Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, Ltd., tells us that the vaccination process of the Chaperone Rich Cell Lysate (CRCL)-AlloVaxTM study protocol involves the intradermal administration of AlloStimTM to the patient, followed immediately by the intradermal injection of CRCL at the same location on the skin. The first injection is given on day 11 of the protocol. Then, says Dr. Michael Har-Noy, three days afterward (day 14 of the study protocol), an additional intradermal dose of AlloStim™ is given in the same location, followed immediately by another CRCL dose. This two day vaccination protocol is then repeated in a new location on day 18 of the protocol, when AlloStim™ is again injected intradermally and is again followed by a CRCL dose. Lastly, says Dr. Michael Har-noy, the process is repeated a fourth time on day 21. This time, the AlloStimTM is injected and then followed by CRCL, both given at the same location as on day 18.
Dr. Michael Har-Noy says that the AlloStim™ and CRCL intradermal injection site is photographed before and after each dose is administered. Usually, swelling and redness occurs at the injection site, indicating that cellular immunity is present and active. This immune response to the injections is classified as a "Delayed Type Hypersensitivity" reaction or "DTH" response. Thus, says Dr. Michael Har-Noy, by measuring the size of the redness around the rejection site, one can visibly confirm that the vaccination phase was effective.
Dr. Michael Har-Noy adds that on the 25th day of the study protocol, the DTH response is used to determine if the patient has mounted a cellular immune response to both the foreign antigens in AlloStim™ and the tumor antigens in the CRCL. To determine if these responses have indeed occurred, first AlloStim™ is injected intradermally in one location and then CRCL alone without AlloStim™ is given intradermally in a second area. Dr. Michael Har-Noy says that within 48 hours of these separate AlloStim™ and CRCL injections, a DTH response should be seen at both locations, thus indicating that successful induction of the patient's cellular immunity has occurred.
Please visit www.immunocare.net for more information about Dr. Michael Har-Noy's phase I/II CRCL-AlloVaxTM study protocol and his Compassionate Use program in Bangkok, Thailand.