On March 15, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported preliminary data from the third dose cohort of the ongoing Phase 1b study OX1222 in patients with relapsed/refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (Press release, Mateon Therapeutics, MAR 15, 2017, View Source [SID1234518125]). OX1222 is a dose-ranging Phase 1b study of OXi4503 combined with cytarabine. The third dose cohort enrolled four patients who received a dose of 6.25 mg/m2 of OXi4503 in combination with an intermediate dose (1g/m2/day x 5 days) of cytarabine. Schedule your 30 min Free 1stOncology Demo! One patient (25%) in the third dose cohort – who has a high risk TP53 gene mutation – had a complete remission. Two other patients demonstrated evidence of AML blast reduction after one cycle, one of which is receiving additional cycles of OXi4503 plus cytarabine therapy, the other of which has since progressed. The fourth patient did not show a response and experienced progressive disease. There were no dose-limiting toxicities observed in this cohort, and the safety review committee has recommended that we proceed to the fourth cohort, which is now enrolling patients at an OXi4503 dose of 7.81 mg/m2.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are excited to continue to see responses in this severe and intractable patient population that currently has few treatment options," stated William D. Schwieterman, M.D., President and Chief Executive Officer. "We hope the data from this study will continue to improve with higher doses of OXi4503 in subsequent cohorts."
Results from the first two cohorts of OX1222 were initially presented at the 58th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) on December 6, 2016, indicating two out of 10 patients (20%) achieved complete remission. With an additional three months of follow-up data now available on these lower-dose patients in remission (3.75 and 4.68 mg/m2), Mateon is providing updated results – one patient remains in remission nine months following treatment and one patient remained in remission for approximately six months following treatment before the disease recurred.
Similar to the first two cohorts, OXi4503 was generally well tolerated in the third cohort. Adverse events were similar to the first two cohorts, with no significant adverse events in the third cohort.
Mateon reminds investors that a webcast of today’s presentation at the 29th Annual ROTH Conference at 7:30 am pacific time will be available on the company’s website at www.mateon.com in "Events & Presentations" under the "Investors & News" tab. Today’s presentation includes an overview of the mechanism of action of OXi4503 in hematological cancers such as AML and preclinical data from the OXi4503 AML program.