Achieves 1st Step in Design and Validation of Clinical Platform to Standardize Clinical Effect and Mode of Action
VANCOUVER, British Columbia, March 09, 2021 (GLOBE NEWSWIRE) -- Juva Life Inc. (CSE: JUVA) (OTCQB: JUVAF) (FRANKFURT: 4VV) (“Juva Life,” “Juva” or the “Company”), a California-based life science company today announced the enrollment of the first human subject into its “Natural History of Disease: Cannabis Registry” Clinical Study. The establishment of this controlled patient registry study is Juva’s first step in establishing the clinical methodology to efficiently gauge the clinical effect of various cannabis-based formulations on human subjects.
Juva Life is focused on developing safe, evidence-based cannabis products. Juva has developed a technology platform that consists of chemistry, clinical and data science that enables the Company to learn how cannabis works at a fraction of the cost compared to competitors. Juva’s initial focus is generally centered on inflammation-defining compositions of matter suitable for consumer and pharmaceutical product development.
The intent of what is known as “the IMPACT Registry” is to develop real-world clinical evidence for cannabis-based products under development. Initial clinical indications being targeted include, but are not limited to pain, sleep, appetite, and other indices of normal function. For more information: https://clinicaltrials.gov/ (ID NCT04726254). The study allows for significant data collection and was assigned a prospective timeline with a start date of February 15, 2021 approved to February 15, 2025. Step one accrual of the multi-faceted registry is aimed to be completed by Q4 of 2021.
In parallel to initiating the clinical registry study, the company is undertaking a systematic evaluation of cannabis formulations in gold-standard pre-clinical laboratory models with respect to anti-inflammatory mode of action. Data obtained in both the clinical and pre-clinical studies will be analyzed together, with the intention of benchmarking formulations to accelerate dose finding and clinical endpoint finding.
Data to be recorded includes:
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Basic demographics of patients using cannabis-based medicaments.
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Disease diagnoses and symptoms for which patients are seeking management.
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Cannabinoid formulation, chemical composition, amount (in milligrams), dose and utilization.
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Patient Reported Outcomes (PRO) for sleep, pain, appetite, and other indications
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Concomitant use of other anti-inflammatory or analgesic medications
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Overall impact on clinical or patient treatment plans.
Vice President of Chemistry for Juva Life, Sanjeev Gangwar Ph.D. states, “Today’s milestone announcement notes our first patient enrollment, but we will quickly surpass this with many others joining the study. The work we are undertaking is critical so that consumers, patients, doctors, regulators, and our prospective partners can gain from well controlled scientific studies that employ FDA equivalent standards. The need for new, safe, and evidence-based cannabis products which target un-met medical needs is large. This is clearly evidenced by the recent $7.2 billion acquisition of the makers of Epidiolex, currently the only FDA-approved drug containing CBD which solely addresses seizures in rare diseases like severe forms of epilepsy. We are aiming to address numerous conditions and in so doing hope to build commensurate value. We look forward to announcing additional advances regarding our registry as well as initial plans for our chemistry program in the coming weeks as we continue to accelerate our efforts.”
For those new to the Juva story, please visit our website at www.juvalife.com.
ON BEHALF OF THE BOARD,
-Doug Chloupek-
Doug Chloupek, CEO & Founder
Juva Life Inc.