LANCASTER, Pa. and ROCKVILLE, Md., May 3, 2012 /PRNewswire/ -- Immunomic Therapeutics, Inc., ("ITI," Lancaster, PA) a privately-held biotechnology company with laboratories in Rockville, MD, announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug Application ("IND") filed for the allergy immunotherapy, JRC- LAMP-vax™. On April 12th, the FDA notified ITI that there will be no clinical hold and that ITI may now proceed with its clinical trial in June for JRC-LAMP-vax in Atlanta with subjects sensitive to Japanese Red Cedar pollen.
JRC-LAMP-Vax is a plasmid-based DNA vaccine that will be studied for the treatment of patients with rhino-conjunctivitis (runny nose) symptoms caused by allergic reaction to Japanese red cedar pollen. Almost 45% of the Japanese people are allergic to Japanese red cedar pollen. In North America, there is allergic rhinitis to mountain cedar pollen, which is 80% cross-reactive with Japanese red cedar pollen allergen. ITI intends to partner with a Japanese pharmaceutical company for studies in Japan and will seek FDA approval of the vaccine in the US.
ITI provided FDA with animal studies of JRC-LAMP-Vax, showing no alteration of the routine clinical pathology, body weight, food consumption, temperature, ophthalmology, dermal irritation or the histopathology of any tissue examined microscopically. Overall, JRC-LAMP-Vax caused no abnormal safety issues in bio-distribution and toxicology studies in animals. This data was consistent with other reported animal and human studies of components of its vaccine.
Animal safety studies and human clinical studies have documented that LAMP DNA vaccine induces a protective antibody immune response consistent with a preferential MHC-II immune system presentation induced by the LAMP component. LAMP-based vaccines hold potential
|SOURCE Immunomic Therapeutics, Inc.|
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