Soon CTIX and the FDA are going to have a long retreat to plan future studies for P, B, and K.
In addition to the P IND you mentioned, CTIX and the FDA will need to plan the Phase 2 Kevetrin and the future Brilacidin trials.
Besides the University of Bologna AML Phase 2 trial which has been announced I look for Phase 2 trials with all the tumors previously mentioned: Renal cell cancer and Melanoma at BI; Multiple myeloma and Lymphoma at MD Anderson; Retinoblastoma. I expect continuation of some of the solid tumors which showed good response in the animal and Phase 1 trial; Ovarian, head and neck squamous cell carcinoma, pancreatic cancer plus a few surprises such as lung, colon and breast cancer.
Yes, Georgejjl these are likely to be primarily combination trials.
The Brilacidin Phase 2/3 or 3 trials should be announced before the end of the year. In addition to the recently announced oral mucocytis trial we should be have plans for the Brilacidin ophthalmic drops, the otic ear drops perhaps coupled with oral Brilacidin for otitis media, Diabetic foot ulcer trial with a dermatologic ointment and oral Brilacidin.
After the first of the year we will hear plans for the oral Candidiasis study and the trial for life threatening multiply resistant Gram negative infections: Klebsiella, Pseudomonas, Actinobacter and E coli.
In 2015 and 2016 will see the FDA studies for the Brilacidin and Kevetrin sister compounds. We have heard about animal studies for multiple resistant TB and malaria. Kevetrin analogues show promise in autoimmune disorders, arthritis, Multiple sclerosis and demyelinating disorders, hypertension. Brilacidin analogues show promise in asthma and COPD. Brilacidin has shown antinfective efficacy as coatings for medical devices such as implants and catheters. I expect we will see a number of these indications studied in the next few years.
It is a long list of studies needed to explore the potential of these new pharmaceutical classes of compounds.If many of the above studies are successful the analogues of our compounds will be carefully scrutinized for other indications.. What we are aware of today may just be the tip of the iceberg.
How can a small company like CTIX manage all of this? The short answer is they can not. IMO CTIX will need help and I look for it to start soon. I expect Mr Ehrlich's skills will really shine when he selects our partnership deals. Again all IMO.
Good luck, Farrell
