PICN is a novel formulation that is Cremophor and Albumin free formulation with the added advantage of a very simple infusion preparation method.
For our Breast Cancer program, we have obtained guidance from USFDA at the end of Phase-II meeting held in December 2013. The Phase-III clinical design has now been finalized. We will submit the complete protocol to USFDA in Q2FY15. We plan to initiate a multi-country clinical trial in Q3FY15.
Paclitaxel is also effective in indications other than breast cancer. We conducted Phase-I trials in India and US and enrolled subjects with all solid tumors. Since this was a Phase-I trial, the number of subjects enrolled was limited; however, we observed efficacy benefits in several tumor types which deserve further the investigation in Phase-II trials. New cancer indications under consideration for Phase-II are Cholangiocarcinoma, Ovarian, Cervical, Anal Canal, Bladder Cancer and Melanoma. We plan to select a couple of indications for initiating Phase-II trials in FY15.
Paclitaxel is also administered in combination with other chemotherapeutic agents. Phase-I studies in combination with Carboplatin have been done and we have identified the maximum tolerated dose of PICN in this combination. Our next step will be to select an indication for Phase-II studies.
We have guidance from USFDA on the Phase-III trial for metastatic breast cancer in a weekly dosing with plans to initiate the trial in Q3 FY15.