Shares of Vical ($VICL) were subjected to a swift ritual slaughter this morning after the small developer announced that it is scrapping its lead drug after it failed a Phase III trial for melanoma. Allovectin failed the primary endpoint--an objective response rate--as well as the secondary endpoint of overall survival, sending shares into a 60%-plus plunge.
San Diego-based Vical recruited 390 patients to test Allovectin (velimogene aliplasmid), a cancer immunotherapy that's been in the clinic for years. The biotech had been bullish about its Phase II data. The company didn't disclose any data this morning, saying that it would release results at a later scientific conference.
"We are disappointed that the trial did not meet either the primary or secondary efficacy endpoints, even though we believe it was well-designed and well-executed," said Vical CEO Vijay Samant. "Based on this outcome, we are terminating the Allovectin program and focusing our resources on our infectious disease vaccine programs."
Vical immediately shifted gears to focus on Astellas' recently launched late-stage study of ASP0113, a therapeutic vaccine designed to control cytomegalovirus, or CMV, for recipients of hematopoietic cell transplants and a Phase II trial of ASP0113 for solid organ transplants slated to launch later this year. Vical says the $70 million it has in the bank can sustain its operations through 2014.
Small developers like Vical have an abysmal record at late-stage cancer drug studies. The Feuerstein-Ratain rule concluded some time ago that micro-cap biotechs have a steady track record of failure in Phase III. Vical adds another notch in that belt.
- here's the press release