- Ultra-thinly traded Cyclacel Pharmaceuticals (CYCC +66.3%) heads north on a whopping 170x surge in volume, albeit on turnover of ~2.1M shares, in response to its announcement of data from a Phase 1 clinical trial assessing sapacitabine and seliciclib in heavily pretreated patients with advanced solid tumors. The results were presented today at ASCO16 in Chicago.
- The regimen was administered sequentially (Part 1) and together (Part 2) in 67 subjects. Antitumor activity was observed in a subgroup of 45 (67.2%) patients with breast, ovarian and pancreatic cancers who were BRCA mutation-positive. The overall disease control rate (DCR) was 35.6% (n=16/45) consisting of one complete responder, five partial responders and 10 with stable disease. In Part 1, the DCR was 37.5% (n=6/16) but eased a bit to 32.1% (n=9/28) in Part 2. The overall response rate was 13.3% (n=6/45), although the press release states 11%.
- Sapacitabine, currently in Phase 3 development in acute myeloid leukemia, is an oral nucleoside analogue prodrug whose metabolite, CNDAC, arrests the cell cycle by breaking up DNA. Orally available seliciclib, currently in Phase 2 for myelodysplastic syndrome , inhibits the enzymes CDK2 and CDK9, which play key roles in cell growth, survival and cell cycle control.