Immunomic Therapeutics Announces Data Analysis of Phase IB Study to Treat Japanese Red Cedar Allergy
ROCKVILLE, MD, UNITED STATES, April 7, 2014 /EINPresswire.com/ -- Hershey, PA & Rockville, MD April 7th, 2014 – Immunomic Therapeutics, Inc., (“ITI”), a Company on the leading edge of transforming vaccines, announced the preliminary results of a Phase IB study of JRC-LAMP-vax™, a novel immunotherapy designed to treat individuals with allergy to Japanese red cedar ("JRC"). The Company is pleased to report that the Phase IB has met and maintained all primary safety and secondary immunological end points that were observed at the conclusion of the Phase IA.
The Phase IB study was a continuation of the Phase IA study conducted at ITI's clinical site in Honolulu, Hawaii. Of the 24 native Japanese who were originally recruited into the Phase IA study, 18 had JRC allergy as determined by skin test (the "gold standard" in determining allergic status). All 24 patients received 4 doses of vaccine. The control group and one of the test groups received full doses while the second test group received a half dose.
At the end of the Phase IA study, for most of the subjects, ITI observed a remarkable conversion of skin test results from positive to negative following immunotherapy for most of the sensitized subjects. As a result, a Phase IB was designed to follow as many of these patients as possible and to evaluate the impact of a single booster shot. At the Phase IB follow up visits, patients who were converted to skin test negative remained skin test negative. Those who were still positive at the conclusion of Phase IA, at day 138, converted to skin test negative by day 220, achieving a 100% conversion rate. In addition, over the study period, ITI showed a statistically valid increase in IgG levels while IgE levels either remained stable or decreased providing further confirmation of the observed skin test results. Further, all safety endpoints were met and there were no severe adverse reactions or allergic responses.
In Q2/Q3 2014, ITI will begin an interim Phase IC safety study to evaluate delivery of JRC-LAMP-vax using a novel delivery method, the BioJector 2000. The study will also enable the Company to further understand and validate the immunological data. ITI also plans to initiate a Phase II study by the end of 2014.
ITI's CEO, William Hearl, commented, "These promising results and upcoming studies enable ITI to continue progress on JRC-LAMP-vax, a novel immunotherapy designed for the 35 million+ who suffer from Japanese Red Cedar allergy. We are well positioned to continue development of other products in our pipeline, including a novel peanut allergy vaccine that we expect to bring into the clinic in 2015. We believe that allergy patients worldwide will benefit from these and future applications of LAMP-vax."
About Immunomic Therapeutics
Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company with lab facilities in Rockville, MD and a process-development plant in Hershey, PA. ITI is developing next generation vaccines based on the patented LAMP Technology. Our LAMP-vax™ vaccine 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 visit www.immunomix.com.
Immunomic Therapeutics, Inc.
1214 Research Blvd, Suite 2016, Hershey, PA 17036
E-mail: info@immunomix.com
Web: www.immunomix.com
Social Media: www.twitter.com/immunomix
Press Release – Phase IB
Issued 4/07/2014
The Phase IB study was a continuation of the Phase IA study conducted at ITI's clinical site in Honolulu, Hawaii. Of the 24 native Japanese who were originally recruited into the Phase IA study, 18 had JRC allergy as determined by skin test (the "gold standard" in determining allergic status). All 24 patients received 4 doses of vaccine. The control group and one of the test groups received full doses while the second test group received a half dose.
At the end of the Phase IA study, for most of the subjects, ITI observed a remarkable conversion of skin test results from positive to negative following immunotherapy for most of the sensitized subjects. As a result, a Phase IB was designed to follow as many of these patients as possible and to evaluate the impact of a single booster shot. At the Phase IB follow up visits, patients who were converted to skin test negative remained skin test negative. Those who were still positive at the conclusion of Phase IA, at day 138, converted to skin test negative by day 220, achieving a 100% conversion rate. In addition, over the study period, ITI showed a statistically valid increase in IgG levels while IgE levels either remained stable or decreased providing further confirmation of the observed skin test results. Further, all safety endpoints were met and there were no severe adverse reactions or allergic responses.
In Q2/Q3 2014, ITI will begin an interim Phase IC safety study to evaluate delivery of JRC-LAMP-vax using a novel delivery method, the BioJector 2000. The study will also enable the Company to further understand and validate the immunological data. ITI also plans to initiate a Phase II study by the end of 2014.
ITI's CEO, William Hearl, commented, "These promising results and upcoming studies enable ITI to continue progress on JRC-LAMP-vax, a novel immunotherapy designed for the 35 million+ who suffer from Japanese Red Cedar allergy. We are well positioned to continue development of other products in our pipeline, including a novel peanut allergy vaccine that we expect to bring into the clinic in 2015. We believe that allergy patients worldwide will benefit from these and future applications of LAMP-vax."
About Immunomic Therapeutics
Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company with lab facilities in Rockville, MD and a process-development plant in Hershey, PA. ITI is developing next generation vaccines based on the patented LAMP Technology. Our LAMP-vax™ vaccine 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 visit www.immunomix.com.
Immunomic Therapeutics, Inc.
1214 Research Blvd, Suite 2016, Hershey, PA 17036
E-mail: info@immunomix.com
Web: www.immunomix.com
Social Media: www.twitter.com/immunomix
Press Release – Phase IB
Issued 4/07/2014
Dr. Bill Hearl
Immunomic Therapeutics, Inc
717-327-1919
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