Boston Life Sciences, Inc. announces that the US Patent and Trademark Office has issued a patent to the President and Fellows of Harvard College, the General Hospital Corporation and Organix, Inc. that covers methods of diagnosing and monitoring attention deficit hyperactivity disorder (ADHD) by assessing the level of dopamine transporter (DAT) in at least one region of a patient's central nervous system.
The patent is exclusively licensed to BLSI under a worldwide licensing arrangement between BLSI and Harvard University. The patent is based on the work of the inventors, Dr. Bertha Madras of Harvard, Dr. Peter Meltzer of Organix, Inc., and Dr. Alan Fischman of Massachusetts General Hospital. Both Dr. Fischman and Dr. Meltzer serve as advisors to BLSI.
The patent claims a variety of diagnostic and monitoring methods for assessing ADHD utilizing labelled compounds that bind to the dopamine transporter and are measured using any imaging technique including single photon emission computed tomography (SPECT) and positron emission tomography (PET). An example of a compound covered by the patent is the Company's Altropane molecular imaging agent currently in phase II clinical trials as an aid to ADHD diagnosis. The company is currently analyzing imaging results and clinical data, both of which were obtained from patients enrolled to-date, to verify findings in prior studies and ensure that the trial design and quantification algorithms are appropriate.
In addition to methods used to objectively diagnose ADHD in adults or children, the patent covers methods that could enable physicians to determine the most effective ADHD drug treatment and/or dosage level for an individual patient, monitor the long-term progress of treatment for ADHD, and aid in identifying individuals at risk for ADHD.
Mark Hurtt, BLSI's Chief Medical Officer, comments, "The use of imaging techniques and dopamine transporter specific imaging agents has the potential to provide an objective, biologically-based diagnosis for ADHD. We are very pleased with the potential scope of this patent. We believe that the new patent enhances our position in this significant area of medical need. According to the Centers for Disease Control, between 3 per cent and 7 per cent of school-aged children and 2 to 4 per cent of adults have been diagnosed with ADHD. We believe that imaging agents may assist physicians in confirming a diagnosis, resolving conflicting diagnoses, calling into question a diagnosis or non-diagnosis of ADHD, or selecting medication."
The new patent issued on July 25, 2006 under US patent number 7,081,238 B2. The application was filed on August 17, 2001 and, under 35 U.S.C. 154(b) had 142 days added to its duration.
According to the Center for Disease Control, Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neurobehavioral disorders of childhood and can persist through adolescence and into adulthood. ADHD affects almost 4 million school-aged children and is among the fastest growing neurobehavioral disorders in adults with an estimated 2-4 per cent of Americans affected. ADHD is now diagnosed by medical and mental health professionals with a set of behavioural criteria but there is currently no objective biological test.