Genetic Immunity, Inc. is a US biotechnology company. We are a wholly owned subsidiary of Power of the Dream Ventures, Inc. a US based technology holding company.
We work with US based industry experts advising us on all phases of drug development, regulatory matters and clinical trials. Over the course of the last twelve years we have conducted three human trails of our lead product candidate HIV vaccine. A Phase I trial in Hungary, an NIH financed and ACTG (Aids Clinical Trials Group) conducted Phase I/II trial in the United States, and a Phase II trial in Germany. All three trials have demonstrated efficacy, immunogenicity, safety and have consistently indicated the optimal dose needed for effective treatment. We have started our FDA regulatory steps, including a submission for Breakthrough Therapy consideration. The agency has provided feedback on our submission.
We now work with our US regulatory expert, DJA Global Pharmaceuticals, Inc. on providing the FDA with the requested documentation. Our principal goal is to make sure we can submit these documents and get clear guidance from the agency on how to achieve marketing approval. We are firmly committed to bringing DermaVir to market in order to help those 35 million infected with the virus.
If approved, DermaVir will become the first new treatment option, a complement to antiretroviral therapy. We are actively seeing partners and investors to accomplish this task. Please see the appropriate sections of this site for more information..