Curis, Inc. (NASDAQ:CRIS) commenced the phase 1 clinical study of CA-4948 in patients suffering from high-risk MDS (myelodysplastic syndromes) and AML (acute myeloid leukemia). The first patient is administered with 200 mg of the drug. It includes 3 patients with MDS and AML in each batch during the Phase 1 clinical trial.
What are the main objectives of phase 1 clinical trial?
In an open-label phase 1 clinical study, the company will evaluate the clinical activity, pharmacodynamics, pharmacokinetics, and safety of the drug by applying 200 mg of CA-4948 daily twice. Maximum tolerated levels of the drug are studied in this clinical study, and that will be the basis for recommending phase 2 clinical study. Each treatment cycle is for 28 days. If no toxicity is observed in this cycle, the company will repeat the cycle. Curis expects to obtain initial data from this trial in Q4 2020.
Demonstrates the pathological role of IRAK4
CEO and President of Curis, James Dentzer, said Director (Hematologic Malignancies) at Albert Einstein College of Medicine, Amit Verma, and Professor at Children’s Hospital in Cincinnati, Daniel Starczynowski showed the importance of IRAK4’s pathological role in MDS and AML in their article in Nature Cell Biology.
Dr. Verma and Dr. Starczynowski showed that IRAK4-L can impact more than 50% of the population with MDS and AML. Curis worked with the US FDA and its clinical investigators to design a clinical trial for CA-4948 for this patient population. Dentzer said the company commenced the clinical study after six months and administered a dose to the first patient. The company will report clinical efficacy data by the end of this year.
Chief (Section of MSS) at Texas University, MD Anderson Cancer Center, Guillermo Garcia-Manero said no single OD (oncogenic driver) of MDS and AML can impact the majority of the patients according to the historical data. This understanding is changed with a recent clinical study. IRAK4-L, which is caused by specific genetic mutations, could be the chief cause of disease in 50% of the patients diagnosed with MDS and AML. CA-4948 expects to target the driver of the disease in patients with AML and MDS and provide a promising cure.