Focus of trial on safety and tolerability for oncology patients undergoing chemotherapy.
() is commencing a safety study for oncology patients undergoing chemotherapy using its patented nutraceutical product, Multibiotic™.
Multibiotic is a multi-species probiotic that helps to support the natural balance of commensal bacteria in the gastrointestinal tract.
It is currently in the market and is used to improve symptoms of medically diagnosed irritable bowel syndrome.
Medlab was granted ethics approval in May and has now received a clinical trial number (CTN) from the Australian Therapeutic Goods Administration enabling the commencement of the oncology trial.
The phase I clinical trial will focus on safety and tolerability for oncology patients throughout their chemotherapy treatment in reducing intestinal inflammatory ulcerations (mucositis), which leads to the development of diarrhoea and other intestinal adverse effects.
The 12-week trial will be led by professor Stephen Clarke at the Northern Cancer Institute in St Leonards, New South Wales.
According to Medlab chief executive officer, Dr Sean Hall, preliminary investigations have shown promising results in the oncology area, with Multibiotic™ potentially complementing other Medlab oncology products like NanaBis™ and NanaBidial™.
Hall added “Since mucositis is common and debilitating, it means it is a significant market globally and we are hoping this research will help improve the general wellbeing of chemotherapy patients.”
READ: Medlab Clinical on schedule with medicinal cannabis cancer trial
In other oncology work, Medlab has developed two cannabis-based medicines for oncology patients, one in pain management and the other in seizures, nausea and vomiting, with the first undergoing a clinical trial with seriously ill cancer patients at Royal North Shore Hospital in Sydney.
In the cannabis clinical trial, Medlab’s NanaBis™ is being administered by Medlab’s small particle medicine delivery platform, NanoCelle™.