GenVec receives Orphan Drug status for TNFerade

In a new feature for OBR readers, we will occasionally get updates relevant to recent oncology headlines or upcoming oncology events from John McCamant, publisher of The Medical Technology Stock Letter ( The information published here is not a recommendation, and is provided for informational purposes only.

GenVec’s stock is up as much as 25% this morning on news that the FDA has given “Orphan drug” designation to TNFerade for the treatment of locally advanced pancreatic cancer. The most important aspect of Orphan drug status is that it provides seven years of market exclusivity after a drug is approved. The news serves as a reminder that TNFerade is a Phase 3 cancer drug development candidate that will address a protected market. Orphan drug status also makes it easier for a potential partner to pull the trigger as they can view TNFerade as a having at least one protected market opportunity. The drug candidate is also being tested in several other hard to treat cancers; head and neck, rectal, and esophageal. When one combines these markets together, it makes it easier to see how a potential partner would be able to leverage the technology to create multiple revenue streams. We met with management last week at the BIO Investor conference and the company is clearly growing more optimistic with the TNFerade PACT trial finally maturing. A planned interim analysis is expected to occur this quarter when the 184 events (deaths) have occurred in the trial. The data then would be announced roughly 10-12 weeks later, after the data has been cleaned, which we would expect to occur sometime during the first quarter of 2010. While we do not expect the trial to be stopped prematurely, once the interim has been passed smoothly, a partnership may materialize before PACT concludes. Our optimism for a partnership is based on two points. The first is the next interim look should provide additional info on TNFerade’s safety and efficacy making it a more desirable partnership candidate. Second, is the fact that there remains a dearth of late-stage cancer drug development candidates that are unpartnered. Thus, our confidence is growing that the combination of these factors may lead to a partnership for TNFerade before PACT concludes. The stock has periodically traded as high as $1.00 and as of 2PM EST was trading at $0.89.

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