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Aileron Therapeutics Announces Positive Interim Results from Phase 1b/2 Clinical Trial of ALRN-6924 for the Prevention of Topotecan-induced Toxicities During Treatment for Small Cell Lung Cancer
- - - Observed a protective effect against severe chemotherapy-induced anemia and thrombocytopenia across all dose levels - - - Management to host a
About this update from Rein Therapeutics, Inc.
[{"type":"text","content":"- - -\n Observed a protective effect against severe chemotherapy-induced anemia and thrombocytopenia across all dose levels - - - Management to host a conference call and webcast today at 8:30 a.m. EDT - - - WATERTOWN, Mass., June 01, 2020 (GLOBE NEWSWIRE) -- Aileron Therapeutics (NASDAQ:ALRN) announced today positive interim data from the open-label Phase 1b dose optimization part of its ongoing Phase 1b/2 clinical trial. In this trial, ALRN-6924 is being evaluated as an agent to protect patients against chemotherapy-induced toxicity, a concept known as chemoprotection (or myelopreservation). Patients in the trial have advanced, p53-mutated small cell lung cancer (SCLC) and are being treated with second-line topotecan following administration of ALRN-6924. 18 patients were enrolled across three ALRN-6924 dose levels in the dose optimization part of the trial of which 17 patients completed the first treatment cycle and therefore met protocol-defined criteria for evaluability. A protective effect against severe chemotherapy-induced anemia and thrombocytopenia was observed across all dose levels as compared to historical controls. In addition, patients treated with 0.3 mg/kg ALRN-6924 met the protocol-defined criteria for reduction of NCI CTC Grade 3/4 neutropenia to ≤50% in the first treatment cycle. Key findings from the interim analysis of the Phase 1b dose optimization part of the trial are as follows: Patients treated with 0.3 mg/kg ALRN-6924 showed the lowest rate of NCI CTC Grade 3/4 hematological adverse events, including 17% with anemia, 33% with thrombocytopenia and 67% with neutropenia, across all treatment cycles.None of the patients treated with 0.3 mg/kg ALRN-6924 required transfusions of red blood cells or platelets. The expansion of the 0.3 mg/kg ALRN-6924 dose level from six to a total of 14 patients is underway.Across all three dose levels, patients showed NCI CTC Grade 3/4 hematological adverse events, including 24% with anemia, 35% with thrombocytopenia and 88% with neutropenia. Across all three dose levels, no patients experienced febrile neutropenia or NCI CTC Grade 3/4 nausea, vomiting, diarrhea or fatigue, which are severe toxicities commonly observed with topotecan-treatment in this patient population. “Large randomized trials designed to evaluate the anti-tumor efficacy of topotecan and other drugs have h...