Cellceutix, a clinical-stage biopharm company developing therapies in oncology, dermatology, and antibiotic applications, reports that the U.S. Food and Drug Administration’s (FDA) 30-day waiting period pertaining to the company’s Investigational New Drug Application (“IND”) for Prurisol™ has now passed and that the company is moving toward the commencement of clinical trials of the drug candidate for the treatment of psoriasis.
“This is another significant moment for our company as we bring our third compound into clinical trials,” Cellceutix CEO Leo Ehrlich stated in the news release. “A steady stream of developments has led to a great start to 2014 for our company. We initiated a multi-center phase 2b trial of our novel antibiotic Brilacidin. The phase 1 trial of our novel anti-cancer compound Kevetrin™ is in the seventh cohort and now Prurisol™ is set to enter human trials, positioning us with three clinical drug candidates targeting three different areas of unmet medical need.”
Ehrlich further explained the company’s research to expand Brilacidin for a wide range of indications.
“We are nearing completion of IND-enabling studies of Brilacidin-OM for oral mucositis. Other pre-clinical studies of Brilacidin are ongoing for otitis and ophthalmic infections,” he stated. “Separately, in our recent acquisition of assets we acquired a library of compounds that have shown promise for Gram-negative bacterial infections. These compounds have been sent to a university laboratory in Texas for further testing. We are actively developing other acquired compounds for anti-fungal treatments. In short, while we are very pleased with the clinical development to date, we feel that there are many other areas of tremendous opportunity for our pipeline and intend to relentlessly research them to define future clinical trials.”
Cellceutix is developing Prurisol under FDA guidance that a 505(b)(2) designation is an appropriate development pathway. Upon successful completion of the crossover trial to demonstrate that Prurisol converts to abacavir in humans, the company plans to initiate a larger phase 2/3 clinical trial under a 505(b)(2) designation, which would permit Prurisol to move to advanced trials.
Cellceutix previously submitted to the FDA an application for an Orphan Drug designation for Brilacidin-OM for the prevention of oral mucositis in head and neck cancer patients. Following its review, the agency advised the company that the data would indicate that Brilacidin-OM could treat a patient population that is actually too large for an Orphan Drug designation. The company said it may narrow the focus of the application and continue the dialogue with the FDA going forward or pursue the larger market.
For more information visit www.cellceutix.com
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