TORONTO, Dec. 1 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc., a biopharmaceutical company dedicated to the development and commercialization of cancer therapies, announced today that it has been granted European Patent, # 1351713, entitled "Anti-Tenascin Monoclonal Antibody Therapy For Lymphoma." The claims cover the use of the Company's lead product for Glioblastoma, 131-Iodine (131I) Neuradiab(TM) candidate (monoclonal antibody 81C6), which binds to tenascin for the treatment of lymphoma, including non-Hodgkin lymphoma, by intravenous administration. The patent includes antibodies that bind to the epitope bound by Neuradiab and the use of numerous radioisotopes conjugated to Neuradiab.
"The issuance of this patent strengthens our patent portfolio and demonstrates the potential value of Neuradiab in applications beyond glioblastoma multiforme," said Alan M. Ezrin, Ph.D., President and Chief Executive Officer of Bradmer. "The localized application of Neuradiab offers direct and specific tumor-killing radiation to solid tumors in the brain in addition to the typical benefits provided by radiolabeled therapies through systemic application. Existing Neuradiab data from Duke University Medical Center have established the safety and quantified the intratumor dosage necessary for patient response. While our primary market remains focused upon glioblastoma, product extensions exist for Neuradiab in other markets. The direct intravenous injection of therapeutic dosages of Neuradiab bodes well for the safety associated with direct local application in brain tumors in which the treatment is embedded in the residual ridge with negligible systemic exposure."
Additional information has been published on the use of Neuradiab in lymphoma patients, titled Phase 1 trial study of 131-I-labeled chimeric 81C6 monoclonal antibody for the treatment of patients with non-Hodgkin lymphoma, Rizzieri et al. Blood. 2004;104:642-648.
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.
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.
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