Threshold Pharmaceuticals, Inc. (THLD) announced that it has completed enrolling patients in its phase III study, which is being conducted to evaluate TH-302 for the treatment of advanced soft tissue sarcoma (STS).
The randomized, pivotal, phase III study will compare TH-302 in combination with Doxil to Doxil alone for treating patients with advanced STS. This study is conducted in partnership with the Sarcoma Alliance for Research through Collaboration (SARCF).
An Independent Data Monitoring Committee (:IDMC) will monitor the safety of patients in this study. The IDMC will conduct an interim analysis for survival, most likely in mid 2014, after 235 events have been reached. The study will be terminated early if the IDMC finds pre-specified statistical results in its interim analysis. Otherwise, the study will continue until the final analysis, after the completion of 434 events. In that case, Threshold Pharma will release top-line results in the first half of 2015
We note that Threshold Pharma is developing TH-302 in collaboration with Merck KGaA (MKGAF). The agreement provides Threshold Pharma an option to co-commercialize TH-302 in the U.S. The completion of enrolment will trigger a payment of $12.5 million from Merck KGaA to Threshold Pharma.
We remind investors that TH-302 enjoys orphan drug status in the U.S. and EU for the treatment of STS.
The successful development of TH-302 will be a major milestone for Threshold Pharma, which currently does not have any marketed product in its portfolio.