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 for the development of potent vaccines for treatment of allergies, infectious disease and cancer. Previous research has specifically indicated that LAMP in the DNA vaccine molecule induces IgG protective antibodies and greatly diminishes the production of the allergy antibody, IgE. This represents a shift of the immune response to the vaccine from Th2 to Th1, the underlying concept for classic allergy desensitization. This re-education of the immune system response is the basis of the medically accepted paradigm for treating allergy by conventional allergy immunotherapy.
Dr. William G. Hearl, CEO of Immunomic Therapeutics, Inc., stated, "The IND authorization is the result of the long-term commitment and support of ITI and the continuous efforts contributed by its researchers and regulatory team. It cannot be overstated what a significant accomplishment this is for our Company. The expeditious FDA review and approval of our Phase I study plan is a testament to a strong scientific foundation and well-planned regulatory strategy."
ITI has begun enrollment for the open label, Phase I, clinical study designed to establish the safety of the LAMP-vax platform and to provide important immune response data as it applies to allergy patients. The study will be conducted in allergy clinical centers based in Atlanta, GA and is expected to begin in June 2012. The primary objective of this Phase I Study is to evaluate both the safety and immunological response of therapeutic doses and the dosing regimen of JRC-LAMP-Vax vaccine.
About Immunomic Therapeutics
Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company headquartered in Lancaster, PA with lab facilities in Rockville, MD. ITI is developing next generation vaccines based on the patented LAMP Technology. Our LAMP-vax platform significantly increases the effectiveness of the immune response to nucleic acid vaccines while simplifying overall vaccine design and delivery, yielding safer, more cost-effective human and animal therapies. Our LAMP constructs have been validated in human clinical trials for cancer and have been applied to a wide breadth of targets including allergy, cancer and infectious diseases. For more information about ITI and LAMP Technology please contact Dr. Bill Hearl at 1-717-327-1919 or email Immunomix@gmail.com, or visit the IMMUNOMIX web site.
Dr. Bill Hearl, President / CEO
Immunomix @ gmail.com
Immunomic Therapeutics, Inc.
313 W. Liberty St., #343, Lancaster, PA 17603
SOURCE Immunomic Therapeutics, Inc.