ViroXis' IND for EISO-derived product to treat HPV skin warts receives FDA approval

ViroXis Corporation today announced that the US Food and Drug Administration (FDA) granted approval for the Company's investigational new drug (IND) application and planned clinical development of a drug substance derived from East Indian Sandalwood oil (EISO) for the topical treatment of Human Papilloma Virus (HPV), common warts of the skin. ViroXis' EISO-derived product is being developed in accordance with the FDA's 2004 Guidance for Development of Botanical Drugs.

“The fact that ViroXis was able to achieve this significant regulatory development milestone so quickly and with minimal capital expenditure is a testament to the efficiency with which the company has been operating. We are optimistic and very excited about the future prospects for the company's drug development efforts.”

"The FDA's swift approval of our IND provides validation of ViroXis' mission to be a leader in the development of botanically-derived topical drugs and strongly supports our proposed clinical development plan for EISO," said Ian Clements, President and CEO of ViroXis. "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 highly prevalent, painful and difficult to treat condition, for which there are currently no approved prescription products."