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The phase 3 MAGNOLIA trial will assess whether abelacimab can prevent venous thromboembolism recurrence in patients with gastrointestinal or genitourinary cancers.
Recruitment has started for a phase 3 trial evaluating abelacimab in patients with gastrointestinal or genitourinary cancers who are at risk for cancer-associated blood clots in the veins, according to Anthos Therapeutics, the pharmaceutical company developing the drug.
The MAGNOLIA trial, which is one of two complementary international trials, will compare monthly treatment with abelacimab with a daily injection of the blood thinner, Fragmin (dalteparin), which is the current standard of care to prevent blood clots. The main goal of the study is to determine abelacimab’s effect on venous thromboembolism recurrence and bleeding in this patient population.
“With a 20-fold increase in risk of (cancer-associated thrombosis) in (gastrointestinal) cancers compared to patients without cancer, we are particularly pleased that abelacimab is being explored to reduce (venous thromboembolism) recurrence and bleeding in (gastrointestinal) and (genitourinary) cancers,” said Dr. Alok A. Khorana, a professor of medicine at Cleveland Clinic Lerner College of Medicine and Case Western Reserve University, in a company-issued press release.
Venous thromboembolism is a common cause of death in patients with gastrointestinal and genitourinary cancers, and drugs to prevent the condition are needed, as current anticoagulants may increase risk of bleeding, according to Anthos Therapeutics.
“Because cancer patients who receive current anticoagulant treatment to manage (venous thromboembolism) have a higher bleeding risk than patients without cancer receiving anticoagulants, it’s too often that physicians are forced to choose between preventing life-threatening clots and putting their patients at risk of uncontrolled bleeding, particularly in patients with (gastrointestinal/genitourinary) cancers,” explained Khorana in the release.
Researchers aim to enroll approximately 2,700 patients across 220 treatment centers in 20 different countries, according to the release. To be eligible, patients must have a high bleeding risk and non-resectable (not eligible to be surgically removed), locally or regionally invasive gastrointestinal or genitourinary tumors.
Of note abelacimab was granted a fast track designation by the Food and Drug Administration (FDA) in July 2022.
"The urgent need for this research and the development of effective and safer anticoagulants is underscored not only by the FDA’s recent fast track designation of abelacimab (for the treatment of thrombosis associated with cancer), but also by the passion and commitment of our CAT Scientific Steering Committee to the patients they treat,” said Dr. Dan Bloomfield, chief medical officer of Anthos Therapeutics, in the release.
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