AVAX Technologies, Inc., has announced the results of the Phase 1/2 study evaluating the safety of its autologous cell vaccine, OVAX, in the treatment of patients with advanced ovarian cancer.
The clinical trial (NCT00660101), which is gathering follow-up data on patients, was designed as a multicenter, three-dose regimen study in patients with stage 3 or 4 ovarian cancer who have relapsed and are chemotherapy resistant. The study’s main endpoints are evidence of treatment-related adverse events, serious adverse events, and delayed-type hypersensitivity (DTH) response, used as the primary measure of the ability to immunize a patient to a specific tumor antigen or tumor cell with DNP-modified and unmodified autologous ovarian cancer cells. CA-125 (cancer antigen 125) levels, a marker for ovarian cancer, and patient survival were also measured.
Of the 34 patients enrolled in the study and treated, two were lost to follow-up. Twelve of the 34 patients are alive in the follow-up, eight for more than three years. The median survival was determined to be 22.7 months and, importantly, no treatment-related serious adverse events were observed. The company reported that it is optimistic about the results and, once completed, plans to submit them to the U.S. Food and Drug Administration to support its application for a subsequent Phase 2 or Phase 3 clinical trial.
“This study indicates that OVAX can be safely administered to patients with advanced ovarian cancer. We are also encouraged by the survival results, which appear promising in this group of very advanced ovarian cancer patients whose tumors were resistant to standard chemotherapy,” Dr. David Berd, chief medical officer of AVAX Technologies, said in a press release.
Cancer Genetics, Inc., (CGI), a biotech firm focused on personalized medicine and immuno-oncology, reports the launch of its portfolio of comprehensive new tests and technologies to help measure and monitor immuno-oncology markers, and to select patients for targeted therapies. CGI’s portfolio includes immunohistochemistry (IHC)-based tests that can detect biomarkers like PD-1 and PD-L1, and flow cytometry-based tests and panels that can assess immune response against cancers by evaluating subsets of immunomodulatory and effector cells. CGI’s portfolio will be available for clinical trials, patient care, and translational research at the company’s facilities in Rutherford, New Jersey, and Los Angeles.