Clinical Development
Lovaxin C
Cervical and Head and Neck cancers
The first-in-man use of attenuated live Listeria as a cancer vaccine vector was conducted by Advaxis in end-stage (IVb) cervical cancer. The trial was intended to demonstrate the safety of this approach. Although efficacy data was collected, this is a stage of severe cancer in which no therapy has ever had much effect.
Lovaxin C administration was accompanied by a flu-like syndrome in all patients. This constellation of symptoms that includes headache, fever, chills, and so forth is presumed to result from substances released by the immune system in response to infection. When the dose got high enough these symptoms became more severe and limiting, however even at the highest dose tested, no new adverse events occurred other than the cytokine mediated effects which are presumed to underlie innate immunity.
At the time of this writing the data from this trial are being analyzed and will be reported soon. It can be said, however, that Lovaxin C was well tolerated in most patients who received the drug, and that a dose dependent pattern of side effects has been found.