ValiRx is extending its early stage trial of a prostate cancer drug, VAL201, after demonstrating disease stabilization, with a lower dose than was predicted by its preclinical evaluations.
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The therapeutic compound was studied for its safety and tolerability and was found to have stabilized the disease on CT imaging in a majority of patients in the trial who also had a decrease in the PSA progression.
ValiRx CEO Satu Vainikka said: “We anticipate that by increasing the dosage we will show a high level of efficacy without compromising the safety and tolerability shown to date to meet the needs of those patients currently under-served by current therapies.
"ValiRx is entering a very exciting phase, which should result in the crystallisation of substantial value".
The company said unlike the present therapies available for advanced prostate cancer, VAL201 doesn’t feature androgen deprivation.
Intended to target a particular pathway from the androgen receptor, VAL201 is said to treat the cancer without several debilitating side effects that most therapies otherwise have which include suppressing of sexual and other functions.
Based on the positive results of the Phase l/II study, ValiRX will add more clinical sites to take part in the next phase of study which is therapeutically relevant and includes escalation of the dosage.
The next phase of the trial will either be carried forward by ValiRx or a partner to result into larger, outcomes-oriented clinical studies aimed at establishing VAL201’s effect on overall survival and health-related quality of life in prostate cancer patients.