On November 16, 2020 Mateon Therapeutics, Inc. ("Mateon" or the "Company") (OTCQB: MATN) reported financial results for the third quarter ended September 30, 2020 ("Q3 2020"), as well as an update on its therapeutic development initiatives, including those related to COVID-19 (Press release, Mateon Therapeutics, NOV 16, 2020, View Source [SID1234571145]).

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Recent Operational Highlights

●ArtiShield (outside of India)/ARTIVeda (India)

oSigned an agreement with Windlas Biotech Pvt. Ltd. of India to commercialize ArtiShield /ARTIVeda, the Company’s lead ethnobiology dru,g designed to be a readily available and cost-effective agent to combat COVID-19;
oArtiShield /ARTIVeda approved for manufacture and marketing by the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy), license number UK.AY-401/2018, for the treatment of various symptoms like fever and inflammation frequently seen in COVID-19 patients;
oDr. Suhas Kshirsagar, B.A.M.S, M.D. (Ayurveda), a worldwide renowned ayurvedic expert, joined Mateon as an advisor for Mateon’s Ayurvedic product ARTIShield /ARTIVeda in its commercialization for COVID-19;
oDr. Suhas Kshirsagar led a successful symposium entitled: "Advancing Ayurveda Through Ethnobiology Drug Development." Topics included Mateon’s ARTIShield/ ARTIVeda for the Treatment of COVID-19 and COVID-19/Influenza Coinfection. Presentations can be viewed at View Source;feature=youtu.be.
oCommenced patient enrollment for its ARTI-19 Phase IV multi-center interventional study to evaluate the safety and efficacy of ArtiShield in the treatment of adults with COVID-19 in India. This global study will evaluate the safety and efficacy of ArtiShield upto 3,000 total patients, 120 of whom are currently from India and further expandable to 300 patients from India. Top line data from ARTI-19 in India is expected between Q4 2020 and Q1 2021;

●OT-101/COVID-19 program
oReceived clearance from regulatory authorities in Argentina and Peru to initiate a Phase II clinical trial of OT-101, a TGF-β antisense, for the treatment of patients with mild to severe COVID-19 infection. Top line data from the study is currently expected during or before Q1 2021. If the outcome is positive, the data will form the basis for Emergency Use Approval (EUA) application to global regulatory bodies. Including the US Food and Drug Administration (FDA);

oContinuing our partnership with Golden Mountain Partners (GMP) and/or their designee with drawdown of the $2.0 M debt financial instrument with GMP to conduct OT-101/COVID-19 clinical trial.

●Oxi4503/ Melanoma

oAnnounced that the US FDA granted Rare Pediatric Disease (RPD) designation to OXi4503 (combretastatin A1-diphosphate; CA1P) for the treatment of acute myeloid leukemia due to genetic mutations that disproportionately affect pediatric patients. The FDA grants RPD designation for diseases with serious or life-threatening manifestations that primarily affect people aged from birth to 18 years, and that affect fewer than 200,000 people in the U.S.; and

●Strengthened our scientific and management teams with the appointments of Anthony Maida, III, Ph.D., MA, MBA as Chief Clinical Officer – Translational Medicine to drive the Company’s clinical development activity.
"We are very encouraged by the progress being made at Mateon through the first nine months of 2020," said Dr. Vuong Trieu, CEO of Mateon. "While our product portfolio addresses significant unmet needs with respect multiple disease states, including glioblastoma, melanoma, and pancreatic cancer, we are most excited by our strategy to focus on COVID-19 and COVID-19/influenza coinfection. We look forward to multiple clinical trial catalysts – notably top line data from our ARTI-19 Phase IV trial between Q4 2020 and Q2 2021 the end of this year – and are excited about the transformational opportunities that our therapies may provide."

"We are excited about the commercialization of ARTIVeda in India. It is expected to be a cost-effective treatment and prophylactic for COVID-19. This is transformational for the Company, as we establish a consortium of manufacturers, distributors, and marketers for the equitable distribution of this COVID-19 therapy," said Amit Shah, CFO of Mateon.