VAL201, the AIM company’s leading anti-cancer therapy, is currently going through a Phase I/II clinical trial at University College London Hospital for the treatment of advanced prostate cancer.
So far, the compound has shown that not only is it safe and well-tolerated in doses up to 4mg/kg, but that there is also “primary evidence of the drug’s activity in prostate cancer”.
Since the trial was extended at the end of 2017, researchers have been increasing the dose to find the maximum amount that humans can tolerate.
This part of the study is in “the concluding stages” and ValiRx expects to have the results at the end of the first half, after which it will decide how it moves forward.
Seeking a partner, licensing the drug to a pharma company and taking VAL201 through a Phase IIb/III trial on its own, all remain on the table.
VAL301 ‘well-placed’ for further development
ValiRx has reformulated VAL201 to make VAL301, a treatment for endometriosis that is currently in late-stage pre-clinical development.
Data so far, though, has shown that it has the potential to reduce endometrial lesions by as much as 50% and the company believes it is “well-placed for further study as a potential treatment”.
Pre-clinical studies have also shown that VAL301 can potentially treat endometriosis without side effects such as loss of bone density and fertility.
“This additional advantage represents a potentially significant further break-through development in the medical treatment for this illness and for other gynaecological conditions,” said ValiRx.
Boss ‘delighted with progress’
Chief executive Satu Vainikka added: “The pre-clinical and clinical development of the VAL201 compound is very encouraging and from scientific and therapeutic perspectives, we look forward keenly to examining both the trial's results and analysis later this year and the opportunities for VAL201's further development and commercialisation.
“As with any small biotechnology company such as ValiRx, its patent portfolio and trial results represent its main assets and value drivers.
“I am delighted therefore with the solid foundation our global patent protection and trial progress represents, which will I am confident be of future benefit to all patients and stakeholders.”
In afternoon trading, ValiRx shares were over 8% higher at 0.54p.
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