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Press Release

Nov 30, 2020
DEVELOPMENT UPDATE FOR ARTIVEDA™/ARTISHIELD™ AGAINST COVID-19

--75% IMPROVEMENT BY DAY 2 ON ARTIVEDA™

Mateon Therapeutics, Inc
COVID-19


AGOURA HILLS, California, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Mateon Therapeutics, Inc. (OTCQB: MATN) (“Mateon”), a leading developer of TGF-β therapeutics for oncology and COVID-19, provided development update for ARTIVedaTM/ArtiShieldTM against COVID-19. ARTIVedaTM is Mateon’s lead Ayurvedic drug against COVID-19 in India and ArtiShieldTM is for Rest-of-World.

  • The India arm of ARTI-19 global study is on track to complete enrollment of the first 120 cohort by Dec 15, 2020, of which 78 patients have already been randomized.
  • Interim analysis of the first 32 pts (8 WHO scale 2 and 24 WHO scale 4 on randomization) was performed.
  • Statistical significant Time dependent improvement in WHO scale following treatment with ARTIVedaTM+SOC versus SOC alone was observed.
  • 75% of WHO scale 4 patients exhibited a drop to WHO scale 3 on Day Two of treatment with ARTIVedaTM. Note: WHO scale 3 does not require hospitalization.
  • 40% of WHO scale 4 patients exhibited a drop to WHO scale 1 on day 5 of treatment with ARTIVedaTM. Note: WHO scale 1 is asymptomatic.

ARTI-19 in India is being conducted by Windlas Biotech Private Limited, as part of Mateon’s global effort in deploying ARTIVedaTM/ArtiShieldTM across India, Africa, and Latin America. Windlas promotes more than 120 chronic and acute care branded products (allopathic, nutraceutical and Ayush formulations) through its “affordable generics platform” spanning over 950 wholesalers across India. Windlas branded medicines and wellness products are sold in several markets across the globe like Sri Lanka, Vietnam, Thailand, Myanmar etc.

Saran Saund, Chief Business Officer and GM of AI division of Mateon, commented, “I am pleased that ARTI-19 is progressing well and yielding early data supportive of a therapeutic potential of ARTIVedaTM against COVID-19. A cost-effective treatment that is also prophylactic is needed to achieve complete control of the pandemic as essential backstop to manage illness resulting from imperfections in vaccine effectiveness and uptake.”

Dr. Vuong Trieu, CEO of Mateon commented, “The early data of ARTI-19 is supportive of our concept that COVID-19 is caused by a TGF-β surge which leads to multitude of symptoms including respiratory failure, lung fibrosis, and long-term damages observed among long-haulers. ARTIVedaTM and OT-101 are inhibitors of TGF-β and are being evaluated across multiple clinical trials against COVID-19.”

About ARTI-19 India
The ARTI-19 trial is registered under the Clinical Trials Registry India (CTRI) with three active sites and additional sites to be added as the trial progresses and expands. ARTI-19 trial registration information can be found at: CTRI/2020/09/028044. Phase IV study to evaluate the safety and efficacy of ArtiShieldTM on COVID-19 subjects as Interventional. http://ctri.nic.in/Clinicaltrials/advsearch.php. Site specific information is: 1) Government Medical College & Government General Hospital, Srikakulam, ANDHRA PRADESH. 2) Rajarshi Chhatrapati Shahu Maharaj Government Medical College and Chhatrapati Pramila Raje Hospital, MAHARASHTRA. And 3) Seven Star Hospital, MAHARASHTRA. This trial will compare the efficacy of oral doses with standard-of-care (SOC) versus SOC alone. Oral administration of Artemisia absinthium Powder 500mg capsule/day for 5 days with SOC per cycle with the option to repeat as needed until disease is resolved or subject is discharged, up to a total of consecutive 3 cycles (“5 days treatment, 5 days off"). SOC is standard-of-care as per Clinical Management Protocol: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division). Safety is defined as: 1) Adverse events (AEs) during the study and 2) Serious adverse events (SAEs) during the study. Efficacy is defined as: 1) Relief in the sign and symptoms of COVID-19 as per WHO Clinical Progression Scale and 2) Relief in the sign and symptoms of COVID-19 per the Duration of Symptoms.

About ARTIVeda and ArtiShieldTM
The product, ARTIVedaTM, is a formulated plant extract of the indigenous plant Artemisia, known in Sanskrit texts as Damanaka. ARTIVedaTM is the first Ayurvedic drug against COVID-19 through TGF-β inhibition. ARTIVedaTM is expected to be effective through the entire infection cycle. The active component of ARTIVedaTM has been identified as artemisinin. Through proprietary GMP quality extraction and manufacturing processes, the Artemisia extract was rendered active against SARS-CoV-2 with robust Safety Index (SI) greater than 100 (ratio of nonspecific cell kill versus viral kill). Other extracts have SI <10. Testing was performed at the US NIAID core viral laboratory. The product is protected by a patent portfolio of over 15 international patents by Mateon’s R&D. The mechanism of action against COVID-19 has been confirmed in 5 key peer reviewed international scientific/medical publications. ARTIVeda™ is designed to target multiple viral threats including COVID-19 by suppressing both viral replication and clinical symptoms that arise from viral infection. A phase IV trial looking at ARTIVeda™ in COVID-19 is ongoing in India and globally. The US name for this drug product is ArtiShieldTM. We are looking to leverage ex-US data for the commercialization of ArtiShieldTM in the US. We are expecting ArtiShieldTM to be cost effective prophylactic suitable for global deployment.

About Mateon Therapeutics
Mateon was created by the recent reverse merger with Oncotelic, which became a wholly owned subsidiary of Mateon, thereby creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics as well as small molecule drugs against cancer and infectious diseases. OT-101, the lead immuno-oncology drug candidate of Mateon/Oncotelic, is a first-in-class anti-TGF-βRNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. OT-101 also has activity against SARS-CoV-2. Mateon/Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Mateon has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi4503). For more information, please visit www.oncotelic.com and www.mateon.com.

Mateon's Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as “may”, “expect”, “anticipate” “hope”, “vision”, “optimism”, “design”, “exciting”, “promising”, “will”, “conviction”, "estimate," "intend," "believe", “quest for a cure of cancer”, “innovation-driven”, “paradigm-shift”, “high scientific merit”, “impact potential” and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the company’s product candidates and the potential use of the company’s product candidates to treat various cancer indications. Each of these forward-looking statements involves risks and uncertainties and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the company’s annual report on Form 10-K filed with the SEC on April 10, 2019 and in the company’s other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information future events, or otherwise.

Contact Information:
For Mateon Therapeutics, Inc.:
Amit Shah
ashah@oncotelic.com

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Source: Mateon Therapeutics, Inc.