(Updated with Tuesday's closing GenVec stock price.)
GAITHERSBURG, Md. (
(GNVC - Get Report)
experimental pancreatic cancer drug TNFerade is no better than a placebo, forcing the shut down a pivotal late-stage study, the company said Monday night.
The failure of the GenVec drug TNFerade after a second interim analysis of the phase III study is a huge setback for the company. GenVec shares closed 71.5% at 80 cents Tuesday.
By my quick calculations, GenVec has roughly 26 cents a share in cash. Throw in a few pennies for the rest of the company's drug pipeline, minus TNFerade, and fair value Tuesday morning should be around 30 cents a share.
TNFerade's blowup is not altogether surprising given the
from the first look at the same study in November 2008.
GenVec's stock price dipped below 40 cents a share at that time, with an assist from the global financial crisis. Yet the stock fully recovered and even breached $3 a share this month, which tells you investors were betting on a
Human Genome Sciences
. Sadly, what investors are getting is a
(MDVN - Get Report)
Pancreatic cancer patients treated with TNFerade combined with radiation and chemotherapy had an 8% reduction in the risk of death compared to treatment with radiation and chemotherapy alone, according to the second interim analysis of the 330-patient phase III study released Monday night.
That corresponds to a hazard of 0.92, just slightly in favor of TNFerade. Simply defined, the hazard ratio is an estimate of the treatment effect of TNFerade plus the standard of care compared to the treatment effect of the standard of care alone.
For perspective, two treatments are equally effective when the hazard ratio of a study hits 1. Unfortunately, TNFerade was getting much closer to placebo over time -- which explains why GenVec was forced to halt the study.
TNFerade efficacy dwindled over time. When
GenVec performed the first interim analysis of the phase III study
in November 2008, the hazard ratio in favor of TNFerade was 0.75, which meant TNFerade patients had a 25 percent reduction in the risk of death.