Pharmos Starts Phase III Trial Of Brain
Injury Drug
By JOHN SHIPMAN
Of DOW JONES NEWSWIRES
NEW YORK -- Small-cap biopharmaceutical company Pharmos Corp.
(PARS) is set to begin Phase III trials for its drug, dexanabinol, which has
shown strong promise as a treatment for the effects of traumatic brain injury.
The Iselin, N.J., company will announce the start of its Phase III Dexanabinol
trial Wednesday, and it hopes to have the study completed some time next
year, said Chief Operating Officer Dr. Gad Riesenfeld.
The study will involve about 860 patients in Israel and several European
countries, Riesenfeld said. Pending approval by the Food and Drug
Administration, the trial will come to the U.S. later this year.
The promise in dexanabinol lies in its apparent ability to control the
consequences of a severe brain injury - most importantly the elevation of
intracranial pressure, which is the leading cause of death as a result of severe
brain trauma, said Dr. Lawrence F. Marshall, professor and chair of the
Division of Neurological Surgery at the University of California, San Diego
Medical Center.
In previous trials, "What is impressive is the fact that the drug's effect was
similar across all populations tested," Marshall said. "Everything with this drug
in each population was in the right direction," he added.
The treatment involves a single dose of the drug, injected in a patient within six
hours of the brain injury.
An important feature of dexanabinol, Dr. Marshall said, is that it seems to
have multiple effects. There's a series of secondary events that take place as a
result of a traumatic brain injury, or "a number of well-defined chemical
abnormalities," he said, which the drug appears to target and control.
In a September press release reporting analysis of the Phase II trial, Pharmos
said, "The results demonstrated that dexanabinol significantly improved
orientation and memory among conscious patients, reduced 10-day brain
related mortality by 50% and significantly prevented the elevation of
intracranial pressure."
Because of its apparent "multiple mechanisms of action," dexanabinol is being
investigated as a treatment for stroke victims and multiple sclerosis, Riesenfeld
said.
Important to investors is the size of the potential market for dexanabinol. Bob
Cook, Pharmos' chief financial officer, estimated its potential revenue at $500
million a year in the U.S., and "I don't think anyone would quibble if I said the
potential in Europe was equal," he said.
That would be quite a jump in sales for Pharmos, which posted 199 revenue
of $3.3 million.
Currently, the company's revenue comes from sales of its two opthalmic
products, Lotemax and Alrex. Lotemax is prescribed for all inflammatory
conditions of the eye, and Alrex is a treatment for eye allergies. The products
were co-developed and marketed by Bausch & Lomb Inc. (BOL) and Cook
said he expects their 2000 sales to rise 50% from 1999. In addition, Pharmos
has another eye drug, currently called LE-T - a combination antibiotic and
anti-inflamation steroid - in Phase III trials. Riesenfeld said Pharmos hopes to
file a new drug application for LE-T later this year.
Dr. Riesenfeld and Cook are quick to point out, though, that the company's
focus is on the potential of dexanabinol, and they are committed to funding its
way through trials and ultimately to market. As a measure of their confidence
in the drug, Riesenfeld said Pharmos is reluctant to engage a partner with
deeper pockets - as they did with Bausch & Lomb - because it may
compromise Pharmos' future profits from the drug.
After seeing the failure of a number of drugs tested to treat the effects of brain
injury over the past 20 years, Dr. Marshall is decidedly optimistic about
dexanabinol. Asked if it holds the most promise among the treatments he's
seen, he responded, "Absolutely."
And enthusiasm is spreading among his colleagues in the U.S., he said, but it
is greater in Europe where Phase III is getting underway.
"It's like watching basketball, and enthusiasm goes up for the playoffs," he
said. "Now we're heading into the playoffs."
-By John Shipman, Dow Jones Newswires, 201-938-5171;
john.shipman@dowjones.com |
