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 60% 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

Ongoing Study:

Phase 1/2 Study of Annamycin in Combination with Cytarabine (Ara-C)in AML in Poland

Multicenter, Open-Label, Dose-Escalation Study to Determine the MTD and RP2D of Liposomal Annamycin in Combination with Ara-C for the Treatment of Subjects with Acute Myeloid Leukemia (AML) that is Refractory to or Relapsed after Induction

Study Highlights:

Enrolling: Up to Subjects

Treatment period: Starting dose of 190 mg/m2/day on Days 1-3 of a 21-day cycle

Dose Escalation: Dose increments of 40 mg/m2 continues until an MTD is reached

Primary Endpoint: Achievement of normal bone marrow morphology, recovery of peripheral blood counts and eligibility for hematopoietic stem cell transplantation

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