BUDAPEST, HUNGARY 7/1/09 -- Power of the Dream Ventures, Inc. (OTC BB: 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 completion of enrollment in the PHPC02 Phase II clinical study. This randomized, placebo-controlled trial is designed to investigate whether DermaVir Patch topical immunization during highly active antiretroviral therapy (HAART) induces elevations of HIV-specific T cell precursors with high proliferative capacity (PHPC) in HIV-1-infected individuals, and whether the quantity of PHPC correlates with the viral load set point following analytical treatment interruption (ATI). This third Phase II study is being conducted at the IRCCS Policlinico San Matteo in Pavia, Italy with a total of sixteen subjects.
"We are enthusiastic to collaborate on this trial with ViroStatics srl, one of Italy's leading biotech companies. Our Italian collaborators have enrolled all subjects in record time in this Phase II trial designed to demonstrate the benefit of our topical immunotherapeutic nanomedicine in the treatment of HIV-disease. In this study we are using DermaVir as an additional drug supplementing HAART to reconstitute the HIV-specific immune system of the patients. We now have two European trials underway in addition to a Phase I/II trial in the USA that is also nearing completion. We look forward to receiving the PHPC02 data once the study is completed in 2010," commented Julianna Lisziewicz, CEO of Genetic Immunity.
"The trial has the potential to introduce and confirm new biomarkers of the body's immune control of HIV and other chronic diseases. We are very fortunate to be able to test the hypothesis by employing DermaVir, one of the best immune-based product candidates available," added Franco Lori, MD, the study’s Protocol Chair.
Subjects in the study are randomized to receive either DermaVir Patch (eight subjects per cohort) or DermaVir Patch Placebo (eight 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.
Patients are on study for a total of 29 weeks (nine weeks of HAART followed by 20 weeks of ATI). Each subject's DermaVir/Placebo application schedule is administered over an 8-week period (Day 0, 28, and 56). HAART is discontinued on Day 63 and is resumed on Day 203. However, individuals who have not met HAART restarting criteria at that time can elect not to restart therapy. After week 29, a safety and immunogenicity follow-up evaluation is done every three months for an additional year for all participants.
For more information please visit the Company's official website at http://www.geneticimmunity.com
At Genetic Immunity:
Dr. Zsolt Lisziewicz
At Power of the Dream Ventures:
Source: Power of the Dream Ventures, Inc.