The company received FDA feedback and guidance on its IND amendment that has allowed a reduction in the size of its Phase 3 pivotal trial protocol evaluating Annamycin in combination with Cytarabine (also known as Ara-C and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for refractory/relapsed Acute Myeloid Leukemia patients.

“While all of the major aspects of the trial remain unchanged, guidance from the FDA recommended an alteration to the statistical plan that will allow us to reduce the size of Part B of our trial by approximately 10%.  Moreover, the nature of the feedback helps us move forward quickly to open sites in the US, in addition to the sites we are expecting to open in Europe and the Middle East. All of this supports the pursuit of an accelerated timeline for new drug approval,” commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.

The MIRACLE Phase 3 study utilizes an adaptive design whereby the first 75 to 90 subjects will be randomized in Part A of the trial to receive high-dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin, which Annamycin doses were recommended by the FDA in the company’s end of Phase 1B/2 meeting.