FOSTER CITY, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (Apollomics or the Company), a clinical-stage biopharmaceutical company developing medicines to address...
GlycoMimetics Announces Independent Presentations on Uproleselan
ROCKVILLE, Md.--(BUSINESS WIRE)--GlycoMimetics, Inc. (Nasdaq: GLYC) a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today announced the U.S. Food and Drug Adistration (FDA) cleared the addition of a protocol amendment to the company’s pivotal Phase 3 study of uproleselan for relapsed/refractory (R/R) Acute Myeloid Leukemia (AML). The amendment will allow a time-based analysis of the primary endpoint of overall survival to be conducted following a defined cutoff date if the 295 survival events originally planned for an event driven analysis have not been observed. With the addition of a time-based analysis, topline results are expected to be reported by the end Q2 2024.
ROCKVILLE, Md.--(BUSINESS WIRE)--GlycoMimetics, Inc. (Nasdaq: GLYC), a clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today announced that Edwin Rock, M.D., Ph.D. has joined the executive leadership team as Chief Medical Officer (CMO). Dr. Rock brings nearly two decades of biopharmaceutical clinical development experience, most recently serving as CMO for Partner Therapeutics, a privately-held commercial stage biotech based in Massachusetts.
Apollomics has dosed the first participant in a Phase III clinical trialnof its new drug, APL-106 (uproleselan injection), in China to treat nrelapsed or refractory acute myeloid leukaemia (AML) patients.
ROCKVILLE, Md.--(BUSINESS WIRE)--GlycoMimetics, Inc. (Nasdaq: GLYC) announced today that Apollomics has dosed the first patient in China in a Phase 3 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML). Apollomics’ Phase 3 trial with APL-106 is part of the overall development program for Apollomics in China that also includes an ongoing Phase 1 pharmacokinetics (PK) and tolerability study. The Phase 3 clinical trial is part of a randomized, double-blind, placebo controlled, bridging study program that will evaluate the efficacy of uproleselan in combination with chemotherapy, compared to chemotherapy alone, for treating relapsed/refractory AML, in Chinese patients. The trial will enroll approximately 140 adult patients with primary refractory AML or relapsed AML (first or second untreated relapse) and eligible to receive induction chemotherapy.
FOSTER CITY, Calif. and SHANGHAI and HANGZHOU, China, Nov. 22, 2021 n(GLOBE NEWSWIRE) -- Apollomics Inc., an innovative biopharmaceutical ncompany committed to the discovery and development of mono- and ncombination- oncology therapies, today announced that the first patient nhas been successfully dosed in a Phase 3 clinical trial of APL-106 n(uproleselan injection) for the treatment of adults with relapsed or nrefractory acute myeloid leukemia (AML) in China. Apollomics licensed nthe Greater China rights for uproleselan from GlycoMimetics.
ROCKVILLE, Md.--(BUSINESS WIRE)--GlycoMimetics, Inc. (Nasdaq: GLYC) today announced completion of enrollment of its pivotal Phase 3 trial evaluating uproleselan in addition to a standard chemotherapy regimen in patients with relapsed/refractory AML. A total of 388 patients across 70 sites in nine countries has now been randomized in the clinical trial, which has a primary endpoint of overall survival, not censored for transplant. GlycoMimetics reiterates its guidance that, based upon current projections, it expects topline results after year-end 2022.
GlycoMimetics (NASDAQ:GLYC) shares jump more than 12% post market after the company highlighted encouraging safety and efficacy data from its Phase 1/2 trial of uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML).
FOSTER CITY, Calif. and HANGZHOU, China and GAITHERSBURG, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, and GlycoMimetics (Nasdaq: GLYC), today announced APL-106 (uproleselan) has been granted Breakthrough Therapy Designation (BTD) from the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for the treatment of relapsed/refractory acute myeloid leukemia (AML).