On December 27, 2019 Mateon Therapeutics Inc. (OTCQB:MATN) reported the publication of a peer-reviewed research article co-authored by Fatih Uckun MD. PhD, the Chief Medical Officer for Mateon, Vuong Trieu, PhD, the Chief Executive Officer and President for Mateon and four hematology/oncology professors from academic US institutions in the prestigious oncology journal Cancers (Basel) (Press release, Mateon Therapeutics, DEC 27, 2019, View Source [SID1234552620]).

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The article describes in detail the data obtained in the recently completed multi-institutional OXI1222 study that was aimed to evaluate the clinical potential of Mateon’s lead anti-leukemia drug Combretastatin A1 (also known as OXi4503) in adult patients with previously treated relapsed acute myeloid leukemia (AML). This clinical study was registered at www.clinicaltrials.gov as NCT02576301. Patients were treated by participating leukemia experts affiliated with the University of Florida, University of Kansas Cancer Center, David Geffen School of Medicine at UCLA, and University of Miami Sylvester Comprehensive Cancer Center, Miami who co-authored the published article. The primary purpose of this Phase 1B study was to define the maximum tolerated dose and safety profile of OXi4503 and cytarabine administered in combination (OXA) in patients with relapsed/refractory AML. The study was completed in August 2019 and met its primary endpoint. The study showed that adding OXi4503 to the standard chemotherapy drug cytarabine was generally well tolerated by AML patients and a maximum tolerated dose level of OXi4503 was identified as the recommended dose for further clinical development of this novel two-drug combination. In 26 evaluable AML patients, there were 4 complete remissions (CR/CRi) and one partial remission (PR). The CR responses were associated with >1-year overall survival times. The combination therapy exhibited a manageable toxicity and a promising benefit to risk profile in older adults with relapsed AML who are in urgent need for effective new therapies. The safety, feasibility, and early clinical activity of this new treatment in relapsed/refractory AML deserves further clinical validation in a randomized registration study.

"This work emphasizes our commitment to find effective new therapies for difficult-to-treat cancers," stated Dr. Vuong Trieu, Chairman and Chief Executive Officer of Mateon Therapeutics.

OXi4503 has received orphan drug designation for AML in both the US and the European Union. Further, the US FDA has granted fast-track designation to OXi4503 for the treatment of relapsed/refractory AML.

"AML is the most common form of adult acute leukemia with >20,000 estimated new cases and >10,000 deaths in the United States (US) for 2019. Despite recent advances in therapy, the five-year overall survival remains < 30% and prognosis is grim in patients who experience a recurrence of their disease after first-line induction therapy, with <10% surviving five years after relapse. The greatest challenge in AML is relapsed or refractory disease. For relapsed or refractory AML, there is no consensus on a single re-induction regimen. By combining OXi4503 with the standard chemotherapy drug cytarabine, we hope to develop an innovative approach that improves outcomes for patients with relapsed AML, especially those who are older and have a dismal prognosis," explained Fatih Uckun, MD, PhD, Chief Medical Officer of Mateon Therapeutics.

The research article "A Phase 1B Clinical Study of Combretastatin A1 Diphosphate (OXi4503) and Cytarabine (ARA-C) in Combination (OXA) for Patients with Relapsed or Refractory Acute Myeloid Leukemia" has been published in Cancers (Basel) as part of the Special Issue Personalized Medicine: Recent Progress in Cancer Therapy and is available online:

Abstract: View Source
PDF Version: View Source/pdf
Special Issue: View Source