HOPKINTON, Mass., April 17 AlseresPharmaceuticals, Inc. (Nasdaq: ALSE) announced today that seven sites for thefirst 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 drugdeveloped by Alseres to enable doctors to distinguish Parkinsonian Syndromesfrom non-Parkinsonian Syndromes in patients with tremor.
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The POET-2 program is a two-part registration program, the first part ofwhich is a clinical study designed to enroll up to 90 subjects with tremor inseven U.S. medical centers. The objective is to acquire the set of ALTROPANEimages which will be used to train the expert readers, a customary practicefor clinical trials of molecular imaging agents. The second part of theplanned POET-2 program will involve two concurrent, replicate, multi-centerPhase III trials using the optimized ALTROPANE imaging protocol Alseresdeveloped for commercial use.
"Both the investigators and institutions participating in this study areamong the best in the country," stated Mark Hurtt, M.D., Alseres Chief MedicalOfficer. "With their help, we are committed to advancing ALTROPANE towardregulatory approval and commercialization to aid in the diagnosis ofParkinson's Disease or Essential Tremor. If these trials are successful andthe drug is approved, we believe that ALTROPANE could be a highly-selectivecentral nervous system diagnostic molecular imaging agent -- and a valuabletool to help clinicians make better, more-accurate diagnoses."
The sites participating in the first stage of the POET-2 clinical trialprogram are: 1) University of Alabama, Birmingham, AL, PrincipalInvestigator: Ray Watts, M.D.; 2) University of Arizona Medical Center,Tucson, AZ, Principal Investigator: Scott Sherman, M.D.; 3) Cedars-SinaiMedical Center, Los Angeles, CA, Principal Investigator: Alan Waxman, M.D.; 4)University of Florida McKnight Brain Institute, Gainesville, FL, PrincipalInvestigator: Ramon Rodriguez, M.D.; 5) Dartmouth-Hitchcock Medical Center,Lebanon, NH, Principal Investigator: David Coffey, M.D.; 6) University ofTexas Houston Medical School, Houston, TX, Principal Investigator: MyaSchiess, 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 ALTROPANEmay represent to those with undiagnosed tremor," commented Dr. Alan Waxman ofCedars Sinai Medical Center, a nuclear-medicine expert, a professor at theUniversity of Southern California, and a principal investigator in theALTROPANE trial. "As an imaging center, we are pleased with ALTROPANE's highquality scans and rapid imaging process which benefits both the patient andthe clinic."
The Tremor Action Network estimates that as many as 10 million people inthe United States are afflicted by essential tremor. Experts estimate that,each year, approximately 140,000 individuals present to their physician withnew, undiagnosed movement disorders such as Parkinson's Disease and EssentialTremor. In 2002, the European Journal of Neurology reported that there is a20- to 30-percent misdiagnosis rate in the early stages of Parkinson'sdisease. Other publications have reported even higher rates of misdiagnosis.The accurate differentiation of Parkinsonian from non-Parkinsonian tremorscould allow physicians to initiate earlier referral for specialty care,prescribe effective treatments, and provide a more-informed prognosis forpatients and their families.
About ALTROPANE Imaging Agent and Parkinsonian Syndromes IncludingParkinson's Disease
ALTROPANE is a molecular imaging agent that specifically binds to thedopamine transporter (DAT) protein found on the sur