Santalis Announces First Subject Enrolled in Phase 2 Trial of East Indian Sandalwood Oil to Treat Pediatric Molluscum contagiosum

SAN ANTONIO–(BUSINESS WIRE)–Santalis Healthcare Corporation (formerly ViroXis Corporation), a wholly
owned subsidiary of TFS Corporation, Ltd. (ASX:TFC), is pleased to
announce that the first subject has been enrolled in a double-blind,
placebo-controlled, randomized Phase 2 trial for the treatment of Molluscum
, testing a topical formulation of the company’s novel
botanical drug candidate, East Indian Sandalwood Oil (EISO).

Santalis Healthcare Corporation is a clinical-stage biopharmaceutical
company developing innovative EISO-based therapies for viral diseases of
the skin. A single dose level of the EISO-based botanical drug candidate
is being evaluated in this clinical study to assess safety and efficacy
in up to 60 pediatric subjects. The on-going trial, which is being
conducted at Texas Dermatology and Laser Specialists in San Antonio, TX,
is expected to be completed in 2016.

Molluscum contagiosum virus (MCV), a member of the poxvirus
family, is responsible for a highly contagious skin infection that
occurs predominately in children. The hallmark of MCV infection is the
appearance of numerous, raised, unsightly lesions on the skin which can
cover large areas of the body, including the face, neck, armpit, arms,
and hands. The lesions may become itchy, sore, red and swollen if
untreated. MCV infection is prevalent throughout the United States, is
spread through skin contact and accounts for approximately 1% of all
diagnoses of skin disorders. There is currently no effective
prescription treatment for this condition.

Molluscum contagiosum is highly contagious and the virus
infects large numbers of children each year,” commented Dr. John C.
Browning, Pediatric Dermatologist and Principal Investigator for the
trial. “When a child has an infection, it can spread to friends and
family and he or she often can’t participate in sports or social
activities due to the contagious nature of the
disease. Current treatment options are often painful and there is a high
unmet medical need for new products that are effective, safe and
non-invasive to treat this large patient group.”


Molluscum contagiosum is a viral infection of the skin caused by
a DNA poxvirus Molluscum contagiosum virus (MCV). This virus is
spread by skin contact and has a higher incidence in children, sexually
active adults, and those who are immunodeficient. Picking or scratching
may lead to further infection or scarring, and in about 10% of the
cases, eczema develops around the lesions.

MCV treatment options are invasive, requiring tissue destruction and
attendant discomfort. Surgical treatments include using liquid nitrogen
to freeze and destroy lesions, as well as scraping them off with a
curette. Scarring and loss of skin color can complicate both these


Santalis Healthcare Corporation (formerly known as ViroXis Corporation)
is a wholly owned subsidiary of TFS Corporation, Ltd. (ASX: TFC).
ViroXis, and its sister company, Santalis Pharmaceuticals, were acquired
by TFS in July 2015 and are developing over-the-counter and prescription
products that utilize TFS’ cultivated, sustainable, pharmaceutical-grade
East Indian Sandalwood Oil. TFS’ prescription drug development programs
are focused in oral health and dermatology, where EISO’s well documented
safety and anti-infective, anti-proliferative and anti-inflammatory
properties are well suited to a number of prevalent and under-served
conditions. In addition to the pediatric Molluscum contagiosum
study, TFS has ongoing Phase 2 studies in oral mucositis, pediatric
atopic dermatitis (eczema) and psoriasis, and is preparing to initiate a
Phase 3 study for pediatric HPV skin warts.


Indian sandalwood has a history as a tradeable commodity spanning
thousands of years, but is now endangered due to the illegal harvest of
wild trees throughout the world. As a result, Indian sandalwood is the
world’s most expensive tropical hardwood. Indian sandalwood oil is a
globally important ingredient in fine fragrances, cosmetics and
toiletries, Indian consumer products and is used for traditional
medicinal purposes (Ayurvedic and Chinese medicine). The wood is used
for high quality carvings and artefacts and religious worship in the
Hindu and Buddhist faiths. The global pharmaceutical market has the
potential to be a significant consumer of Indian sandalwood.


Santalis Healthcare Corporation
Ian Clements, COO, 210-399-2315
Mobile: 210-643-8847