Healthcare Industry News: Regeneration Technologies
News Release - June 27, 2007
Alseres Pharmaceuticals Announces FDA Clearance to Increase Dose Level in Cethrin(R) Phase I/IIa Clinical Trial for Acute Spinal Cord Injury at U.S. SitesHOPKINTON, Mass., June 27 (HSMN NewsFeed) -- Alseres Pharmaceuticals, Inc. (Nasdaq: ALSE ) formerly Boston Life Sciences, Inc. (BLSI) announced today that the U.S. Food and Drug Administration (FDA) has authorized an increase in the dose level of Cethrin to 9mg in the Company's ongoing Phase I/IIa clinical study for the treatment of acute spinal cord injury (SCI). In April, the Company announced that dosing at the 9mg level had begun in Canadian trial sites under a Canadian Clinical Trial Application.
Patients with acute SCI are enrolled in the open label study at sites across Canada and the United States. Previous dose groups included in the study were 0.3mg, 1mg, 3mg and 6mg. 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) rating scale. That means 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 four times the conversion rate seen with the standard of care reported in the literature (6.7%, Burns, 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.
"We are pleased that the FDA has authorized the use of the 9mg dose of Cethrin and allowed the continuation of this trial at the Company's U.S. clinical trial sites," commented Mark Hurtt, Alseres' Chief Medical Officer. "We believe that this action will further support our efforts to design a well-controlled Phase IIb/III clinical study in the coming months."
By the end of the third quarter, the Company plans to meet with regulatory authorities to review its plans for its proposed Phase IIb/III clinical study. If agreement with regulatory authorities can be reached in a timely manner, the Company expects to begin the Phase IIb/III clinical study by the end of the year or 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 Alseres Pharmaceuticals, Inc.
Alseres Pharmaceuticals, Inc. (ALSE) is engaged in the clinical development of diagnostic and therapeutic products for central nervous system (CNS) disorders. Cethrin®, 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®, a 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. Alseres' 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 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 March 31, 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.
Source: Alseres Pharmaceuticals
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