Santalis Announces First Subject Enrolled in Phase 2 Trial of East Indian Sandalwood Oil to Treat Pediatric Molluscum contagi...
26 January 2016 - 10:29AM
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 contagiosum, 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."
ABOUT MOLLUSCUM CONTAGIOSUM
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 treatments.
ABOUT SANTALIS
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.
ABOUT INDIAN SANDALWOOD
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160125006621/en/
Santalis Healthcare CorporationIan Clements, COO,
210-399-2315Mobile: 210-643-8847Ian@santalispharma.com
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