Partnership Underway to Develop Extensive Protocols and Submissions for US Food & Drug Administration to Uncover Safety and Efficacy for Targeted Medical Cannabis Treatments in the US
- CB2 chosen to advance application with the US FDA for study on safety and efficacy of cannabis-based topical treatments by leading multistate operator, Vireo.
- Project marks the start of the clinical trial process for Vireo’s topical creams, lotions and gels to be used by patients for pain management.
- Company will develop full protocols and manage Investigational New Drug (IND) application on behalf of Vireo and will work with the FDA towards approvals.
- Vireo will also be licensing the Company’s Sail technology platform for full data collection to ensure structured, clean data availability when required.
CB2 Insights (CSE:CBII, OTCQB:CBIIF) (“CB2” or the “Company”), a leading data-driven company focused on bringing real-world evidence driven from the point-of-care to the medical cannabis community, today announced it has partnered with Licensed Producer, Vireo Health International Inc. (“Vireo”) (CNSX:VREO, OTCQX:VREOF), to advance the proof of safety and efficacy for cannabinoid therapy as it relates to metered-dosing for patients with ailments in which cannabis-based medicine is believed to support. CB2 will oversee the protocol development and Investigational New Drug (IND) Application directly with the US Food & Drug Administration (FDA). The successful completion will position Vireo for industry leadership when it comes to cannabis-based topical medication used to treat pain. Vireo will also license the Company’s Sail technology platform for full data collection and management.
“Vireo is a cannabis company that understands the importance of full-scale research to prove out the true safety and efficacy of their products as they come to market,” said Prad Sekar, CEO, CB2 Insights. “As we have seen with the FDA over the past year, they are steadfast in ensuring that cannabis-based medicines follow the same protocols as other traditional pharmaceuticals. We are proud to have been chosen to advance that process with Vireo as we move forward with the IND application.”
Vireo is a physician-founded, science-focused vertically integrated cannabis company focused on bringing medical science and engineering effective cannabis-based medicine. Thousands of patients across seven U.S. states have used Vireo’s products for a wide range of conditions including chronic pain, cancer, epilepsy and many others as permitted under various state laws. Vireo’s line of cannabis-based topical products – currently available in Minnesota and scheduled to launch in other markets in 2020 – will be the focus of this project. CB2 Insights will manage the process of designing the protocol and working with the FDA on IND application approval.
“At Vireo, we are working to illustrate the positive impact that cannabis-based products can have for patients seeking to manage chronic or intractable pain through alternative treatment options,” said Kyle Kingsley, M.D. Chief Executive Officer, Vireo Health. “Our partnership with CB2 Insights will help us solidify the understanding and acceptance of cannabis-based medicine by following traditional healthcare protocols to achieve what many others in this space have been unable to do – produce clinical evidence of our products’ efficacy.”
CB2 Insights has active technology, data and research projects in North America, the UK and Colombia. As a cannabis-focused Contract Research Organization (CRO), the Company is able to support Licensed Producers, Multi-State Operators and other industry stakeholders from pre-clinical trial activities through to product commercialization by following traditional healthcare protocols regardless of the jurisdiction. CB2 also owns and operates the largest multi-state cannabis evaluation and education centers in the US, overseeing the care of more than 100,000 patients which expedites the development of patient registries and ultimately recruitment for clinical studies.
Both companies look to complete the initial stage of the project by Q1 2020.
About CB2 Insights
CB2 Insights (CSE:CBII) is a global leader in clinical operations, technology & analytics solutions and research and development services with a mission to mainstream medical cannabis into traditional healthcare. Providing immediate market access through its wholly-owned clinical network across 12 jurisdictions, proprietary data-driven technology solutions and comprehensive contract research services designed for those in both the medical cannabis and traditional life sciences industries, CB2 Insights is able to support its partners across the entire data and research spectrum.
CB2’s Clinical Operations business unit leverages extensive experience to develop clinical models with standard operating procedures, advanced workflows, training and ongoing management support. CB2 also owns and operates its own specialty clinics including the brands Canna Care Docs and Relaxed Clarity which assess nearly 100,000 patients seeking medical cannabis treatment to provide immediate market access to US-based product manufacturers for clinical trial and research programs.
The Company has built both electronic data capture (EDC) and clinical data management software (CDMS) which work to support its partners of any size to execute their data and clinical strategies.
CB2 also offers comprehensive contract research organization (CRO) services including full scale clinical trial management, trial design, monitoring and other key research functions used by licensed producers, multi-state operators and traditional pharmaceutical companies entering the medical cannabis space.
For more information please visit www.cb2insights.com.
About Vireo Health International, Inc.
Vireo Health International, Inc.’s mission is to build the cannabis company of the future by bringing the best of medicine, engineering and science to the cannabis industry. Vireo’s physician-led team of more than 400 employees provides best-in-class cannabis products and customer experience. Vireo cultivates cannabis in environmentally friendly greenhouses, manufactures pharmaceutical-grade cannabis extracts, and sells its products at both company-owned and third-party dispensaries. The Company currently is licensed in eleven markets including Arizona, Maryland, Massachusetts, Minnesota, New Mexico, New York, Nevada, Ohio, Pennsylvania, Puerto Rico, and Rhode Island. For more information about the company, please visit www.vireohealth.com.
For CB2 Insights
Dan Thompson – Chief Corporate Officer
1.855.874.4999 ext. 120
For Vireo Health International Inc.
Albe Zakes – VP, Communications
Forward Looking Statements
Statements in this news release that are forward-looking statements are subject to various risks and uncertainties concerning the specific factors disclosed here and elsewhere in CB2’s filings with Canadian securities regulators. When used in this news release, words such as “will, could, plan, estimate, expect, intend, may, potential, believe, should,” and similar expressions, are forward-looking statements.
Forward-looking statements may include, without limitation, statements regarding the opportunity to provide services and software to the U.S. cannabis industry.
Although CB2 has attempted to identify important factors that could cause actual results, performance or achievements to differ materially from those contained in the forward-looking statements, there can be other factors that cause results, performance or achievements not to be as anticipated, estimated or intended, including, but not limited to: dependence on obtaining regulatory approvals; investing in target companies or projects which have limited or no operating history and are subject to inconsistent legislation and regulation; change in laws; reliance on management; requirements for additional financing; competition; hindering market growth and state adoption due to inconsistent public opinion and perception of the medical-use and recreational-use marijuana industry and; regulatory or political change.
There can be no assurance that such information will prove to be accurate or that management’s expectations or estimates of future developments, circumstances or results will materialize. As a result of these risks and uncertainties, the results or events predicted in these forward-looking statements may differ materially from actual results or events.
Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release are made as of the date of this release. CB2 disclaims any intention or obligation to update or revise such information, except as required by applicable law, and CB2 does not assume any liability for disclosure relating to any other company mentioned herein.