Cellceutix Corp (OTCMKTS:CTIX) reported that the U.S. FDA granted Orphan Drug Designation to its lead drug Kevetrin for the cure of ovarian cancer. With the new status the companies can get special incentives to evaluate its lead product for use in rare disease, normally that affect fewer than 200,000 people in the U.S.
The incentives can be any form including federal grants and tax credits, or lower filing fees during advancement or at the time of application for commercialization approval. Once permitted, the drug may receive the marketing exclusivity in the U.S. for seven years.
The expert view
Leo Ehrlich, the CEO said that it is an important development for company’s novel compound Kevetrin. It will help Cellceutix to move forward with its plans to commence a Phase 2/3 trial of Kevetrin to treat ovarian cancers. He added that they wanted to share the promising news with shareholders immediately and will be providing more updates on clinical developments to shareholders shortly.
In unrelated news, the company stated that the U.S FDA permitted them to progress with Phase III study of Brilacidin for ABSSSI. Cellceutix reported that in a meeting with the FDA scheduled after the completion of Phase II study, the approval was granted. In the meeting, the two parties evaluated effectiveness and safety data of Brilacidin Phase II study.
After evaluation of data, and considering the basic elements of planned Phase III study, the FDA approved to commence Brilacidin Phase III Study in ABSSSI. The upcoming Phase 3 trial is divided in two parts, as per the requirements of the U.S. FDA. The first trial would be an interim assessment on first few enrolled subjects in the trial.
In last trading session, the stock price of Cellceutix Corp (OTCMKTS:CTIX) declined more than 2% to close the trading session at $2.71.The decline came at a share volume of 268,875 compared to monthly average share volume of 288,777.