Allos Updates Phase II Study Results in Non-Small Cell Lung Cancer at ASCO
- Results Show a 65% Improvement in Median Survival Time Over Like Study With Addition of RSR13 -
ORLANDO, Fla., May 20 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (Nasdaq: ALTH - News) today announced updated positive survival results from a Phase II clinical trial evaluating the use of RSR13 (efaproxiral) in patients with locally advanced, unresectable, non-small cell lung cancer receiving thoracic radiation therapy following induction chemotherapy. The updated study, with a median follow up of 22.9 months, showed median survival results of 20.6 months, 1-year survival rate of 67 percent and an estimated 2-year survival rate of 35 percent. Data from this study were presented today at the 38th Meeting of the American Society of Clinical Oncology (ASCO).
RSR13 is a synthetic small molecule that increases the release of oxygen from hemoglobin and has the potential to enhance the effectiveness of standard radiation therapy.
This open-label, multi-center Phase II study was led by Hak Choy, M.D., Clinical Director, Center for Radiation Oncology, Vanderbilt-Ingram Cancer Center. "A median survival of 20.6 months continues to be very encouraging, considering that the results from of the relevant comparison group for this study (ASCO Abstract #1160, Arm 1) showed 12.5 months for the identical treatment, minus RSR13," said Dr. Choy.
The study was conducted in 49 evaluable patients with locally advanced, unresectable, stage IIIA/IIIB non-small cell lung cancer. The objectives of this study were to evaluate overall survival, progression-free interval in the chest, complete and partial response rates in the chest (radiation portal) and time to disease progression outside of the radiation portal. The patients received two courses of induction chemotherapy with paclitaxel and carboplatin followed by daily RSR13 combined with thoracic radiation therapy for 32 doses.
"Non-small cell lung cancer can be aggressive and very difficult to treat," said Abdenour Nabid, M.D., Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec and lead enroller in the study. "The combination of RSR13 and thoracic radiation therapy was very well tolerated by these patients with advanced non-small cell lung cancer."
RSR13 Clinical Trials
Allos Therapeutics is in the process of preparing the protocol and plans to initiate a Phase III clinical study of RSR13 in patients with Stage III non-small cell lung cancer in 2002. Currently, the Company is conducting a pivotal Phase III randomized study evaluating the safety and efficacy of RSR13 and whole brain radiation therapy in patients with brain metastases. Enrollment is expected to be completed in the second half of 2002. RSR13 has been assigned Fast Track status by the Food and Drug Administration (FDA)...
About Allos Therapeutics and RSR13
Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative drugs for improving cancer treatments. The Company is conducting a pivotal Phase III trial for the treatment of brain metastases with its lead clinical candidate, RSR13 (efaproxiral). RSR13 is a synthetic small molecule that increases the release of oxygen from hemoglobin, the oxygen carrying protein contained within red blood cells. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy and some chemotherapy agents in the treatment of cancer. By increasing tumor oxygenation, RSR13 has the potential to enhance the efficacy of standard radiation therapy and certain chemotherapeutic drugs. Unlike chemotherapeutics or other radiosensitizers, RSR13 does not have to cross the blood brain barrier and enter the tumor for efficacy. Enhancement of oxygen release from hemoglobin to oxygenate the tumor is the means of enhancing the effectiveness of radiation therapy and chemotherapy. For more information about the Company, please consult www.allos.com . |
