prexigebersen (BP1001)

News alerts, weekly reports and conference planners

Company:

Bio-Path

Drug class:

GRB-2 inhibitor

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10ms

BP1001-201-AML: Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML (clinicaltrials.gov)

P2, N=108, Recruiting, Bio-Path Holdings, Inc. | Phase classification: P2a --> P2 | Trial completion date: Dec 2024 --> Dec 2028 | Trial primary completion date: Dec 2024 --> Dec 2027

10 months ago

Phase classification • Trial completion date • Trial primary completion date

Chr t(15;17)

Venclexta (venetoclax) • decitabine • prexigebersen (BP1001)

4years

Safety and Efficacy of Lower Intensity Induction Therapy with Intravenous Prexigebersen (BP1001) in Patients with High-Risk and Relapsed/Refractory Acute Myeloid Leukemia (AML) (ASH 2021)

A Phase I/IB single center study (Ohanian, Lancet Haematol 2018) in relapsed/refractory AML patients demonstrated BP1001 safety up to 90 mg/m 2 and demonstrated CR/CRi in 3 of 6 relapsed/refractory AML patients treated with BP1001 + low dose cytarabine combination in the Phase IB portion. Preclinical studies indicated that BP1001 enhanced the inhibitory effects of decitabine (DAC), or DAC + venetoclax (VEN) against AML cells... BP1001-based combination therapy has been safely administered to high-risk and relapsed/refractory AML patients who were considered unsuitable for standard chemotherapy. Preliminary data showed the combination treatment of BP1001 + DAC or BP1001 + DAC + VEN was well-tolerated, with encouraging efficacy signals. The study will continue enrollment across all three cohorts.

4 years ago

Clinical

KRAS (KRAS proto-oncogene GTPase) • FLT3 (Fms-related tyrosine kinase 3) • NRAS (Neuroblastoma RAS viral oncogene homolog) • NF1 (Neurofibromin 1) • PTPN11 (Protein Tyrosine Phosphatase Non-Receptor Type 11)

KRAS mutation

Venclexta (venetoclax) • cytarabine • decitabine • prexigebersen (BP1001)