Clinical Trial of JRC-LAMP-Vax

The Company sponsored a Phase I clinical study of JRC-LAMP-Vax at a clinical site in Honolulu, Hawaii in 2013. The primary endpoint of the study, testing the JRC-LAMP-Vax vaccine, was safety. Twenty-four native Japanese were recruited into the study, 18 with JRC allergy as determined by skin test (the “gold standard” in determining allergic status). All 24 patients received 4 doses of vaccine with the control group (#1) and one of the test groups (#3) receiving full doses and group #2 receiving a half dose. At the end of study, we observed a conversion of skin test results from positive to negative following JRC-LAMP-Vax treatment for most of the allergic subjects. As a result, we elected to follow as many of these subjects as possible in a Phase Ib and to evaluate the impact of providing a single booster shot. At the follow up visits, subjects who were converted to skin test negative remained skin test negative and those who were still positive at day 138 converted to skin test negative by day 220. Perhaps most importantly, however, all of our safety endpoints were met.

The results of the study are given below:

ITI finished a Phase IC clinical study at the Hawaii site on March 2015.  This study was a small study designed to test intradermal delivery method for JRC-LAMP-Vax.

On January 2015, ITI and Astellas announced that they entered into an exclusive license agreement for Japan to develop and commercialize JRC2-LAMP-Vax vaccine.  Astellas initiated a Phase 1 trial of JRC2-LAMP-Vax in Japan on July 1, 2015 ( Identifier: NCT02469668). Following this, in October 2015, Astellas and ITI announced an Exclusive Worldwide License Agreement for the Lamp-Vax platform to prevent and treat allergies.