Quetzal Therapeutics Announces First Patient Dosed in Phase 3 QUATRO-APL Trial of QTX-2101 for Frontline Acute Promyelocytic Leukemia
CHICAGO, June 11, 2026 (GLOBE NEWSWIRE) -- Quetzal Therapeutics, a biopharmaceutical company focused on developing therapies for rare hematologic malignancies, today announced that the first patient has been dosed in QUATRO-APL, the company’s global Phase 3 clinical trial evaluating QTX-2101, an investigational oral capsule formulation of arsenic trioxide, in combination with all-trans retinoic acid (ATRA), for the treatment of patients with newly diagnosed, low-risk Acute Promyelocytic Leukemia, or APL.
"Dosing the first patient in QUATRO-APL is an important clinical development milestone for Quetzal," said Usman Ahmed, Chief Executive Officer and Chairman of Quetzal Therapeutics. "We look forward to continued enrollment and to working with our investigators, clinical sites, and partners as the trial progresses."
"Current standard-of-care regimens for APL require a significant number of intravenous infusions over the course of therapy, which can be burdensome for patients and healthcare systems," said Shaad Abedin, M.D., Chief Medical Officer of Quetzal Therapeutics. "QUATRO-APL is designed to evaluate whether an oral formulation of arsenic trioxide can offer a potential alternative to intravenous administration. We are grateful to the investigators, site teams, and partners whose commitment made this milestone possible."
Quetzal Therapeutics expects continued site activation and patient enrollment across the United States and Europe as the global Phase 3 program advances and plans to provide additional updates on study progress as enrollment continues.
About the QUATRO-APL Trial
QUATRO-APL (QTX-2101-301) is a pivotal, open-label Phase 3 clinical study evaluating the efficacy, safety, and pharmacokinetics of QTX-2101, an oral capsule formulation of arsenic trioxide, in combination with all-trans retinoic acid (ATRA), in adult patients with newly diagnosed, low-risk acute promyelocytic leukemia. The comparator arm is intravenous arsenic trioxide plus ATRA.
Additional information is available at ClinicalTrials.gov (NCT07504458) and the EU Clinical Trials Information System (2025-524810-28-00).
About Acute Promyelocytic Leukemia
APL is a rare and aggressive subtype of acute myeloid leukemia, accounting for approximately 10-15% of all AML cases. It is defined by the PML-RARA gene fusion and is associated with severe bleeding complications and rapid disease progression if untreated. While advances in therapy have transformed outcomes, current treatments often require patients to undergo a large number of lengthy intravenous infusions over the course of therapy. This relentless treatment schedule can disrupt daily life and place a significant burden on both patients and their support networks. There remains a clear need for innovative and more accessible therapies.
About Quetzal Therapeutics
Quetzal Therapeutics is a biopharmaceutical company dedicated to developing treatment for rare diseases, including hematologic malignancies. The company’s lead product is QTX-2101, a novel, investigational approach for treating patients with APL. Quetzal is also advancing QTX-2102, a pre-clinical, next-generation antifungal and antiparasitic therapy designed to enhance efficacy while minimizing toxicity.
QTX-2101 is an investigational, oral capsule formulation of arsenic trioxide. It is being evaluated as a potential oral alternative to intravenous arsenic trioxide. QTX-2101 has been granted Orphan Drug Designation by the U.S. FDA and the European Commission, as well as FDA Fast Track designation. QTX-2101 has not been approved by any regulatory authority, and its safety and efficacy have not been established. This press release contains forward-looking statements reflecting current expectations for ongoing development, which may evolve over time.
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