HOPKINTON, Mass., Dec. 18 /PRNewswire-FirstCall/ -- Alseres Pharmaceuticals, Inc., , announced today 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. 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.
scorreia@alseres.com
CONTACT: Sharon Correia, Director, Corporate Communications of Alseres
Pharmaceuticals, Inc., +1-508-497-2360, Ext. 224, scorreia@alseres.com
Web site: http://www.alseres.com//
