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GlycoMimetics (NASDAQ: GLYC) has announced that Apollomics has successfully dosed the first patient in a Phase 3 clinical trial of APL-106 (uproleselan) for treating adults with relapsed or refractory acute myeloid leukemia (AML) in China. This trial is part of a bridging study aimed at assessing the efficacy of uproleselan in combination with chemotherapy versus chemotherapy alone. The primary endpoint is overall survival, while secondary measures include remission rates and chemotherapy-related side effects. The trial will recruit approximately 140 patients across 20 research centers in China.
Positive
The initiation of the Phase 3 trial for uproleselan marks a significant step in the clinical program for treating AML.
Uproleselan has received Breakthrough Therapy Designation from both the U.S. FDA and the Chinese National Medical Products Administration.
Negative
None.
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.
“Dosing of the first patient in this Phase 3 clinical trial in Greater China is a significant accomplishment for Apollomics and comes quickly on the heels of our recent completion of enrollment in our own pivotal Phase 3 trial evaluating uproleselan in addition to a standard chemotherapy regimen in patients with relapsed/refractory AML,” commented Harout Semerjian, GlycoMimetics Chief Executive Officer.
The primary endpoint for the Apollomics Phase 3 trial is overall survival. Secondary outcome measures include the rate and duration of remission, and whether uproleselan could reduce the rate of oral mucositis, a chemotherapy-related side effect. Apollomics expects to conduct this study at approximately 20 blood cancer clinical research centers across China. Additional information on the Phase 3 trial can be found on clinicaltrials.gov (NCT05054543)
About Apollomics Inc.
Apollomics Inc. is an innovative biopharmaceutical company committed to the discovery and development of monotherapies and combination therapies of tumor-targeting and immuno-oncology agents. The Company’s product pipeline has several programs at different stages of development, including novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. Apollomics has operating entities in Foster City, California, USA, Hangzhou and Shanghai, China. For more information, please visit www.apollomicsinc.com.
About Uproleselan
Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA and from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including acute myeloid leukemia (AML), and for inflammatory diseases with high unmet need. The Company’s science is based on an understanding of the role that carbohydrates play on the surface of every living cell and applying its specialized chemistry platform to discover small molecule drugs, known as glycomimetics, which alter these carbohydrate-mediated pathways in a variety of disease states, including signaling in cancer and inflammation. As a leader in this space, GlycoMimetics is leveraging this unique targeted approach to advance its pipeline of wholly owned drug candidates, with the goal of developing transformative therapies for serious diseases. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.
Forward-Looking Statements
This press release contains forward-looking statements. These forward-looking statements include those relating to the planned or potential clinical development and commercialization of the Company’s product candidates, as well as the presentation of data from preclinical studies and clinical trials, and the potential benefits and impact of the Company’s drug candidates. Actual results may differ materially from those described in these forward-looking statements. For a further description of the risks associated with these statements, as well as other risks facing GlycoMimetics, please see the risk factors described in the Company’s annual report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 2, 2021, and other filings GlycoMimetics makes with the SEC from time to time. Forward-looking statements speak only as of the date of this release, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law.
What is the purpose of the Phase 3 clinical trial for GLYC's uproleselan?
The Phase 3 clinical trial aims to evaluate the efficacy of uproleselan in combination with chemotherapy for adults with relapsed or refractory acute myeloid leukemia.
How many patients will be enrolled in the uproleselan Phase 3 trial in China?
Approximately 140 adult patients will be enrolled in the Phase 3 trial.
What are the primary and secondary endpoints of the Phase 3 trial for uproleselan?
The primary endpoint is overall survival, while secondary endpoints include remission rates and the reduction of chemotherapy-related oral mucositis.
What distinguishes uproleselan as a drug candidate for AML?
Uproleselan is a first-in-class targeted inhibitor of E-selectin, designed to disrupt the resistance mechanisms of leukemic cells in the bone marrow.
What stage is GlycoMimetics' development program for uproleselan currently at?
Uproleselan is currently in a comprehensive Phase 3 development program for acute myeloid leukemia.
