dm+d

Unassigned

New Medicines

Metastatic castration resistant prostate cancer - with chemotherapy

Information

New molecular entity
Sotio
Sotio

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
May 21Sotio currently has no plans to file to the MHRA as stapuldencel-T failed to reach the primary endpoint in the pivotal PIII trial [5].
Jan 20SOTIO, a biotechnology company owned by the PPF Group, announces the opening of offices of SOTIO Biotech AG at the Technology Park Basel, Switzerland. The SOTIO office will host the clinical development team, as well as other functions to progress its broad clinical development pipeline towards filing for marketing authorisation and commercial launch [4].

Category

An active cellular immunotherapy (ACI) comprised of autologous dendritic cells pulsed with prostate cancer cells. Manufactured by selectively extracting leukocytes, by leukapheresis, from patients blood and isolating & cultivating immature dendritic cells
Prostate cancer is the most common cancer in men and makes up 26% of all male cancer diagnoses in the UK. The age-standardised incidence of prostate cancer in England in 2016 was 173.7 per 100,000 in 2016 [1].
Metastatic castration resistant prostate cancer - with chemotherapy
Subcutaneous injection

Trial or other data

Jan 21Results of PIII VIABLE study submitted to US trial registry but have not yet been announced [2,4].
Jan 20PIII VIABLE study completes [2].
Apr 17Sotio completes the SP001 trial that evaluated stapuldencel-T, in combination with chemotherapy, in 60 patients with castrate-resistant, metastatic prostate cancer in the Czechia (NCT02105675). The purpose of this study is to determine whether DCVAC/PCa added onto standard of care therapy can improve survival rate [2,3].
Apr 14PIII VIABLE trial to evaluate the efficacy and safety of stapuldencel-T versus placebo, in combination with first-line chemotherapy, in patients with metastatic, castration-resistant prostate cancer starts (SP005; NCT02111577). The purpose of this study is to determine whether DCVAC/PCa added onto standard of care therapy can improve survival rate. 1,182 adult men will be recruited in countries including the UK, Europe and US. UK sites include The Clatterbridge Cancer Centre, University Hospitals Birmingham NHS Foundation Trust, Bristol Haematology and Oncology Centre, Cambridge University Hospitals NHS Foundation Trust, Royal Free Hospital London, The Royal Marsden NHS Foundation Trust, The Christie NHS Foundation Trust and the Northern Centre for Cancer Care, Freeman Hospital. Collection of primary outcome data is due to complete Dec 19 [2].