WASHINGTON -- Immune Response Corp. will participate in aNov. 12 Food and Drug Administration advisory committeemeeting that will consider the use of surrogate markers --similar to those now being used by the company -- in PhaseII/III clinical trials to measure the effectiveness of AIDSvaccines.
Shares of Immune Response (NASDAQ:IMNR), which isdeveloping an AIDS therapeutic vaccine, have jumped nearly 50percent this week. The stock closed Thursday at $59.25, up$6.13.
On Tuesday, Montgomery Securities analyst Brandon Fraddmade an "aggressive buy" recommendation on the San Diegocompany. Using the guidelines for the recent FDA's expeditedapproval of the AIDS drug ddI, Fradd said Immune Responsemight be able to request accelerated approval of its vaccine inthe second quarter of 1992.
Fradd told BioWorld that Thursday's price surge apparently was"in anticipation of some positive news on Nov. 12."
Surrogate markers, such as blood parameters and cell changes,are an alternative to traditional methods of observing patienthealth. The ddI approval was based on increasing the number ofT cells by 10 or by 10 percent over four weeks, Fradd said.
The company's vaccine, which triggers the activity of T cells,is composed of inactivated virus from which the envelope hasbeen removed. The drug is intended to prevent or delayprogression of HIV to AIDS by stimulating the natural immuneresponse.
Company spokesman Steven Basta told BioWorld that ImmuneResponse won't be discussing its clinical data at the Vaccinesand Related Biological Products advisory committee meeting.Immune Response representatives will discuss the markers thecompany is using and how its clinical trial is progressing, hesaid.
"I think they are trying to evaluate what markers aremeaningful to look at in the treatment of AIDS," Basta said."We are encouraged that they are discussing surrogatemarkers, and we are pleased that we will be participating."
While there is speculation that the FDA's willingness todiscuss surrogate markers could lead to more rapid approval ofan AIDS vaccine, Basta said the outcome of the meeting wouldnot affect Immune Response's clinical trials. "We haveselected the markers we are looking at, and we will proceed,"he said.
"We are in the middle of our Phase II clinical trial schedule, tobe completed in September 1992," Basta said. "Everything is ontrack for that study and we expect it to run its course."
-- Kris Herbst BioWorld Washington Bureau
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