Cannabis-based medicinal products to revolutionize traditional medicine

Altasciences Clinical Research
Cannabis-based medicinal products to revolutionize traditional medicine
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New research has shown that the constituents of cannabis can lead to possible therapeutic effects within the central and peripheral nervous system. This discovery has led our researchers to investigate the potential for cannabis-based medicines to treat conditions, such as pain (breakthrough, neuropathic or localized), epilepsy, nausea, insomnia, multiple sclerosis, spinal cord injuries, dermatological conditions, cancer and autoimmune diseases — all illnesses for which there are currently few effective treatments.

 

Our groundbreaking cannabis case study

Altasciences Clinical Research has been conducting studies on cannabinoid-based products for over 10 years and has run over 34 studies to date with cannabinoids or requiring cannabis users. Furthermore, our scientists have developed multiple bioanalytical cannabidiol methods and analyzed close to 20,000 related study samples. We are also at the forefront of testing vaping devices and combustibles, have extensive experience with products delivered by inhalation, and an expertise in all the different delivery methods of cannabinoid therapies. Just recently, we designed and conducted a safety and tolerability study on the world’s first cannabis extract (PPP001) being developed as a drug for regulatory submission by our sponsor Tetra Bio-Pharma, and will soon be initiating our second Phase I study for the sponsor, to characterize the safe use of cannabis oil medicines in humans.

As a result of our successful Phase I study, Tetra Bio-Pharma is now ready to initiate its Phase III clinical trial of PPP001 in terminal cancer patients, the first registration trial in the world for smokable cannabinoid-based drugs, to evaluate the therapeutic benefits in improving the quality of life and treating pain in these terminally ill patients.

Dr Graham Wood, PhD quote

Study Purpose

This innovative study had two objectives. First, to determine the safety and tolerability of PPP001 following its administration over one day and seven consecutive days when smoked/inhaled using a specialized delivery device, as intended for therapeutic use. Second, to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of tetrahydrocannabinol (THC) and cannabidiol (CBD).

Methods

This was a first-in-human, single-center, double-blind, placebo-controlled, randomized within dose study to assess safety, tolerability, PK and PD of single and multiple ascending doses of cannabis by smoking/inhalation in a total of 48 healthy male and female participants.

Results

The PK and PD results showed that the very fast onset of action will make PPP001 suitable for the treatment of breakthrough pain, and might produce a sustained therapeutic effect after hopefully diminishing the pain. An amendment was made to the dose titration and was successful in greatly reducing the adverse events experienced on the first day of dosing.

Conclusion

The PK and PD profiles seen were very promising for PPP001 to potentially be effective for the treatment of pain, and definitely warrant the continuation of the drug’s clinical development.

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