Annamycin Overview

Annamycin: Next generation non-cardiotoxic anthracycline

Annamycin is the Company’s “next generation” anthracycline that has recently been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin (the standard of care chemotherapy for STS lung metastases). Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of acute myeloid leukemia (AML), so we believe that the use of Annamycin may not face the same usage limitations imposed on doxorubicin. Annamycin is currently in development for the treatment of AML and STS lung metastases.

  • Novel non-cardiotoxic anthracycline
  • Demonstrated ability to overcome multidrug resistance
  • >30x better accumulation in lungs than doxorubicin
  • Potent topoisomerase-II position with wider therapeutic window than doxorubicin
  • Clinically evaluated stable liposomal formulation

Annamycin, represents a much-needed breakthrough in the battle against multidrug resistance.

Annamycin – AML Clinical Benefit to Date

  • 22 patients1 treated in both US and EU trials
  • 7 patients with CR/PR (at subtherapeutic does levels)
  • 15 relapsed patients1 treated in both US and EU trials
  • 14% refractory patients1 with PR
  • 40% relapsed patients1 with CR/PR
  • 67% 240 mg cohort patients1 with CR/PR
  • 100% non-cardiotoxic

1: Patients receiving a full course of treatment. Trial is ongoing, preliminary data

We believe Annamycin is better than the currently approved induction therapy drugs in four key ways:

  • It has demonstrated clinical activity in a patient population for whom there are currently no effective therapies,
  • It appears to be capable of avoiding the “multi-drug resistance” mechanisms that often limit the effectiveness of currently approved anthracyclines;
  • In a number of tumor cell lines, it has been shown to be more potent than doxorubicin (one of the leading approved anthracyclines);
  • It has been shown to accumulate in certain targeted organs (“sanctuary sites”), including the lungs, liver, pancreas and spleen, at significantly higher levels than doxorubicin.