Ascent Pharma's original Class 1 new drug APG-115 for the treatment of hematological tumors in a phase Ib clinical study completed the first patient administration in China

AXA Pharma today announced that the company has completed its first phase Ib clinical study of the original class 1 new drug MDM2-p53 inhibitor APG-115 as a single drug and co-treatment of adult recurrence or difficult treatment of acute myeloid leukemia (AML), recurrence or progression of high-risk/extremely high-risk myelogenic abnormal syndrome (MDS), inc.I.
as the first MDM2-p53 inhibitor to enter clinical phase in China for the treatment of solid tumors, this is the first clinical study of APG-115 to engage in blood tumor indications.
the study as a national multicenter Ib clinical study designed to assess the safety, pharmacokinetics, and pharmacodynamics characteristics of patients with abloodtumors such as APG-115 as a single and allied astinaside or aglycosine treatment for relapsed or difficult to treat AML, recurrence or progression of high-risk/extremely high-risk MDS and other blood tumors.
AML is a cloned proliferative disease of bone marrow, the incidence increases with age, is the most common leukemia in China, about 1.62 to 2.32 people / 100,000 people.
treatment for AML has been based on a "7-plus-three" combination (7-day glycosine plus 3-day cycloidal drugs) as the standard induction therapy, but up to 40% of newly diagnosed AML patients are still unable to achieve full remission (CR), i.e. incurable, or relapse within 6 months of obtaining CR.
MDS is a group of heterogeneous hematopoietic diseases derived from abnormally pluripotent stem cells characterized by low hematopoietic function, bone marrow failure, reduction of peripheral blood cells and decreased survival rate.
in China, the incidence of MDS is about 5 per 100,000 people.
demethylation drugs have a high response rate for Treatment of MDS, many patients end up developing resistance to the effects of demethylated drugs.
once drug resistance occurs, the overall prognosis becomes very poor.
in high-risk MDS patients, the failure of demethylation drugs was associated with an average survival of less than 6 months.
so there is an urgent need for new treatments and more effective treatments for AML or MDS patients with relapse progression.
APG-115 is an oral bioavailable, highly selective small molecule MDM2 inhibitor developed by AXA Pharmaceuticals, which has a high binding affinity for MDM2 and restores p53 tumor inhibition by blocking MDM2-p53 interactions.
APG-115 has previously conducted a number of clinical studies in China and the United States to treat solid tumors, and is the first MDM2-p53 inhibitor to enter a clinical phase in China.
is currently working on the global clinical development of a number of APG-115 blood tumor indications. "There is still a large and unmet clinical need for the treatment of blood tumors such as AML and MDS, " said Dr. Yifan Yin Yifan, chief medical officer of
AxaPharmaceutical.
we also note that the development of drugs targeting MDM2-p53 is receiving increasing attention from the industry. As
the first MDM2-p53 inhibitor to enter clinical phase in China, aPG-115 has shown good safety and initial efficacy in clinical studies on solid tumors.
we will further explore the potential of APG-115 in blood tumors to provide more treatment options for AML and MDS patients in China and around the world.
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