Home > Press > Genetic Immunity, InPlay: Second Phase II Clinical Trial Commences in Italy on Company's Lead Product Candidate DermaVir Patch HIV Vaccine
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 an ongoing basis.
Genetic Immunity is pleased to announce the commencement of an exploratory Phase II clinical trial of the Company's DermaVir Patch HIV nanomedicine vaccine lead product candidate being conducted at Policlinico San Matteo in Pavia, Italy.
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 +36-1-272-0364.
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. www.geneticimmunity.com
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About Power of the Dream Ventures, Inc.
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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