US Phytotherapy, Inc. (USPI), a research and development company, announced the successful completion of preclinical studies on PROACT-D, a novel therapeutic for the treatment of dengue.  This success enables USPI to start preparing the Investigational New Drug (IND) file to move to phase 1 human clinical trials.

“The completion of preclinical studies is a key milestone for our company, and means that we are now ready to move towards human trials,” said Bob Rosen, of USPI.  “Our innovative approach is based on USPI’s expertise and leadership in the field of phytotherapy. This approach has made it possible for us to develop the first in a series of new-generation drugs using natural artemisinin and berberine to treat a range of mosquito borne viruses with no side effects. We are excited to be advancing our first compound for dengue toward clinical trials.”

In preparation for an IND filing, USPI will be engaging an expert contract research organization to perform final toxicity, pharmacokinetic, pharmacodynamic and metabolism studies in various animal species. Thereafter the IND file will be submitted with phase 1 clinical trials targeted for the first half of 2017.

PROACT-D is a proprietary patented plant based solution for the treatment of dengue. During preclinical studies (in-vitro and in-vivo in mice), PROACT-D demonstrated significant ability to treat dengue infection. It also exhibited an excellent safety profile and therapeutic activity at very low doses.

Preclinical studies on PROACT-Z, another lead compound targeting zika infection, are scheduled for completion in Q4 2016.

US Phytotherapy, Inc., is a research and development company based in the United States, dedicated to the discovery, advancement, production, and distribution of natural, plant-based formulas which are safe and effective in their use as a treatment against invasive diseases.