Genta's stock took a nosedive yesterday on news that its lead drug Genasense, a Phase III candidate for melanoma, did not show a statistically significant benefit for its co-primary endpoint of progression-free survival. Additionally, the AGENDA trial drug failed to meet secondary endpoints of overall response rate and disease control rate. The only bright spot in the data was that the drug passed the statistical test for survival, though it's still too early to tell whether patients in the Genasense arm survived longer than those in the control group.
The drug had previously been rejected by the FDA in 2004 when the agency determined that it failed to demonstrate a strong enough survival data. The AGENDA study was done in a subset of melanoma patients who the company hoped would have a stronger response to the drug.
The disappointing results are a major blow to the company, which has been struggling financially for some time now. "However, the immediate failure to confirm a significant improvement in progression-free survival will preclude our submission of a regulatory application this year," said Dr. Raymond P. Warrell., Jr., Genta's CEO. "Management and the Board are currently assessing the impact of these data on the Company's strategic direction."
- take a look at Genta's release
- for more, read this report from TheStreet