MATEON ANNOUNCES FIRST PATIENT ENROLLED IN ARTI-19: A MULTICENTER INTERVENTIONAL STUDY OF ARTISHIELD™ AGAINST COVID-19
Mateon Therapeutics (OTCQB: MATN) announced the enrollment of the first patient in its Phase IV study ARTI-19, aimed at evaluating ArtiShield for COVID-19 treatment. The trial, which has regulatory approval in India, aims to register 3,000 patients, with top-line results expected by the end of 4Q20. Windlas Biotech is conducting the trial across several centers in India. The study compares ArtiShield with standard of care to assess safety and efficacy. India's COVID-19 crisis remains severe, with over 6.7 million cases reported.
- Phase IV study ARTI-19 for ArtiShield has commenced with the first patient enrolled.
- Study aims to include 3,000 patients, enhancing the drug's visibility and potential market presence.
- ArtiShield shows promising in vitro results against COVID-19, inhibiting TGF-β activity.
- Trial results are pending, leading to uncertainty about the efficacy and safety of ArtiShield.
- COVID-19 continues to surge in India, potentially complicating trial logistics and patient enrollment.
TOP-LINE DATA ANTICIPATED IN FOURTH QUARTER 2020
AGOURA HILLS, California, Oct. 07, 2020 (GLOBE NEWSWIRE) -- Mateon Therapeutics, Inc. (OTCQB: MATN) (“Mateon”), a leading developer of TGF-β therapeutics for oncology and COVID-19, announced the first patient enrolled this week in its Phase IV study ARTI-19. This is a global study with India to contribute at least 120 pts to the total aggregate of 3000 pts. The study evaluates the safety and efficacy of Artemisia absinthium Powder 500mg capsule (ArtiShieldTM ) in the treatment of adults with COVID-19. Top-line data from ARTI-19 is expected by end of 4Q20.
The ARTI-19 trial was recently cleared by Indian regulatory authorities, and 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
ARTI-19 in India is being conducted by Windlas Biotech Private Limited, as part of Mateon’s global effort at deploying ArtiShieldTM across India, Africa, and Latin America. Windlas is a 20-year-old company with large scale manufacturing facilities in India employing more than 1500 employees and is the 5th largest Contract Development and Manufacturing Organization (CDMO) serving pharma companies across the world. Abiogenesis is the Clinical Research Organization conducting the trial.
Saran Saund, Chief Business Officer and GM of AI division of Mateon, commented, “I am excited that we have achieved this milestone and will continue to push the deployment of this potentially effective and affordable therapeutic against COVID-19. My thanks to the investigators, staff, and patients for supporting this trial.”
Vuong Trieu PhD, CEO of Mateon commented, “We are very concerned with the upcoming flu season, which could exacerbate the COVID-19 situation, and are anxious to have ArtiShieldTM and possibly Trabedersen/OT-101, available to patients afflicted by this virus. These agents can act as pan-anti-viral agents and potentially target both the virus itself and the symptoms associated with the infection.”
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 has surged to more than 100,000 and is on track to exceed the US. India's new cases detected per day are more than double the daily average of the United States and Brazil. The country now has greater than 6.7 million total cases of coronavirus, including approximately 935,000 active cases and almost 5.6 million recoveries (link for data: https://www.ndtv.com/india-news/74-442-new-coronavirus-cases-in-india-total-cases-over-66-lakh-903-deaths-in-24-hours-1-02-lakh-total-deaths-2305128)
About ArtiShieldTM
ArtiShieldTM is Ayurveda - Dvipaantara Damanaka- and is labeled as capsule containing Artemisia absinthium Powder 500mg. Ayurveda is a natural system of medicine, originated in India more than 3,000 years ago. Its use in this trial to treat COVID-19 is per Ayurvedic text: fever and inflammation. Artemisinin is an active component of ArtiShieldTM. 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 superior to remdesivir and chloroquine. The unpurified herb extract has no anti-viral activity. ArtiShieldTM is designed to target multiple viral threats including COVID-19 by suppressing both viral replication and clinical symptoms that arise from viral infection. ArtiShieldTM 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, 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
FAQ
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