Ongoing Studies:

Phase 1b/2 Study of Annamycin in STS Lung Mets in the United States

Multi-Center, Open-Label, Single-Arm Study of Liposomal Annamycin for the Treatment of Subjects with Soft-Tissue Sarcomas (STS) With Pulmonary Metastases

Preliminary Phase 1b Data Demonstrated No Cardiotoxicity

and Demonstrated Clinical Activity1

Study Highlights:

Enrolling: ~25 Subjects in Phase 2 portion

Treatment Period: Single dose every 21 days

RP2D: 360mg/m2 (protocol provides for a reduction to 330 mg/m2 after the first 3 patients treated if warranted based on tolerability)

Phase 1b Concluded: RP2D determined to be 360mg/m2

Phase 2 Recruitment Open: Expansion at 360 mg/m2 with option to decrease to 330 mg/m2

For complete study details, please view the study listing on clinicaltrials.gov: ClinicalTrials.gov Identifier: NCT04887298

1: Data are preliminary. Defined as stable disease or better. As of August 12, 2022, preliminary data demonstrated 12 of 14 patients measured had SD after two cycles of Annamycin.

 

Phase 1b/2 Study of Annamycin in STS Lung Mets in Poland

Single-Center, Open-Label, Dose Escalation Study of Annamycin in Patients with Previously Treated Soft-Tissue Sarcomas (STS) with Pulmonary Metastases (ANNA-SARC) in Poland

Primary objective of the Phase 1B is to establish safety and tolerability of weekly dosed Annamycin in monotherapy in subjects with STS with lung mets and the Phase 2 portion is
to determine the efficacy of Annamycin in subjects with STS with lung mets

Study Highlights:

Enrolling: Up to 64 subjects

Treatment period: 3 weeks on/1 week off 28-day cycle

Dose Escalation: First dose level of 35 mg/m2  escalating up to 100mg/m2

Primary Endpoint: Determine RP2D

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