Boston Life Sciences, Inc. Announces Presentation of Cethrin(R) Phase I/IIa 6-Month Results at 75th Annual Meeting of the Americ
April 16 2007 - 12:57PM
PR Newswire (US)
Company Announces Extension of Phase I/IIa Trial to 9 mg Dosage
Level HOPKINTON, Mass., April 16 /PRNewswire-FirstCall/ -- Boston
Life Sciences (NASDAQ:BLSI) announced today that clinical data on
its lead nerve repair therapy, Cethrin(R), were presented in the
Neurotrauma and Critical Care Scientific Session at the 75th Annual
Meeting of the American Association of Neurological Surgeons (AANS)
in Washington, DC. The oral presentation, "Results of the Cethrin
Phase I/IIa Prospective Clinical Trial of a Rho Inhibitor for the
Treatment of Acute Spinal Cord Injury," was given by Michael G.
Fehlings, MD, PhD, FRC, Medical Director of the Krembil
Neuroscience Center and Head of the Spinal Program at the
University Health Network of the University of Toronto and
principle investigator in the study. Co-authors are Nicholas
Theodore, MD, James Harrop, MD, Gilles Maurais, MD, Charles Kuntz,
MD, Christopher Shaffrey, MD, Brian Kwon, MD, Jens Chapman, MD,
Albert Yee, MD, Patrick Tremblay, PhD, and Lisa McKerracher, PhD.
"The preliminary results in this study show that Cethrin may offer
great promise for restoring sensory and motor function for patients
with new cases of acute SCI," stated Dr. Mark Hurtt, BLSI's Chief
Medical Officer. "We have extended the Phase IIa trial to include a
9 mg dose. Currently, three patients have been enrolled at this
level and we expect the enrollment at this dosage extension to
continue to the 3rd quarter of 2007. Additionally, based on the
positive findings to-date in the Phase I/II trial, we are drafting
a protocol for a Phase IIb/III study. We plan to meet with the FDA
and with Health Canada and plan to initiate this trial in North
America by the end of this year or early 2008." Thirty-seven
patients with acute SCI were enrolled in the open label study at
nine sites across Canada and the United States. All patients were
classified with a complete SCI assessed as American Spinal Injury
Association (ASIA) A. That means they suffered a complete thoracic
or cervical injury (i.e. having no sensory or motor function below
the level of the SCI). ASIA grades are designated from A through E,
with 'A' designating complete SCI, and 'E' being normal. Grades 'B'
through 'D' designate increasing levels of motor and sensory
improvements. An escalating dose of Cethrin(R) (0.3, 1.0, 3.0, or 6
mg.) was administered to the injured spinal cord during surgical
decompression/reconstruction. This occurred within five days of the
SCI incident, with the average time being 53 hours. All adverse
events were recorded and neurological outcomes were assessed using
ASIA standards at 0, 1.5, 3, 6 and 12 months. The following
outcomes were noted: -- There were no serious adverse effects
related to Cethrin(R). -- The complete 6-month patient data showed,
28 percent of patients (10 of 36) improved by one or more ASIA
grades as compared to reported literature results of 6.7% (Burns,
J.Neurotrauma, 2003). -- Five patients improved to ASIA C and two
patients improved to ASIA D. One patient with a thoracic SCI died
from acute respiratory distress syndrome (ARDS). About Cethrin
Cethrin is a recombinant protein drug intended to facilitate the
re-growth of axons during the critical period immediately after a
major injury to the spinal cord. Following an SCI, about two-thirds
of patients undergo decompression/stabilization surgery. In this
surgery, Cethrin is delivered in a single dose directly onto the
injured region of the spinal cord without the need for further
invasive procedures. Cethrin has been designated an Orphan Drug.
About Boston Life Sciences Boston Life Sciences, Inc. (BLSI) is
engaged in the research and clinical development of diagnostic and
therapeutic products for central nervous system (CNS) disorders.
Cethrin(R), a recombinant-protein-based drug designed to promote
nerve repair after acute spinal cord injury, has reported positive
interim results in a Phase I/IIa clinical trial. ALTROPANE(R)
molecular imaging agent is in Phase III clinical trials for the
diagnosis of Parkinson's Disease (PD). The company's research and
pre-clinical CNS programs include Inosine for the treatment of
spinal cord injury and stroke, a DAT blocker for the treatment of
Parkinson's disease, and a second generation technetium-based
molecular imaging agent for PD and ADHD. BLSI's current research
collaborations include Harvard Medical School and Children's
Hospital Boston. Safe Harbor The foregoing release contains certain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Forward- looking
statements include statements regarding Boston Life Sciences'
expectations, beliefs, intentions or strategies regarding the
future, including the Company's development efforts regarding the
Company's ALTROPANE and CETHRIN programs and the Company's
pre-clinical candidates. Forward- looking statements can be
identified by terminology such as "anticipate," "believe," "could,"
"could increase the likelihood," "estimate," "expect," "intend,"
"is planned," "may," "should," "will," "will enable," "would be
expected," "look forward," "may provide," "would" or similar terms,
variations of such terms or the negative of those terms. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors including those risks,
uncertainties and factors referred to in the Company's Annual
Report on form 10-K for the year ended December 31, 2006, filed
with the Securities and Exchange Commission under the section "Risk
Factors," as well as other documents that may be filed by Boston
Life Sciences from time to time with the Securities and Exchange
Commission. As a result of such risks, uncertainties and factors,
the Company's actual results may differ materially from any future
results, performance or achievements discussed in or implied by the
forward-looking statements contained herein. Boston Life Sciences,
Inc. is providing the information in this press release as of this
date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a
result of new information, future events or otherwise. BLSI
Contact: Sharon Correia 508 497 2360 x224 DATASOURCE: Boston Life
Sciences, Inc. CONTACT: Sharon Correia, Director of Corporate
Communications and Investor Relations of Boston Life Sciences,
Inc., +1-508-497-2360, ext. 224, Web site:
http://www.bostonlifesciences.com/
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