Satipharm has sublicensed the pharmaceutical application of Gelpell® Microgel process to PhytoTech Therapeutics Ltd in Israel, responsible for Satipharm's clinical development activities. In March 2016, PhytoTech Therapeutics completed a phase 1 clinical study which highlighted the safety and performance of Satipharm's Gelpell® Microgel CBD capsules in delivering CBD compounds to trial subjects. These results are now published in Clinical Pharmacology in Drug Development (“CPDD”), an international Medical Journal;
Phase 2 Clinical Trials
PhytoTech Therapeutics has also commenced two phase 2 clinical studies into the efficiency of the CBD Capsules at a leading Israeli healthcare facility; One in treating intractable epilepsy in children and another into the ability of the next generation of Gelpell® Microgel Capsules in treating spasticity-related symptoms associated with multiple sclerosis patients. If successful, these phase 2 clinical trials will provide key data towards the commercial development of Satipharm's Gelpell® Microgel CBD capsules as a prescription drug.
On July 24th, 2018, MMJ PhytoTech released favourable results in regards to the phase 2 clinical trial on pediatric epilepsy.
Key findings of the trial
- Satipharm’s CBD capsules significantly reduced monthly seizures in treatment resistant children when added to current medications. The median reduction was -82% in the 12-week treatment period.
- 9/16 patients (56%) who started the treatment had a reduction of at least 50% in total number of seizures during the entire treatment period, compared to observation
- Following 12 weeks of treatment, 8/11 patients (73%) were rated as “very much improved/improved” in overall condition on the Caregiver Global Impression of Improvement scale and 9/11 patients (82%) were rated as “very much reduced/reduced” on that scale
Prof. Uri Kramer, Director of Pediatric Epilepsy Service, Tel Aviv Sourasky Medical Center and Principal Investigator of the trial commented that, “Notwithstanding the small number of patients treated, the efficacy of Satipharm’s CBD capsules as add-on therapy in the treatment of pediatric, intractable epilepsy has been shown. Moreover, these results compare favourably to other similar studies of cannabidiol, including those published by GW Pharmaceuticals. Importantly, the significant reductions in seizure frequency while demonstrating satisfactory safety and tolerability profile, in these very difficult to treat patients, have the potential to be a life-altering event for these patients and their families. I would be greatly interested in prescribing such standardized and clinically tested product as Satipharm’s CBD.”