Astex Pharmaceuticals Has a Catalyst-Driven Year Ahead (Part II)
The Pipeline and the Year in Catalysts
SGI-110 is being developed, essentially, as an improved Dacogen; it’s administered subcutaneously as opposed to Dacogen’s IV formulation, has a longer systemic exposure time, improved pharmacodynamics, and greater half-life (translating into potentially better efficacy). While SGI-110 incorporates a similar structure to decitibane, it’s actually a dinucleotide of decitabine and deoxyguanosine form, which slows degradation compared to Dacogen. SGI-110 is currently in a Phase I/II clinical trial in MDS and AML that began as a dose escalation study (Phase I), which subsequently rolled into a dose expansion phase to evaluate safety and efficacy at maximum tolerated doses. The AML/MDS study enrolled 78 patients, and Phase I data were presented at the meeting of the American Society for Hematology (ASH) in December of last year. The trial has since moved into the dose expansion phase, and the company initiated a Phase II trial in advanced HCC in January. Given the open-label design of these trials and the Phase II PROC study, the company will be updating the medical community throughout the year, creating numerous catalysts that can create shareholder value.
For instance, this weekend at the meeting of the AACR in Washington D.C., Astex will present six posters on SGI-110, and although all of these posters will offer just pre-clinical and updated Phase I data, the company plans to release Phase II preliminary data at ASH in December of this year, and possibly early results at the European Society for Medical Oncology (ESMO) in September. Phase II data presents a key catalyst for investors, as it will reveal SGI-110’s efficacy, safety, and thus, clinical benefit. Analysts speculate that positive Phase II results could lead to a partnership with a major drug or biotech company, or perhaps a buy-out of ASTX. Meaningful catalysts anticipated this year include: