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Mateon Therapeutics downgraded to Neutral on clinical hold at H.C. Wainwright. As previously reported, H.C. Wainwright analyst Joseph Pantginis downgraded Mateon Therapeutics to Neutral from Buy after the FDA placed OXi4503 on partial clinical hold based on two potential dose-limiting toxicities seen in the ongoing OX1222 study in relapsed/refractory AML patients. He had been optimistic on the company's prospects based on the "compelling" OXi4503 data delivered to date, but now believes investors need to be provided increased comfort that the company can fund operations and whether dosing at 9.76 mg/m2 can be a viable dose for a path forward for OXi4503. Mateon is up 6% to 15c per share in early trading.
Mateon Therapeutics announced earlier that the U.S. FDA placed a partial clinical hold on Study OX1222 during a telephone conversation held with the Company on August 16, 2018. OX1222 is the Company's clinical trial of OXi4503 in combination with cytarabine for the treatment of relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes. The partial clinical hold applies to the 12.2 mg/m2 dose of OXi4503. The FDA is allowing the study to continue to treat and enroll patients using a dose of 9.76 mg/m2 of OXi4503, which the Company previously tested in cohort 5 of Study OX1222. The partial clinical hold follows two potential dose-limiting toxicities observed at the 12.2 mg/m2 dose level that was being evaluated in cohort 6 of Study OX1222. These DLTs consist of one patient experiencing hypotension shortly following initial treatment with OXi4503, and another patient experiencing acute hypoxic respiratory failure approximately two weeks after receiving OXi4503 and cytarabine. Both events were deemed "possibly-related" to OXi4503, and both patients recovered following treatment. The protocol for Study OX1222 generally defines a DLT as any grade 3 serious adverse event where a relationship to OXi4503 cannot be ruled out. The FDA has indicated that additional data on patients receiving 9.76 mg/m2 of OXi4503 must be evaluated before the company resumes dosing at 12.2 mg/m2. "Although it is disappointing that we are not currently continuing with the higher dose of OXi4503, we look forward to gathering more safety and efficacy data at the previous dose level, where we observed two complete remissions in the four patients that we treated," said William D. Schwieterman, M.D., CEO of Mateon.
Mateon Therapeutics director Donald Rogers disclosed in a filing that he had purchased 250,000 shares of company stock at an average price of 40c per share on April 12. The total value of the purchase was $100,000.