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Santalis Announces First Subject Enrolled in Phase 2 Trial of East Indian Sandalwood Oil (EISO) to Treat Mild to Moderate Plaque Psoriasis

Santalis Pharmaceuticals today announced it has enrolled its first patient into a single-center, open label, efficacy and tolerability proof of concept study using a unique 10% East Indian Sandalwood Oil (EISO) serum formulation for the treatment of mild to moderate plaque psoriasis. Patients will be at least 18 years of age with a maximum of 10% treatable body surface area (BSA) involvement of plaque psoriasis. Up to 15 patients will be enrolled to look at preliminary efficacy after 28 days of twice a day treatment. TFS’ pharmaceutical grade EISO has been demonstrated to inhibit a broad range of inflammatory and proliferative pathways thought to underlie this condition, including down-regulation of PDE4 activity.

“We see many patients looking for new drugs that can work in this problematic skin condition,” said Professor Kurt Gebauer, Lead Investigator at the Fremantle Dermatology Group. “New, efficacious and safe topical products that can be used over prolonged periods of time are very much in need and we are very pleased we can help both patients and a local company with a potentially game-changing new botanical treatment.”

“It’s fantastic to have local clinical support for Santalis’ prescription drug development program,” said Frank Wilson, Managing Director of TFS Corporation. “We have invested significantly into developing a unique drug substance with the worlds only sustainable supply of cGMP produced, pharmaceutical-grade East Indian Sandalwood Oil.”

“Australia is an important clinical development location for Santalis, as EISO is already a Listed Medicine with the Therapeutic Goods Administration,” said Paul Castella, CEO of Santalis Pharmaceuticals. “Therefore, unlike many other drugs in development, we can quickly complete clinical studies and learn more about EISO’s clinical utility. In addition, we can then present this data to other regulatory authorities such as FDA and the EU, speeding up the regulatory process in these countries.”

ABOUT PLAQUE PSORIASIS
Psoriasis is an autoimmune disease that causes raised, red, scaly patches to appear on the skin. Psoriasis typically affects the outside of the elbows, knees or scalp, though it can appear on any location. People report that psoriasis is itchy and painful, and the skin can crack and bleed. The skin cells in people with psoriasis grow at an abnormally fast rate, which causes the buildup of psoriasis lesions. Men and women develop psoriasis at equal rates. Psoriasis also occurs in all racial groups, but at varying rates. About 1.9 percent of African-Americans have psoriasis, compared to 3.6 percent of Caucasians. Psoriasis often develops between the ages of 15 and 35, but it can develop at any age. About 10 to 15 percent of those with psoriasis get it before age 10. Plaque psoriasis is the most common form of the disease and appears as raised, red patches covered with a silvery white buildup of dead skin cells or scale.

Topical Treatments with and without steroids usually are the first choice in treating psoriasis. Prescription topical drugs slow down skin cell growth and reduce inflammation. Treatment can include Phototherapy which involves exposing the skin to ultraviolet light on a regular basis and under medical supervision. Systemic medications are often prescribed for individuals with psoriatic arthritis and those with moderate to severe psoriasis whose symptoms are unresponsive to other treatments. Systemic medications are taken orally, by injection or infusion and fall into two categories, traditional systemics and biologics.

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

ABOUT INDIAN SANDALWOOD
Indian sandalwood has a history as a tradable 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 artifacts and religious worship in the Hindu and Buddhist faiths. The global pharmaceutical market has the potential to be a significant consumer of Indian sandalwood.

Contacts
Santalis Pharmaceuticals, Inc.
Ian Clements, COO
210-399-2315 - Direct
210-643-8847 - Mobile
Ian@santalispharma.com

Source: http://www.businesswire.coml back

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