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Pancreas Cancer

TNFerade article was posted 03/30/2010 01:52 pm by anon
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GenVec Inc. has opted to shut down its advanced clinical trials for its lead pancreatic cancer drug after it failed to show significant differences from standard care, delivering a massive blow to the Gaithersburg biotech and causing its stock price to lose nearly three-quarters of its value in pre-market trading Tuesday.

The company had been testing its treatment, TNFerade, along with standard of care on 330 patients in the third and final phase of clinical tests. Now at a midpoint examination of the trial results, GenVec said TNFerade helped lower the risk of death for pancreatic cancer victims by only 8 percent compared with those without TNFerade -- not enough to have won regulatory approval for the drug.

After a premarket trading crush, GenVec (NASDAQ: GNVC) opened on Tuesday morning at 73 cents, a 74 percent plunge from its Monday closing price of $2.81 and nearing its 52-week low of 40 cents. Tuesday's trading volume has shot up by more than five times the recent monthly average. GenVec's stock price had risen as high as $3.35 in the last year.

Analysts anxiously awaiting the results had questioned the viability of the company if these trademark trials had failed. This latest move could likely mean cuts at the company, which had spent considerable resources on the TNFerade testing track.

But company leaders said they will continue to focus on a host of fully funded research programs, mostly through government grants, that use GenVec technology to treat HIV, malaria and influenza, among other diseases. GenVec had also nailed a partnership with Novartis AG for the larger pharmaceutical company to license its technology for a hearing loss treatment, a deal that yielded the local company $5 million in upfront payments and could net another $213 million if all conditions and milestones are met.

'We are very disappointed with the data, particularly given the lack of adequate treatments for pancreatic cancer,' said Paul Fischer, president and CEO of GenVec, in a statement. 'As our shareholders know, in addition to TNFerade our research and development pipeline consists of a number of funded vaccine programs based on our industry-leading technology. At this time, we will continue to focus on those programs and supporting our collaboration with Novartis to develop treatments for hearing loss.'

The company said it will continue to monitor the effects of TNFerade on the trial patients. 'We will, of course, continue to follow the patients currently enrolled in the trial and are conducting additional analyses of the data from the trial and expect that the results will be presented in the future at an appropriate scientific meeting,' said Mark Thornton, senior vice president of product development at GenVec.

TNFerade, which had won a regulatory fast-track and market exclusivity designations because of the difficulty in treating pancreatic cancer, had shown lower survival chances over time. While showing promise after 12 months of use -- demonstrating a 39.9 percent lower risk of death for patients compared with 22.5 percent of those not taking TNFerade -- the drug's effects dropped to demonstrate only 10.6 percent overall survivability in patients compared with 11.3 percent with standard care. Those interim results, released in November 2008, had caused GenVec's stock to fall by 36 percent, or 42 cents, at the time.

Though, the company has shored up some cash recently, pumping up a cashbox that had been precipitously low through much of 2009. In January, GenVec raised $28 million from selling 14 million shares at a roughly 19 percent discount.

TNFerade acts as gene-delivery technology that torpedoes treatment into the heart of a tumor before spreading it outward, while strengthening the immune system.

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*DISCLAIMER: This page is an unmoderated forum, and the opinions expressed herein do not necessarily reflect the viewpoint of The Johns Hopkins Medical Institutions. Patients are advised to consult their personal physicians before making any medical decisions.
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