Data Safety Monitoring Board (DSMB) Authorizes Enrollment of Cervical
Patients at Current Highest Authorized Dosage Level
HOPKINTON, Mass., Sept. 24 /PRNewswire-FirstCall/ -- Alseres Pharmaceuticals (Nasdaq: ALSE) today announced that its independent Data Safety Monitoring Board (DSMB) has unanimously authorized expanding the Company's Phase I/IIa clinical trial in acute spinal cord injury (SCI) to allow subjects with cervical SCI to be treated with a 9 mg dose of Cethrin(R). This recommendation is based on the safety analyses of data from thoracic subjects who have been treated at the 9mg dosage level and overall evaluation of safety of the drug in this clinical trial to date.
In this clinical trial each dose level is first given to thoracic SCI subjects and then, following review by the DSMB, the dose level is extended to cervical subjects. Authorization to administer a 9 mg dose in this clinical trial was given by the U.S. Food and Drug Administration in June 2007 and earlier by Health Canada. Cervical spinal cord injuries occur in the vertebrae of the neck and often result in quadriplegia; thoracic spinal injury occurs in the region of the back between the neck and the pelvis often resulting in paraplegia.
Alseres' DSMB is composed of independent medical and statistical experts who evaluate the safety of the clinical trial being conducted at 9 sites in the US and Canada. The Company expects enrollment in the trial to conclude by the end of 2007.
"The DSMB's recommendation is an important step in the Cethrin clinical plan," commented Dr. Mark Hurtt, Alseres' Chief Medical Officer. "The inclusion of 9 mg cervical subjects will increase our understanding of the encouraging efficacy data for Cethrin at lower doses, and provide additional safety data to support the Phase IIb/III clinical study, expected to begin patient enrollment in early 2008."
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. During surgery, Cethrin is delivered by a single application to the injured region of the spinal cord. Cethrin has been designated as an Orphan Drug by the FDA.
About the Cethrin(R) Phase I/IIa Clinical Trial
Patients with acute SCI are enrolled in the open label study at sites across Canada and the United States. Dose groups included in the study are 0.3mg, 1mg, 3mg, 6mg and 9mg. All patients enrolled in the trial have "complete" spinal cord injuries, referred to as "ASIA A" as assessed under the American Spinal Injury Association (ASIA) Impairment Scale. This means that each study participant 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.
Interim results reported to date on the thirty-seven patients enrolled in the first four dose groups indicate that Cethrin is well tolerated. The interim efficacy analysis in these groups indicates that Cethrin treated patients experience a frequency of post-treatment conversions from ASIA A to ASIA B or greater which is up to four times the conversion rate seen with the standard of care reported in the literature (6.7%, Burns et al., J. Neurotrauma, 2003). When subgroups of patients treated with Cethrin are analyzed, patients with cervical injuries exhibit a more pronounced response compared to patients with thoracic injuries, showing a conversion rate that is six to seven times greater than the full patient group treated with the standard of care reported in the publication above. In patients with cervical injuries, the interim efficacy data also suggest that the response rate observed is dose dependent at the doses tested to date.
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. Our 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. Our lead product candidate is ALTROPANE(R) which is in Phase III clinical trials for the diagnosis of Parkinson's disease. Alseres 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, Inc. future expectations, beliefs, intentions, goals, strategies, plans or prospects regarding the future, including the development and commercialization of ALTROPANE and Cethrin, the prospects of the Company's CNS therapeutics program, the Company's strategies to develop and commercialize axon regeneration technologies and the breadth of the Company's technologies and intellectual property portfolio. 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 June 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, Inc. 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, Inc. is providing the information in this press release as of this date and assumes no obligations to update the information in this press release.
Director, Corporate Communications
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|SOURCE Alseres Pharmaceuticals|
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