David R Elmaleh
Dr. Elmaleh is an Associate Professor at Harvard Medical School and the Director of Contrast Media Chemistry at the Massachusetts General Hospital. He is a renowned molecular imaging expert and inventor of numerous molecular imaging agents including three drugs that are in use in man or in late stage clinical trials, including the radiopharmaceutical preparation of (2FDG) which has been used in millions of PET imaging procedures. Dr. Elmaleh also recently received patent protection for the use of 18F-FDG PET for imaging atherosclerosis, for tracking inflammation within plaques, and for monitoring the response to drug therapy; a promising use that should be part of the future diagnostic armament. Dr. Elmaleh is a founder of several biotech companies including Molecular Insight (formerly Biostream) and Mersana (formerly NanoPharma) that recently closed a drug deals for over $700 million with big pharma. He also co-founded Puretech health that recently went public on The London Stock Exchange, at a valuation over $500 million. Dr. Elmaleh holds a BS in Physics and Chemistry, and an MS and PhD in Organic Chemistry. Dr. Elmaleh is a recipient of numerous NIH and DOE grants. His recent work includes extensive research on imaging compounds, platforms to improve the speed and effectiveness of cardiovascular disease diagnosis, ischemia, infarction, and plaque formation which have enabled several drug technologies licensed from MGH to a new start-up. He is a co-author on over 130 publications and book chapters, an inventor of over 100 issued and pending patents in a range of disciplines, including molecular imaging and pharmaceuticals.
Alzheimer’s disease is a significant unmet medical need. It is the sixth leading cause of death in the United States, affecting one in eight elderly Americans and nearly 35 million adults worldwide. Globally, it is estimated that more than $800 billion is spent annually caring for dementia patients. The disease has no cure or viable commercial or clinical treatment option, and patients continue to rely on inadequate therapies to treat symptoms. FDA-approved drugs for the treatment of Alzheimer’s disease, such as AriceptTM (donepezil) and NamendaTM (memantine), temporarily treat symptoms of dementia without impacting disease progression. Analysts have projected that disease-modifying Alzheimer’s therapeutics will be rapidly adopted as a breakthrough product. ALZT-OP1 is a novel, patented combination of two small molecule drugs (OP1a and OP1b) previously approved by the United States Food and Drug Administration (FDA) for non-CNS indications. Our combination use of these molecules is proprietary, as is our formulation, preparation, low dosing and delivery administration that increases brain accessibility, all of which sets us apart from prior uses. The previously approved dosing and delivery of these molecules is ineffective for AD treatment due to its limited blood concentration availability. Our in-vitro, in-vivo APP/PS1 and Tg2576 animal models results support ALZT-OP1’s mechanism of action and utility, demonstrating that our drug attacks and modifies the complex neurodegeneration process associated with aging. Two separate (Phase , Ib) human blood and CSF pharmacokinetic studies in a mix of 48 normal and AD subjects confirm the blood and brain drug combination availability in healthy and AD patients. These studies indicate ALZT-OP1 has the potential to halt Alzheimer’s disease early in a safe administration and allowed for the Phase III, SPA FDA agreement.