MicroGeneSys Inc. was in a "quiet" holding pattern onThursday, one day after the National Institutes of Healthannounced it will take over funding of an AIDS vaccine trialfrom the U.S. Army. The company has not yet decided if it willdonate its vaccine to the new, multivaccine trial.
"This was sprung on them by the NIH," said Tom O'Toole ofPowell Tate, a Washington, D.C., agency that responded to callsmade Thursday to the Meriden, Conn., company.
MicroGeneSys successfully lobbied Congress last October tohave a $20 million grant proposal for a single-vaccine AIDStrial amended to a Department of Defense appropriations bill.
A panel convened by NIH Director Bernadine Healy concludedthree weeks later that a Phase III trial of multiple vaccineswould be preferable. Late Wednesday, the Department ofDefense announced the funds will be transferred under theEconomy Act to the Department of Health and Human Servicesso that NIH can oversee a trial of 6,000 to 12,000 patients.
The scope and funding of a multivaccine trial means thatMicroGeneSys must decide whether it is willing to donate itsgp160 vaccine, VaxSyn, a costly prospect that O'Toole said is "atissue."
While donating its vaccine was not part of the company'sagreement with the Army, MicroGeneSys still may do it,depending on the terms, he said.
O'Toole, responding to a call that had been placed to companyPresident and Chief Executive Officer Franklin Volvowitz, said,"The company's being quiet today."
He added that the company thinks the switch of agencies is"illegal." He maintained that Congress must first approve thechange, which he said many lawyers "are willing to challenge --both on the floor of Congress and in the courts."
Genentech Inc. of South San Francisco, Calif., said Thursday itwill provide its gp120 experimental vaccine free of charge forthe NIH trial. A comparative trial will "provide the greatestpublic health benefit," Genentech's statement said. "We alsobelieve the action is consistent with the best interests of AIDSpatients."
While it was not immediately known which other vaccines arebeing considered, Biocine, a joint venture between Chiron Corp.and Ciba-Geigy, has also said it would be willing to make itsvaccine available free of charge for a multi-vaccine trial.
-- Nancy Garcia Associate Editor
(c) 1997 American Health Consultants. All rights reserved.