Alseres
Pharmaceuticals, Inc., (Nasdaq: ALSE), announced that it has enrolled
the first subject in the initial stage of the ALTROPANE(R) Parkinson's or
Essential Tremor - 2 (POET-2) Phase III clinical trial program. This
subject was enrolled at the University of Alabama, Birmingham trial site
under the direction of Principal Investigator Dr. Ray L. Watts, MD,
Professor and Chairman of the Department of Neurology.
ALTROPANE is a diagnostic molecular imaging agent being developed to
aid in the differentiation of Parkinsonian Syndromes from non-Parkinsonian
tremor. An estimated 10 million Americans are presently living with tremor.
Currently, tremor disorders are diagnosed by subjective clinical evaluation
which, according to the Canadian Journal of Neuroscience, is associated
with an error rate among general neurologists of 25% to 35%.
Dr. Mark Hurtt, the Company's Chief Medical Officer, commented, "The
enrollment of the first subject in the POET-2 Phase lll program is an
important milestone for Alseres as we continue the process of moving
ALTROPANE toward regulatory approval. We believe that ALTROPANE has the
potential to help doctors more accurately diagnose tremor to minimize the
side-effects of unnecessary treatments. ALTROPANE may also provide
diagnostic support to monitor disease progression and the effects of
emerging therapeutics."
Dr. Ray L. Watts, M.D. of University of Alabama -- Birmingham, Movement
Disorder Specialist, stated "ALTROPANE may prove to be a valuable tool in
assisting neurologists with their clinical diagnosis of Parkinsonian
Syndromes, especially in the early stages."
About the "Parkinson's or Essential Tremor" (POET-2) Trial Program
The POET-2 program is a two-part registration program that will begin
with a clinical study in subjects in up to 15 centers to acquire a set of
ALTROPANE images which will be used to train the expert readers as is the
customary requirement for clinical trials of molecular imaging agents. The
second part of the planned POET-2 program involves two concurrent,
multi-center Phase III trials of approximately 150 subjects each using the
optimized ALTROPANE imaging protocol developed for commercial use.
About ALTROPANE Imaging Agent and Parkinsonian Syndromes (PS) 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 Parkinsonian Syndromes. 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.
The International Essential Tremor Foundation estimates that as many as
10 million people in the United States are afflicted by essential tremor.
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. 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 could have
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 central nervous system diagnostic molecular imaging
agent -- and a valuable tool to help clinicians make better, more-accurate
diagnoses.
About Alseres Pharmaceuticals, Inc.
Alseres Pharmaceuticals, Inc. (Nasdaq: ALSE) is a biotechnology company
engaged in developing breakthrough regenerative therapeutics to treat
traumatic injuries and degenerative diseases. The Company maintains a
world- class intellectual property position in the field of regenerative
therapeutics. The Company's energy and focus is reflected in several
important initiatives. Cethrin(R), a recombinant-protein-based drug
designed to promote nerve repair after acute spinal cord injury,
demonstrated positive interim results in a Phase I/IIa clinical trial. The
Company's research and pre-clinical programs include, Inosine for the
treatment of spinal cord injury and stroke, Oncomodulin for the treatment
of ocular injury and disease and research programs directed at a number of
regenerative therapies including bone repair. The Company has a robust
molecular imaging development program targeting diagnosis of Parkinson's
disease and potentially dementia and ADHD. The Company's lead molecular
imaging product candidate is ALTROPANE(R) which is in Phase III clinical
trials for the diagnosis of Parkinsonian Syndromes including Parkinson's
Disease. The Company has research collaborations with Harvard Medical
School and Children's Hospital Boston.
ALTROPANE is a registered trademark of Alseres Pharmaceuticals, Inc.
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 Alseres
Pharmaceuticals' 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 September 30, 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 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 is providing the information in this press release
as of this date and assumes no obligations to update the information in
this press release.
Alseres Pharmaceuticals, Inc.
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