|[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
"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.
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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