Genetic Immunity Clinical Trial Data Published in PLoS ONE
Genetic Immunity
17.05.2012 16:00
---------------------------------------------------------------------------
DermaVir Immunization Boosted Long-lasting Memory T-cell Responses in Every
Patient
MCLEAN, Va. and BUDAPEST, Hungary, 2012-05-17 16:00 CEST (GLOBE NEWSWIRE) --
Genetic Immunity Inc., a privately-held, biopharmaceutical company developing
Langerhans cell-targeted immunotherapies, published its human proof-of-concept
clinical trial, in PLoS ONE, a highly-regarded medical industry publication.
The data demonstrated the induction of long-lasting memory T cell responses
after a single immunization of DermaVir, the Company's lead vaccine candidate
for patients infected with the human immunodeficiency virus (HIV). The
publication is free to access in
www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0035416.
'The results of our clinical trial confirmed our preclinical safety and
immunogenicity data,' said Genetic Immunity Founder, President & Chief Science
Officer Julianna Lisziewicz, PhD. 'These central memory T cell responses are
associated with the protection from infectious diseases such as HIV, Hepatitis
C and malaria. Our findings demonstrate that our Langerhans cell-targeted
delivery system is suitable to induce broad and potent T cell immunity.'
Regarding the result of the study, Denes Banhegyi, MD, the principal
investigator of the study, added, 'Decades of drug treatment can neither
eliminate HIV-infected cells from the reservoirs nor reconstitute HIV-specific
immunity. A broad epitope pool is key to long-term, non-progression. With a
DermaVir immunization, patients can have hope that their daily drug burden
could be lessened.'
About the GIHU004 study:
The dose escalation study, labeled GIHU004, was conducted with three (3)
topical DermaVir doses targeted to epidermal Langerhans cells to express
fifteen (15) HIV antigens simultaneously in several draining lymph nodes.
Antigen presentation in the lymph nodes is required to boost the immune system.
Safety, tolerability and HIV-specific T cell responses against five (5) of the
fifteen (15) DermaVir antigens were evaluated.
DermaVir-associated side effects were not dose-dependent and limited to mild,
transient skin reactions. One of the more noteworthy results of the study was
the dose-dependent expansion of HIV-specific central memory T cells with high
proliferation capacity. The potent induction of Gag, Tat and Rev-specific
memory T cells suggests that DermaVir boosts T cell responses specific to all
15 HIV antigens expressed from the single DNA. This is the first time that a
vaccine induces memory T cell responses against all fifteen (15) antigens in
human subjects.
About the DermaVir HIV Therapeutic Vaccine:
Today, HIV/AIDS is managed with life-long highly active antiretroviral therapy
(HAART). This treatment, although widely accepted as the standard, raises
concerns about adverse effects, resistance and the financial burden of
treatment. A short fall of HAART is that it does not cure the disease because
it does not kill infected cells in the latent reservoirs. Based upon our
trials, DermaVir boosts and maintains killer T cells in HIV-infected human
subjects. It has the broadest specificity in vaccine candidates that limits the
development of resistance. Three (3) independent clinical trials, conducted in
the USA and EU have consistently demonstrated the safety, immunogenicity and
preliminary antiviral efficacy of DermaVir treatments.
About Genetic Immunity:
Genetic Immunity Inc., is a privately-held, U.S. biopharmaceutical company that
has developed a proprietary Langerhans cell targeting delivery system which can
induce long-lasting T cell immunity for therapeutic vaccinations against
infectious diseases and cancer. Our proprietary system delivers a genetically
targeted nanomedicine formulation that can simultaneously express 15
disease-specific antigens. All of our medicines are delivered topically using
our CE-marked medical device, DermaPrep(tm).
Today, the National Institutes of Health (NIH) is sponsoring a clinical trial
in 72 HIV-positive adolescents. Genetic Immunity plans to start a Phase IIB
study on 120 HIV-positive adults and a Phase II study on Hepatitis C/HIV
co-infected patients the later part of 2012. For more information on the
Company, our products and our trials, please visit us on the web at:
www.geneticimmunity.com.
Forward-Looking Statements
Certain statements contained in this press release are forward-looking
statements that involve risks and uncertainties. The statements contained
herein that are not purely historical are forward looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended. Forward-looking
statements deal with the Company's current plans, intentions, beliefs and
expectations and statements of future economic performance. Forward-looking
statements involve known and unknown risks and uncertainties that may cause the
Company's actual results in future periods to differ materially from what is
currently anticipated. Factors that could cause or contribute to such
differences include those discussed from time to time in reports filed by the
Company with the Securities and Exchange Commission. The Company cannot
guarantee its future results, levels of activity, performance or achievements.
CONTACT: Conrad F. Mir
Chairman/CEO
Genetic Immunity Inc.
