Genetic Immunity, InPlay: Company Completes Patient Enrollment in Phase II Trial of DermaVir Patch HIV Immunotherapeutic Nanomedicine Lead Product Candidate

June 11, 2009 |

4 min read

BUDAPEST, HUNGARY--(Marketwire - June 11, 2009) - 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 is pleased to announce completion of patient enrollment in the Company’s Phase II randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, immunogenicity, and antiretroviral activity of DermaVir Patch in treatment-naïve HIV-1-infected patients. The study is conducted in Hamburg, Germany with a total of thirty-six patients.

“We are very happy with completion of patient enrollment in this seminal trial because it allows us to conclude the immunization schedule in this year. This trial has a unique design to investigate DermaVir Patch as mono-immunotherapy in HIV-infected individuals who are not treated with antiretroviral drugs. We are very excited to learn how our immune therapeutic nanomedicine affects the immune system and disease of this patient population. With this trial we plan to demonstrate the safety and efficacy of DermaVir Patch as monotherapy administered every 6 weeks for the treatment of HIV,” commented Julianna Lisziewicz, CEO of Genetic Immunity.

This novel plasmid DNA-based nanomedicine vaccine candidate, DermaVir Patch, has been under development in the last ten years. Phase I trial showed preliminary safety and tolerability and induction of memory T-cell immunity in all HIV-1-infected individuals. DermaVir is based on a single plasmid DNA capable to express most HIV antigens and to form a virus-like particle (VLP+). Plasmid DNA is formulated with a polymer to mimic a pathogen. DermaVir enters into the body via the Langerhans cells of the skin and induces memory immune responses in the lymph nodes.

The primary outcome of this phase II study measures safety and tolerability of DermaVir Patch, while secondary outcome includes HIV-1 RNA measurements to assess the antiretroviral activity of the DermaVir Patch, changes in CD4+, CD8+ T-cell counts and HIV-specific immunogenicity during DermaVir Patch treatment.

The study randomized patients into one of 6 arms: Arm 1 patients will receive low dose DermaVir patch (0.2 mg DNA, n=9); Arm 2 patients will receive low dose placebo patch (n=3); Arm 3 patients will receive medium dose DermaVir patch (0.4 mg DNA, n=9); Arm 4 patients will receive medium dose placebo patch (n=3); Arm 5 patients will receive high dose DermaVir patch (0.8 mg DNA, n=9); Arm 6 patients will receive high dose placebo patch (n=3).

Immunization will be done on days 0, 42, 84, and 126. The total number of patches that a patient will receive throughout the study will be 8, 16, or 32 in the low, medium, and high dose arms, respectively. The patch sites for immunization are preferably the left or right upper back and left or right upper ventral thighs. The same skin sites might be used for all patch immunizations that last for 3 hours.

Patients will be on-study for 282 weeks. The immunizations will be administered over an 18-week period with an identical follow up schedule continuing until week 24; patients will be followed for an additional 24 weeks for additional safety and immunogenicity evaluations. An additional 234 weeks safety follow-up will be performed including chemistry and hematology assessments and physical examinations.

For more information please visit the Company’s official website at http://www.geneticimmunity.com

About Genetic Immunity

Genetic Immunity is a US/Hungarian 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 visit our website at http://www.powerofthedream.com