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| |  ASTRO: RSR13 Plus Radiotherapy Improves Brain Cancer Survival DENVER, CO. -- November 5, 1999 -- Allos Therapeutics, Inc. announces positive Phase II patient survival results with RSR13, its radioenhancement agent, in patients with newly diagnosed glioblastoma multiforme (GBM) brain cancer receiving standard cranial radiation therapy. When used in combination with standard radiation therapy, RSR13 treatment improved median survival to 12.0 months compared to 9.2 month for the historical control group. RSR13 is a synthetic allosteric modifier of hemoglobin that noncovalently binds to hemoglobin, reduces oxygen-binding affinity to hemoglobin, and thus increases oxygen delivery to hypoxic (oxygen deprived) tissue. By increasing oxygen delivery to tumors during radiation therapy, RSR13 enhances the cytotoxic effect of radiation treatment. Allos is focusing on the clinical development of RSR13 as a broad radioenhancement agent to potentiate the cytotoxic effect of radiation therapy for the treatment of malignant tumors, including GBM, brain metastases, non-small cell lung cancer, and other solid tumors. Dr. Lawrence Kleinberg, of Johns Hopkins Oncology Center, presented on November 2, 1999 the study results at the 41st Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO) in San Antonio, TX. The results were from an open-label, multi-center Phase II study conducted by the National Cancer Institute sponsored New Approaches to Brain Tumor Treatment (NABTT) CNS consortium. A total of 50 patients with newly diagnosed GBM (Karnofsky Performance Status greater than or equal to 60) received daily RSR13, administered at 100 mg/kg, IV over 30 minutes, just prior to receiving standard radiation therapy (60 Gy/30 fractions). Seventy six percent of the 50 patients completed the planned RSR13 dosing as defined by receiving greater than or equal to 90 percent of the planned RSR13 doses. Ninety eight percent of patients completed the planned radiation therapy. Patients discontinued due to RSR13 or non-RSR13 related reasons, including nausea/vomiting, bacterial infections, allergic reaction, thrombosis, transient renal dysfunction or hypoxemia. All patients were evaluated for survival and compared to the NABTT historical control group of 133 patients, per study protocol. The study results demonstrated a statistically significant improvement in median survival of 12.0 months for the RSR13-treated patients compared to the NABTT historical control group, p=0.03 by Wilcoxon test. These results confirm that RSR13 can be safely administered during a six-week course of radiation therapy and increases median survival of patients with newly diagnosed GBM, when used in combination with standard cranial radiation therapy. Because of these Phase II efficacy results, the NCI sponsored NABTT CNS consortium has recommended a randomized pivotal study of RSR13 combined with standard cranial radiation therapy in patients with newly diagnosed GBM brain cancer. "We are very encouraged by these efficacy results which show that RSR13 plus standard radiation therapy increases survival in patients with glioblastoma multiforme, a very aggressive and deadly form of brain cancer," said Michael Gerber, MD, Allos Therapeutics’ Vice President of Medical Affairs. "The NABTT consortium has been a great collaborator in this trial and we are planning a confirmatory study of RSR13 in this indication."
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