Data Safety Monitoring Board recommends continuation of BioAxone's phase I/IIa clinical trial with its lead product Cethrin(R) (BA-210) in acute spinal cord injury
MONTREAL, June 6 /CNW Telbec/ - BioAxone Therapeutic Inc. announced today
that an independent Data Safety Monitoring Board (DSMB) has reviewed the
safety data for the first six patients in its phase I/IIa clinical trial with
BA-210 in acute spinal cord injury. The DSMB's unanimous recommendation was
that BioAxone continue the trial without any modifications. This interim
review by the DSMB was prospectively specified in the original protocol and
was based on the review of the safety data from at least 5 patients who have
completed a minimum of 3 weeks of assessments following treatment with 0.3 mg
of BA-210. The DSMB's recommendation has allowed BioAxone to move forward with
the clinical protocol as planned and initiate patient treatment with a higher
dose of BA-210, namely 1.0 mg.
Dr. Henry E. Khouri, Vice President of Clinical Development said, "We are
pleased with the safety profile of BA-210 obtained in patients up to this
point. This successful review from third-party physicians reinforces our
confidence for the development of BA-210 in acute spinal cord injury."
The phase I/IIa clinical trial is a multinational study in which up to 48
patients with acute spinal cord injury will be administered Cethrin(R). The
study is designed to evaluate the safety and pharmacokinetics of escalating
doses of Cethrin(R), following a single extra-dural administration during
surgery for acute thoracic and cervical spinal cord injury. The patients will
be recruited from about 10 sites in Canada and the US.
"This recommendation represents excellent progress of our lead drug
candidate, Cethrin(R), and shows that we are on track to reach all our
milestones", said Dr. Frank Bobe, President & CEO of BioAxone.
The DSMB is comprised of three independent medical experts and was
established by BioAxone as part of the Company's compliance with good clinical
practices guidelines. The DSMB is responsible for monitoring the safety of
patients participating in the phase I/IIa clinical trial and for reviewing the
safety data throughout its duration.