LYON, France & NORTH BRUNSWICK, N.J.--(October 10, 2007)--World Vaccine Congress: A first-in-man trial of a live Listeria vaccine was reported by Advaxis Inc. (OTCBB: ADXS - News). The Phase I/II trial was testing Lovaxin C in advanced cervical cancer patients. Lovaxin C is being developed by Advaxis as an immunotherapy that is intended to treat patients with cancers that result from human papilloma virus (HPV), including cervical cancer and head and neck cancer.
In the safety study, Advaxis reported treating fifteen patients in three dosage groups with thirty-minute 250 ml infusions of Lovaxin C at three-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 two women, all patients were stage IVb (end stage). Every patient experienced a flu-like syndrome in the three-to-twelve hours after dosing comprised of fever, chills, nausea, and occasional vomiting, which is consistent with immune stimulation. In the lower two doses, symptoms were well tolerated and resolved with the use of over the counter analgesics and antihistamines. In the highest cohort the pattern of symptoms was the same, however more severe and dose limiting; which required that the study be stopped at that point as a dosage ceiling was defined. The endpoint 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.
Although efficacy was not a primary endpoint anecdotal information was obtained. Patients' tumors were assessed by CT scans and any tumor changes were scored using RECIST criteria. Two patients had only a single tumor measurement, making the assessable efficacy population thirteen patients. It was observed that five patients progressed, seven patients were stable (defined by RECIST as changes in tumor sizes of under 30%), and one patient had a reduction of her tumor burden by 32%, qualifying as an objective partial response. Of the seven stable patients, three had reductions in their tumor mass subsequent to treatment. While most lesions increased in size, tumor reduction was seen in a number of lesions and two tumors disappeared completely. One patient, who was staged at IVb, had failed two prior courses of chemotherapy and one course of radiation. After treatment, she was deemed sufficiently healthy to resume chemotherapy and was removed from the trial early for this purpose. Following additional chemotherapy and surgery she is currently tumor free, with normal hematologic function, and all laboratories within normal limits.
"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," said Dr. John Rothman, VP of Clinical Development in assessing the trial data.
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