Phase II Clinical Trials Prostate Cancer

In the spring of 2012, SOTIO initiated four Phase II (SP001-SP004) clinical trials to analyze the safety and efficacy of the treatment of prostate cancer at various stages. A fifth clinical trial (SP010) was launched in December 2013. All of these clinical trials were conducted at medical centers in the Czech Republic. Several hundred prostate cancer patients at different stages of the disease were recruited and treated in these trials.

Description of Phase II Clinical Trials (DCVAC/PCa):

Clinical Trial SP001 (Eudra CT: 2011-004735-32) was a randomized, open-label, parallel-group, multi-center Phase II clinical trial of active cellular immunotherapy with DCVAC/PCa in patients with castrate-resistant prostate cancer concurrently treated with docetaxel and prednisone. This clinical trial started in February 2012 and was completed in February 2017. The number of patients randomized was 62. For more information visit www.clinicaltrials.gov.

Clinical Trial SP002 (Eudra CT: 2011-004986-34) was a randomized, open-label, parallel-group, multi-center Phase II clinical trial of active cellular immunotherapy with DCVAC/PCa in combination with hormone therapy in patients with metastatic prostate cancer. This clinical trial started in March 2012 and was completed in June 2016. The number of patients randomized was 63. For more information visit www.clinicaltrials.gov.

Clinical Trial SP003 (Eudra CT: 2011-004985-14) was a randomized, open-label, parallel-group, multi-center Phase II clinical trial of active cellular immunotherapy with DCVAC/PCa in patients with localized prostate cancer after primary radical prostatectomy. This clinical trial started in April 2012 and was completed in May 2017. The number of patients randomized was 150. For more information visit www.clinicaltrials.gov.

Clinical Trial SP004 (Eudra CT: 2011-004967-65) is a randomized, open-label, parallel-group, multi-center Phase II clinical trial of active cellular immunotherapy with DCVAC/PCa in patients with localized high-risk prostate cancer after primary radiotherapy. This clinical trial started in March 2012, recruitment was completed, and the number of patients randomized was 62. For more information visit www.clinicaltrials.gov.

Clinical Trial SP010 (Eudra CT: 2013-003809-26) was an open-label, one-arm, multi-center Phase II clinical trial with second cycle of active cellular immunotherapy DCVAC/PCa in patients with localized prostate cancer after primary radical prostatectomy and without objective progression on the first cycle of DCVAC/PCa. This clinical trial started in December 2013 and was completed in March 2017. The number of enrolled patients was 23. For more information visit www.clinicaltrials.gov.

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