Cellceutix to Expand its Skin Product Pipeline

BEVERLY, MA–(Marketwired – Mar 2, 2015) Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to announce that it is expanding its dermatology pipeline to include novel Human Defense Protein (HDP) mimetics for the treatment of chronic skin conditions, such as acne vulgaris, rosacea, and hidradenitis suppurativa (HS).  Recently conducted pre-clinical research supports these conditions as targets due to the robust antimicrobial and anti-inflammatory properties of Cellceutix’s HDP mimetics.  These are conditions for which there is no consistently effective treatment, as in the case of HS, or there is room to improve upon current therapies, as in acne vulgaris or rosacea.  In these conditions, topical antibiotics have been used, with mixed or disappointing results, most likely due to a lack of anti-inflammatory activity in concert with an inability to treat bacteria, such as Propionibacterium acnes, that are growing increasingly resistant to current therapies. The HDP mimetics can overcome both hurdles: they have anti-inflammatory properties and they can kill key bacteria without promoting further resistance. The latter is important, because traditional antibiotics, when chronically used, are likely to promote resistance, whereas HDP mimetics, given their unique structure and mechanism of action, are unlikely to promote resistance.

Building upon completed research for other indications Cellceutix is developing drugs to treat, it has been determined that the most promising application is the treatment of hidradenitis suppurativa (HS), also known as “acne inversus”, a chronic inflammatory condition of the sweat glands, characterized by painful lumps and sores, often discharging pus, and resulting in scarring and tunnels under the skin. There is no known cure, and no consistently effective treatment.  Approximately 1% of the population suffers from this condition, representing a large unmet medical need.   Conventional antibiotics have been used with minimal success, while increasing the risk of antimicrobial resistance among skin bacteria.  Infliximab, a TNF alpha inhibitor, has been used off-label in severe refractory cases with mixed results, though the risk/benefit ratio has not been fully established in this indication. TNF alpha inhibitors and other biologics are powerful drugs given by IV infusion and their long-term safety profiles have not been well established in this condition. Moreover, treatment courses are very expensive.

“These novel HDP mimetics, are a great addition to our growing dermatology pipeline, which already includes Prurisol for psoriasis,” said Leo Ehrlich, Chief Executive Officer at Cellceutix.  ”With the HDP mimetics, we can expand into a variety of chronic skin conditions, which require antibiotic compounds with anti-inflammatory properties—with minimal risk of resistance. This is truly an area of unmet medical need and a fantastic complement to our HDP mimetic franchise. We see a very clear regulatory pathway for hidradenitis suppurativa and will file an IND with the FDA once the formulation is completed.”