by MICHAEL FITZHUGH
A late-stage failure for GenVec's (GNVC) pancreatic cancer gene therapy TNFerade sent investors fleeing March 30. Shares of GenVec fell nearly 75 percent to 80 cents a share from $2.81 on news the Gaithersburg, Maryland company would discontinue a last-stage trial of TNFerade. After taking stock of the study data so far, an independent monitor found TNFerade wasn't proving more effective than the current standard of care for people with locally advanced pancreatic cancer.
During 2009, an estimated 42,470 new cases of pancreatic cancer were diagnosed in the U.S., according to the National Cancer Institute. More than 35,000 people died from the disease.
“We are very disappointed with the data, particularly given the lack of adequate treatments for pancreatic cancer,” says Paul Fischer, GenVec's president and CEO.
For now, the company will focus on its funded vaccine programs, which address HIV, malaria and Foot and Mouth disease. GenVec also has a nice arrangement with Novartis (NVS), which agreed in January to pay as much as $213.6 million for GenVec's pre-clinical treatment for hearing loss and balance disorders.
Studies of TNFerade's potential for treating several other cancers, including esophageal cancer, rectal cancer, and head and neck cancer, will continue.
In another bit of good fortune, GenVec raised $28 million from institutional investors back in January, when the company's prospects for filing a Biological License Application for TNFerade in 2012 seemed rosier.
GenVec isn't alone in having a rough lot. Two other purveyors of late-stage gene therapies aren't having much luck either. Japan is very slowly pondering approval of Daiichi Sankyo and Sosei's treatment for peripheral vascular disease, HGF DNA Plasmid. Ark Therapeutics (OTC:ARKTF) is looking for someone to buy the company after European regulators requested substantial new data about their gene therapy for brain cancer, Cerepro.
Sanofi (SNY) is eagerly awaiting data from its own gene therapy, XRP0038 for Critical Limb Ischemia, by year's end.