+1. 973.798.8882
conradfmir@geneticimmunity.com
News Source: NASDAQ OMX
17.05.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Genetic Immunity
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9902042996
WKN:
End of Announcement DGAP News-Service
---------------------------------------------------------------------------
Genetic Immunity
17.05.2012 16:00
---------------------------------------------------------------------------
DermaVir Immunization Boosted Long-lasting Memory T-cell Responses in Every
Patient
MCLEAN, Va. and BUDAPEST, Hungary, 2012-05-17 16:00 CEST (GLOBE NEWSWIRE) --
Genetic Immunity Inc., a privately-held, biopharmaceutical company developing
Langerhans cell-targeted immunotherapies, published its human proof-of-concept
clinical trial, in PLoS ONE, a highly-regarded medical industry publication.
The data demonstrated the induction of long-lasting memory T cell responses
after a single immunization of DermaVir, the Company's lead vaccine candidate
for patients infected with the human immunodeficiency virus (HIV). The
publication is free to access in
www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0035416.
'The results of our clinical trial confirmed our preclinical safety and
immunogenicity data,' said Genetic Immunity Founder, President & Chief Science
Officer Julianna Lisziewicz, PhD. 'These central memory T cell responses are
associated with the protection from infectious diseases such as HIV, Hepatitis
C and malaria. Our findings demonstrate that our Langerhans cell-targeted
delivery system is suitable to induce broad and potent T cell immunity.'
Regarding the result of the study, Denes Banhegyi, MD, the principal
investigator of the study, added, 'Decades of drug treatment can neither
eliminate HIV-infected cells from the reservoirs nor reconstitute HIV-specific
immunity. A broad epitope pool is key to long-term, non-progression. With a
DermaVir immunization, patients can have hope that their daily drug burden
could be lessened.'
About the GIHU004 study:
The dose escalation study, labeled GIHU004, was conducted with three (3)
topical DermaVir doses targeted to epidermal Langerhans cells to express
fifteen (15) HIV antigens simultaneously in several draining lymph nodes.
Antigen presentation in the lymph nodes is required to boost the immune system.
Safety, tolerability and HIV-specific T cell responses against five (5) of the
fifteen (15) DermaVir antigens were evaluated.
DermaVir-associated side effects were not dose-dependent and limited to mild,
transient skin reactions. One of the more noteworthy results of the study was
the dose-dependent expansion of HIV-specific central memory T cells with high
proliferation capacity. The potent induction of Gag, Tat and Rev-specific
memory T cells suggests that DermaVir boosts T cell responses specific to all
15 HIV antigens expressed from the single DNA. This is the first time that a
vaccine induces memory T cell responses against all fifteen (15) antigens in
human subjects.
About the DermaVir HIV Therapeutic Vaccine:
Today, HIV/AIDS is managed with life-long highly active antiretroviral therapy
(HAART). This treatment, although widely accepted as the standard, raises
concerns about adverse effects, resistance and the financial burden of
treatment. A short fall of HAART is that it does not cure the disease because
it does not kill infected cells in the latent reservoirs. Based upon our
trials, DermaVir boosts and maintains killer T cells in HIV-infected human
subjects. It has the broadest specificity in vaccine candidates that limits the
development of resistance. Three (3) independent clinical trials, conducted in
the USA and EU have consistently demonstrated the safety, immunogenicity and
preliminary antiviral efficacy of DermaVir treatments.
About Genetic Immunity:
Genetic Immunity Inc., is a privately-held, U.S. biopharmaceutical company that
has developed a proprietary Langerhans cell targeting delivery system which can
induce long-lasting T cell immunity for therapeutic vaccinations against
infectious diseases and cancer. Our proprietary system delivers a genetically
targeted nanomedicine formulation that can simultaneously express 15
disease-specific antigens. All of our medicines are delivered topically using
our CE-marked medical device, DermaPrep(tm).
Today, the National Institutes of Health (NIH) is sponsoring a clinical trial
in 72 HIV-positive adolescents. Genetic Immunity plans to start a Phase IIB
study on 120 HIV-positive adults and a Phase II study on Hepatitis C/HIV
co-infected patients the later part of 2012. For more information on the
Company, our products and our trials, please visit us on the web at:
www.geneticimmunity.com.
Forward-Looking Statements
Certain statements contained in this press release are forward-looking
statements that involve risks and uncertainties. The statements contained
herein that are not purely historical are forward looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended. Forward-looking
statements deal with the Company's current plans, intentions, beliefs and
expectations and statements of future economic performance. Forward-looking
statements involve known and unknown risks and uncertainties that may cause the
Company's actual results in future periods to differ materially from what is
currently anticipated. Factors that could cause or contribute to such
differences include those discussed from time to time in reports filed by the
Company with the Securities and Exchange Commission. The Company cannot
guarantee its future results, levels of activity, performance or achievements.
CONTACT: Conrad F. Mir
Chairman/CEO
Genetic Immunity Inc.
+1. 973.798.8882
conradfmir@geneticimmunity.com
News Source: NASDAQ OMX
17.05.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Genetic Immunity
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US9902042996
WKN:
End of Announcement DGAP News-Service
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