Cellceutix Submits IND To FDA For Prurisol And Initiates Trial For Brilicidin
By Cyndi Root
Cellceutix Corporation announced in a press release that it has submitted an Investigational New Drug Application (IND) to the Food and Drug Administration (FDA) for Prurisol, a treatment for psoriasis. The FDA must review the application within 30 days. Clinical trials may begin if the FDA has no concerns. Cellceutix also announced that a Phase 2b trial is recruiting to study Brilacidin for skin infections. Leo Ehrlich, Chief Executive Officer at Cellceutix said, “Our team has moved with precision to have Brilacidin enrolling patients in a mid/late-stage clinical trial only five months after we acquired it. Now the IND for Prurisol is filed, positioning us to initiate a third clinical trial in an area of great unmet medical need.”
Psoriasis and Prurisol
Psoriasis is a skin disease characterized by patches of red, thick, scaly skin. When skin cells rise to the surface before maturing, psoriasis occurs. The condition occurs in men and women, mostly adults, about five million people. Prurisol is a novel agent developed under FDA guidance 505(b)(2). Cellceutix intends to do an initial Phase 1 study with the primary endpoint that proves Prurisol converts to abacavir in humans. This crossover has been proven in animal studies. After the 45 day study, Phase 2 and 3 trials will commence.
Skin Infection and Brilacidin
Brilacidin is indicated for Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The FDA released guidance on this condition in 2013 for the purpose of assisting drug sponsors in developing drugs for the condition. The FDA defines
ABSSSI as “cellulitis/erysipelas, wound infection, and major cutanenous abscess.” Brilacidin is a synthetic immunomodulatory antimicrobial, also known as a defensin-mimetic. Underway and recruiting, the Phase 2b multi-center trial for Brilacidin will evaluate three doses of Brilacidin.
Brilacidin is also being considered for use in ophthalmic and otitis conditions. Cellceutix is aggressively targeting these conditions because the market is large, with limited treatments. The company may work with other entities in partnership to pursue this market.
About Cellceutix
Cellceutix Corporation is headquartered in Beverly, Massachusetts. It is a clinical stage company focused on oncology, dermatology, and antibiotic applications. Its portfolio includes the investigational cancer drug Kevetrin and Brilacidin-OM for Oral Mucositis.
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