Bradmer Pharmaceuticals Inc. to Present Poster on Progression Free Survival and Overall Survival Data from Neuradiab(TM) Phase II Trials
TSX: BMR
TORONTO, Nov. 19 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc., a biopharmaceutical company dedicated to the development and commercialization of cancer therapies, announced today that it will be presenting an abstract on the Phase II data from Neuradiab(TM) at the Society for Neuro-Oncology's (SNO) 13th Annual Scientific Meeting. The abstract, outlining the results from two previously conducted Phase II trials, is titled An update on the effects of Neuradiab(TM) on Patients with Newly Diagnosed Glioblastoma Multiforme (GBM). The SNO meeting is being held in Lake Las Vegas, Nevada from November 20th to 23rd at the Loews Lake Las Vegas Resort. The abstract will be presented between 5:00pm and 7:00pm on Saturday, November 22nd during the Meeting's General Poster Session.
The abstract describes the response of newly diagnosed GBM patients treated with Neuradiab as an adjunct to the current standard of care, consisting of surgery, temozolomide and external radiation. A recent analysis of study 01128 after 231 weeks of median follow-up (n = 14) showed a median overall survival of 102.1 weeks, and a median progression free survival of 77.3 weeks, or 17.8 months. Study 05018 showed a median overall survival of 107.7 weeks and a progression free survival of 74.6 weeks, or 17.2 months, (n = 5). The increase in overall survival and progression free survival will be presented in comparison to historical data from other third-party published trials. A copy of the abstract will be posted on the Company's website on November 23rd at www.bradmerpharma.com.
The analysis of the 231 week follow-up data was conducted after the submission and publication of the studies in Neuro-Oncology, reference:
Reardon et al., J Neuro-Oncology, Doc. D06-00199, February 20, 2008 or
http://neuro-oncology.dukejournals.org (DOI:10.1215/15228517-2007-053.
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 to the current standard of care therapy, consisting of surgery, radiation and adjuvant chemotherapy (temozolomide), for patients diagnosed with primary glioblastoma multiforme. The randomized trial was initiated in July 2008 and 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.
About Neuradiab(TM)
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.
Each year up to 30,000 new cases of GBM are diagnosed in the world's seven largest healthcare markets. 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., Mr. Brian Brohman, Chief Business
Officer, Phone: (502) 657-6038, Fax: (502) 657-6039, 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