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Introduction: The third phase of the trial IDHENTIFY failed in the treatment of acute myeloid leukemia with the combination therapy of The hundred-time Meishi Shiguibo Idhifa.
, BMS announced the failure of Idhifa's phase III trial IDHENTIFY for acute myeloid leukemia, which failed to significantly improve the overall survival rate (OS) of patients.
phase III trial of IDHENTIFY was conducted in patients with recurring or incurable acute myeloid leukemia (r/r AML) with mutations in the iso-citric acid dehydrogenase 2 (IDH2) gene.
trial compared the efficacy of Idhifa's combined best-supporting therapy (BSC) with conventional care options, including BSC, nitrogen hethytosine plus BSC, small or medium doses of agarose cytosine plus BSC.
Idhifa combination therapy failed to reach the main endpoint of the expected OS improvement.
the secondary endpoint of the trial included the overall mitigation rate, event-free lifetime, mitigation duration, and mitigation time.
trials, Idhifa showed no significant difference in safety from previous studies.
company said it would complete a comprehensive assessment of IDHENTIFY trial data and work with researchers to present detailed results at future medical conferences.
previously, in a one-arm study of 199 patients, the median time for treatment with Idhifa was 8.2 months, with 19 percent showing no signs of disease and recovery of whole blood cell counts.
tests confirmed that the drug also helped some patients avoid plate plate plate reduction.
that the failure of the IDHENTIFY trial did not affect the FDA's "original green light" given to Idhifa.
Idhifa was approved by the FDA as early as August 2017 for the treatment of adult r/r AML carrying the IDH2 gene mutation, which is currently the only FDA-approved drug for the allergy and does not rely on any validative research.
Idhifa therapy is currently approved in Australia and Canada.
, about 19% of patients with acute myeloid leukemia are associated with IDH2 mutations.
, BMS announced another oncology business development, confirming plans to acquire Forbius.
Forbius is a company dedicated to the development of highly selective and powerful TGF-beta 1 and TGF-beta 3 inhibitors, which are key media for immunosuppression and fibrosis.
agreement, Shishi Shiguibao will acquire Forbius' TGF-beta research and development program, including the AVID200.
acquisition, BMS may focus its research and development efforts on the AVID200 in oncology and may consider moving the asset to other diseases such as fibrosis in the future.
companies expect the acquisition to be completed in the fourth quarter of 2020.
the two companies did not disclose any financial details other than that Forbius would receive advances and milestone payments.
: 1, Bristol Myers Squibb Update on Phase 3 IDHENTIFY Trial in Patients with Relapsed or Refractory Acute Myeloid Leuk 2, Bristol Myers Squibb's Idhifa Flunks Acute Myeloid Leuk Trial 3, Bristol Myers Squibb's targeted AML drug Idhifa to Property.