Santalis Pharmaceuticals, Inc. announced today the Notice of Allowance by the United States Patent Office of a patent containing nine claims covering the use of East Indian sandalwood (Santalum album) oil-containing compositions to treat Clostridium infections including Clostridium difficile (C. diff). This will be the first patent issued to Santalis Pharmaceuticals for the use of sandalwood oil to treat infectious disease.

Clostridium difficile infection (CDI) is a potentially-fatal infection caused by the spore-forming bacteria. Bacterial toxins cause often-severe diarrhea, nausea, abdominal pain and inflammation of the colon. C. diff spores are very resistant to most antibiotics and make treatment of the disease very challenging. More recently, fecal transplants have been used to treat CDI where antibiotics have failed.

According to the Centers for Disease Control and Prevention (CDC), C. diff causes almost half a million infections among patients in the United States yearly and about 15,000 deaths were estimated to be directly attributable to C. diff infections. More than 80 percent of the deaths associated with CDI occurred among Americans aged 65 years or older. CDI has become the most common microbial cause of healthcare-associated infections in U.S. hospitals and costs up to $4.8 billion each year in excess healthcare costs for acute care facilities alone.

East Indian sandalwood oil (EISO) is an essential oil with a long history of use in traditional medicine and its broad range of biological activities and excellent safety profile make it an attractive, unique drug candidate for clinical development in a variety of indications. While current clinical testing mostly relates to dermatological diseases, EISO was previously listed in the US Pharmacopoeia as an oral medication to treat urinary tract infections.

Santalis’ Chief Scientific Officer, Dr. Corey Levenson stated: “EISO is known to be active against many gram-positive bacteria, such as Clostridium, as well as the drug-resistant varieties of these organisms. What was especially surprising was that EISO was also active against the C. diff spores, which are particularly resistant to many other types of antibiotics. We’re hopeful that the promising preclinical findings outlined in our patent will translate in the clinic to a benefit for those who are suffering from CDI.”

ABOUT SANTALIS PHARMACEUTICALS:

Santalis Pharmaceuticals, Inc. is a wholly owned subsidiary of TFS Corporation, Ltd. (ASX: TFC). Santalis is developing scientifically- and clinically-validated over-the-counter and prescription products that utilize TFS’ cultivated, sustainable, pharmaceutical­grade East Indian Sandalwood Oil. EISO’s well documented safety and anti-infective, anti­proliferative and anti-inflammatory properties are well suited to a number of prevalent and under­served conditions. Santalis is currently studying EISO-based drug candidates in several Phase 2 clinical trials in Australia and the US for the treatment of psoriasis, warts, atopic dermatitis (eczema) and molluscum contagiosum. In addition, EISO is being evaluated in a Phase 2 clinical trial for prevention of oral mucositis in head and neck cancer patients undergoing high dose radiation therapy.

Santalis Pharmaceuticals, Inc.Jim Traa, CBO, 210-399-2318jim@santalispharma.com

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