Sareum Holdings Plc (LON:SAR) shares shot up nearly 35% today as the cancer drug specialist received the regulatory green light for clinical trials of its candidate CCT245737.
The go-ahead from the UK Medicines and Healthcare products Regulatory Agency (MHRA) means that subject to final approval from the NHS, clinical studies are expected to begin in the second quarter of 2016.
The main centre for the trials will be the Royal Marsden hospital in London.
Chief executive Dr Tim Mitchell told investors: "This approval for CCT245737 is another significant milestone along its path to being the first from our development pipeline to enter clinical trials."
Speaking to Proactive, the company boss added there was a "world of difference" between first stage testing of a candidate to a trial with humans."
"It's a step on the way to getting the drug firmly into patients," he said.
Studies have shown that oral dosing of CCT245737 can boost the activity of relevant chemotherapies to combat lung, pancreatic and colon cancers.
Chemotherapy aims to shrink tumours and cause DNA damage to cancer cells but unfortunately cancer cells are able to repair damage at certain points or checkpoints.
Sareum's candidate disrupts these checkpoints and improves the extent of death to the cells caused by chemotherapy.
Planned are two Phase I clinical trials in cancer patients in collaboration with co-development partner the CRT Pioneer Fund.
One trial will use CCT245737 in combination with standard-of-care chemotherapy and will ultimately target lung and pancreatic cancer patients.
The other trial will use CCT245737 as a single anti-cancer agent and will initially target various cancers.
Mitchell explained how he expected first patients to be dosed in the second quarter with the main aim of the first phase to test safety, tolerability and to establish a maximum dose tolerance, which could take a couple of years.
A phase II trial would dose more patients and look at efficacy, he added.
Longer term, Sareum will not take the drugs to market itself.
"Our goal is to license the programme to one of the major pharmaceutical companies any time from now really," said Mitchell.
Also by the end of this year, the firm hopes to complete pre-clinical studies on the Aurora+FLT3 programme targeting acute myelogenous leukaemia (AML) and other blood cancers.
On its TYK2 (tyrosine kinase 2) inhibitors there should be more data forthcoming and Mitchell said the firm may have selected a candidate for pre-clinical by the end of the year.
Today, shares in the group gained 34.97% to stand at 0.965p.
---UPDATES WITH SHARE PRICE AND CEO COMMENT---