E-mail: email@example.com