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FDA granted Orphan Drug Designation to ASLAN003 for acute myeloid leukemia (AML) treatment

Orphan Drug Designation has been granted to ASLAN003 which is a product of ASLAN Pharmaceuticals by USFDA for the treatment of acute myeloid leukemia (AML). ASLAN003 is an orally active potent inhibitor of human dihydroorotate dehydrogenase (DHODH) which depletes the intracellular pool of pyrimidines thereby lowering the levels of adenosine triphosphate and induction of the tumor suppressor p53 which at high levels can trigger apoptosis (programmed cell death).

Currently ASLAN003 is undergoing phase 2 clinical trial in Asia. No of patients include 8 with t patients in each dose cohort: ASLAN003 will be administered once daily with 100 mg in first cohort, another cohort 200 mg and last cohort 300 mg. Part 2 of the study will be an expanded trial consisting of 20 patients and the purpose would be to identify the optimum dose of the drug selected by the steering committee. The optimum dose will be selected from at least 1 cohort showing tolerable safety profile and clinical benefit in disease presentation.

The primary outcome of the trial is the overall complete remission (OCR) rate as measured in timeframe of 4 months after Leadership Practices Inventory (LPI) whereas the secondary outcome measures include incidence of Adverse Events (AEs) as categorized in accordance with CTCAE 4.03 and changes from baseline in safety parameters (including vital signs, ECG parameters, clinical laboratory tests) as measured through 28 days post-last study medication administration.

According to IWG Response Criteria in AML, “The OCR is defined as the proportion of patients with a best response of complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) from day 29”. Relapse Free Survival is defined as the time the criteria for remission (CR or CRi) are first met until there is evidence of patient relapse, regardless of whether the patient is still taking the study drug as measured through study completion, an average of 6 months. Clinical Benefit Rate is defined as the proportion of patients with an AML IWG best response of CR, CRi or PR as measured in the timeframe of 4 months after LPI. Tumor % change is defined from baseline in BM blasts at day 29 as measured in the timeframe of 29 days after LPI. Interim data from phase 2 is expected to be reported in second half of 2018.