XOMA falls as investors fret vague Neuprex report
NEW YORK, Aug 17 (Reuters) - Shares of California biotech
company XOMA Ltd. <XOMA.O> plummeted Tuesday after investors
grew concerned over scanty information about results of a
late-stage trial of the company's drug Neuprex for treatment of
severe meningococcemia, analysts said.
Its stock was off 2-9/16, or 34 percent, to 5-1/16, in
heavy late-morning trading on Nasdaq, where it was among the
highest percentage losing issues on the morning.
Meningococcemia, a rare disease caused by the meningococci
bacterium, causes life-threatening systemic infections that
primarily affect children. XOMA in May announced it had
completed enrollment of a Phase III trial involving nearly 400
patients in the United States and United Kingdom.
The active ingredient of Neuprex is the company's
proprietary BPI (bactericidal/permeability-increasing) protein
which it has said has multiple anti-infective properties.
Late Monday, XOMA said in a statement accompanying its
second quarter financial results that it was in the process of
analyzing data from the pivotal trial.
"Based on its preliminary analysis XOMA believes the data
show a clinical benefit in mortality and morbidities," XOMA
said. Mortality refers to length of time a patient lives, while
morbidity refers to the type and severity of illness.
Although XOMA indicated some benefit was acheived, it did
not specify whether the benefit was "statistically significant"
enough to prove the drug's effectiveness in the trial.
The company added it was scheduling a meeting with the U.S.
Food and Drug Administration "to determine the adequacy" for
filing a marketing-approval application of Neuprex for the
illness.
XOMA, based in Berkeley, Calif., could not be immediately
reached Tuesday morning for further details or comment.
Carl Gordon, a pharmaceuticals analyst for OrbiMed Advisors
of New York, said investors apparently were concerned by the
sketchy nature of the Neuprex study results.
"The press release was vague regarding results of the
clinical trial. XOMA said it planned to talk with the FDA but
didn't say the trial was successful. That makes people
skeptical about the data. It sounds like the data didn't meet
the endpoints (clinical goals) the FDA required," Gordon said.
XOMA shares have risen sharply in recent months, helped by
enthusiasm for Neuprex -- which is undergoing a separate Phase
III trial of patients who have suffered hemorrhages due to
trauma.
In addition, XOMA is collaborating with California biotech
company Genentech Inc. <DNA.N> on development of a humanized
antibody meant to treat autoimmune diseases by inhibiting T
cells -- important bacteria-fighting cells made by the thymus
gland that sometimes attack the body's own tissues and cells.
REUTERS
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