Threshold Pharmaceuticals Inc., a biotech company focused on building a pipeline of drugs superior to conventional anticancer drugs, recently announced its ongoing phase III clinical trial results for its clinical stage hypoxia-activated prodrug, TH-302, which were presented at the Connective Tissue Oncology Society (CTOS) Meeting in Chicago.
Sant P. Chawla, M.D., of the Sarcoma Oncology Center in Santa Monica and principal investigator for the study, gave the oral presentation summarizing the phase II results from the company’s fully enrolled 403 trial, which was comprised of patients with metastatic or locally advanced unresectable soft tissue sarcoma who were not previously received chemotherapy outside of the adjuvant or neoadjuvant setting. The trial treated patients at the TH-302 maximum tolerated dose to investigate the candidate in combination with doxorubicin.
“The data from the complete set of patients in the large phase II portion of our study of TH-302 in combination with standard doxorubicin in soft tissue sarcoma patients is impressive,” Dr. Chawla stated in the press release. “Most notable, the data suggest a sizable improvement in efficacy over conventional doxorubicin alone. Combined with its tolerability, the regimen has the potential to establish a new standard-of-care for the treatment of soft tissue sarcomas and provides ample justification for pursuing the registration of TH-302 in the ongoing phase III trial comparing TH-302 plus doxorubicin versus doxorubicin alone.”
The company reports that 91 patients were included in the analyses, including 89 patients with at least one evaluable post-treatment tumor assessment. Data demonstrates two complete responses; 30 partial responses; 43 patients with stable disease for an overall response rate of 36%; and a stable disease or better rate of 84%.
In February 2011, Threshold Pharmaceuticals reached agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment of the phase III study, which includes a primary efficacy endpoint of overall survival.
The 403 trial is the basis for the ongoing pivotal phase III study designed to compare the same regimen investigated in the phase II portion of the 403 study against single agent doxorubicin.
For more information visit www.thresholdpharm.com
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