21st Mar 2019 09:53
LONDON (Alliance News) - ValiRx PLC on Thursday said an interim inspection of its VAL201 early phase cancer trial shows the drug is performing as predicted.
Shares in ValiRx were up 13% at 0.56 pence on Thursday morning.
VAL201 is currently in its phase one/two clinical trial at University College London hospital as a treatment for advanced prostate cancer and other hormone-induced unregulated growth.
Thus far, the trial has shown VAL201 has been shown to be safe and well-tolerated at doses of up to 4 milligrams per kilogram of body weight, with primary evidence of the drug's activity in prostate cancer having already been seen.
The trial has been extended to a dose calculation of up to 16 milligrams per kilogram and is now progressing with a goal of determining the maximum dose that can be tolerated in humans.
"An interim inspection of the trial's output indicates that the compound is and continues to perform as predicted from the pre-clinical findings," said ValiRx.
Results from the trial are expected at the end of the first half of 2019, with analysis due to start in the third quarter.
The dosing trial is required in order to being pre-market authorisation efficacy studies, and its results will be used to determine whether ValiRx should find a partner or licencing deal with a pharma company, or whether it should move to the next phase of trials.
Another ValiRx drug, VAL301, is currently in late-stage pre-clinical development to treat endometriosis. VAL301 is derived from VAL201 and is expected to have the same mode of action.
Endometriosis, a major cause of female infertility, is characterised by the presence of endometrial-like tissue outside of the uterus. In pre-clinical studied, VAL301 reduced endometrial lesions by as much as 50% without side effects like loss of bone density or infertility.
Chief Executive Satu Vainikka said: "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".
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