GenVec secures $30 million; TNFerade trial expands to phase 2/3

By Elaine Rigoli

Tampa, Fla., March 15 - GenVec, Inc. said it has received clearance from the Food and Drug Administration to expand its current phase 2 clinical trial with TNFerade in locally advanced pancreatic cancer into a phase 2/3 trial with a 12-month survival endpoint.

Targeted enrollment will be expanded to 330 patients from 74 patients, and the trial will include additional study sites outside the United States, according to a company news release.

In order to support the expanded study, GenVec said it has entered into a $30 million committed equity financing facility with Kingsbridge Capital Ltd., an institutional investor, under which Kingsbridge will make available to GenVec up to $30 million in capital over a three-year period through the purchase of newly issued shares of GenVec's common stock.

Under the terms of the facility, GenVec will determine the exact timing, amount and price of any financings, subject to certain conditions, the release said.

"Working closely with the FDA has allowed us to expand the TNFerade study into a phase 2/3 trial for U.S. product registration. Expanding the phase 2 study in this manner will allow us to continue to enroll patients at current clinical sites, avoid the potential delays associated with starting a new trial and facilitate international registration and partnering efforts by including medical centers from outside the United States," said Paul Fischer, president and chief executive officer, in a statement.

GenVec, located in Gaithersburg, Md., is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines.

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