Regulators at the FDA have presented GenVec with orphan drug status for TNFerade, an experimental therapy that spurs development of an immune system protein which helps fight advanced pancreatic cancer. And investors swiftly bid up the company's stock (GNVC) by 35 percent in premarket trading.
GenVec started out the year with a restructuring that claimed the jobs of 22 employees. Nine months ago the developer said that the cutbacks would leave enough money to operate for 18 to 24 months as it pushed ahead with its late-stage program for TNFerade and pursued talks with a partner. And since then it's received new grant money and completed two stock offerings.
Last summer Gaithersburg, MD-based GenVec unveiled interim Phase III survival data for TNFerade, demonstrating a 25 percent reduction in the risk of death when combined with standard treatment. In the standard of care arm, 75 percent of the patients died within 11.8 months, but that mortality rate wasn't hit in the combination arm until 19.4 months.
GenVec CFO Douglas Swirsky tells FierceBiotech this morning that finding a partner for the drug remains a "top priority," but he isn't providing any clues on when a deal can be wrapped. The next key event for the company, he adds, will come later this quarter when researchers expect to see its pivotal trial hit a key point on overall survival. The trial recruited 330 patients and will conclude on the death of the 276th patient. The 184th death, two thirds of the total, should occur before the end of the year, with new data out in the first quarter. GenVec comes out with its quarterly numbers tomorrow and is keeping its financial cards close to its vest until then.
- check out GenVec's release
- here's the Reuters report