Edison Investment Research Comments on Threshold Pharmaceuticals Following Protocol Amendment

In a report published Wednesday, Edison Investment Research analyst Dr. Mike Aitkenhead commented on recent developments related to Threshold Pharmaceuticals (NASDAQ: THLD).

In the report, Edison Investment Research noted, “Threshold has amended the protocol of its ongoing TH-302 Phase III study in frontline STS, with the FDA agreeing to changes under the existing SPA agreement. The trial is evaluating TH-302 + doxorubicin vs. doxorubicin alone in subjects with metastatic or locally advanced unresectable STS. The trial expansion to 620 patients (from 450) and elimination of an interim PFS analysis (mid-2013) relates to the higher overall survival (OS) benefit seen with doxorubicin in recent studies (12.8 months in EORTC 62012) and faster-than-expected recruitment. The addition of 170 patients maintains the study's 85% power to detect a four-month increase in median OS for TH-302+dox (16 months) vs dox alone (12 months). With the OS analysis based on 434 events (previously 323), the enlarged sample size strengthens the trial's ability to detect a clinically meaningful (four-month) and statistically significant (p<0.05) benefit for TH-302. Eliminating the interim PFS futility analysis makes sense in our view, given that the trial will be largely enrolled (around year-end 2013) by the time the analysis would be conducted and, moreover, an OS benefit is required for FDA approval.”

Threshold Pharmaceuticals closed on Tuesday at $5.58.