ValiRx PLC (LON:VAL) chief executive Dr Satu Vainikka said the company was entering a “new and exciting phase” after being given the go-ahead by regulators to expand and accelerate its early-stage cancer study.
The Medicines and Healthcare Regulator Agency and Research Ethics Committee are allowing the researchers to substantially raise the dosing of VAL201, a treatment for metastatic prostate cancer and other solid tumours.
It will do this to find the correct therapeutic levels of treatment to administer in order to try to stop the disease’s spread.
The change to the Phase I/II dose escalation study will also help ValiRx assess at what stage of the cancer’s progression VAL201 is most effective.
This in turn will allow the drug developer to plan “larger, outcome-oriented clinical trials”.
It will also help determine which route and with whom to take the project to its next stage. In other words, does it go-it-alone in the next phase, or partner with a company with deeper pockets?
Safe and well tolerated
The decision to accelerate the process follows on the back of data which showed VAL201 was extremely safe and well tolerated during the first stage of clinical development.
CEO Vainikka called the fast-track approval a “substantial breakthrough”.
“Since VAL201 has demonstrated disease stabilisation, with a lower dose than was predicted, we anticipate that by increasing the dosage we will be able to see further anti-cancer activity,” she explained.
“This accelerated study will speed-up the human development of the compound and by doing so, it will save both time and money.
“Most importantly, this potential treatment will more speedily meet the needs of those patients currently under-served by existing therapies.
“The pharmaceutical industry is increasingly looking for novel new therapies in the oncology arena."
Large potential market
Certainly, the drug, if successful, has the blockbuster potential as it is tapping into a market worth US$8.2bn annually.
The latest success follows hard on the heels of a good news update last week from ValiRx on its other main compound, VAL401.
In a Phase II lung cancer trial, the drug delivered a “statistically significant” improvement in overall survival for patients with non-small cell lung cancer compared to those receiving no treatment.
The company had previously reported back in September that 2mg doses of VAL401 were “broadly safe and tolerated”, while the treatment also demonstrated “suitability of our proposed treatment paradigm”.
More in the pipeline
ValiRx is also developing 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.
Its work to date 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.
In September, ValiRx said it would accelerate the pre-clinical trials of its VAL101 molecule after making a breakthrough with its development.
Based on ValiRx’s proprietary GeneICE platform, it works by switching off the gene that expresses Bcl-2 – a protein that is implicated in about half of all carcinoma cancers.
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.
In today’s statement, boss Vainikka said: “We are entering a new and very exciting phase, which should result in the crystallisation of substantial value.”
At 12.45pm, the shares were up 24% and changing hands for 6.83p each and have increased in value by 638% in the last month.