Ayala Pharmaceuticals Inc (fka ADXS)

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ADXS has traded as high as .40 cents today, a new 52 week high. News out today: Advaxis To Enter Fourth Cohort Of Patient Dosing In Cervical Cancer Treatment Trial

Apr 17, 2007 (financialwire.net via COMTEX) -- April 17, 2007 (FinancialWire) Advaxis Inc. (OTCBB: ADXS) has completed the enrollment and dosing of the third cohort of patients diagnosed with advanced, recurrent, or progressive cervical cancer in its phase I/II clinical trial of Lovaxin C. The current assessment by an independent safety panel has found that Lovaxin C, a modified Listeria-based live vaccine, is safe, even in end-stage cancer patients, and dose escalation is ongoing.
The trial is currently designed to test four different doses in cohorts of five patients. Side effects experienced by patients included transient mild-moderate fever and chills and transient nausea, all of which usually resolved within hours of dosing. Advaxis has now begun the dosing in the fourth and last cohort of patients. The company is required to have the results of each dosing from each cohort reviewed by the committee prior to continuing the study and increasing the dosage in patients. The primary endpoint of this work, which is being conducted in Israel, Serbia, and Mexico, is to establish a maximal safe dose of Lovaxin C.

This is the first human study by Advaxis in its development of a new class of cancer therapies using the company's broadly enabling Listeria technology platform. These therapies use modified Listeria to deliver tumor-specific antigen fusion proteins, which have the ability to generate a robust immune response involving simultaneous and multiple integrated immune mechanisms to produce an unusually strong and effective therapeutic immune response to existing cancers and other diseases. Unlike current products on the market, which are ineffective in women already infected with the human papilloma virus, the cause of cervical cancer, Lovaxin C is designed to treat women who have already developed this cancer as a result of the infection