EVERY Shareholder needs to read the 10K filed tonight: We also continue to follow patients who have enrolled in our earlier Phase 1 and Phase 2 clinical trials and announce updated long-term efficacy and safety data from time to time at major scientific conferences and in our press releases. In June 2015, we announced long-term follow up from PACE, our pivotal Phase 2 trial of Iclusig in heavily pretreated patients with resistant or intolerant CML or Ph+ ALL. The study showed that, with a median follow-up of approximately 3.5 years for chronic phase CML, or CP-CML, patients and a median follow-up of approximately 2.9 years in all patients in the trial, Iclusig continued to demonstrate anti-leukemic activity in patients with limited treatment options. Responses have been maintained long-term in CP-CML patients. Eighty-three percent of CP-CML patients who achieved a MCyR are estimated to remain in MCyR at three years. Additionally, 95 percent of CP-CML patients who underwent Iclusig dose reductions maintained their MCyR. Approximately 23 percentage of CP-CML patients experienced a serious adverse event, or SAE, and approximately 4 percent and 5 percent of CP-CML patients, respectively, experienced a venous thromboembolic SAE or an adverse event, or AE. The most common all-grade treatment-emergent AEs occurring in greater than or equal to 40 percent of CP-CML patients were abdominal pain (46%), rash (46%), thrombocytopenia (45%), headache (43%), constipation (41%), and dry skin (41%); the discontinuation rate due to adverse events was 18 percent in CP-CML.
Additionally, twelve investigator-sponsored trials, or ISTs, in the ponatinib program are open to patient enrollment, and twelve additional ISTs are pending protocol finalization, regulatory or institutional review board approval, or contract finalization. This includes twelve trials in CML or Ph+ALL, six trials in acute myeloid leukemia, or AML, and six in various other solid tumors (including in non-small cell lung cancer, or NSCLC, cholangiocarcinoma, recurrent glioblastoma multiforme, and gastrointestinal stromal tumors) with varying genetic aberrations (e.g., FGFR, RET, and KIT). We expect that additional investigator-sponsored clinical trials will be initiated in 2016 in various indications.
Wow. This data says we get to $12.
