Topline Data on Astex Candidate - Analyst Blog

Astex Pharmaceuticals, Inc. ( ASTX ) recently announced topline data from an ongoing phase II study on its candidate, SGI-110. SGI-110 is being developed for the treatment of patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

In the randomized study on SG-110, patients were administered a dosage of either 60 or 90 mg/m2 daily for 5 days in a 28-day course. Minimum 3 months follow-up was carried on 67 AML patients for the end of June data cut-off. Patients were divided into two cohorts.

The relapsed/refractory AML cohort had 50 patients. The second cohort was formed by 17 elderly AML patients who were treatment naïve and not suitable for induction chemotherapy.

Overall remission rate is the primary endpoint of the study. Topline results showed an overall remission rate of 25% -- 8 remissions were in relapsed/refractory AML and 9 in treatment-naive elderly AML.

In Jun 2013, Astex had presented data from the phase I portion (dose-escalation) of the SGI-110-01 study in patients with intermediate or high risk relapsed or refractory myelodysplastic syndromes (r/r MDS).

15 intermediate or high risk r/r MDS (including chronic myelomonocytic leukemia) patients were enrolled in the study - the patients had been treated earlier with either Vidaza (azacitidine) or Dacogen (decitabine). About 40% of the patients had undergone treatment with both therapies. Six of the 15 patients achieved an overall response rate of 40%.

We note that other companies are also actively developing candidates for the treatment of MDS. In Jun 2013, MEI Pharma, Inc. ( MEIP ) commenced a phase II study on pracinostat in combination with Vidaza for the treatment of myelodysplastic syndrome (MDS).

Astex is trying to develop a portfolio of cancer drugs, with candidates such as AT13387, SGI-110, AT7519, AT9283 and AT13148.

Apart from Dacogen, all other products of Astex are in the development phase. Dacogen was approved by the U.S. Food and Drug Administration in 2006.

Astex carries a Zacks Rank #3 (Hold). Currently, companies which look attractive include Gilead Sciences Inc. ( GILD ) and Jazz Pharmaceuticals ( JAZZ ), with a Zacks Rank #1 (Strong Buy) and a Zacks Rank #2 (Buy), respectively.


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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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