MATEON THERAPEUTICS, INC. (OTCMKTS:MATN) Files An 8-K Other Events
Item 8.01
Press releases
We issued several press releases related to our OT-101 program against COVID-19. They are filed herewith.
OT-101 is an antisense againt the host TGF-β protein required for viral replication and its overexpression likely to cause the wide range of clinical symptoms associated with COVID-19 including Kawasaki syndrome (Fatih M. Uckun, Vuong Trieu. Targeting Transforming Growth Factor-beta for Treatment of COVID-19-associated Kawasaki Disease in Children. Clin Res Pediatr 2020; 3(1): 1-3) and acute respiratory distress syndrome (ARDS) (Fatih M. Uckun, Larn Hwang, Vuong Trieu. Selectively targeting TGF-β with Trabedersen/OT-101 in treatment of evolving and mild ARDS in COVID-19. Clin. Invest. (Lond.) 2020; 10(2), 167-176. DOI: 10.4172/ Clinical-Investigation.1000166.).
TGF-β is elevated in COVID-19 (Xiong Y. et al. Transcriptomic characteristics of bronchoalveolar lavage fluid and peripheral blood mononuclear cells in COVID-19 patients. Emerging Microbes & infections 2020; 9:1, 761-770, DOI: 10.1080/22221751.2020.1747363. Agrati C. et al. Expansion of myeloid-derived suppressor cells in patients with severe coronavirus disease (COVID-19). Cell Death & Differentiation 2020; https://doi.org/10.1038/s41418-020-0572-6.).
OT-101 is also being developed as an adjuvant for second generation COVID-19 vaccine. To avoid the two potential issues with 1st generation vaccine against COVID-19, we will be combining the 1st generation COVID-19 DNA vaccine with a TGF-β inhibitor (OT-101) to stimulate a strong immune response while suppressing the IgA class switching that could aggravate the disease through Kawasaki reaction- IgA vasculitis. The company is aggressively pursuing the development of this 2nd generation COVID-19 vaccine expecting that the 1st generation vaccines would not be fully effective and may not be sufficiently protective to counter the current pandemic.
Pharma Forum Presentation on OT-101 and COVID-19
September 21, 2020 (GLOBE NEWSWIRE) — Mateon Therapeutics “Mateon” (OTC.QB: MATN), announced that on September 21, 2020, Dr. Vuong Trieu, CEO of Mateon, will be presenting as Webinar “Trabedersen-Drug Development using phosphorothioate antisense platform” at Pharma Forum 2020/ Pharmacology and Toxicology/September 21, 2020. Of significant is the finding that OT-101 treatment reduced IL-6 level among treated pancreatic cancer patients suggesting that OT-101 would be effective in controlling the cytokine storm in COVID-19.
The ability to leverage antisense platform to develop a rapid response to emerging viral infection such as COVID-19 and future zoonoses is presented. The presentation is filed herewith
Regulatory clearance of C001 clinical trial
October 19, 2020 – Mateon Therapeutics, Inc. (“Mateon” or the “Company”) (OTCQB:MATN) announced the receipt of approval from Republica Argentina – Poder Ejecutivo Nacional, the regulatory agency of Argentina, to initiate the Company’s Phase 2 clinical trial of OT-101, a TGF-β antisense, for the treatment of patients with mild to severe COVID-19 infection. Argentina now has the fifth highest tally of confirmed coronavirus cases worldwide, with the latest additions taking it past Colombia in a global ranking compiled by John Hopkins University.
This multi-center, double blind, randomized, placebo-control study will evaluate the safety and efficacy of OT-101 in combination with standard of care on two (2) patient cohorts – 1) mild or moderate disease, and 2) severe disease requiring mechanical ventilation or intubation. The study will enroll approximately 24 patients in Argentina with an aggregate total of 72 pts study wide. The primary efficacy endpoint is the proportion of subjects with clinical improvement score (measured by an 8 point World Health Organization [WHO] COVID 19 Clinical Improvement Ordinal Scale) as assessed by the Odds Ratio (OR) at Day 14.
(d) Exhibits.
| 99.1 | Pharma Forum Press Release | Filed herewith. |
| 99.2 | Argentina Regulatory Clearance Press Release | Filed herewith |
| 99.3 | Pharma Forum Presentation | Filed herewith. |
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MATEON THERAPEUTICS INC Exhibit
EX-99.1 2 ex99-1.htm Exhibit 99.1 OT-101 Presentation at Pharma Forum 2020 AGOURA HILLS,…
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About MATEON THERAPEUTICS, INC. (OTCMKTS:MATN)
Mateon Therapeutics, Inc., formerly OXiGENE, Inc., is a biopharmaceutical company. The Company is focused on the development of vascular disrupting agents (VDAs) for the treatment of cancer. The Company is engaged in developing two clinical stage investigational drugs: VDAs-CA4P and OXi4503. Its lead compound is CA4P, which is also known as combretastatin A4-phosphate, fosbretabulin tromethamine, fosbretabulin and ZYBRESTAT. VDAs selectively targets the vasculature of cancer tumors and obstructs a tumor’s blood supply without disrupting the blood supply to normal tissues. VDAs are in a class of drugs called vascular targeted therapies (VTTs), which also includes anti-angiogenic agents (AAs). CA4P is a reversible tubulin binding agent that selectively targets the endothelial cells that make up the blood vessel walls in solid tumors. The Company is pursuing the development of a product candidate, OXi4503, which is a dual-mechanism VDA.
