SAN ANTONIO--(BUSINESS WIRE)--Santalis Pharmaceuticals today announced positive results from its single-center, open-label, efficacy and tolerability proof-of-concept study using a proprietary 10% East Indian Sandalwood Oil (EISO) serum formulation for the treatment of mild-to-moderate plaque psoriasis. The results of the study showed the EISO serum formulation to be safe, well tolerated, and efficacious for patients 18 to 65 years of age with a maximum of 10% treatable body surface area involvement of mild-to-moderate plaque psoriasis. Santalis’ research has shown EISO is a broad-acting anti-inflammatory agent that strongly suppresses the activity of factors including PDE4 and IL-17 that are believed to contribute to psoriasis. In addition, EISO has been shown to reduce the hyper-proliferation in psoriatic skin that leads to plaque formation.
The 28-day treatment regimen consisted of a twice-daily application of 10% EISO serum to the affected areas. Preliminary results indicated that the EISO treatment was effective, safe and well tolerated. Of the 12 patients enrolled in the pilot study with mild to moderate psoriasis, 9 patients experienced resolution of all the treated plaques, and 2 patients experienced mild to moderate improvement of their psoriatic skin. One patient withdrew with a mild application site adverse event that resolved upon discontinuation of the study medication.
“Plaque psoriasis can cause significant skin irritation and discomfort for patients and significantly impact their overall quality of life,” said Professor Kurt Gebauer, Lead Investigator at the Fremantle Dermatology Group. “We are pleased with the results of the recent study and look forward to the development of a new, efficacious and safe botanical drug to support our goal of meaningfully improving outcomes for all our patients psoriatic disease. The performance of the serum is evidenced by the fact that all of the patients asked to continue using the product after the end of the study.”
"These results provide preliminary confirmation that the anti-inflammatory and anti-proliferative effects of EISO we’ve seen in our prior pre-clinical studies will translate well to the clinic,” stated Dr. Corey Levenson, Chief Scientific Officer of Santalis. “We’ve leveraging EISO’s ability to target inflammatory and proliferative pathways to treat skin diseases such as eczema and psoriasis. We believe that TFS’ pharmaceutical-grade EISO, with its very favorable safety profile and multi-target activity, could provide a unique treatment option for patients.”
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 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 known as VlroXis Corporation), were acquired by TFS in July 2015. TFS operates the world’s largest East Indian Sandalwood tree plantations in Australia and is the only source of cultivated, sustainable, pharmaceutical-grade East Indian Sandalwood Oil. Santalis is developing scientifically and clinically validated over the counter and prescription products that utilize TFS' EISO, with development programs 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.
