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TMCNet:  ViroXis Corporation Achieves Key Clinical Milestones

[February 20, 2014]

ViroXis Corporation Achieves Key Clinical Milestones

SAN ANTONIO --(Business Wire)--

ViroXis Corporation today announced that the final patient has completed treatment in its Phase 2 clinical study of the Company's East Indian Sandalwood Oil (EISO) based therapy for HPV/common skin warts. Efficacy and safety results will be known once the data is analyzed in April following a three-month follow-up period.

A total of 183 patients have completed enrollment and the products have been very well tolerated with very few adverse events reported. In a prior Investigator-sponsored clinical study of EISO to treat patients with HPV/common warts (including pediatric patients), EISO was very well tolerated and demonstrated significant efficacy results over placebo. The Company hopes to confirm these initial results in this larger four-arm, double-blind, placebo controlled Phase 2 trial.

ViroXis also announced plans to initiate a second Phase 2 clinical study in a new indication, Molluscum contagiosum (MCV), in a peiatric population. MCV is a very prevalent, highly contagious pox virus skin infection for which there are currently no approved prescription treatments. A small preliminary study of EISO in MCV patients (including pediatric patients) was completed, and it was found that EISO was effective and very well tolerated. For the Company's four-arm, double-blind, placebo controlled MCV study, a proprietary cream was developed to complement the ointment formulation being used in the HPV trial.

"ViroXis has quickly emerged as leader in the development of botanical drug products, a new and important group of drug candidates afforded a distinct approval process by the FDA. We are developing EISO to treat highly prevalent viral skin conditions in both adults and children, for which there are currently no approved prescription products," said Ian Clements, Chief Executive Officer of ViroXis Corporation.

About ViroXis

ViroXis' mission is to develop and commercialize novel, safe and effective prescription and over-the-counter botanical products for the treatment of virally-induced skin conditions. Botanically-derived drugs have formed the backbone of the pharmaceutical industry and the 2004 FDA botanical drug development guidelines aim to streamline the approval of drugs, such as ViroXis' lead drug candidate, that are traditional plant-derived mixtures rather than a single chemical entity, and that have a historical record of safe human use. ViroXis' EISO-based drug candidates are sourced under an exclusive long-term supply agreement from TFS Corporation, Ltd. of Australia (ASX: TFC). TFS manages the world's largest commercial, sustainable plantations of East Indian sandalwood trees and is the only supplier qualified by ViroXis to meet the requirements as an EISO botanical drug substance supplier.

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