HOPKINTON, Mass., Sept. 24 AlseresPharmaceuticals (Nasdaq: ALSE) today announced that its independent DataSafety Monitoring Board (DSMB) has unanimously authorized expanding theCompany's Phase I/IIa clinical trial in acute spinal cord injury (SCI) toallow 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 thoracicsubjects who have been treated at the 9mg dosage level and overall evaluationof safety of the drug in this clinical trial to date.
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In this clinical trial each dose level is first given to thoracic SCIsubjects and then, following review by the DSMB, the dose level is extended tocervical subjects. Authorization to administer a 9 mg dose in this clinicaltrial was given by the U.S. Food and Drug Administration in June 2007 andearlier by Health Canada. Cervical spinal cord injuries occur in thevertebrae of the neck and often result in quadriplegia; thoracic spinal injuryoccurs in the region of the back between the neck and the pelvis oftenresulting in paraplegia.
Alseres' DSMB is composed of independent medical and statistical expertswho evaluate the safety of the clinical trial being conducted at 9 sites inthe US and Canada. The Company expects enrollment in the trial to conclude bythe end of 2007.
"The DSMB's recommendation is an important step in the Cethrin clinicalplan," commented Dr. Mark Hurtt, Alseres' Chief Medical Officer. "Theinclusion of 9 mg cervical subjects will increase our understanding of theencouraging efficacy data for Cethrin at lower doses, and provide additionalsafety data to support the Phase IIb/III clinical study, expected to beginpatient enrollment in early 2008."
Cethrin is a recombinant protein drug intended to facilitate the re-growthof axons during the critical period immediately after a major injury to thespinal cord. Following an SCI, about two-thirds of patients undergodecompression/stabilization surgery. During surgery, Cethrin is delivered bya single application to the injured region of the spinal cord. Cethrin hasbeen 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 sitesacross Canada and the United States. Dose groups included in the study are0.3mg, 1mg, 3mg, 6mg and 9mg. All patients enrolled in the trial have"complete" spinal cord injuries, referred to as "ASIA A" as assessed under theAmerican Spinal Injury Association (ASIA) Impairment Scale. This means thateach study participant suffered a complete thoracic or cervical injury (i.e.having no sensory or motor function below the level of the SCI). ASIA gradesare designated from A through E, with 'A' designating complete SCI and 'E'being normal. Grades 'B' through 'D' designate increasing levels of motor andsensory improvements.
Interim results reported to date on the thirty-seven patients enrolled inthe first four dose groups indicate that Cethrin is well tolerated. Theinterim efficacy analysis in these groups indicates that Cethrin treatedpatients experience a frequency of post-treatment conversions from ASIA A toASIA B or greater which is up to four times the conversion rate seen with thestandard of care reported in the literature (6.7%, Burns et al., J.Neurotrauma, 2003). When subgroups of patients treated with Cethrin areanalyzed, patients with cervical injuries exhibit a more pronounced responsecompared to patients with thoracic injuries, showing a conversion rate that issix to seven times greater than the full patient group treated with thestandard of care reported in the publication above. In patients with cervicalinjuries, the interim efficacy data also suggest that the response rateobserved is dose dependent