Boston Life Sciences, Inc. Announces Presentation of Cethrin Phase I/IIa 6-Month Results at 75th Annual Meeting of the American Association of Neurological SurgeonsCompany Announces Extension of Phase I/IIa Trial to 9 mg Dosage Level
HOPKINTON, Mass., April 16, 2007 /PRNewswire-FirstCall/ -- Boston Life Sciences 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).
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.
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
Posted: April 2007