2. Completion of a registered direct common stock offering with net proceeds of approximately $25.8 million.
GALAXY Phase 2b
The 240 adenocarcinoma patient enrollment target for the Phase 2b portion of the GALAXY trial was achieved in October. Per protocol, additional adenocarcinoma patients with elevated baseline levels of lactate dehydrogenase (LDH) or with tumors exhibiting KRAS mutations, which are pre-specified patient subpopulations with especially high medical need, may continue to be enrolled until a specified maximum number of patients with these characteristics has been achieved. We expect to enroll up to 60 additional patients in these subpopulations.
Based on our current projections, Synta anticipates final progression free survival (PFS) and updated overall survival data from the Phase 2b portion of GALAXY in the first half of 2013, and final overall survival data in the second half of 2013.
GALAXY Phase 3
Synta recently completed an End-of-Phase 2 (EOP2) meeting with the Food and Drug Administration (FDA) to review plans for the Phase 3 portion of the GALAXY program. Synta has incorporated comments from the EOP2 meeting into the Phase 3 protocol and is currently initiating this trial. Enrollment is expected to begin early next year.
The Phase 3 trial has the same design as the Phase 2b trial. Adenocarcinoma patients with advanced NSCLC who have received one prior chemotherapy regimen will be randomized 1:1 to treatment with either docetaxel plus ganetespib or docetaxel alone. The same dose and schedule used in the Phase 2b trial will be used in the Phase 3 trial. Patients on both arms will receive docetaxel generally for four to six 21-day cycles, as per standard practice at their treatment center. After completion of docetaxel treatment, patients on the ganetespib arm are eligible to continue to receive ganetespib monotherapy as maintenance treatment. The trial will be conducted in many of the 60 centers across Europe and North America that participated in the Phase 2b trial, together with up to 60 additional centers.