MATEON THERAPEUTICS TO INITIATE COMMERCIALIZATION OF ARTISHIELD™.

Rhea-AI Summary

Mateon Therapeutics (OTC.QB: MATN) announced the approval of ArtiShield^TM by India's Ministry of AYUSH for treating fever and inflammation. Co-developed with Windlas Biotech, ArtiShield^TM aims to be a cost-effective COVID-19 therapy. The product is currently undergoing evaluation in the phase IV ARTI-19 study, comparing its efficacy against standard care. With India's COVID-19 cases surging to 6.5 million and over 101,000 deaths, the urgent need for affordable treatments is evident.

Positive

• Approval of ArtiShield^TM for manufacturing and marketing enhances Mateon's product portfolio.
• Collaboration with Windlas Biotech provides manufacturing capability for COVID-19 therapy.
• ArtiShield^TM is a cost-effective treatment targeting COVID-19 symptoms.

Negative

• High COVID-19 case rate in India may hinder trial success and market penetration.
• Potential competition from established treatments may impact ArtiShield^TM's market acceptance.

AGOURA HILLS, Calif., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Mateon Therapeutics “Mateon” (OTC.QB: MATN), a leading developer of TGF-β therapeutics for oncology and COVID-19, today announced that ArtiShield^TM is now 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. ArtiShield^TM is in co-development with Windlas Biotech Pvt. Ltd., Mateon’s commercial partner for India. ArtiShield^TM is being evaluated against COVID-19 in ARTI-19- a phase IV study in India. ArtiShield^TM is designed to be a readily available and cost-effective agent to combat COVID-19, with Windlas providing the capability to manufacture the doses necessary to support this endeavor.

Saran Saund, Chief Business Officer and GM of AI division of Mateon commented “My sincere appreciation of the hard work by the teams at Mateon and Windlas for achieving this milestone. There is an urgent need for a cost-effective therapy against COVID-19 in India, as in the entire world. India has a population of 1.38 Billion people equivalent to 17.7% of the world population according to UN data. India currently has the highest rate of new infections and new deaths.”.

About ARTI-19 India

ARTI-19 in India is a “A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19”. 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 COVID-19 in India

India's COVID-19 death toll surged to pass 100,000 and on track to exceed US and 1,114 deaths were reported across the country in past 24 hours. India's new cases detected per day are more than double the daily average of the United States and Brazil. India has emerged as the worst hit country globally in terms of new COVID-19 cases discovered every day. The country now has 6,549,373 total cases of coronavirus, including 937,625 active cases and 5,509,766 recoveries. A total of 101,782 people have lost their lives to COVID-19 till now

About ArtiShield^TM

ArtiShield^TM is the Ayurveda - Dvipaantara Damanaka- and is labeled as capsule containing Artemisia absinthium Powder 500mg. Its use in this trial is per Ayurvedic text: fever and inflammation. The application of Ayurvedic agent to treat the symptoms of COVID-19 such as fever, headache, and inflammation is appropriate. Artemisinin is an active component of ArtiShield^TM. Artemisinin is able to inhibit TGF-β activity and is able to neutralize SARS-CoV-2 (COVID-19) in vitro at an EC50 of 0.45 ug/ml (based on Mateon’s test result at Utah State University), and a Safety Index of 140, which is better than remdesivir and chloroquine. The unpurified herb extract has no anti-viral activity. ArtiShield^TM is designed to target multiple viral threats including COVID-19 by suppressing both viral replication and clinical symptoms that arise from viral infection. ArtiShield^TM is being evaluated against COVID-19 in ARTI-19- a phase IV study in India.

About Mateon Therapeutics

Mateon was created by the recent reverse merger with Oncotelic which became a wholly owned subsidiary of Mateon Therapeutics Inc. 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

FAQ

What is the significance of ArtiShield^TM's approval for Mateon (MATN)?

The approval allows Mateon to manufacture and market ArtiShield^TM, potentially increasing revenue and market presence.

What is the ARTI-19 study related to Mateon (MATN)?

The ARTI-19 study is a phase IV clinical trial evaluating the safety and efficacy of ArtiShield^TM in treating COVID-19.

Why is ArtiShield^TM important for COVID-19 treatment in India?

India faces a severe COVID-19 crisis, and ArtiShield^TM aims to provide a cost-effective therapeutic option.

How does ArtiShield^TM work against COVID-19?

ArtiShield^TM contains Artemisia absinthium, which is designed to inhibit viral replication and alleviate symptoms.

What challenges does Mateon (MATN) face in the COVID-19 market?

Mateon competes in a crowded market with established COVID-19 treatments, which may affect ArtiShield^TM's acceptance.