At St George’s University London, the UK-based NeoART trial will start recruitment of up to 200 colorectal cancer patients for a two week course of the oral drug artesunate.
The WHO-qualified antimalarial is being investigated to see if it can reduce the risk of cancer recurring after surgery in patients with stage II/III operable bowel cancer.
“Research into repurposing drugs in this way for new disease indications is vital and an excellent use of resources for the NHS,” said Devinder Kumar, at the Department of Colorectal Surgery St George’s.
Outsourcing-Pharma spoke to Sanjeev Krishna, a professor of Molecular Parasitology and Medicine at St George’s University of London who is also co-running the NeoART trial.
Due to the low cost of the drug – priced at around 70 pence per tablet ($0.85) – finding Big Pharma partners was a challenge, Krishna explained, leading to the decision to partially crowdfund the trial.
NeoART raised £54,000 ($66,000) through a campaign on FutSci, a crowdfunding platform for research and technology in the life sciences.
Krishna told us the funds were used to cover pharmacy costs, set up a website and secure database, and filing the paperwork for regulatory aspects of the trial.
“If it hadn’t been for [the charity] Bowel Disease UK, which donated £200,000 ($243,000), we wouldn’t have been able to start at all. The crowdfunding was used to supplement this," he said.
For patient recruitment, Krishna explained the UK National Health Service (NHS) encourages sites to join clinical trials through core funding.
“Our trial has been adopted by the National Institute for Health Research (NIHR) and is officially approved for certain streams of funding which encourage third parties to get involved,” he added.
Therefore, Krishna told us not getting involved in an outsourcing partnership has accelerated the trial’s timeline and offers “string free results to benefit patients.”
“We can’t afford a contract research organisation (CRO) [to help run the trial. Anything we did with outside parties would have taken quite a lot of time, and we were so keen to test the idea for the benefit of patients that we just wanted to get on with it,” he added.
The NeoART trial is now opening enrolment at St. George’s University hospital, with new partnership centres waiting finalisation of paperwork at Ashford and St Peter’s University Hospitals, as well as Kingston University Hospital NHS Foundation Trusts.
Manufacturing a £0.70 Generic
Krishna explained, “Surgery is the main treatment. So the philosophy is what we’re using this drug for is to 'mop up' the micro-tumors which aren’t detected in the bowel – so the chance of the cancer coming back is reduced”
However, despite this, the drug is not licensed in the UK.
“As an anti-malarial it’s on the prequalification list from the WHO – so it’s okay to use it in malarial endemic areas and we use it for IV treatment of malaria cases. But you can’t just buy it,” Krishna explained.
Therefore, the NeoART trial has commissioned the manufacturing of artesunate and the placebo formulation from the Belgian generics firm DAFRA Pharmaceuticals NV.
Krishna told us the team has the necessary documents in terms of quality of manufacturing that is needed to get approvals from ethics review boards and the UK MHRA.
“We are very small and tight on funds, so at St George’s we have a joint research enterprise office which is the one which helps [with regulations] and also sponsors drug trials,” he added.
‘Mopping up’ microtumors
The two-week trial period for artesunate is carried out during a 62-day waiting period while the patient waits for a definitive treatment following diagnosis, which is when patients are referred for biopsies and colonoscopies.
During this time the drug is trialled as a pre-operative treatment to attempt to reduce the chance of the cancer recurring.
“Most of the drugs managed for bowel cancer are pretty toxic … you’d have to wait six weeks after stopping their use before you’d be able to have the surgery,” Krishna added.
“For artesunate it has a very short half-life and it’s safe, so just two days is needed.”