The company is inviting nonprofits such as non-government organizations to participate in this trial if they have the logistics to participate in observational trials and to distribute the Artemisinin in their home countries. The trial is expected to accrue a minimum of 3,000 patients.
Artemisinin is derived from an abundantly grown herb Artemisia annua L. (Sweet wormwood) and has been used medicinally to treat fevers for centuries in eastern countries. Like other potential COVID-19 therapeutic agents, the efficacy of Artemisinin remains to be tested in well-controlled and sufficiently powered clinical trials. However, given the known safety profile and the widespread use of Artemisinin, the company anticipates that it can be used as frontline therapy in countries with less developed healthcare systems.
Previously, the company’s in vitro laboratory tests revealed that Artemisinin is highly potent at inhibiting the ability of the COVID-19 virus to multiply, similar to Remdesivir while also having an excellent safety index. The reported results indicated that Artemisinin had an EC50 = 0.45 ug/ml and Safety Index = 140.
“Our motivation to mount a global humanitarian effort to save lives has already engaged several nonprofits and we look forward to accepting new organizations so we can address this pandemic together,” said
By targeting the host protein TGF-beta that is essential for virus replication, Artemisinin may avoid future drug resistance mutations associated with the virus. By downregulating TGF-beta, it can act as both an anti-viral and anti-lung damage agent. This potential mechanism of action is similar to the company’s leading drug candidate OT-101 which is also being developed to target the COVID-19 virus.
Artemisinin can target multiple viral threats including COVID-19 by suppressing both viral replication and clinical symptoms that arises from viral infection. Viral replication cannot occur without TGF-β. Artemisinin, purified from an herb (Artemisia annua), 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 (Mateon’s test result at
Mateon was created by the recent reverse merger with Oncotelic which became a wholly owned subsidiary of
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.
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Source: Mateon Therapeutics