Recently Completed Study:
Phase 1b/2 Study in AML in Poland
Multi-Center, Open-Label, Dose Escalation Study of Liposomal Annamycin for the Treatment of Subjects with Acute Myeloid Leukemia (AML)
Announced Prelim 80% ORR in Last Cohort of Single Agent AML Trial
Data are Preliminary Pending Database Lockout
Study Highlights:
Enrolling: ~75 Subjects
Treatment period: Infusions days 1, 2 & 3 with 21 days off
Dose Escalation: Single-agent Preliminary RP2D of 240 mg/m2 established
Primary Endpoint Met: Single agent trial established safety and RP2D
Initiated Phase 1/2 of Annamycin with Cytarabine (AnnAraC)
with 190 mg/m2 Initial Annamycin Dose
Based on sponsored research conducted in a highly aggressive AML mouse model, Annamycin in combination with Cytarabine (Cytarabine is also known as Ara-C, hence the combination is referred to as AnnAraC) demonstrated a 68% improvement in the median overall survival (OS) compared to Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone. Based on these data, the Company plans to advance its AML clinical development program in a Phase 1/2 clinical trial in Europe evaluating AnnArac utilizing the clinical data from its two prior Phase 1 clinical trials to establish the starting dose of 190 mg/m2
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For complete study details, please view the study listing on clinicaltrials.gov: ClinicalTrials.gov Identifier: NCT03388749