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Advaxis, Inc. phase I/II results of lovaxin C in cervical cancer study released
Date:10/10/2007

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 fiv
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Contact: Janet Vasquez
janet@investorrelationsgroup.com
212-825-3210
Advaxis, Inc.
Source:Eurekalert

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