SOTIO receives EMA approval

March 28, 2013

SOTIO receives European Medicines Agency approval to initiate Phase III VIABLE Clinical Trial of DCVAC/PCa, an active cellular immunotherapy drug targeted for prostate cancer patients. Lead Candidate from SOTIO’s DCVAC program.

SOTIO announced that it has received approval from the European Medicines Agency (EMA) via the Voluntary Harmonization Procedure (VHP) to initiate the Phase III VIABLE clinical trial to assess the safety and efficacy of DCVAC/PCa as add on therapy to 1st line standard of care (SOC) chemotherapy (Docetaxel +Prednisone) in men with metastatic castration resistant Prostate Cancer (mCRPC). The approval process was divided into two parts: the clinical, where the regulator assessed the protocol of the Phase III VIABLE clinical trial, and the manufacturing, where it analyzed the quality of the manufacturing procedure. Throughout the process, the European Medicines Agency held above all the objective of ensuring patient safety as regards both the tested drug and the therapeutic procedure.

The Phase III VIABLE clinical trial will assess overall survival (OS) of mCRPC patients treated with DCVAC/PCa versus SOC alone. DCVAC/PCa is the first SOTIO product candidate to enter clinical evaluations. Docetaxel is the active ingredient in Taxotere®, which is approved in major cancer indications, including breast, prostate and lung.

Following approval by national regulators and ethics committees in the following European countries: Belgium, Bulgaria, Czech Republic, France, Italy, Hungary, Germany, Netherlands, Portugal, Austria, Spain, Sweden, and the UK (via the VHP process) and in Croatia, Poland, Serbia, and Turkey (via the standard process) patients can be recruited for clinical evaluations.

In addition, SOTIO plans to file an application for approval of the Phase III VIABLE clinical trial in the United States, with the Food and Drug Administration (FDA), within the second quarter of the year. SOTIO expects enrollment of the first patients to initiate in the trial in the second half of 2013. Altogether 1,170 prostate cancer patients from Europe and the US will be enrolled into the trial.

Description of the clinical trial
SP005 VIABLE (Eudra CT: 2012-002814-38): A randomized, double-blind, multi-center parallel-group Phase III study designed to assess the efficacy and safety of the DCVAC/PCa drug, in comparison with a placebo, in men with metastatic castration-resistant prostate cancer indicated for chemotherapy.

Short Title
A Phase III study 1st line chemotherapy (Docetaxel+Prednisone) with or without DCVAC/PCa in Men with Metastatic Castration Resistant Prostate Cancer.

The active cellular immunotherapy drug being evaluated; it is intended for prostate cancer patients; DCVAC/PCa is produced individually for each patient; it contains dendritic cells (that are part of the immune system), which induce an immune reaction against a broad range of tumor antigens.