Research to be led by neurologist Orrin Devinsky, M.D., director of NYU Langone's Comprehensive Epilepsy Center and world leader in the study of epilepsy, and Dr. Terry Hamlin, associate executive director of The Center for Discovery, renowned for complex care
Study will investigate the optimal dose of Columbia Care's ClaraCeed™ and ClaraCeed Ultra™ cannabis-derived tablets to reduce seizures
NEW YORK and HARRIS, N.Y., Nov. 14 2018 /PRNewswire/ -- Columbia Care LLC ("Columbia Care"), the nation's leading medical cannabis company, and The Center for Discovery ("The Center"), an internationally renowned provider of advanced specialty care to individuals with complex medical and behavioral conditions, recognized for its groundbreaking research, today announced a partnership to study the efficacy of Columbia Care's proprietary, dose metered, full-spectrum high cannabidiol (CBD) and ultra-high CBD tablets, ClaraCeed and ClaraCeed Ultra, in treating qualifying pediatric and adult patients with intractible epilepsy who choose to use Columbia Care products.
The research team will be led by Orrin Devinsky, M.D., professor of neurology, neurosurgery and psychiatry at NYU School of Medicine and medical director of NYU Langone's Comprehensive Epilepsy Center. Dr. Devinsky is an expert in new drug development and diagnostic procedures. He served as principal investigator for the Epidiolex trials in the United States that ultimately led to FDA approval of the first cannabis-derived drug for the treatment of two rare forms of epilepsy. Dr. Devinsky receives honoraria for his consultation and work on advisory boards for medical cannabis companies.
"The Center for Discovery has been advancing care and research for complex conditions for many decades. We hope that this research, drawing on the expertise of Dr. Devinsky and The Center for Discovery's renowned medical team, will advance the treatment of drug-resistent epilepsy and have implications far beyond our community at The Center for Discovery," said Dr. Terry Hamlin, associate executive director at The Center and key investigator on this study.
Rosemary Mazanet, M.D., Ph.D., chief scientific officer and chair of the scientific advisory board at Columbia Care added, "This partnership highlights Columbia Care's dedication to evidence-based research validating the therapeutic benefits of our precisely manufactured cannabis-derived medicines. We are honored to have been selected as a partner by the prestigious Center for Discovery as well as to have the opportunity to collaborate with such a world-renowned epilepsy expert as Dr. Devinsky. We are looking forward to better understanding how our ClaraCeed and ClaraCeed Ultra medications can best be utilized to treat patients who are suffering from treatment-resistant epilepsy safely and effectively."
The observational study will enroll fifty Center for Discovery patients with drug-resistant epilepsy, aged 8-40 years old, who choose Columbia Care as their medical cannabis provider in accordance with current New York State Department of Health guidelines. The study will evaluate the optimal dose for safety, tolerability and potential reduction of convulsive seizures using ClaraCeed and ClaraCeed Ultra medical cannabis tablets as an adjunct treatment in children and adults with drug resistant epilepsy.
Patrick H. Dollard, president and chief executive officer of The Center, added, "This research is part of The Center's bold mission to create life-changing advances that lead to better outcomes and more targeted treatments for individuals with chronic, complex conditions, including seizure disorders. We won't rest until the treatment options for these complex seizures are significantly improved."
About ClaraCeed and ClaraCeed Ultra
Columbia Care's proprietary ClaraCeed and ClaraCeed Ultra medications are precisely-dosed, long-lasting, hard-pressed tablets that contain high and ultra-high doses of CBD, respectively. Each tablet also contains a balanced portfolio of 11 other functional cannabinoids to retain a balanced, full spectrum benefit. The ClaraCeed Ultra tablets contain almost three times the dose of CBD in comparison to the ClaraCeed tablets.
About Columbia Care LLC
Columbia Care is the nation's largest and most experienced manufacturer and provider of medical cannabis products and services. The Company has been vetted by more regulators and successfully awarded more licenses in highly selective and regulated jurisdictions than any other company in the nation. Columbia Care has completed more than 750,000 successful patient interactions since its inception and is working in collaboration with some of the most renowned and innovative teaching hospitals and medical centers in the world. Columbia Care is a patient-centered healthcare company setting the standard for compassion, professionalism, quality, caring and innovation for a rapidly expanding new industry focused on providing the transparency and education patients need with the product quality clinicians expect. By the end of first quarter 2019, Columbia Care anticipates selling its proprietary, pharmaceutical-quality EleCeed™, TheraCeed™ and ClaraCeed medications in tablet, vaporization, tincture, suppository and topical formulations throughout its national distribution network in order to treat patients with varying unmet medical needs. For more information on Columbia Care, please visit www.col-care.com.
About The Center for Discovery
The Center for Discovery (TCFD) is a leading provider of healthcare and education services for more than 1,200 children and adults with complex conditions, medical frailties and Autism Spectrum Disorders, located 90 miles northwest of New York City. Named a Center of Excellence in 2016, TCFD has long been a leader in developing new models of care for individuals with complex conditions. On 1,500 acres of land in Sullivan County, TCFD houses school campuses, residences, medical and research facilities, organic and biodynamic farmland, and leased private businesses. Deeply focused on an individual's personal potential and possibilities, rather than a disability, TCFD strives to create better care and unique and challenging opportunities for the most vulnerable populations.
For more information about TCFD, please visit https://thecenterfordiscovery.org/.
Columbia Care Media Contact:
Josephine Belluardo, Ph.D.
LifeSci Public Relations
The Center for Discovery Media Contact:
Executive VP of Marketing and Strategic Communications
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SOURCE The Center for Discovery
Released November 14, 2018