Immunomic Therapeutics (ITI) has dosed the first patient in its Phase I trial of JRC-LAMP-vax vaccine for the treatment of symptoms caused by exposure to Japanese red cedar pollen.
Japanese expatriates previously exposed to Japanese red cedar, known as ‘Sugi’ in Japan, will participate in the study.
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The study will assess the safety and immunological activity of JRC-LAMP-vax vaccine, a plasmid-based DNA vaccine, in the treating patients with rhino-conjunctivitis symptoms caused by an allergic reaction to Japanese red cedar pollen.
45% of Japanese people are estimated to be allergic to Japanese red cedar pollen, and many Americans suffer from a closely related allergy to mountain cedar pollen.
Study participants were given the first of a four dosing vaccine regimen and were observed for three hours during which no adverse events were reported.
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ITI anticipates completing enrolment in November 2012, the dosing of all patients early in 2013, and the initiation of a Phase II trial in 2013.
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By GlobalDataITI regulatory and clinical affairs vice president Dr Bruce Mackler said the company plans to expand its clinical programme based on the outcome of this vaccine.
"We plan to move rapidly into the clinical testing of the multivalent vaccine in naturally sensitive Japanese ex-patriates as well as US subjects with sensitivity to mountain cedar," Mackler said.
"This study will support our food allergy program which will treat peanut allergy in sensitive patients; that study should begin in 2013."
