Boston Life Sciences, Inc. Announces Findings from Review of POET-1 Study of ALTROPANE(R) Molecular Imaging Agent
26 9월 2006 - 1:33AM
PR Newswire (US)
HOPKINTON, Mass., Sept. 25 /PRNewswire-FirstCall/ -- Boston Life
Sciences, Inc. (NASDAQ:BLSI) today reported statistically
significant results for the Primary Endpoint from the POET-1
(Parkinson's or Essential Tremor) trial for the ALTROPANE molecular
imaging agent. The POET-1 trial was designed to assess whether
ALTROPANE imaging is more accurate than the clinical diagnosis of
primary care physicians (PCP) to distinguish between tremors caused
by Parkinsonian Syndrome and those associated with other disorders,
as judged by comparison to a definitive diagnosis by Movement
Disorder Specialists (MDS). ALTROPANE scans showed statistically
significant superiority over the diagnosis of PCPs on measures of
both specificity and sensitivity, the Primary Endpoint of the
trial. Based on data analyzed to date, with the exception of one
"possibly-related" urinary tract infection that resolved after
treatment, there were no drug-related serious adverse events. In
order to avoid potential bias to further clinical development of
ALTROPANE and in keeping with FDA guidance to the Company, detailed
results of the trial cannot be disclosed at this time. As
previously announced in March 2006, the Company ended the POET-1
trial early with approximately 30 percent fewer patients than
originally specified because non-blinded data indicated that the
error rate of general practitioners in the trial was higher than
had been anticipated in the trial design. BLSI's President and
Chief Operating Officer, Dr. Mark Pykett, said, "We believe these
results will be instrumental in advancing our efforts to sign a
commercial partner for ALTROPANE -- a primary business objective
for our Molecular Imaging program. We are working with expert
advisors and the FDA to determine the most-direct route to FDA
approval, and to finalize our plans for POET-2 and the remaining
clinical development of ALTROPANE. We plan to provide further
guidance to our investors as we gain insight into what further work
will be required to seek regulatory approval, including specifics
regarding POET-2 and any other studies that may be necessary."
BLSI's Chief Medical Officer, Mark Hurtt, MD, commented, "This is
the outcome we anticipated when we ended the POET-1 trial. Our
results are particularly encouraging because the readers made their
diagnoses based on their evaluations of the ALTROPANE scans alone;
they had no access to patient clinical data, such as the age of the
patient, in these "fully-blinded" evaluations. In normal practice,
nuclear-medicine physicians would evaluate clinical information
along with the scans, to further enhance their diagnostic
accuracy." Dr. Alan Waxman of Cedars Sinai Medical Center, a
nuclear-medicine expert, a professor at the University of Southern
California, and a principal investigator in the POET-1 trial,
stated, "We found in our clinic that ALTROPANE was convenient to
use, and routinely produced high-quality scans. We were able to
complete each patient's testing in about an hour." About ALTROPANE
Imaging Agent and Parkinsonian Syndromes, Including Parkinson's
Disease ALTROPANE is a molecular imaging agent that specifically
binds to the dopamine transporter (DAT) protein found on the
surface of dopamine-producing neurons, making it visible during
Single Photon Emission Computed Tomography or SPECT, imaging. Since
most forms of Parkinsonian Syndromes result in a decreased number
of dopamine-producing cells, it would be expected that these
patients also have fewer DATs than do patients without PS. Thus, we
believe that ALTROPANE used in conjunction with SPECT imaging could
be a useful test to distinguish Parkinsonian Syndrome tremors from
non-Parkinsonian tremor: non-Parkinsonian patients would have more
ALTROPANE-binding visible in the SPECT image, while Parkinsonian
patients would have less. There are several conditions that are
considered Parkinsonian Syndromes. Parkinson's Disease is the most
common form of Parkinsonian Syndrome. Other less common
Parkinsonian Syndromes include multiple system atrophy (MSA),
Progressive Supranuclear Palsy (PSP), and drug-induced
Parkinsonism. Experts estimate that, each year, approximately
140,000 individuals present to their physician with new,
undiagnosed movement disorders such as Parkinson's Disease and
Essential Tremor. The International Essential Tremor Foundation
estimates that as many as 10 million people in the United States
are afflicted by essential tremor. In 2002, the European Journal of
Neurology reported that there is a 20- to 30-percent misdiagnosis
rate in the early stages of Parkinson's disease. Other publications
have reported even higher rates of misdiagnosis. We believe that
the accurate differentiation of Parkinsonian from non-Parkinsonian
tremors has important clinical implications. Physicians may be able
to initiate earlier referral for specialty care, prescribe
effective treatments, and provide a more-informed prognosis for
patients and their families. If these trials are successful and the
drug is approved, we believe that ALTROPANE could be a
highly-selective CNS diagnostic molecular imaging agent -- a
valuable tool to help clinicians make better, more-accurate
diagnoses. Explanation of Terms: POET -- Parkinson's or Essential
Tremor Phase III clinical trial SPECT -- single photon emission
computed tomography, an imaging technique Specificity -- In this
study, it is the ability of the nuclear medicine experts and PCPs
to correctly diagnose the absence of Parkinson's Disease when it is
not present based on the diagnosis of a Movement Disorder
Specialist. Sensitivity -- In this study, it is the ability of the
nuclear medicine experts and PCPs to correctly diagnose Parkinson's
Disease when it is present based on the diagnosis of a Movement
Disorder Specialist. NOTE: Overall accuracy of a diagnostic test
depends upon both specificity and sensitivity. Statistical
significance -- Statistical significance is measured by a p-value,
which is a mathematical calculation used to determine the
likelihood that the measured result was obtained by chance. A
p-value of 0.05 means that the probability that this result
occurred by chance is one in 20. A low p-value indicates a greater
likelihood that the observed result did not occur by chance, and
therefore implies greater statistical significance. About Boston
Life Sciences, Inc. Boston Life Sciences, Inc. (BLSI) is engaged in
the research and clinical development of diagnostic and therapeutic
products for central nervous system (CNS) disorders. ALTROPANE(R)
molecular imaging agent is in Phase III clinical trials for the
diagnosis of Parkinsonian Syndrome (PS) and Phase II clinical
trials for the diagnosis of Attention Deficit Hyperactivity
Disorder (ADHD). The Company's research and pre-clinical CNS
programs include Inosine for the treatment of stroke, a DAT blocker
for the treatment of Parkinson's disease and a second generation
technetium-based molecular imaging agent for PS and ADHD. BLSI's
current research collaborations include Harvard Medical School and
Children's Hospital Boston. Safe Harbor 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 Boston Life
Sciences' future expectations, beliefs, intentions, goals,
strategies, plans or prospects regarding the future, including the
Company's clinical development and trials for ALTROPANE, the
prospects of FDA approval of ALTROPANE and the commercialization,
including partnering opportunities, of ALTROPANE. 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, 2006
filed with the Securities and Exchange Commission under the section
"Risk Factors," as well as other documents that may be filed by
Boston Life Sciences 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. Boston
Life Sciences is providing the information in this press release as
of this date and assumes no obligations to update the information
in this press release. Contact: Sharon Correia -- 508-497-2360 ext
224 Boston Life Sciences, Inc. DATASOURCE: Boston Life Sciences,
Inc. CONTACT: Sharon Correia of Boston Life Sciences, Inc.,
+1-508-497-2360, ext. 224, Web site:
http://www.bostonlifesciences.com/
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