"This
stuff is potent," said Warren Wasiewski,
a neurologist and vice president and
chief medical officer with
Neurobiological Technologies, the
California company that is funding the
clinical trial of Viprinex.
Indeed, the drug may have been too
effective, causing unacceptable rates of
bleeding in the brain in earlier
clinical trials.
Last
week the company presented research at a
stroke conference in France suggesting
that a new dosing regimen of the drug
should improve its effectiveness and
reduce the rate of bleeding in the
brain.
The
drug now is infused over a three-hour
period rather than five to seven days.
"We
found that a shorter infusion would do
the trick," Wasiewski said.
The
drug was close to proving it was
beneficial several years ago, but
because of problems with bleeding its
development was temporarily halted, said
Ralph Sacco, a professor and chairman of
neurology at the University of Miami
Miller School of Medicine.
Sacco,
who is not a part of the study, said he
was pleased to see that the company has
revised the protocol for the clinical
trial.
"In
the past, we gave up on drugs when there
was a glimmer of hope," he said.
Up to
1,300 stroke patients at hospitals
around the country, including Aurora St.
Luke's Medical Center and Froedtert
Hospital, where Lukaszewicz and Cox,
respectively, were treated, are expected
to be enrolled in the trial.
In
addition to using a drug derived from an
unconventional source _ snake venom _
the trial is unusual in that two major
hospitals in the area are taking part in
the research. That means stroke patients
from a large area could be offered the
opportunity to be in the trial.
Under
the design of the trial, there is a
50-50 chance that patients will get the
drug or a saline placebo.
Lukaszewicz, 71, says she is certain she
got the real thing.
On
April 1 she was at home when she started
feeling queasy. She sat down on a chair
in her living room.
"That's all I remember," she said. "I
lost three days."
During
that time she was unable to move or
speak.
Arvind
Ahuja, a neurosurgeon at St. Luke's,
told Lukaszewicz's husband, Paul, there
were three options:
Do
nothing, go into her brain through an
artery with a device that could break up
the clot, or enroll her in the Viprinex
study.
Ahuja
said that in patients with her kind of
stroke there is about a 50 percent
chance of dying in the first 30 days.
Since
enrolling in the study, Lukaszewicz has
recovered nearly all of her speech and a
substantial amount of movement. She said
she is hoping that with continued
therapy she will be able to walk with a
cane.
She
said she is convinced that she got the
drug because of her dramatic
improvement.
The
trial is double-blinded, meaning neither
patients nor doctors know who gets the
drug, but Ahuja said he has no reason to
doubt her.
"She
has really done well," he said. "If I
had to guess, I would say, `yes.'"
Likewise, Cox, who had her stroke in
March 2007, said she believes she got
the drug after she was taken to
Froedtert Hospital.
Cox,
75, had lost a considerable amount of
movement on the left side of her body.
But three days after she was treated she
was able to move normally, she said.
So
far, the hospital has not had any cases
of bleeding in the brain, said Michel
Torbey, an associate professor of
neurology and neurosurgery at the
Medical College of Wisconsin who
practices at Froedtert.
"In
general, we've seen patients who have
done very well, and we've seen patients
who have stayed about the same," he
said.
Because so few people get to the
hospital early enough to get t-PA,
another drug that can be administered by
IV beyond six hours is needed, he said.
"As
far as a quick (drug) therapy, there is
nothing else out there," he said. "We
definitely need to fill that gap."
