Moleculin Biotech Inc MBRX provided a preliminary update on recent clinical activity from annamycin lead development programs.
Annamycin is the company's next-generation anthracycline that has been designed to be non-cardiotoxic (unlike currently prescribed anthracyclines) and has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin (a commonly prescribed anthracycline and the standard of care chemotherapy for advanced STS).
It also demonstrated the ability to avoid the multidrug resistance mechanisms.
The company is currently conducting a Phase 1B/2 trial evaluating Annamycin plus Cytarabine as both first-line therapy and for subjects who are refractory to or relapsed after induction therapy (MB-106).
The complete response (CR) rate of 38% (N=8) was observed with durability up to 8 months.
Builds on CR with incomplete recovery of the bone marrow (CRi) rate of 60% in MB-105 monotherapy AML trial last cohort (N=5).
Moleculin also completed enrollment in the Phase 2 portion of its U.S. Phase 1B/2 trial evaluating Annamycin as monotherapy for soft tissue sarcoma lung metastases (MB-107).
Phase 1B median extended overall survival of 11 months for heavily pre-treated subjects (N=15) was observed.
The median progression-free survival (PFS) of 3.4 months for subjects dosed at or below 330 mg/m2 and less than three prior therapies (N=9)
100% of Annamycin subjects in multiple studies (N=66) showed no signs of cardiotoxicity during the study.
Price Action: MBRX shares are up 13.10% at $0.61 on the last check Monday.
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