Bradmer announces Phase II results published in newly diagnosed glioblastoma which demonstrate improved survival and support upcoming Phase III study

    TSX: BMR

    TORONTO, Feb. 26 /CNW/ - Bradmer Pharmaceuticals Inc., a
biopharmaceutical company dedicated to the development and commercialization
of cancer therapies, today announced that Phase II data on the Company's
Neuradiab product candidate as a treatment for newly diagnosed glioblastoma
multiforme (GBM) were published in the journal, Neuro-Oncology.
( This
report summarizes the most recent clinical results utilizing patient-specific
dosing of Neuradiab (I-131 mAb81c6) as an adjunctive therapy to oral
chemotherapy, surgery and external beam radiation in patients with newly
diagnosed GBM.
    The study, conducted at Duke University Medical Center evaluating the
efficacy and toxicity of Neuradiab as an adjunct to standard of care therapy
in a 21 patient trial, demonstrated a 42 percent increase in overall survival
compared to a historical control of the current standard of care. The article
titled, "A pilot study: 131I-Antitenascin monoclonal antibody 81c6 to deliver
a 44-Gy resection cavity boost", written by David A. Reardon and Michael R.
Zalutsky as lead authors, will be published in the April 2008 edition of
    "This article represents a detailed review of the results from the
patient-specific dosing protocol utilized in the Neuradiab Phase II trial. The
study forms the basis for the design of our multi-center Phase III trial. We
are pleased to have the results published and look forward to working with Dr.
David Reardon as the principal investigator and our extensive base of
investigators and thought leaders as we approach the start of our multi-center
trial," said Alan M. Ezrin, Ph.D., President and Chief Executive Officer of
Bradmer. "The article outlines the potential benefit of patient-specific
dosing with Neuradiab in which dosing is based upon the tumor burden left
after surgical resection. The data suggest a marked increase in overall
survival that builds on the significant body of previous work completed to
date. This is the seventh clinical publication on Neuradiab in the GBM
population and we look forward to the start of the multi-center trial based
upon a well designed data driven approach."
    The primary objective of the published Phase II trial (Study 01128) was
to determine the feasibility of patient-specific dosing of Neuradiab. The
article outlines the procedure that enabled each patient to receive an optimal
dose of 44-Gy radiation based on the individual surgical resection and the
tumor burden. The results confirm that patient-specific dosing can be readily
and consistently performed. The trial also monitored overall survival from the
time of Neuradiab administration to patient death. The 21 patient trial
demonstrated a median overall survival of 90.6 weeks which represents an
encouraging increase in survival compared to the historical control of 64
weeks in the current standard of care. The optimal dose of 44 + 10% Gy
internal radiation boost to this population was designed based upon a previous
meta-analysis of the Neuradiab population that had been treated at Duke
allowing for an evaluation of therapeutic target dose based upon benefit/risk
profiles (Akabani G, et al., J Nucl Med. 1999;40:631 - 638.). The present
study confirms the standard execution of a personalized dosing that will be
done in each patient between the time of surgery and initiation of standard of
care therapy and also confirms the safety and benefit of the patient-specific
    In preparation for its pending multi-center Phase III trial, the Company
has completed the final validation phase of the manufacturing process for
Neuradiab under Good Manufacturing Practices (GMP). The initial manufacturing
data were reviewed with the U.S. Food and Drug Administration (FDA) in a
recently held guidance meeting. Bradmer has qualified the initial clinical
sites in the study, received IRB approval or is in the process of completing
the approval at the other sites and is continuing the IRB process and
budgetary discussions at the first tier centers. The goal of the Phase III
trial is to replicate the patient-specific dosing protocol as adjunct to
standard of care in a controlled study at multiple leading GBM centers in
North America.
    Bradmer expects very shortly to submit the final manufacturing update and
the standard clinical and regulatory documents to the FDA for their final
review and approval. Allowing for the standard review period by the FDA, and
pending its approval, the Company expects to be in a position to begin dosing
GBM patients immediately after receiving notification from the FDA.
    Bradmer's proposed Phase III trial, evaluating Neuradiab as a treatment
for primary glioblastoma multiforme, is a randomized two arm multi-center
study targeting 380 patients in each arm comparing the current standard of
care with a group receiving Neuradiab as an adjunct to the current standard of

    About Bradmer Pharmaceuticals Inc. (

    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 pivotal 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

    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.

    %SEDAR: 00023367E

For further information:

For further information: Bradmer Pharmaceuticals Inc., Mr. Brian
Brohman, Chief Business Officer, Phone: (416) 361-6058 (Ext. 804), E-mail:, Internet:; Investor
Relations, Ross Marshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext.
238), Fax: (416) 815-0080, E-mail:

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