HOPKINTON, Mass., April 17 /PRNewswire-FirstCall/ -- Alseres Pharmaceuticals, Inc. announced today that seven sites for the first stage of the ALTROPANE(R) Parkinson’s or Essential Tremor - 2 (POET-2) Phase III clinical trial program are now open for patient enrollment. ALTROPANE molecular imaging agent is an investigational, diagnostic drug developed by Alseres to enable doctors to distinguish Parkinsonian Syndromes from non-Parkinsonian Syndromes in patients with tremor.
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The POET-2 program is a two-part registration program, the first part of which is a clinical study designed to enroll up to 90 subjects with tremor in seven U.S. medical centers. The objective is to acquire the set of ALTROPANE images which will be used to train the expert readers, a customary practice for clinical trials of molecular imaging agents. The second part of the planned POET-2 program will involve two concurrent, replicate, multi-center Phase III trials using the optimized ALTROPANE imaging protocol Alseres developed for commercial use.
“Both the investigators and institutions participating in this study are among the best in the country,” stated Mark Hurtt, M.D., Alseres Chief Medical Officer. “With their help, we are committed to advancing ALTROPANE toward regulatory approval and commercialization to aid in the diagnosis of Parkinson’s Disease or Essential Tremor. 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.”
The sites participating in the first stage of the POET-2 clinical trial program are: 1) University of Alabama, Birmingham, AL, Principal Investigator: Ray Watts, M.D.; 2) University of Arizona Medical Center, Tucson, AZ, Principal Investigator: Scott Sherman, M.D.; 3) Cedars-Sinai Medical Center, Los Angeles, CA, Principal Investigator: Alan Waxman, M.D.; 4) University of Florida McKnight Brain Institute, Gainesville, FL, Principal Investigator: Ramon Rodriguez, M.D.; 5) Dartmouth-Hitchcock Medical Center, Lebanon, NH, Principal Investigator: David Coffey, M.D.; 6) University of Texas Houston Medical School, Houston, TX, Principal Investigator: Mya Schiess, M.D.; 7) University of Texas Southwestern Medical Center, Dallas, TX, Principal Investigator: Padraig O’Suilleabhain, M.D.
“We continue to be optimistic about the diagnostic value that ALTROPANE may represent to those with undiagnosed tremor,” commented 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 ALTROPANE trial. “As an imaging center, we are pleased with ALTROPANE’s high quality scans and rapid imaging process which benefits both the patient and the clinic.”
The Tremor Action Network 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. The accurate differentiation of Parkinsonian from non-Parkinsonian tremors could allow physicians to initiate earlier referral for specialty care, prescribe effective treatments, and provide a more-informed prognosis for patients and their families.
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 Parkinsonian Syndromes. 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.
About Alseres
Alseres Pharmaceuticals, Inc. (ALSE) is engaged in the development of therapeutic and diagnostic products primarily for disorders in the central nervous system (CNS). The Company maintains a world-class intellectual property position in the field of regenerative therapeutics. The Company’s focus is reflected in several important initiatives. CETHRIN, 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 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.
Forward-Looking Statements
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 development and commercialization of ALTROPANE and CETHRIN, the prospects of the Company’s CNS and regenerative therapeutics program, the Company’s strategies to develop and commercialize axon regeneration technologies and the breadth of the Company’s technologies and intellectual property portfolio. 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 Annual Report on Form 10-K for the year ended December 31, 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 is a trademark and CETHRIN and ALTROPANE are registered trademarks of Alseres Pharmaceuticals, Inc.
Contact: Sharon Correia -- 508-497-2360 ext 224 scorreia@alseres.com or
CONTACT: Sharon Correia of Alseres Pharmaceuticals, Inc., +1-508-497-2360,
ext. 224, scorreia@alseres.com, or Adam Friedman, +1-212-981-2529, ext. 18,
adam@adam-friedman.com, for Alseres Pharmaceuticals, Inc.
Web site: http://www.alseres.com//
