Immunomic Therapeutics, Inc., ("ITI," Lancaster, PA) a leader in developing novel allergy immunotherapies, announced today that it has dosed the first patient in a Phase I clinical trial of its lead candidate, JRC-LAMP-vax™ vaccine, at its clinical site in Honolulu, Hawaii. Initial subjects include Japanese ex-patriates previously exposed to Japanese red cedar, or "Sugi," as it is known in Japan. JRC-LAMP-vax vaccine is a plasmid-based DNA vaccine that will be studied for its safety and immunological activity in the treatment of patients with rhino-conjunctivitis symptoms caused by allergic reaction to Japanese red cedar pollen. Enrollees in the study each received the first of a four (4) dosing vaccine regimen and were followed for 3 hours; no adverse events were observed in these patients.
ITI intends to complete enrollment in the study in November, the dosing of all patients early in 2013, and to follow up with a Phase II trial beginning in 2013. ITI's CEO, Dr. William Hearl, commented, "The successful initiation of this clinical study marks a significant milestone in the history of Immunomic Therapeutics. We are both pleased and excited that we are now a clinical - stage company. We are looking forward to completing the study and advancing the development of this important vaccine and other LAMP-vax™ vaccines."
Dr. Bruce F. Mackler, Vice President of Regulatory and Clinical Affairs, Immunomic Therapeutics, Inc., indicated that "ITI is committed to the rapid expansion of its clinical program based on the outcome of this first Japanese red cedar vaccine. We plan to move rapidly into the clinical testing of the multivalent vaccine in naturally sensitive Japanese ex-patriates as well as U.S. subjects with sensitivity to mountain cedar. This study will support our food allergy program which will treat peanut allergy in sensitive patients; that study should begin in 2013."
In Japan, it is estimated that up to 45% of the Japanese people are allergic to Japanese red cedar pollen. In North America, especially Texas, individuals suffer from a closely related allergy to mountain cedar pollen. During this Phase I study, ITI will also be monitoring the response to mountain cedar allergens in these subjects.
Key to the success of ITI's vaccines is the incorporation of LAMP Technology. Pre-clinical studies have documented that LAMP-based vaccines induce a protective antibody IgG immune response consistent with a preferential MHC-II immune system presentation induced by LAMP. Multiple studies applying LAMP Technology in human clinical trials have shown that incorporation of the LAMP element dramatically increases the CD4+ response to the target antigen. In addition to providing important safety data on LAMP, the studies confirm that LAMP vaccines activate the human immune system. LAMP-based vaccines hold potential for the development of potent vaccines for treatment of allergies, infectious disease and cancer.
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