SEATTLE, May 18, 2016 (GLOBE NEWSWIRE) -- Sydys Corporation (OTCQB:SYYC), a clinical stage biotechnology company focused on the development of immunotherapies, today announced the publication of findings from a study demonstrating the potential of CVac™ in ovarian cancer in the Journal for ImmunoTherapy of Cancer.
The study entitled “Progression-free and overall survival in ovarian cancer patients treated with CVac™, a mucin 1 dendritic cell therapy in a randomized Phase 2b trial was led by Dr Heidi Gray at the University of Washington Medical Center, WA, USA with Dr Jeffrey C Goh of Greenslopes Private Hospital, Queensland, Australia and included several universities and institutions in the United States and Australia (NCT01068509), including;
- Scripps Cancer Center, San Diego, CA
- Peter MacCallum Cancer Centre, East Melbourne Vic, Australia
- Cleveland Clinic Foundation, Cleveland, OH
- Duke Cancer Institute, Duke University Health System, Durham, NC
- University of California, San Francisco & Sutter Health Research Institute, San Francisco, CA
- Stanford University Cancer Institute, Stanford, CA
The publication outlines results obtained from a Phase 2b clinical trial evaluating the safety, efficacy and immune outcomes of CVac™ in patients with advanced epithelial ovarian cancer.
The randomized, open label trial enrolled 56 patients undergoing first or second clinical remission. Twenty seven patients received the standard of care, while 20 patients received CVac™, a mucin 1 targeted-dendritic cell (DC) treatment as a maintenance therapy, over a period of 56 weeks. The primary endpoint was efficacy measure through progression free survival (PFS), while the secondary endpoint included overall survival (OS).
The findings obtained from the study demonstrated that CVac™ was safe and well tolerated in ovarian cancer patients.
Sub group analysis of patients with second clinical remission (CR2) cohort showed PFS for patients treated with CVac™ was greater than 13 months compared to 5 months for the standard of care group. Similarly, sub-analysis of remission status in CR2 patients at 42 months of follow up exhibited that patients receiving standard of care had attained a median OS of 26 months, while patients treated with CVac™ had not reached median OS, suggesting an extension of more than 16 months of life for patients being treated with CVac™.
Joseph Hernandez, Executive Chairman of Sydys Corporation, commented, “Advanced epithelial ovarian cancer signifies a compelling unmet medical need as more than 70% of patients develop recurrent disease. Mucin proteins, specifically epithelial mucin surface antigen 1, represent a promising target for immunotherapy. We are very pleased with the encouraging data generated from this study. Peer reviewed publications, such as in Journal for ImmunoTherapy of Cancer, continue to add immense validation and support the potential of our lead program. These important data provide the basis for further development of the therapy.”
Dr. Heidi Gray, Associate Professor in Gynecologic Oncology at University of Washington (UW), added, “This study will be instrumental in advancing our understanding of CVac’s role and ability to target mucin 1 proteins that are overexpressed in late stage epithelial ovarian cancer. We believe that CVac™ immunotherapy has the potential to exhibit both PFS and OS benefit in patients with advanced epithelial ovarian cancer, which continues to be a major unmet medical need.”
CVac™ has been granted Fast Track and Orphan Designation by the FDA. The company intends to initiate registration studies in advanced ovarian cancer.
About Sydys Corporation
Sydys Corp. is a globally active, publicly traded biotechnology company developing immuno-oncology products including an autologous dendritic cell immunotherapy that recently completed Phase II trials for ovarian cancer. That trial generated clinically meaningful progression free survival (PFS) and overall survival (OS) data. More information is available at www.sydyscorp.com.
Sydys Corp. Forward-Looking Statements
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Sydys Corp. business and Sydys Corp. undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.