Its lung cancer candidate, VAL401, finished the recruitment phase of its phase II trial back in June and this week the company also announced it had completed the dosing phase.
The study remains on track to be completed by the end of this year, which will then be followed by the processing of the data to determine VAL401’s potential positive impact on patient quality of life.
The ongoing phase I/II trial of ValiRx’s lead compound, VAL201, has demonstrated safety and tolerability with “signs of activity” in patients with advanced prostate cancer.
As for VAL301 – which is essentially a slight tweaking to VAL201 and is initially being developed to treat endometriosis – it is currently in the late pre-clinical trial phase.
Those studies have shown that the drug has minimal impact on bone density or fertility – two common problems with standard treatments – and the plan is to get the necessary regulatory approvals to move 301 into the clinic next year.
Clinical trials of VAL101 to be accelerated
Earlier this month, ValiRx said it will accelerate the pre-clinical trials of its VAL101 molecule after making a breakthrough with its development.
VAL101 is based on ValiRx’s proprietary GeneICE platform and works by switching off the gene that expresses Bcl-2 – a protein that is implicated in about half of all carcinoma cancers.
READ: ValiRx to accelerate pre-clinical trials of cancer-fighting molecule after development breakthrough
The first generation of the molecule was successful in reducing Bcl-2 and killing the cancer cells but it needed a few tweaks here and there to make it ready for commercial production.
ValiRx went away and developed an optimised second generation, which has shown “improved technical efficacy and commercially viable efficient manufacturing” whilst still reducing Bcl-2.
The plan here is to get the pre-clinical studies completed and prepare for the compound’s entry into the clinic.
Management pleased with progress
"We have seen considerable progress across our therapeutic portfolio in the last six months, adding value to the company's assets and bringing us closer to the point where our clinical programmes for VAL201 and VAL401 will deliver meaningful data and will bring the Company closer to finding a partner,” said non-executive chairman Oliver de Giogio-Miller.
“I am pleased with the momentum generated as we move towards clinical developmental milestones and potential value inflection points for VAL401 and VAL201 as we approach the year-end. "
He added: “Our portfolio of therapeutic drugs collectively address multi-billion dollar markets and meet significant unmet need.
“I therefore strongly believe that ValiRx and its assets offer investors or joint venture partners an increasingly attractive and investable proposition as we strengthen our position among frontrunners in the fields of personalised and precision medicine."
Losses narrowed slightly
Given that ValiRx is in the pre-revenue stage, it recorded a loss after tax of £2.06mln in the six months to 30 June (H1 2016: £2.12mln).
After a £1.6mln fundraise back in March, the company has £383,500 in cash and cash equivalents (H1 2016: £568,800).