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Columbia Care enters into agreement with Mount Sinai to drive Medical Marijuana Research

Columbia Care, one of the nation's leading medical marijuana companies, announced a research agreement today with the Icahn School of Medicine at Mount Sinai, an internationally acclaimed research institution in New York City, to advance the science and safe practice of medical marijuana therapy.

The agreement funds ongoing retrospective research already underway. The two institutions are also discussing the formation of the New York State Medical Marijuana Research Network (MMRN), which will develop a registry research project to explore the safety and efficacy of medical marijuana in treating a range of clinical conditions.

The MMRN is expected to serve as the prototype for a national clinical research program that would be sponsored by Columbia Care, coordinated by Mount Sinai and expanded subject to federal and state laws and regulations.

By leveraging the infrastructure being developed for the MMRN in New York, a rigorous and diverse clinical trial portfolio is expected to be initiated and studied in due course that could materially and permanently change the way this treatment is recommended, administered and manufactured.

The initial ongoing retrospective research is analyzing existing data from the national Columbia Care Patient Registry, focusing on HIV-associated peripheral neuropathy and cancer-associated anorexia and cachexia. Both of these conditions were identified as areas of significant unmet need by clinical researchers.

In the future, the MMRN, which will include other renowned medical research organizations in New York State, aims to investigate cohorts of patients being treated actively for specific conditions under the New York State medical marijuana program. The ultimate goal is to design rigorous hypothesis-driven studies in additional areas of need, including epilepsy.

To our knowledge, the MMRN is the first industry-funded initiative of its kind in the United States. As envisioned, the scientific efforts would be led by the Icahn School of Medicine at Mount Sinai, which will serve as the data and clinical coordinating centers, and the central architect for the research studies.

To ensure the long-term success of the MMRN, Columbia Care has committed to creating a charitable foundation, the Columbia Care Foundation for Research and Policy (CCFRP), which will receive a portion of the profits generated by Columbia Care NY and serve as a funding source for novel scientific research.

Currently licensed to operate in five highly regulated, medically focused state sponsored programs, Columbia Care has created one of the first and largest national medical marijuana patient registries, with data derived from more than 100,000 patient interactions who suffer from over 20 disease categories.

Prior to commencing research with Mount Sinai, preliminary analysis by Columbia Care personnel yielded the following descriptive information that is suggestive of potential benefit:

– 84% of HIV/AIDS patients and 100% of cancer patients noted medical marijuana significantly better than other treatments for pain management, including highly addictive opioids;

– 84% of patients reported improved pain relief while using medical marijuana;

– 73% of medical marijuana patients discontinued other prescription pain medications;

– 46% of patients reported reduced cost of other pain medication (up to $1,200 annually) while using medical marijuana.

"Columbia Care was founded with one mission in mind – to improve and rehabilitate lives and communities," said Columbia Care CEO Nicholas Vita.

"Our activities are limited to marijuana for medical use and we emphasize health and healing through proven science. We are proud to partner with one of the most globally renown and prestigious research and medical institutions, Mount Sinai, to foster the safe, effective and, most importantly, proven use of medical marijuana to ensure reliable, safe and consistent outcomes for patients in need.

"We believe that rigorous scientific study and clinical data offer the means to mitigate the risks and unintended consequences that can come with such a novel application of this natural alternative."

The Agreement comes on the heels of the submission of Columbia Care’s New York State medical marijuana license application that was submitted on June 5th. The award of New York licenses is expected to be announced by the State in mid-to-late summer 2015.

Columbia Care is also in discussions to form a consulting agreement with experts at The Mount Sinai Hospital that will be focused on pharmacy and security operations.

The best practices developed through this collaboration will result in Columbia Care personnel being trained to the highest standards from a medical marijuana and pharmacy perspective. The proposed consultative services are contingent upon Columbia Care receiving a license from New York State.