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A leading biopharmaceutical company dedicated to the research, development and commercialization of innovative tumor therapies - Deqi Pharmaceutical Co.
, Ltd.
today announced that a new generation of selective inhibitor of nuclear export (Selective Inhibitor of Nuclear Export) eltanexor (ATG-016) is an I/ Phase II clinical trial (HATCH) completed the first patient administration in China for the treatment of myelodysplastic syndromes at risk in IPSS-R (Revised International Prognostic Scoring System) that failed demethylation drugs (HMA) treatment (MDS)
.
This is a single-arm, open clinical trial designed to evaluate the safety and effectiveness of eltanexor as a single agent in the treatment of such MDS patients
MDS is a malignant disease derived from bone marrow hematopoietic stem cells, and its incidence increases significantly with age
.
The median overall survival (OS) of middle-risk, high-risk, or very high-risk MDS patients are 3 years, 1.
Eltanexor is a new generation of selective nuclear export inhibitors and a specific antagonist of nuclear export protein XPO1
.
Elevated XPO1 levels are usually associated with poor prognosis or chemotherapy resistance.
According to the research data published at the 2019 American Society of Hematology (ASH) annual meeting, in a phase I/II clinical study of eltanexor for the treatment of higher-risk MDS patients who have failed demethylation drugs, the objective response rate (ORR) ) Reached 35%, and all 35% of the tested patients achieved complete bone marrow remission (mCR)
.
At the same time, clinical data shows that the overall safety and tolerance are good
Dr.
Mei Jianming, Founder, Chairman and CEO of Deqi Pharmaceuticals, said: "The news that the first MDS patient in the HATCH trial received medication is very exciting.
It marks that our second selective nuclear export inhibitor has entered the clinic.
Research.
Eltanexor has demonstrated good tolerability and safety in preclinical trials, and has also shown strong anti-tumor activity in xenograft models
.
At the same time, it has shown preliminary clinical studies in the treatment of high-risk MDS patients The efficacy and good safety and tolerability of
