HERSHEY, PA and ROCKVILLE, MD, USA I April 24, 2013 I Immunomic Therapeutics, Inc., (“ITI,” Hershey, PA), a leading developer of novel allergy immunotherapies, announced the preliminary results of a Phase I Study to treat individuals with an allergy to Japanese red cedar (“JRC”). The Company is pleased to report that the immunotherapeutic vaccine, JRC-LAMP-vax™, appears to have met all of its primary safety end points. In addition, preliminary allergic marker results indicate a favorable trend in resolving the allergy.
Within the three subject sub-groups, (24 total patients) there were no reports of any Severe Adverse Events (SAE). A small number of mild adverse events were reported in about 10% of the vaccinations, generally related to soreness associated with the intra-muscular injection. The safety results are consistent with other clinical studies that have incorporated LAMP, which also showed the vaccine to be safe and well tolerated. In addition to monitoring vaccine safety, subjects were also evaluated for immunological markers of allergy including circulating IgE, immunoglobulin G (IgG) and skin test reactivity.
At the 2013 BIO International Convention, the CEO of Immunomic Therapeutics, Dr. William Hearl, presented the preliminary data for cedar specific IgE and for skin test reactivity. All patients had stable IgE levels including those patients who entered the study as non-allergic to JRC. This observation indicates that the vaccine does not induce a new IgE antibody response in either naive or allergic subjects.
Skin testing is perhaps the oldest and most reliable form of allergy testing. Skin testing has been performed for 100 years and continues to be the test of choice for the diagnosis of allergic disease. A number of the subjects, both skin test positive and skin test negative at the start of the trial, were found to be skin test negative at the end of the study: 5 of 6 converted from positive to negative for whole JRC extract and all subjects were negative for the specific cedar allergen Cry J2. In addition, all skin test negative subjects (5) remained skin test negative at the end of the Phase I study.
“Immunomic Therapeutics, Inc., is proud to present these promising results for our first in human Phase I study. While we are quite excited about the initial skin test results it is important to note that this is a very small number of subjects and we have no indication that the treatment would alleviate the subjects’ rhinitis upon exposure to cedar pollen. Nevertheless, the skin test results are extraordinary in that reversal of a positive result within 132 days of treatment is not usually observed with traditional immunotherapy which may last years and require a 100 or more shots. To have seen that result within the course of this study gives us – and everyone with an allergy – hope that a solution may be on the horizon.”
The Company is planning to continue collecting data for about the next 30 days and will have a more complete report available later this year. ITI is also planning on initiating a Phase II study of JRC-LAMP-vax later this year and following that in 2014 with our first food allergy immunotherapy for peanut allergy, ARA-LAMP-vax.
About Immunomic Therapeutics
Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company with lab facilities in Rockville, MD and 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.
SOURCE: Immunomic Therapeutics
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HERSHEY, PA and ROCKVILLE, MD, USA I April 24, 2013 I Immunomic Therapeutics, Inc., (“ITI,” Hershey, PA), a leading developer of novel allergy immunotherapies, announced the preliminary results of a Phase I Study to treat individuals with an allergy to Japanese red cedar (“JRC”). The Company is pleased to report that the immunotherapeutic vaccine, JRC-LAMP-vax™, appears to have met all of its primary safety end points. In addition, preliminary allergic marker results indicate a favorable trend in resolving the allergy.
Within the three subject sub-groups, (24 total patients) there were no reports of any Severe Adverse Events (SAE). A small number of mild adverse events were reported in about 10% of the vaccinations, generally related to soreness associated with the intra-muscular injection. The safety results are consistent with other clinical studies that have incorporated LAMP, which also showed the vaccine to be safe and well tolerated. In addition to monitoring vaccine safety, subjects were also evaluated for immunological markers of allergy including circulating IgE, immunoglobulin G (IgG) and skin test reactivity.
At the 2013 BIO International Convention, the CEO of Immunomic Therapeutics, Dr. William Hearl, presented the preliminary data for cedar specific IgE and for skin test reactivity. All patients had stable IgE levels including those patients who entered the study as non-allergic to JRC. This observation indicates that the vaccine does not induce a new IgE antibody response in either naive or allergic subjects.
Skin testing is perhaps the oldest and most reliable form of allergy testing. Skin testing has been performed for 100 years and continues to be the test of choice for the diagnosis of allergic disease. A number of the subjects, both skin test positive and skin test negative at the start of the trial, were found to be skin test negative at the end of the study: 5 of 6 converted from positive to negative for whole JRC extract and all subjects were negative for the specific cedar allergen Cry J2. In addition, all skin test negative subjects (5) remained skin test negative at the end of the Phase I study.
“Immunomic Therapeutics, Inc., is proud to present these promising results for our first in human Phase I study. While we are quite excited about the initial skin test results it is important to note that this is a very small number of subjects and we have no indication that the treatment would alleviate the subjects’ rhinitis upon exposure to cedar pollen. Nevertheless, the skin test results are extraordinary in that reversal of a positive result within 132 days of treatment is not usually observed with traditional immunotherapy which may last years and require a 100 or more shots. To have seen that result within the course of this study gives us – and everyone with an allergy – hope that a solution may be on the horizon.”
The Company is planning to continue collecting data for about the next 30 days and will have a more complete report available later this year. ITI is also planning on initiating a Phase II study of JRC-LAMP-vax later this year and following that in 2014 with our first food allergy immunotherapy for peanut allergy, ARA-LAMP-vax.
About Immunomic Therapeutics
Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company with lab facilities in Rockville, MD and 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.
SOURCE: Immunomic Therapeutics
Post Views: 367
