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http://www.pharmatimes.com/magazine/2018/october_2018/ai_has_arrived
Confirmation was received this week that Principal Investigators have approved and signed the Clinical Study Report and that the process of submission to and approval by the local ethics committees has commenced. Notification of receipt of the Clinical Study report was filed to the Ministry of Health in Tbilisi, before the end of July 2018 in accordance with regulatory expectations.
Commercial activity surrounding VAL401 has continued. Detailed discussions are in progress in respect to a pivotal Phase III Clinical Trial. Partners external to ValiRx and ValiSeek will have substantial input into the trial design, with first dosing anticipated next year.
VAL201
(VAL201 is currently in Phase I/II clinical trials for patients affected by hormone- sensitive and hormone-resistant prostate cancer.)
The VAL201 compound has demonstrated consistent high safety and tolerability, and signs of efficacy throughout its clinical study. A preliminary inspection of the clinical data derived from the original dosing regimen has been completed regarding all the subjects that have been treated to date. This inspection considered all dosing regimens. In summary, our preliminary observations highlight a dose-related impact on patients' physiology and chemistry, such as androgen PSA and various cell and protein turnover factors, which are important in the treatment of cancer. These are in line with anticipated outcomes as far as cancer reduction is concerned.
With this trial now successfully completed, a further commercial arrangement is under negotiation with parties to run the final required trial, with possibilities still available for inward investment in exchange for regional commercialisation rights, equity positions in ValiSeek, or options for future commercial rights.
https://www.scitecheuropa.eu/lung-cancer-therapeutics-valiseek/88655/