Cellceutix Corporation, has signed an agreement with Girindus America, Inc, for the manufacture of Kevetrin's active pharmaceutical ingredient (API) under Current Good Manufacturing Practices (cGMP). Terms of the agreement were not disclosed.
"This is a big step toward our short-term goal of filing for an investigational new drug exemption (IND) with the FDA," said George Evans, CEO of Cellceutix. "We will use the API material manufactured by Girindus to do the last animal toxicology studies needed for the filing of an IND, as well as for phase-1 human trials. We are excited to have Girindus as a development and manufacturing partner for Cellceutix as we bring forward Kevetrin to market. Girindus' extensive experience in bringing new compounds from 'bench into market' is exactly what Cellceutix was looking for in a cGMP manufacturing relationship," Evans concluded.
Kevetrin is being developed to treat certain cancers. The company has recently reported encouraging results in animal models of several drug resistant cancer cell lines.
Cellceutix is an emerging bio-pharmaceutical company in the business of developing small molecule therapies in areas of unmet medical needs.