PHOENIX, USA
Die Studie Vaccine Against Canine Cancer Study (VACCS) (www.vaccs.org) reported on their formal biennial safety assessment of a vaccine for the prevention of cancer in healthy dogs. The largest canine cancer clinical trial is sponsored by the Open Philanthropy Project, with additional support from Calviri, Inc., a biotechnology spin-off from Arizona State University (ASU).
The VACCS trial intends to enroll up to 800 dogs in an equal-armed, double-blind clinical trial of the vaccine versus a sham vaccine. The Data Safety Monitoring Board (DSMB) for the VACCS study is led by Dr. Rod Page, director of the Flint Animal Cancer Center at Colorado State University (CSU). The DSMB evaluated the clinical records of over 600 dogs in the study, 300 of whom received the vaccine with an annual booster, after two years. The DSMB concluded that none of the study arms had any serious adverse events related to the vaccination protocol.
“This is an important milestone in the development of a preventive vaccine,” said Stephen Albert Johnston, co-inventor of the vaccine and founding chairman of Calviri. “One of the criticisms of these vaccine efforts, besides the unlikelyness that the vaccine would work, was that it could trigger autoimmune reactions. The DSMB comes to the conclusion that there is no cause for concern with the more than 300 dogs vaccinated so far. ”
“The VACCS study collects extensive clinical data on the participating dogs. Two independent veterinary oncologists and I checked the data and found no evidence of safety concerns. The dogs in the study are 6 to 11 years old at the time of enrollment, so many of them may develop various types of age-related illnesses sooner or later, but there was no evidence of serious effects from the vaccine, “Page said.
“This study provides a wealth of other information besides testing the vaccine,” said Dr. Douglas Thamm, clinical director of the study and professor of oncology at the CSU Flint Animal Cancer Center. “For example, we see a higher percentage of dogs with early-stage tumors than late-stage tumors than is seen in normal practice. We think this may be due in part to the regular six month checkups the dogs receive. ”
Entry into the study is expected to be completed by the end of the year. The safety and effectiveness are assessed every year. “Due to the latency period for tumor detection, we do not expect the tumor incidence to decline until after the second year, the primary clinical endpoint if the vaccine has a preventive effect. We continue to enjoy this study in our mission to end cancer deaths. We thank the dogs and owners who participated in this groundbreaking clinical trial, ”said Marc Wolff, CEO of Calviri, Inc.
Via Flint Animal Cancer Center
The Flint Animal Cancer Center’s mission is to improve the prevention, diagnosis and treatment of cancers in pets and to transfer research and knowledge for the benefit of human cancer patients as well. The center offers the latest and most advanced diagnostics and treatment in surgery, chemotherapy and radiation therapy. It accomplishes its mission through innovative cancer study, prudent and compassionate care and care, specialized treatment options and procedures. The Flint Animal Cancer Center continues to pursue a cure for cancer through its oncology clinical services, clinical trials, advanced clinical and research training for veterinarians, innovative research, and specialized counseling services available to clients and referring veterinarians. For more information, see www.csuanimalcancercenter.org.
About Calviri, Inc.
Calviri is a biotech whose mission is to offer a wide range of fundamentally different vaccines and companion diagnostics for the prevention and treatment of cancer in at-risk or diagnosed patients. Calviri is focused on using frameshift neoantigens, derived from errors in RNA processing, to provide breakthrough anti-cancer products. The company is a spin-off from the Biodesign Institute of Arizona State University (ASU). For more information, see www.calviri.com.
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Marc Wolff
[email protected]
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