Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, Ltd., an Israeli biotechnology company, will test his proprietary anti-cancer vaccine AlloVaxTM in patients with refractory hepatocellular carcinoma (HCC). Dr. Michael Har-Noy says that the ultimate purpose of this study is to ascertain the safety of the vaccine in these metastatic cancer patients. The study will also measure the immunological, pathological, and radiological effects of AlloVaxTM in patients with refractory HCC who are not eligible for any currently available HCC treatments or in whom such approved treatments have failed. Dr. Michael Har-Noy indicates that his AlloVaxTM product is a personalized anti-tumor vaccine that combines Chaperone Rich Cell Lysate (CRCL), an antigen source prepared from the patient’s tumor, with AlloStimTM, his company’s flagship product. The combination of these two compounds forms a vaccine that stimulates the patient’s immune response to seek out and eradicate malignant cells.

This study’s primary outcome measure, says Dr. Michael Har-Noy, will be to assess any laboratory abnormalities and/or adverse events associated with AlloVaxTM administration. He says that this is, in fact, a preliminary safety trial. The secondary outcome parameters will be to assess whether AlloVaxTM elicits any detectable tumor-specific immunity, and to measure the concentrations of various biomarkers at different time points in the study protocol. Dr. Michael Har-Noy notes that other outcome measures tracked by the study will be any radiologic and pathologic evidence of an immune-mediated anti-tumor response, as well as overall patient survival.

Dr. Michael Har-Noy says that all study patients will undergo tumor harvesting. The tumor samples will be made into personalized CRCL vaccine for each patient. Dr. Michael Har-Noy goes on to detail that the study will consist of three separate phases: the priming, vaccination, and activation phases. Intradermal AlloStimTM is given to each patient during the priming phase. The purpose of this is to increase the titer of circulating Th1 cells. Next, says Dr. Michael Har-Noy, the vaccination phase, consisting of intradermal injections of both AlloStimTM and CRCL, is tailored to produce a tumor-specific immune response. Lastly, patients will be subjected to the activation phase of the protocol. Dr. Michael Har-Noy says that this phase involves intravenous AlloStimTM infusion, and is designed to activate natural killer and memory cells and stimulate them to migrate to tumor sites.

Dr. Michael Har-Noy goes on to describe the details of the experimental protocol. One milliliter of AlloStimTM will be injected intradermally (ID) into each study patient on days four and seven. Then, one milliliter of CRCL will be given ID in the same left arm location on days 11 and 14 and then again in the same right arm location on days 18 and 21. Then, says Dr. Michael Har-Noy, five milliliters of intravenous AlloStimTM and a CRCL intradermal injection will both be administered to each study patient on day 27 of the protocol.