Threshold Pharmaceuticals Initiates Phase 2 Clinical Trial Evaluating Glufosfamide in Patients With Soft Tissue Sarcoma
Monday April 9, 9:00 am ET
REDWOOD CITY, Calif., April 9 /PRNewswire-FirstCall/ -- Threshold Pharmaceuticals, Inc. (Nasdaq: THLD - News), today announced that it has initiated patient enrollment for a Phase 2 clinical trial evaluating the efficacy and safety of glufosfamide in patients with previously treated, advanced, soft tissue sarcoma.
Soft tissue sarcoma includes cancers of cartilage, fat, muscle, blood vessels, or other connective or supportive tissue.
"The treatment of advanced, soft tissue sarcoma remains a major unmet medical need that disproportionately affects younger patients," said Lee Cranmer, M.D., Ph.D, Arizona Cancer Center, and a clinical investigator for the trial. "New agents are definitely needed. I am hopeful that glufosfamide may provide a new treatment option for these patients. I look forward to collaborating with this important exploratory trial."
Phase 2 Clinical Trial Design
Twenty-two patients with previously treated, advanced, soft tissue sarcoma are planned to enroll in the Phase 2, open-label, clinical trial at various sites in the United States. All patients are to receive 5000 mg/m^2 of glufosfamide every three weeks for up to six cycles.
The primary efficacy endpoint of the trial is objective response rate. The secondary endpoints of the trial include duration of response, progression- free survival, overall survival and various safety parameters. Tumor response will be evaluated at baseline and every six weeks using the Response Evaluation Criteria In Solid Tumors (RECIST). One exploratory objective of the trial is to evaluate the biological effects of glufosfamide on metabolic profile as determined by FDG-PET (fluorodeoxyglucose-positron emission tomography). The role of this procedure is to detect metabolically active malignant lesions and to monitor their metabolic response to glufosfamide therapy. An additional exploratory objective of the trial is to correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins.
About Soft Tissue Sarcoma
Soft tissue sarcomas are treated with surgery, chemotherapy and radiation. Usually a combination of these modalities offers the best chance to treat the disease successfully. Doxorubicin and ifosfamide are the most commonly used chemotherapeutic agents in patients with advanced soft tissue sarcoma, but response rates are low and toxicity is significant. The American Cancer Society estimates that 9,220 people will be diagnosed with a soft tissue sarcoma in the United States in 2007, and approximately 3,560 people will die from these diseases.
About Threshold Pharmaceuticals
Threshold is a biotechnology company focused on the discovery and development of small molecule therapeutics for the potential treatment of cancer. By selectively targeting abnormally-proliferating tumor cells, the Company's drug candidates are designed to be potentially more effective and less toxic to healthy tissues than conventional treatments. For additional information, please visit our website (www.thresholdpharm.com)