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Helsinn Group and MEI Pharma Announce First Patient Dosed in Phase 2 Dose-Optimization Study of Pracinostat and Azacitidine in Myelodysplastic Syndrome

15 Jun 17

Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, and MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, today announced that the first patient has been dosed in a Phase 2 dose-optimization study of pracinostat in combination with azacitidine in patients with higher risk myelodysplastic syndromes (MDS) who are previously untreated with hypomethylating agents (HMAs).

 

The two-stage study will be conducted at approximately 25 sites and is expected to enroll up to 120 patients with high and very high risk MDS per the Revised International Prognostic Scoring System (IPSS-R). The high and very high risk groups represent the highest unmet need in MDS, with median survival estimates of only 1.6 years and 0.8 years, respectively[1]. The cost of this study will be shared by Helsinn and MEI Pharma. Data from the first stage is expected in the first quarter of 2018.

 

“Based on our clinical experience with the combination, we believe that a reduced dose of pracinostat has the potential to improve tolerability in patients with higher risk MDS, thereby improving efficacy of the combination compared to azacitidine alone,” said Robert D. Mass, MD, Chief Medical Officer of MEI Pharma. “We look forward to working with the study’s investigators and Helsinn to evaluate this hypothesis in the clinic while we await the outcome of our pivotal Phase 3 study of the combination in acute myeloid leukemia (AML).”

Sergio Cantoreggi, PhD., Helsinn Group Chief Scientific Officer said, “We are pleased to announce that the first patient with higher risk myelodysplastic syndromes has been dosed in this Phase 2 dose-optimization study of pracinostat in combination with azacitidine. Pracinostat is a promising late-stage asset and a key part of Helsinn’s broadened focus into therapeutic clinical development and we look forward to seeing the results in early 2018.”

 

In a recently published, placebo-controlled Phase 2 study (MEI-003) conducted in 102 patients with intermediate-2 and high risk MDS, pracinostat (60mg) and azacitidine failed to increase the complete response rate, the study’s primary endpoint, compared to azacitidine and placebo[2]. Drug discontinuation within the first two months of treatment, due to poor tolerability (primarily fatigue and myelosuppression), occurred twice as frequently in the pracinostat group compared to placebo. A sensitivity analysis, including 54 patients who received at least four cycles of study therapy (pracinostat or placebo) and azacitidine showed a trend for better progression-free survival and overall survival (hazard ratio = 0.37 and 0.59, respectively) compared to the control group. These data suggest that insufficient exposure to treatment may have limited the overall efficacy of the combination and are

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