Advaxis cancer vaccine shows encouraging results

In the safety study, Advaxis reported treatment of 15 patients in three dosage groups with 30 minute 250ml infusions of Lovaxin C at 3-week intervals. Patients were observed for a total of 111 days. All patients had either advanced, recurrent, or progressive cervical cancer, and with the exception of 2 women, all patients were stage IVb (end stage).

Every patient experienced a flu-like syndrome in the 3-12 hours after dosing comprised of fever, chills, nausea, and occasional vomiting, which is consistent with immune stimulation. In the lower 2 doses, symptoms were well tolerated and resolved with the use of over the counter analgesics and antihistamines.

The end point of the study, safety, was met as the assessments confirmed that Lovaxin C was safe to administer intravenously, that the pattern of adverse responses observed, as previously stated above, were consistent with immune stimulation, and that, for this population of patients, a dosage ceiling was determined.

Dr John Rothman, vice president of clinical development in assessing the trial data, said: “Our long held belief that live Listeria vaccines are safe, even in end stage cancer patients, has been confirmed by this study. We have just entered the age of safe bacterial therapies. This milestone has given us the direction for the continued development of Lovaxin C as well as future therapeutic agents.”