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Catalyst pick – Astex Pharmaceuticals (ASTX) Price Target opinion = $5.75 -$6 short term, near $7 running into its catalyst event.
It’s anticipated SGI-110 data from a randomized Phase II study of the drug in MDS and AML patients to be announced late Q3/early Q4. Data presentation will be made at the European Society for Medical Oncology (ESMO) in late September and at the American Society of Hematology (ASH) conference in December. In an April 10 press release the company stated:
“The company also announced that the ongoing clinical phase 2 expansion study (Part B of Study SGI-110-01) in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) has been expanded to approximately 200 patients by including an additional cohort of relapsed/refractory MDS patients to the ongoing three other cohorts (front-line MDS; front-line elderly AML; and relapsed/refractory AML). The phase 2 expansion trial has already enrolled more than half of the patients needed to complete the study. While data were not mature enough for presentation at the upcoming American Society of Clinical Oncology (ASCO) meeting, more mature data presentations will be submitted to other scientific conferences. The trial is still on track to submit data from the relapsed/refractory AML cohort in the phase 2 expansion study to the American Society of Hematology (ASH) meeting for presentation in December this year.”
These trials will evaluate SG-110 in several ways. The efficacy, safety, and clinical benefit to patients will be determined by the second part of the study. The Expansion Part (Part B), will have a primary objective of estimating overall response rates in four patient cohorts: relapsed/refractory AML, relapsed-refractory MDS, front-line elderly AML not suitable for induction chemotherapy, and front-line MDS. Secondary objectives include estimating the incidence and severity of adverse events, duration of response, overall survival, and the correlation of demethylation, genetic, and pharmacologic biomarkers.
It is also very important to mention that there were two AML patients that achieved complete responses, or complete remissions of their cancers. This is very encouraging that AML patients seem to be responding to the therapy, since neither Dacogen nor its competitor Vidaza (azacitidine) are approved for this indication (even though they are both used for off-label treatment of AML). All this is very encouraging for SGI-110 and bodes well for the chances of Phase II data being very good.
Astex also recently stated that updated clinical data from the dose escalation part of the study will be announced at an oral presentation at ESMO on September 28th, providing yet another catalyst for the stock within the next several months. With anticipation of such important data, interest in Astex should start to increase from here.
If SGI-110 receives approval, it could be a blockbuster for just AML alone, because it would be the first approved drug for that indication in the US. It is difficult to predict approvals and events that may or may not occur so far down the road in biotechnology, but for the long term investor these are all possible positives. SGI-110 could expect a PDUFA by early 2015 if Phase II and III trials went well. It is also very likely that SGI-110 could be worth a lot more than Dacogen if approved. In 2012, the MDS market was valued at an estimated $810 million dollars, growing at a compound annual growth rate of about 12%.
