Results from Phase 1 Clinical Study won't hold much in terms of effect on SP IMO. The trials are aimed at healthy people ensuring their will be no adverse reactions, rashes, nausea ect. These studies have been done to death on medical cannabis so nothing but good news should be expected, but also not expecting to get any results until late Feb/ early March.
The Phase 1 Study
The Phase 1 study will be a single-centre, randomised, crossover study to compare the safety, tolerability and pharmacokinetics in healthy volunteers of the two new oral THC and CBD formulations, when administered as single doses.
As part of the study objectives, the Company will select the optimal THC:CBD formulation for delivering THC and CBD, and advance it to a Phase 2 clinical study which will focus on the drug's capability to relieve pain and spasticity in Multiple Sclerosis (MS) patients, of which there are over 2.3 million worldwide (Source: National MS Society).
The Phase I study will be performed in Sourasky Medical Clinical Research Center, one of the largest and highly regarded clinical sites in Israel.
It has been designed to fulfil all the regulatory requirements needed for the New Drug Application (NDA) to the Food and Drug Administration (FDA).
The Phase 1 clinical study is planned to commence in Q4 2015 following IRB and the committees' approvals, and is expected to conclude after a 9-week period.
The Phase 2 Study
The Phase 2 study will assess the drug's capability to relieve pain and spasticity in Multiple Sclerosis (MS) patients in comparison to Sativex(R), GW Pharma's leading buccal delivery CBD:THC product for the treatment of muscle spasticity in MS patients.
Upon a successful completion of the Phase 1 study, the Company expects to begin the Phase 2 study during 2016 and plans to complete such study during 2017. In parallel, the Company will continue to develop validated manufacturing and testing methods, will upgrade the production of the formulated capsule and will carry out long-term stability studies.
THC:CBD in the treatment of Multiple Sclerosis symptoms
Multiple Sclerosis is a disabling neurological lifelong condition affecting young adults. According to the National MS Society over 2.3 million people worldwide suffer from MS. The market for disease-modifying Multiple Sclerosis therapies is predicted to expand at an annual rate of 10% per year, reaching nearly US$21 billion in 2018 (Source: Decision Resources).
Spasticity is one of the most common and most disabling symptoms, affecting up to 84% of patients (World Health Organisation). One of the most successful treatments for Multiple Sclerosis pain and spasticity was found to be the use of a safe and tolerable combination of THC and CBD at a 1:1 ratio. The therapeutic rationale for the THC and CBD combination has been established, however an optimal oral dosage form is yet to be available due to the substantial "first pass" metabolic effect of the cannabinoids (THC and CBD) in the gastrointestinal tract leading to very limited oral bioavailability of ~6%.
Pre-clinical study results
Favourable pre-clinical studies with the Company's THC:CBD oral formulations have indicated a potentially high bioavailability when administered as an oral capsule.
Oral administration is regarded as the best route to deliver the drug due to the decreased variability in dosage, no delivery system side effects, decreased dosing frequency, longer shelf life, ability to store at room temperature storage and its low cost. Oral capsules administering medical cannabis as a treatment are therefore expected to have an increased compliance in comparison to the current non-oral delivery routes.
MMJ Price at posting:
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