Download Sydys Corp. Announces Publication of Phase 2b CVac™ Data

 Sydys Corp. Announces Publication of Phase 2b CVac™ Data
Against Ovarian Cancer in Journal for ImmunoTherapy of Cancer
Data Demonstrate Significant Overall and Progression Free Survival
Improvements in Second Remission Ovarian Cancer Patients
Seattle, Washington – May 17th, 2016 – 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;
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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 immunooncology 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. Forwardlooking 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.
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