DermaVir Patch is the Genetic Immunity's candidate Nanomedicine Vaccine designed for HIV-specific immune reconstitution. The Antiviral Mechanism of Action is based on inhibition of viral replication by cytotoxic killing of HIV-infected cells. Currently, there are no approved immune therapy or vaccine products on the market for HIV/AIDS.

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Genetic Immunity, InPlay: Second Phase II Clinical Trial Commences in Italy on Company's Lead Product Candidate DermaVir Patch HIV Vaccine
Apr 16, 2009

This Phase II, randomized, placebo-controlled trial is designed to investigate whether therapeutic immunization during highly active antiretroviral therapy (HAART) induces elevations of HIV-specific memory T cells in HIV-1-infected individuals, and whether the quantity of these memory T cells correlate with the viral load set point following analytical treatment interruption (ATI). Subjects are being randomized to receive either DermaVir Patch (8 subjects per cohort) or Placebo Patch (8 subjects per cohort) every four weeks for three applications while receiving maximally suppressive HAART. HAART will be discontinued at Week 9 for an ATI period of 20 weeks. The trial will employ a novel assay of memory T-cell function known as the PHPC (Precursors with High Proliferative Capacity) assay developed by ViroStatics, srl, the Italian partner of Genetic Immunity.

"I look forward to obtaining results from this, our second in-progress Phase II trial for DermaVir. I believe results will be outstanding and closely correlate with those of our first Phase II trial underway in Germany and allow us to quickly move forward to Phase III in the not too distant future. When successful, DermaVir can become the first effective HIV immune-based treatment on the market within the next few years," commented Julianna Lisziewicz, CEO of Genetic Immunity.

"The trial has the potential to indicate biomarkers of immune control of HIV. We are very glad we can test the hypothesis by employing DermaVir, one of the best immune-based product candidates available," added Franco Lori, Protocol Chair of the Trial.

A total of 16 subjects will be enrolled and randomized to receive DermaVir Patch (8 subjects) or DermaVir Patch Placebo (8 subjects). As of the date of this press release three patients have already been enrolled.

For more information please visit the Company's official website at http://www.geneticimmunity.com or contact Zsolt Lisziewicz directly at +3612720364


http://www.marketwire.com/press-release/Power...-Ventures-Inc-975469.html

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Clinical Trials involving DermaVir Patch, 2009

Location
(clinicaltrials.gov ID) Title Status

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GIHU004
Hungary
(NCT00712530)
To read Study Synopsis click here...


A Phase I Study to Evaluate the Tolerability and Safety of DermaVir Immune Therapy in HIV-infected Subject under Treatment with HAART
Excellent safety, tolerability, and immunogenicity: DermaVir evoked long-lasting gag-specific T cells 6- to 18,000 fold above pre-treatment values in all nine patients, in dose dependent manner.



ACTG 5176
USA
(NCT00270205)
To read Study Synopsis click here...


A Phase I/II, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of DermaVir Patch Immune Therapy in HIV-infected Subjects Currently Under Treatment with HAART
24 of the 24 patients enrolled, the trial is still blinded.

GIEU006
Germany
(NCT00711230)
To read Study Synopsis click here...

A Phase II, Randomized, Study to Evaluate the Safety, Tolerability, Immunogenicity and Antiviral Activity of DermaVir Patch Immune Therapy in HIV-1 Infected treatment-nadve Subjects 33 of the 36 patients are enrolled. Trial so far shows excellent safety and tolerability, still blinded for efficacy.


PHPC-02
Italy Antiretroviral sparing concept: a Phase II, randomized, single blind placebo controlled study to investigate the effect of DermaVir immunization on the quantity of HIV-specific T cells during HAART followed by analytical treatment interruption

Enrollment of the 16 patients has been initiated. 3 of 16 patients are enrolled.


IMPAACT-P1049
USA

A Phase I/II study of the safety, tolerability and immunogenecity of a topical therapeutic DNA denritic cell vaccine (DermaVir Patch) in children, adolescents and young adults with hiv-1 infection on highly active antiretroviral therapy (HAART).

In preparation