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Home > Press > Genetic Immunity, Retrospective: Phase 1 Trial Results for the Company's HIV Vaccine Candidate Lead Product

Abstract:
Power of the Dream Ventures, Inc. (OTCBB: PWRV), Hungary's premier technology acquisition and development company, is pleased to present this Genetic Immunity release, based on a previously announced agreement whereby Power of the Dream Ventures will issue communications for Genetic Immunity on a going forward basis.

Genetic Immunity, Retrospective: Phase 1 Trial Results for the Company's HIV Vaccine Candidate Lead Product

Budapest, Hungary | Posted on March 4th, 2009

Phase 1 trial results for Genetic Immunity's DermaVir Patch HIV vaccine.

Background:

Genetic Immunity's proprietary DermaVir Patch nanomedicine has been developed to attenuate clinical disease in HIV-infected individuals by induction of long-lasting, HIV-specific T-cells. Preclinical studies on SIV-infected and naive macaques demonstrated that the potent T cell response induced by DermaVir is associated with clinical benefits, including viral load reduction and extended survival. Phase 1 human data for safety and immunogenicity was presented at the 15th Conference on Retroviruses and Opportunistic Infections.

Test methodology:

Nine HIV infected individuals on fully suppressive HAART were treated a single-time with an increasing number of DermaVir nanomedicine containing 0.1, 0.4 and 0.8 mg of multiple HIV genes encoded plasmid DNA. HAART was maintained during a one-year follow-up. Safety was assessed with standard clinical evaluation, laboratory assays and dermatological analysis of skin reaction. HIV-specific (gag, tat, rev) effector T cells were measured by standard ELISPOT and memory T cells with high proliferative capacity PHPC assay as published in J Immunol 2008, 180: 5907-5915.

Safety and immunogenicity results

All DermaVir Patch doses were safe and well tolerated. In all patients, plasma HIV RNA, CD4 and CD8 counts remained in the pre-vaccination level throughout the study. The magnitude of gag-specific memory T cells (PHPC counts) increased from < 200 (baseline) to 2,500-21,500 and 3,000-37,000 at the end of week 48, when administered in medium (0.4mg) and high dose (0.8mg) amounts. The broadening of T cell response was demonstrated by the induction of new rev- and tat-specific memory T cells. These were mostly undetectable prior to immunization and increased between 3,000 and 30,000 (rev) and 60 to 30,000 (tat) in the medium dose and up to 1,000 to 7,000 (rev) and 600 to 4,000 (tat) in the high dose. In the medium dose cohort, for example, the average frequency of total memory and of effector T cells (shown in parenthesis) prior to vaccination were 124 (20); 28 days after vaccination 231,403 (720), and one year later 82,776 (not measured), indicating > 10 fold expansion of effectors and > 100 fold of long-lived memory T cells.

Needleless topical immunization with DermaPrep device.

DermaVir nanomedicine is administered topically with DermaPrep, Genetic Immunity's proprietary transdermal vaccine delivery device. DermaPrep delivers nanomedicine through the stratum corneum into the precursors of dendritic cells, the Langerhans cells. The proprietary antigen formulation into nanomedicines facilitates the presentation of antigens in lymph node dendritic cells. DermaPrep device together with the nanomedicine antigen formulation replaces the cumbersome ex vivo dendritic cell vaccination method. It is also an alternative to syringes, eliminating many problems associated with needles.

Conclusions

Our DermaVir nanomedicine immunization in HIV positive subjects was safe and well tolerated. Single DermaVir Patch treatments broadened and significantly increased the HIV-specific memory T cell pool in a dose dependent manner from 6 to 18,000 fold. DermaVir-induced T cell response was long lasting, detectible in all immunized subjects up to a year later. DermaVir nanomedicine can be used for repeated immunization without the constraints of anti-vector immunity or additional immune activation. These trial results suggest the excellent safety and immunogenicity profile of this new generation of DNA vaccine for human subjects.

Based on the successful completion of this Phase 1 study, a larger, double blind placebo controlled Phase 2 trial is currently underway in Hamburg, Germany.

####

About Genetic Immunity
Genetic Immunity is a US/Hungarian development stage biopharmaceutical company establishing leadership in Nanomedicines for immune amplification. Nanomedicine, an offshoot of nanotechnology, refers to highly specific medical intervention at the molecular scale for treating disease or repairing damaged tissues. By leveraging its proprietary immune amplification platform technology, the company aims to address new markets for infectious diseases, cancer and allergies through the discovery, development and commercialization of topically administered nanomedicines. These indications represent a significant unmet medical need and the potential for alternative treatment approaches.

About Power of the Dream Ventures

Power of the Dream Ventures, Inc. is a leading technology holding company. We identify and harness the unique technological prowess of Hungary's high-tech industry, turning promising ideas and ready to market products/technologies into global industry leaders. We focus on developing, acquiring, licensing, or co-developing technologies that originate exclusively in Hungary that are in prototype stage based on existing patents; in prototype stage prior to patenting; existing products that require expansion capital to commercialize; emerging science and high-technology research projects that require help in patenting, developing the product and marketing, University spin-off technologies, and ideas from the very early stage that represent "disruptive technologies." We primarily focus on providing enabling solutions in the fields of environmental technologies, power generation and storage, software products and services, biotechnology, medical devices and what we call 'disruptive technologies.'

For more information, please click here

Contacts:
At Genetic Immunity:

Dr. Zsolt Lisziewicz
Chief Operating Officer
Phone: +36-1-272-0364
Fax: +36-1-272-0364

At Power of the Dream Ventures:

Viktor Rozsnyay
President and CEO
Phone: +36-1-456-6061
Fax: +36-1-456-6062

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