Date: 2015-05-06
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Vaccinogen (USA - MD)
Product: OncoVAX®
Action
mechanism: immunotherapy product/cell therapy. OncoVAX® is an autologous cancer vaccine manufactured with a patented process to leverage a patient’s own tumor cells to launch a potent and customized immune response against residual cancer cells that may reside in the body after surgery. Killing these residual cells is key to preventing the recurrence of the cancer. OncoVAX® is delivered in four doses: the first two include BCG, the last two are simply the cancer cells alone. During the first two injections, a large welt (or induration), forms at the injection site. This is the physical evidence that the patient’s immune system is launching an attack on all the cells: bacteria and cancer. The last two injections also form indurations, a reaction which would not have occurred without the prior “training” injections.
OncoVAX® is a proprietary method for using a patient’s own tumor to prevent cancer from returning after surgery. Once removed, the tumor is taken apart cell by cell and manufactured into an injectable, sterile vaccine. However, simply injecting tumor cells into a patient is not enough to generate a potent immune response against the cancer cells remaining in the body. The vaccine requires an adjuvant, or immune stimulator, to effectively pull the mask off the cancer cells and expose them for what they are: diseased cells which need to be destroyed. In this case, the company uses Bacillus Calmette-Guerin (BCG), a bacterium which tricks the immune system into recognizing previously hidden cancer cells as a foreign invader.
Disease: stage II colon cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: OncoVAX® is the first cancer vaccine that both prevents cancer recurrence and addresses the diversity of cancer cells. In this pivotal randomized, multicenter Phase IIIb study in patients with Stage II colon cancer, OncoVAX is designed to use a patient's own cancer cells to mobilize the body's immune system to prevent the return of colon cancer following surgery. (NCT02448173)
Latest
news: * On May 6, 2015, a Phase 3 trial sponsored by Vaccinogen was published on the NIH website ClinicalTrials.gov for OncoVAX® and is currently recruiting participants.
