- PFS data from Neuradiab(TM) compares favorably to data from other
TORONTO, July 17 /CNW/ - Bradmer Pharmaceuticals Inc. (TSX: BMR), a
biopharmaceutical company dedicated to the development and commercialization
of cancer therapies, today released progression free survival (PFS) data from
two previously conducted Phase II trials of Neuradiab(TM) in glioblastoma
multiforme (GBM) patients. As an exploratory endpoint of the single arm
Phase II trials, the data showed a mean overall PFS of 17.2 months in 19 GBM
patients treated with Neuradiab. Bradmer is currently conducting a Phase III
clinical trial, termed the GLASS-ART Trial, evaluating Neuradiab as an adjunct
therapy to the current standard of care for GBM patients. The primary endpoint
of the GLASS-ART Trial is the increase in median overall survival in the
treated arm compared to the standard of care control arm.
"These PFS data from the Phase II Neuradiab trials exceed the results
achieved in any other clinical trial in newly-diagnosed GBM to our knowledge.
This is compelling because of recent inquiries from the U.S. Food and Drug
Administration (FDA) which suggested that Bradmer may opt to evaluate
sensitivities around the merits and use of PFS as an additional interim marker
of prognostic benefit," said Dr. Alan M. Ezrin, President and Chief Executive
Officer of Bradmer. "While the GLASS-ART Trial is being conducted with a clear
primary endpoint of median overall survival, the opportunity for Neuradiab to
demonstrate a patient benefit via the parameter of PFS could provide an
augmented regulatory approval path. We have examined the PFS outcomes from the
previous studies of Neuradiab and intend to discuss with the FDA the most
appropriate method in which to use PFS data from the GLASS-ART Trial."
Recent communications from the FDA have led Bradmer to consider using PFS
data not only as a secondary endpoint in the GLASS-ART Trial but to evaluate
such data in a blinded and centrally reviewed manner in order to be able to
use the PFS data for additional labeling consideration. As the trial is
currently designed, PFS data is being collected as an exploratory secondary
endpoint. New regulatory submissions can include secondary endpoint data to
support labeling claims for registration purposes if the data are collected in
an acceptable manner. In some cases, secondary endpoint data can also provide
early insight into patient benefit from an ongoing Phase III trial.
A recent article published in Neuro-Oncology (Lamborn et al, 2008)
examined six-month progression free survival as a predictor of overall
survival in glioma patients. The article included data from 597 adult patients
with recurrent high-grade gliomas that enrolled in Phase II trial protocols
collected by the North American Brain Tumor Consortium between 1998 and 2002.
The study concluded that progression status at 9, 18, and 26 weeks were strong
predictors of survival and that progression free survival is a valid endpoint
for trials of therapies for recurrent malignant glioma.
Bradmer's PFS analysis is based on 19 GBM patients in two recent
single-arm Phase II trials of Neuradiab with a targeted dose of 44 Gy
delivered as an adjunct to the current standard of care consisting of surgery,
temozolomide and external radiation therapy (study 01128; n = 21 (Reardon et
al., J Neuro-Oncology, Doc. D06-00199, February 20, 2008)
(http://neuro-oncology.dukejournals.org) (DOI:10.1215/15228517-2007-053) and
study 05018; n = 5).
In addition, Bradmer has reviewed the existing external GBM literature,
and in nine of the eleven studies published between 2003 and 2008 by outside
parties that the Company analyzed, progression free survival ranged from 4 to
10 months, with two other studies achieving 13 month and 17 month PFS results.
The results from the external studies covered 16 different newly diagnosed GBM
patient populations receiving various combinations of approved and
investigational therapies. Bradmer has submitted its PFS data (Reardon et al.)
as an abstract for inclusion at the 13th Annual Scientific Meeting of the
Society of Neuro-Oncology to be held in November, 2008.
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. The goal of the GLASS-ART trial is to replicate the increase survival
benefit recently reported by investigators from Duke University in patients
treated with Neuradiab(TM) (Reardon et al., in J Neuro-Oncology, Doc.
D06-00199, February 20, 2008) (http://neuro-oncology.dukejournals.org)
(DOI:10.1215/15228517-2007-053). 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(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 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(TM) 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(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 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:
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