Clinical and Manufacturing Plans Approved for Neuradiab(TM) Multi-
center Clinical Trial
TORONTO, June 3 /CNW/ - 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.
Neuradiab(TM) is a monoclonal antibody, conjugated to radioactive iodine,
used to treat glioblastoma multiforme (GBM), the most common and advanced form
of brain cancer. Neuradiab(TM) 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 the internationally renowned
Preston Robert Tisch Brain Tumor Center at Duke University, over US$60 million
in research grants and related support was invested to produce a series of
Phase I and Phase II clinical trials on Neuradiab(TM) and other closely
related technologies. Approximately 200 brain cancer patients, including over
160 with GBM, have been treated with the Neuradiab(TM) therapy regimen, and
survival benefits have significantly exceeded historical controls in each
completed trial. Neuradiab(TM) 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(TM) therapy is delivered directly into the
surgical resection cavity in a separate procedure after the initial surgery.
Neuradiab(TM) 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 the GLASS-ART Trial (www.glassarttrial.com)
This Phase III study 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
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 and whether the drug regimen is
safe. The randomized trial will enroll up to 760 patients at leading treatment
centers across the United States. The goal of the Glass-Art trial is to
replicate the increase survival benefit recently reported by the investigators
at Duke University in patients treated with Neuradiab(TM) (Reardon et al., in
J Neuro-Oncology [serial online], Doc. D06-00199, February 20, 2008. URL
Further information regarding inclusion/exclusion criteria, study coordinator
contacts, and other general information can be accessed at
http://clinicaltrials.gov by searching the term "Bradmer" or the study
identifier NCT00615186. Additional information is also available at
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(TM), 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(TM) 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
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