Hi all,
The DOPASCAN, DATSCAN and ALTROPANE are three DIFFERENT agents
to diagnose PD. All three are in a different stage of development.
- DATSCAN is approved in Europe for the market.
- DOPASCAN is in a -to me- unclear phase after completing a trial in 1996.
( see
http://www.parkinson-study-group.org/Completed%20Clinical%20Trials.html )
- ALTROPANE has just completed clinical trial Phase III.
( see article or http://biz.yahoo.com/bw/000727/ma_boston_.html ).
Hans.
Thursday July 27, 9:29 am Eastern Time
Company Press Release
Boston Life Sciences' Altropane Successful in Phase III Study
Parkinson's Disease Diagnostic Demonstrates Statistically Significant
Positive Results
BOSTON--(BW HealthWire)--July 27, 2000--Boston Life Sciences, Inc.
(NASDAQ: BLSI - news) announced that the results of its Phase III clinical
trial of
Altropane as a diagnostic for Parkinson's Disease (``PD'') had successfully
confirmed Altropane's ability to differentiate Parkinson's movement
disorders (including Parkinson's Disease) from other movement disorders. The
primary efficacy endpoints, ``Specificity'' and ``Sensitivity'' were both
statistically significant. The Company's Phase II clinical trial previously
demonstrated Altropane's utility in differentiating normal patients from
those with PD.
``We are delighted with these results which, we believe, document
Altropane's ability to reliably differentiate Parkinsonian from
non-Parkinsonian movement disorders,'' stated Dr. Marc Lanser, Chief
Scientific Officer of BLSI. ``We believe that the results obtained in this
study for Specificity and Sensitivity rank among the best reported for
approved diagnostic nuclear medicine agents in general, and are further
complemented by the excellent results achieved in our Phase II trial. It is
widely acknowledged that the accuracy of the initial clinical diagnosis of
PD by physicians needs to be improved. There is no other diagnostic for PD
in the U.S., either approved or in active clinical trials. We believe,
therefore, that Altropane could be a unique new and effective tool in
increasing the reliability of initial diagnosis, and thus aid in the
determination of appropriate therapy,'' added Dr. Lanser.
The multi-center Phase III study was designed to assess the Sensitivity and
Specificity of Altropane-SPECT scanning in a sample population
representative of those individuals that consult with neurologists or
internists for undiagnosed movement disorders. The study enrolled 95
subjects having the clinical diagnosis of Parkinsonian Syndrome (``PS'') and
70 patients having non-Parkinsonian Syndrome movement disorders with
clinical features similar to PS but whose symptoms are caused by something
other than a destruction of dopamine producing cells. These clinical
diagnoses were made by expert neurologists specializing in movement
disorders. Altropane SPECT scans were performed on each subject and were
reviewed by an independent three-member panel of nuclear medicine physicians
specializing in neuroimaging, who had no knowledge of the clinical
diagnosis. The Altropane scans were read and categorized as being consistent
with either PS or non-PS, and were then compared to the expert clinical
diagnosis. Specificity was 86%, Sensitivity was 75%, and overall accuracy
was 80%. ``Since clinical diagnosis has been shown to be wrong 25-30% of the
time, we believe that the excellent specificity shown by Altropane in this
study is particularly important,'' noted Dr. Lanser. Only six scans (out of
160) could not be read due to technical or other difficulties. There were no
Altropane-related adverse events reported in the study. The Company looks
forward to presenting the Phase III and other related data to the FDA.
However, there can be no assurance that these clinical results, or the
related safety and manufacturing data, will be sufficient for the filing of
an NDA or for approval of the product.
BLSI is developing novel diagnostics and therapeutics for Parkinson's
Disease (PD) and Attention Deficit Hyperactivity Disorder (ADHD) as well as
treatments for cancer, autoimmune disease, and central nervous system
disorders. BLSI's products in development include: Altropane, a radioimaging
agent for the diagnosis of PD and ADHD; Troponin I, a naturally-occurring
anti-angiogenesis factor for the treatment of solid tumors; AF-1 and
Inosine, nerve growth factors for the treatment of acute and chronic CNS
disorders; novel therapies for the treatment of PD and ADHD; and
transcription factors that may control the expression of molecules
associated with autoimmune disease and allergies.
Statements made in this press release other than statements of historical
fact represent forward-looking statements. Such statements include, without
limitation, statements regarding expectations or beliefs as to future
results or events, such as the expected timing and results of clinical
trials, discussions with regulatory agencies, schedules of IND, NDA and all
other regulatory submissions, the timing of product introductions, the
possible approval of products, and the market size and possible advantages
of the Company's products. All such forward-looking statements involve
substantial risks and uncertainties, and actual results may vary materially
from these statements. Factors that may affect future results include: the
availability and adequacy of financial resources, the ability to obtain
intellectual property protection, delays in the regulatory or development
processes, results of scientific data from clinical trials, the outcome of
discussions with potential partners, regulatory decisions, market acceptance
of the Company's products, and other possible risks and uncertainties that
have been noted in reports filed by the Company with the Securities and
Exchange Commission, including the Company's Annual Report on Form 10-K.
Contact:
Boston Life Sciences, Inc.
Maria Zapf
617.425.0200, ext.17
www.bostonlifesciences.com
or
The Trout Group
Brandon Lewis
212.477.9007, ext. 15
www.troutgroup.com
or
Boston Life Sciences, Inc.
Marc Lanser, MD
617.425.0200
or
Schwartz Communications
Jim Weinrebe
781.684.0770
www.schwartz-pr.com
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