Alseres pharmaceuticals concludes enrollment in the Cethrin phase I/IIa clinical trial in acute spinal cord injury
Alseres Pharmaceuticals, Inc., announced that it has concluded enrollment in the Phase I/IIa clinical trial of Cethrin in acute spinal cord injury (SCI). A total of 48 subjects have been enrolled at 9 sites in the United States and Canada. We expect to release periodic updates of the data in 2008 following protocol-specified patient evaluations.
“We continue to be encouraged by the safety and efficacy observations of the trial. The rate and magnitude of improvement of many subjects seems greater than the expected pattern of recovery,” commented Dr. Mark Hurtt, Alseres Chief Medical Officer. “The findings of the Phase I/IIa study serve as a strong foundation for the acceleration of our development plans for Cethrin.”
Alseres intends to move forward with its previously announced plans for the placebo-controlled, Cethrin Phase IIb trial in acute spinal cord injury at sites in the U.S., Canada, Europe and other countries in 2008. “We believe that Cethrin continues to be the most advanced drug candidate in the clinic for the treatment of acute spinal cord injury in the world. If approved, Cethrin may offer hope for the nearly 11,000 new cases annually in the U.S. alone whose healthcare costs in the first year post-injury exceed $4 Billion,” noted Dr. Mark Pykett, President and COO of Alseres. “We are pleased that the enrollment of the Phase I/IIa trial has concluded. Interim reported data have demonstrated encouraging safety and efficacy results over a 30-fold dose range. We look forward to the initiation of the Phase IIb trial in the first half of 2008.”
Cethrin contains a proprietary protein that inactivates the action of Rho, a key enzyme that prevents Axon Regeneration and recovery after SCI. It has been granted Orphan Drug Status in the U.S. In February 2005, enrollment began in an open-label, non-placebo-controlled, dose-escalating Phase I/IIa trial in subjects with acute SCI at sites in the United States and Canada. The trial assessed 5 dose levels of Cethrin from 0.3 mg to 9 mg in both Thoracic and Cervical injuries.
The trial design includes a number of post-treatment evaluations of the subjects for safety and efficacy for up to one year after treatment. The efficacy measurements assess changes in subjects’ sensory and Motor functions, as well as overall recovery as measured by the American Spinal Injury Association, or ASIA, Impairment Scale. The ASIA Impairment Scale is used to score subjects within five categories from A to E, with A being complete impairment with no sensory or motor function below the site of injury and E being normal. Grades B through E designate increasing levels of motor and sensory function. The subjects in the Cethrin Phase I/IIa trial suffered a complete thoracic or cervical SCI and were thus classified as an A on the ASIA Impairment Scale at the time of enrollment in the trial.
The 6-month interim data on 37 of these subjects treated with doses of up to 6 mg indicate that 27% of the Cethrin treated subjects improved from ASIA A to ASIA B or better. This is more than 400% greater than the conversion rate seen with the standard of care in a similarly designed study reported by Burns and colleagues in the Journal of Neurotrauma. When subjects with cervical injuries who were treated with Cethrin were analyzed separately, about 46% of the subjects exhibited a conversion rate from ASIA A to ASIA B or better. Moreover, about 18% of subjects overall and 38% of subjects with cervical injuries improved to ASIA C or better over the six months the hallmark of which is recovery of some motor function. In subjects with cervical injuries, the interim efficacy data also suggest that the response rate observed is dose-dependent at the doses up to 6 mg.
To date, the safety and tolerability data for dose levels up to 6 mg indicate that Cethrin appears to be safe and well tolerated. There have been no serious adverse events related to Cethrin as determined by the investigators and the independent Data Safety Monitoring Board, or DSMB. There were two deaths of subjects enrolled in the trial. The DSMB and the clinical investigators attributed the two deaths to causes related to the subjects’ initial Spinal Cord Injury, other injuries, or preexisting conditions and not related to Cethrin.
About Alseres Pharmaceuticals, Inc.
Alseres Pharmaceuticals, Inc. (Nasdaq: ALSE) is a Biotechnology company engaged in developing breakthrough regenerative therapeutics to treat traumatic injuries and degenerative diseases. The Company maintains a world- class intellectual property position in the field of regenerative therapeutics. The Company’s energy and focus is reflected in several important initiatives. Cethrin(R), a recombinant-protein-based drug designed to promote nerve repair after acute spinal cord injury, demonstrated positive interim results in a Phase I/IIa clinical trial. The Company’s research and pre-clinical programs include, Inosine for the treatment of spinal cord injury and stroke, Oncomodulin for the treatment of ocular injury and disease and research programs directed at a number of regenerative therapies including bone repair. The Company has a robust molecular imaging development program targeting diagnosis of Parkinson’s disease and potentially dementia and ADHD. The Company’s lead molecular imaging product candidate is ALTROPANE(R) which is in Phase III clinical trials for the diagnosis of Parkinsonian Syndromes including Parkinson’s Disease. The Company has research collaborations with 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 Alseres Pharmaceuticals’ future expectations, beliefs, intentions, goals, strategies, plans or prospects regarding the future, including the Company’s clinical development and trials for CETHRIN, the prospects of FDA approval of CETHRIN and the commercialization, including partnering opportunities, of CETHRIN. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 filed with the Securities and Exchange Commission under the section “Risk Factors,” as well as other documents that may be filed by Alseres Pharmaceuticals 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. Alseres Pharmaceuticals is providing the information in this press release as of this date and assumes no obligations to update the information in this press release.
©2008 Alseres Pharmaceuticals, Inc.