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Aptose Biosciences Inc (NASDAQ: APTO) highlighted data from its luxeptinib currently in two Phase 1 a/b trials - one in relapsed or refractory acute myeloid leukemia (AML) and another in relapsed or refractory B cell malignancies.
In Relapsed or Refractory AML or High-Risk MDS trial, APTO-253 has been well-tolerated in the patients treated at 20, 40, 66, 100, and 150 mg/m2 over multiple cycles supporting continued dose escalation.
APTO-253 monomer rapidly transformed to and co-existed with the Fe(253)3 conjugate in peripheral blood.
Serum levels of APTO-253 and the Fe(253)3 conjugate were dose-proportional, with significantly higher Fe(253)3 conjugate concentrations than monomer.
In Relapsed or Refractory B-Cell Malignancies, the anti-tumor activity observed in multiple patients, including follicular lymphoma (FL), Waldenstrom’s (WM), Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Tumor reduction in a patient with follicular lymphoma (FL) upon dose escalation from 450 mg to 600 mg.
IgM reduction in a patient with Waldenstrom’s (WM) at 750mg dose.
Dose escalation well-tolerated from 150 – 600 mg twice daily over multiple cycles.
One apparent dose-limiting toxicity of hypertension led to expansion at 750 mg – upon further review appears unlikely related.
Currently treating patients with B-cell malignancies at 750 mg BID in cohort 5; continued dose escalation planned.
See the slide presentation here.
Price Action: APTO shares are down 31.5% at $3.79 during the market session on the last check Friday.
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