OK, looks like a reasonable trial design. It would be nice to know how long it will take. Perhaps they'll give us a hint when they actually initiate it. I wouldn't think that, at 25 centers, enrollment would take that long.
>>BOSTON--(BUSINESS WIRE)--April 1, 2004-- Boston Life Sciences, Inc. (NASDAQ: BLSI - News) announced that the Company has reached a binding agreement from the FDA regarding the Company's protocol design for a new Phase III clinical trial of ALTROPANE®, a radioimaging agent under development by Boston Life Sciences for the differentiation of Parkinsonian tremors from tremors due to other, non-Parkinsonian causes. This written Agreement represents the culmination of a number of teleconferences, meetings and protocol revisions occurring over an eight-month period in which the Company and FDA refined the study design for this single, pivotal trial. The resulting agreement binds the FDA and the Company to the precise design and statistical plan outlined in the approved protocol. The Company believes that, if successful, i.e. that the endpoints are met and no significant safety concerns or protocol deviations occur, this Phase III trial will provide the basis for an NDA submission and ultimate approvability of ALTROPANE.
This Phase III study will enroll at least 500 subjects (250 with Parkinsonian tremor and 250 with non-Parkinsonian tremor) in up to 25 centers in the U.S.; most of which are university-based. Subjects suspected of having tremor will be referred to a neurology clinic for enrollment in the study. Upon diagnosis of Parkinsonian or non-Parkinsonian tremor by the subjects' internist or general practitioner, the subjects will be administered ALTROPANE and a SPECT image will be obtained. Subsequent to SPECT scanning, the subject will be evaluated and diagnosed by a Movement Disorders Specialist (MDS). Throughout the two-day period of evaluation, the subjects will be monitored for safety.
Upon completion of the study, various analyses of the data will be conducted. Primary analyses will comprise assessments of the sensitivity and specificity of the ALTROPANE SPECT procedure versus the diagnosis of an internist or general practitioner. The primary endpoint of the study is to demonstrate statistically significant superiority of the ALTROPANE scan diagnosis compared to that of an internist or general practitioner, using the diagnosis of a Movement Disorder Specialist (MDS) as the "gold standard". Because we have elected to pursue this single, large Phase III trial, we have powered the trial to achieve a high level of significance.
"We are extremely pleased to have obtained this binding agreement from the FDA on our proposed protocol. The FDA allowed us to revise our protocol in February without incurring the delays in having to submit a new SPA filing. The written correspondence that we have received from the FDA expressly states that the agreement we have now reached constitutes 'a binding agreement, as described in the Guidelines for Industry-Special Protocol Assessments.' As a result, the agreement gives us a clear pathway to an NDA filing for this important indication. We hope to initiate this pivotal study shortly," stated Dr. Marc Lanser, President of BLSI.<<
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Cheers, Tuck |
