Vical Off 28% Following Washington Post Article
Dow Jones Newswires
By Beth M. Mantz
NEW YORK -- Vical Inc.'s (VICL) shares fell 13% Thursday morning
after a Washington Post article recounted the death of one of Vical's
late-stage, phase III trial participants and reported that one of the trial
centers decided to put enrollment in the trial on hold.
Shares of Vical were recently down 7 7/16 to 49 5/8, on volume of 1.6
million shares, compared with average daily volume of 380,200.
But considering that the Food and Drug Administration and other safety
panels have not censured Vical or requested changes in the study testing
Vical's gene therapy Allovectin-7, as well as the continued testing and
enrollment of phase III study in metastatic melanoma, Robertson Stephens
& Co. analyst Lesley Wright Marino is not concerned about the San Diego
company.
"Patients with life-threatening cases of cancer unfortunately die," she said,
adding that the news is old and has been dealt with and the reaction is "a
little over the top."
Vical officials were not immediately available to comment.
Allovectin is designed to be injected directly into a tumor, where malignant
cells absorb the therapy and elicit antigens.
According to the American Cancer Society, about 480,000 Americans
suffer from malignant melanoma, a form of skin cancer.
As reported in the Washington Post Thursday, in early September one of
the trial participants at the University of Arkansas died. Laura Hutchins, the
principal investigator at the center, initially declared the death unrelated to
the treatment.
An autopsy, however, found an accumulation of ascites - a fluid in the
abdomen of the deceased.
As reported by the Washington Post, the autopsy proposed that this fluid
buildup might have been caused by the new genes and contributed to the
death.
In accordance with protocol governing serious adverse events, the death
was reported to the Food and Drug Administration, Marino said. In
choosing whether to classify the event as "unlikely," "possibly or probably,"
or "certainly" related to the treatment, Hutchins, the investigator, classified
the death as "possibly or probably related to the event" in light of the
autopsy result, Marino said.
Robertson Stevens' Marino said that after the death was reported and
classified, "it appears the FDA, RAC (recombinant DNA advisory panel of
experts that consults the FDA and reviews all gene therapy experiments),
Independent Drug Safety Review board and the (University of Arkansas)
center's IRB were completely comfortable that the underlying disease, not
the study drug, led to the patient's death."
Months after the death, a trial center in Florida heard about the event. That
center's hospital administrator, not the researcher, decided to halt
enrollment last week until there was further information about the event,
said Marino, who expects Vical to provide that data.
"Once the center reviews, it will probably start enrollment," said Marino,
adding that the University of Arkansas center hadn't halted the study but
continued it. Additionally, the FDA hasn't asked Vical to change its
protocol, or pull the study.
Recently, RAC met for its periodic review of adverse gene-therapy events
that occurred in the previous quarter. The panel reviewed the death in the
Vical study, and then moved on, according to Marino. "My understanding
- since I wasn't there - (the event) was not made into a big deal, and didn't
warrant undue additional discussion."
Vical officials weren't immediately available for comment.
-Beth M. Mantz; Dow Jones Newswires; 201-938-5393 |
