The US Food and Drug Administration (FDA) suggested Cellceutix that an application for a 505(b)(2) designation for Prurisol will be an acceptable approach that allows the company to advance Prurisol into advanced stages of clinical trials.
Cellceutix chief scientific officer Krishna Menon said that they have conducted multiple meetings with companies to manufacture Prurisol and are aligning their strategies to advance the drug candidate into human trials as expeditiously and efficiently as possible.
"Our confidence is high for Prurisol™ and we are systematically deciding the best procedures going forward with it to maximize outcomes and shareholder value," Krishna added.
The company also said that the Site Initiation Visit ("SIV") for its anti-cancer compound, Kevetrin, will happen this week at Harvard Cancer Center, which enables the researchers to commence clinical trials at Harvard’sDana-Farber Cancer Center and partner Beth Israel Deaconess Hospital.
Cellceutix chief executive officer Leo Ehrlich said all the documentation and requirements to begin the clinical trials of Kevetrin are now in place.
”The SIV visit this week is the final step before we will begin the patient enrollment process,” Ehrlich added.