The Immune Response Corp.'s stock took a hit Wednesday, evenbefore it had a chance to make a case for its HIV product at today'sFDA advisory committee meeting.
The warning letter sent last week by the FDA to the Carlsbad, Calif.,company concerned supposed deficiencies in a Phase II/III trial of anHIV immunotherapeutic vaccine being developed by ImmunizationProducts Ltd., a joint venture between Immune Response and Rhone-Poulenc Rorer Inc, of Collegeville, Pa. Immune Response is meetingwith the FDA's Vaccines and Related Biological Products AdvisoryCommittee today, seeking approval to conduct a large-scale Phase IIItrial.
Charles Cashion, vice president and chief financial officer of ImmuneResponse, told BioWorld that the company completed its response tothe warning letter last Friday. "We think the questions have beenreplied to promptly and completely, and we think this is part ofongoing communications with the FDA regarding the clinicaldevelopment process, particularly as it relates to HIV treatment.
"We don't think the questions nor our answers impact in any way theresults of the Phase II/III clinical trials that were previouslydisclosed," he said. "This letter and our responses are likely to bepart of the discussion at [today's] advisory committee meeting."
Investors didn't like the content of the warning letter, as ImmuneResponse's stock (NASDAQ:IMNR) was down 22 percentWednesday, or $1.38, closing at $5 per share.
Cashion's response to the drop: "The outcome of [tomorrow's]meeting is the proof of whether we have a real difficulty with respectto this letter."
He said the FDA put its warning letter in a public reading room andsomeone, presumably a short seller, got hold of it and faxed it to anumber of people Wednesday.
The much-anticipated results of the Phase II/III trial were presentedin June 1993 at the Ninth International AIDS Conference in Berlin.Data from the one-year surrogate-marker study of 103 asymptomaticpatients were good, but anything short of spectacular would havedisappointed those awaiting the results.
The FDA's letter said that the study was not conducted according tothe protocol. For example, the letter said at least 31 subjects did notmeet entrance criteria for CD4 counts. The letter also cited allegedfailures in adequately reporting safety and effectiveness of the drugas it was obtained from the clinical investigator. It said there was afailure to comply with good manufacturing practices, and pointed outother auditing and statistical problems the agency believes occurred.n
-- Jim Shrine
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