Phase III Trials for CEROVIVE (NXY-059) Will Continue as Planned Following Interim Data Analysis
prnewswire.com
SOUTH SAN FRANCISCO, Calif., Oct. 14 /PRNewswire-FirstCall/ -- Renovis,
Inc. (Nasdaq: RNVS) announced today that AstraZeneca, exclusive licensee of
CEROVIVE (NXY-059), will continue as planned with the Phase III trials (SAINT
I and II) to determine the drug's effect on disability and neurological
recovery in acute ischemic stroke patients. This decision is based upon a
recommendation from the Independent Data and Safety Monitoring Board (IDMB)
and the trial Steering Committee.
The decision follows a recent IDMB interim analysis of these trials, which
included data on stroke outcomes after a three-month follow-up period in 1,000
patients. The purpose of this analysis was to assess whether it would be
futile (not meaningful) to continue patient enrollment in the SAINT trials
when looking at the degree of post-stroke disability experienced by patients
who received drug as compared to patients who received placebo, and to
determine if there were safety concerns.
The SAINT trials for CEROVIVE (NXY-059) are being conducted worldwide and
planned to enroll subjects in approximately 400 centers across 40 countries
(Europe, Asia, Australia, New Zealand, South Africa, United States, Canada and
Latin America) to evaluate the effect of the compound in acute ischemic stroke
patients. The safety of patients included in the trials is being continually
evaluated.
"This interim analysis was the first time in the SAINT trials that the
IDMB reviewed patient outcomes in addition to safety data for CEROVIVE (NXY-
059)," said Corey Goodman, Ph.D., CEO of Renovis. "The IDMB's positive
recommendation represents another encouraging milestone in the development of
CEROVIVE (NXY-059) for the treatment of stroke patients."
Commenting on this news, Tomas Odergren, M.D., Global Product Director for
CEROVIVE (NXY-059) at AstraZeneca said, "AstraZeneca is pleased to learn the
IDMB's recommendation to continue the SAINT trials as planned. Like Renovis,
AstraZeneca is committed to the research and development of new therapies that
have the potential to improve patients' lives and will continue to work
closely with the IDMB and trial Steering Committee to ensure the best possible
chance of success for CEROVIVE (NXY-059)."
Additionally, the CHANT (Cerebral Hemorrhagic And NXY-059 Treatment) trial
initiated enrolment in August 2004. CHANT is a double-blind, randomized,
placebo-controlled, parallel-group, multicenter, Phase IIb study to assess the
safety and tolerability of 72 hours intravenous infusion of CEROVIVE (NXY-059)
in adult patients with acute intracerebral hemorrhage. The trial will involve
approximately 150 centers in 21 countries.
CEROVIVE (NXY-059), a neuroprotectant with free-radical trapping
properties, is a drug under development by AstraZeneca and licensed from
Renovis, Inc.
Also see: nitrone.com |
