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Australia- PhytoTech Medical eyes cannabinoid MS clinical studies for oral capsules

















Medical cannabis company PhytoTech Medical Limited (ASX:PYL) is advancing towards clinical studies for its unique oral capsules to treat pain and spasticity in multiple sclerosis patients.


The poor water solubility of THC and CBD compounds has always been an issue and this trial will seek to increase the oral bioavailability through use of capsules.

The company has submitted key documents to the Institutional Review Board and National Clinical Trial Committee in Israel to start Phase 1 clinical studies with its tetrahyrocannabidiol (THC) and cannabidiol (CBD) oral capsules.

Submission of Clinical Study Protocol and Investigative Brochure is a key milestone indicating its advanced development stage and readiness to start studies.

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.

The Phase I study will be performed in Sourasky Medical Clinical Research Center one of the largest and highly regarded clinical sites in Israel.
    
This is planned to commence in Q4 2015 following IRB and the committees’ approvals and is expected to conclude after a 9-week period.

Initial pre-clinical study results have indicated a potential high bioavailability of the formulations.

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 US21 billion in 2018.

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. 

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%.



Story Source: The above story is based on materials provided by MIDDLEEASTNORTHAFRICAFINANCIALNETWORK
Note: Materials may be edited for content and length

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