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news.ViroXis has received the US Food and Drug Administration (FDA) approval for its experimental new drug (IND) application to treat Human Papilloma Virus (HPV), common warts of the skin.
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ViroXis has started a Phase II trial evaluating a drug substance derived from East Indian Sandalwood oil (EISO).
The trial will be a double-blinded, placebo-controlled, dose range-finding trial with four arms looking at safety and efficacy of three doses of EISO in an ointment base.
The primary efficacy endpoint of the trial will be complete resolution of warts.
ViroXis president and CEO Ian Clements said the FDA’s swift approval of the IND provides support to their proposed clinical development plan for EISO.
"Based on promising data in previous clinical trials with sandalwood, we are optimistic that the anti-viral activity and safety profile of this essential oil will lead to a new and effective treatment for this prevalent, painful and difficult to treat condition, for which there are currently no approved prescription products," Clements said.
ViroXis has received $2.5m investment from the State of Texas’ Emerging Technology Fund (ETF) to support the clinical program.