Australian penny stock Zelda Therapeutics (ASX:ZLD) announced last week that it has completed an observation trial in Chile, and is reporting successful results for treating core symptoms of autism with medical cannabis extracts. Zelda officials say they now plan to build on those results with clinical trials in the second half of 2017.
The trial, in collaboration with a Chilean medical cannabis and alternative healthcare non-profit called Fundación Daya, aimed to treat core autism symptoms including difficulties with social interaction, language and repetitive behaviour.
The results found that in a cohort of 21 patients (median age of 9 years and 10 months), cannabis extracts were significantly more effective than the conventional medicines the children were using, including atypical antipsychotics.
Patients in the study were treated over a 12-week period and were examined by EEG, neuropsychological analysis, metabolism and genetic tests.Those treated with cannabis extracts demonstrated significant improvements in at least one core symptom (social interaction, language or repetitive behaviors) in 71.4% of cases and 66.7% of treated patients showing significant general overall improvement.
Harry Karelis, Executive Chairman of Zelda was excited with the results, as he sees a promising future with treating autism symptoms with cannabis.
“The results from this observational study are very exciting and supports the anecdotal evidence we have, showing the positive effect medicinal cannabis has on treating autism symptoms,” Karelis said in a statement.
“Zelda will use this baseline data to design its clinical trials and generate rigorous scientific data that validates the clinical benefit of medicinal cannabis,” Karelis added. “We hope that in the near future Zelda Therapeutics can provide an alternative treatment for sufferers of this condition which is of major global significance.”
There is little scientific literature covering the use of cannabis to treat autism. In 2011, a study published in Current Neuropharmacology demonstrated that Δ9-THC improved mobility and mood in a breed of mice which exhibit autism-like behaviour. However, a study in mice is a long way from solid peer-reviewed studies in humans.
Clinical trials are critical for establishing the safety and effectiveness of a treatment, but also for ensuring its acceptance by regulators like Australia’s Therapeutic Goods Administration. In the case of cannabis as an autism treatment, the lack of published studies makes successful clinical trials all the more important for Zelda.
But clinical trials of unproven medicines are time consuming, expensive, and far from certain. Zelda should take heed of the troubles of Zynerba Pharmaceuticals – a cannabidiol company which has a string of unsuccessful clinical trials behind it. Initially testing its cannabis-based medicine on epilepsy sufferers, Zynerba switched to treating osteoarthritis after poor results.
But following another lengthy and expensive trial, no significant improvements were seen in patients suffering from osteoarthritis, and Zynerba’s stock (NASDAQ:ZYNE) took a serious hit.
Curiously, Zynerba has reported some initial success in using its cannabis-extract formulation to treat Fragile X, a genetic condition which frequently overlaps with autism spectrum disorders.
Zelda may find room for collaboration – or face competition – as it builds out its cannabis-based autism-treatment medicine trials.
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