TORONTO, April 19 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc. , a biotechnology company dedicated to the development and commercialization of cancer therapies, has signed a three-year contract with MDS Nordion for the formulation development and clinical trial supply of Neuradiab in preparation for the planned multi-center clinical trial.
“Establishing the supply and production components of clinical grade material is an important step toward the initiation of the planned multi- center clinical trial for Neuradiab. This agreement with MDS Nordion, a leader in medical isotope and radiopharmaceutical services, together with our earlier agreement with Laureate Pharma, for the manufacturing of the Neuradiab antibody, completes the manufacturing component in preparation for the next clinical trial,” said Mark C. Rogers, M.D., Chief Executive Officer of Bradmer.
Bradmer intends to initiate a multi-center clinical trial at the leading U.S. glioblastoma multiforme (GBM) treatment sites across the country in late 2006 or early in the first quarter of 2007. Bradmer is currently recruiting sites to participate in the clinical trial and expects to receive feedback on the design of the clinical trial from the U.S. Food and Drug Administration during the second or third quarter of 2006.
“MDS Nordion is well positioned to provide biotechnology and pharmaceutical companies, like Bradmer Pharmaceuticals, with unique products and services for developing radiotherapeutics produced in a world-class Good Manufacturing Practice facility,” said Steve West, President of MDS Nordion. “Our wealth of expertise and dedication in getting products to market quickly will help contribute to Neuradiab’s development and its potential success.”
MDS Nordion will develop the radiolabeling process and final formulation of the finished drug, Neuradiab, for the planned multi-center clinical trial.
Neuradiab Treatment
Neuradiab is a monoclonal antibody, conjugated to radioactive iodine, used to treat glioblastoma multiforme (GBM), the most common and deadly 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 7 Phase I and Phase II clinical trials. 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 and every completed trial. In a recent Phase II trial of newly diagnosed GBM patients, Neuradiab, used in combination with the current standard therapy, extended median survival by 42% to 91 weeks compared with 64 weeks for a historical control group.
Each year over 30,000 new cases of GBM are diagnosed in 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 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 biotechnology 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. Bradmer is currently in the process of organizing a multi-center clinical trial of the licensed treatment. Neuradiab was recently granted Orphan Drug Status by the U.S. Food and Drug Administration.
About MDS Nordion (www.mds.nordion.com)
MDS Nordion is a world leader in radioisotopes, radiation and related technologies. MDS Nordion is part of MDS Inc. . MDS Inc. has more than 8,800 highly skilled people in 27 countries. We provide a diverse range of superior products and services to increase our customers’ speed, precision and productivity in the drug development and disease diagnosis processes. We are a global, values-driven health and life sciences company, recognized for our reliability and collaborative relationships as we help create better outcomes in the treatment of disease. Find out more at www.mdsintl.com or by calling 1-888-MDS-7222, 24 hours a day.
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.
Bradmer Pharmaceuticals Inc.
CONTACT: Bradmer Pharmaceuticals Inc., Mr. Brian Brohman, Chief FinancialOfficer, Phone: (502) 657-6038, Fax: (502) 657-6039, E-mail:bbrohman@bradmerpharma.com, Internet: www.bradmerpharma.com; InvestorRelations, Ross Marshall, The Equicom Group Inc., Phone: (416) 815-0700(Ext. 238), Fax: (416) 815-0080, E-mail: rmarshall@equicomgroup.com
