The company expects lab results, pharmacokinetic studies, and analysis to take about two months.
If the results shows bioequivalence of Prurisol with Abacavir Sulfate, Cellceutix will then schedule a meeting with the US Food and Drug Administration (FDA) regarding the start of a Phase II/III trial of Prurisol through the 505(b)(2) regulatory pathway.
The company would also like to update shareholders on other ongoing clinical trials and laboratory research.
The seventh group has been completed in the Phase I trial of the company’s anti-cancer drug candidate Kevetrin being carried out at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center.
The company expects that dosing will be increased by about 33%, or about 215mg/m2, but there are no assurances as any dosing increases are at the sole discretion of the safety committee.
The Phase IIb trial of the company’s antibiotic Brilacidin is progressing as planned with about 60% of patient enrollment completed.
Separately, the company had entered into a research agreement with a renowned non-profit research institution for studies of anti-fungal compounds in its portfolio.
The research is to be funded by a $1.5m grant from the National Institute of Health, Small Business Innovation Research (SBIR) to the non-profit institution.