A California life science company has launched a patient registry study and enrolled its first subject.
San Francisco Bay Area-based Juva Life today announced the enrollment of the first human subject into its “Natural History of Disease: Cannabis Registry” clinical study.
According to Juva Life, the study is the company’s first step in establishing a clinical methodology to properly evaluate the clinical effect of different cannabis formulations on human subjects.
Juva Life says that its technology platform, consisting of chemistry, clinical, and data science, allows the company to learn how cannabis works at a fraction of its competitors’ costs.
The IMPACT Registry focuses on filling gaps associated with the use of cannabidiol (CBD), delta-9 tetrahydrocannabinol (THC), and other cannabinoid formulations.
The primary goal of the IMPACT Registry is to rapidly advance research and understanding of cannabis use to manage health issues.
Alongside the clinical registry study, Juva Life is also conducting a systematic evaluation of cannabis formulations.
Juva Life says that the evaluation will be done in gold-standard pre-clinical laboratory models with respect to anti-inflammatory mode of action.
The company will analyze clinical and pre-clinical study data together with the intention of benchmarking formulations to “accelerate dose finding and clinical endpoint finding.”
Recorded data will include cannabis patient demographics, disease diagnoses and symptoms, cannabinoid formulations, dosages, utilization, patient outcomes, and overall impact on clinical or patient treatment plans.
“Today’s milestone announcement notes our first patient enrollment, but we will quickly surpass this with many others joining the study,” says Juva Life VP of Chemistry Sanjeev Gangwar Ph.D. “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.”
Gangwar says that the need for new, safe, and evidence-based cannabis products to target unmet medical needs is large.
The need, says Gangwar, is clearly evidenced by the $7.2 billion acquisition of G.W. Pharmaceuticals by Jazz Pharmaceuticals in February.
G.W. Pharmaceuticals is the manufacturer of the CBD-based medication Epidiolex, used to treat severe forms of epilepsy.
“We are aiming to address numerous conditions and in so doing hope to build commensurate value,” says Gangwar. “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.”
Concentrating its efforts on developing safe, evidence-based cannabis products, Juva Life says that its initial focus is generally on inflammation-defining formulations suitable for consumer and pharmaceutical product development.