Medolife Rx Submits Final Clinical Trial Data for Escozine Approval as a COVID-19 Treatment in The Dominican Republic
Medolife Rx, a biopharmaceutical company and subsidiary of Quanta (OTCQB: QNTA), has submitted final clinical trial data to the Dominican Republic's Ministry of Health for approval of Escozine as a COVID-19 treatment. This follows a meeting with government officials, demonstrating the product's efficacy against SARS-CoV-2 variants. Medolife plans to engage with the US FDA for pilot study approval later this month to advance Escozine's development in the US market.
- Final clinical trial data for Escozine submitted to the DR Ministry of Health.
- Interest from the Dominican government in registering Escozine as a COVID-19 treatment.
- Product has shown effectiveness against variations of SARS-CoV-2.
- Approval from the DR Ministry of Health is still pending.
- Potential delays in advancing Escozine for treatment protocols.
BURBANK, Calif., Jan. 19, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Medolife Rx, Inc. ("Medolife"), a global integrated biopharmaceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. (OTCQB: QNTA), announced today that the Company submitted the final clinical trial data to the Dominican Republic (“DR”) Ministry of Health (“MoH”) for approval of the Company’s product, Escozine, as a COVID-19 treatment. The product, which is registered as an alternative oncological medicine in the DR, has shown to be effective against variations of the SARS-CoV-2 virus.
After the recent meeting between Medolife CEO Dr. Mikaelian and DR Vice-President Raquel Peña de Antuña that concluded with interest from the government to register the product as a treatment for COVID-19 in the country, the Company was required to present data to various governmental institutions prior to receiving a governmental order for Escozine, such as:
- Program for Essential Medicines and Logistical Support Center (“PROMESE/CAL”)
- National Health Insurance (“SeNaSa”)
- High-Cost Medicines and Medical Assistance Program (“PMAC”)
The information was received well by these institutions, and the Company was directed to seek final approval for Escozine as a COVID-19 treatment from the DR MoH.
The final medical and scientific data on Escozine has been submitted to the office of the DR Minister of Public Health Daniel Rivera, and the DR Vice-Minister of Public Health Eladio Perez Antonio. Since then, the Company also had a video conference with Mr. Rivera and members of the DR MoH, where Dr. Mikaelian and Medolife Chief Scientific Officer Dr. Khalid Matalka presented the data on Escozine. A video conference was suggested by MoH due to the high rate of Omicron cases registered in their administration. During the conference, Dr. Matalka demonstrated Escozine’s mechanism of action as a calcium (Ca2+) ion channel inhibitor, which prevents the SARS-CoV-2 virus from entering the host cell, meaning Escozine can be an effective therapy against variants of the virus. Upon the completion of the data review, the DR MoH will decide whether to approve Escozine as a COVID-19 treatment, or to simply include it in the treatment protocol against COVID-19 using its existing registration in the DR as a cancer treatment.
“I appreciate the interest that the government shown toward our product and technology in their fight against the SARS-CoV-2 virus,” says Dr. Mikaelian.
End of January, the Company also plans to request a meeting with the United States (“US”) Food & Drug Administration (“FDA”) in order to explore the possibility of a change from PIND to IND status and approving Escozine for a 30-to-60 patient pilot study to show proof of concept within the US.
About Medolife Rx
Medolife Rx, Inc. is a global biotechnology company with operations in clinical research, manufacturing, and consumer products. Medolife Rx was created through the merger of Medolife, a private company founded by Dr. Arthur Mikaelian, who pioneered the unlaying polarization technology, and Quanta, Inc., a direct-to-consumer wellness product portfolio company. The Company’s lead clinical development programs include Escozine®, a proprietary formulation consisting of small molecule peptides derived from Rhopalurus princeps scorpions, which is amplified by the Company’s polarization technology and is being researched as a treatment of various indications, including COVID-19 and cancer. The Company intends to pursue product registration and drug approval in multiple countries.
Through its subsidiary AELIA, Medolife manufactures and distributes consumer wellness products in consumer areas such as pain relief, beauty, and general wellness. AELIA products are designed using Dr. Mikaelian’s polarization technology, which applies advances in quantum biology to increase the potency of active ingredients. Ultimately, Quanta's mission is to deliver better, more effective ingredients to elevate product efficacy, reduce waste, and facilitate healthier, more sustainable consumption.
Beyond its own clinical and consumer applications, the polarization technology used by Medolife and its subsidiaries has many potential applications. From potentiating bio-ingredients, to producing more-effective carbon-trapping plants, to transformative anti-aging solutions, Medolife could have the opportunity to upend how commercial and pharmaceutical products are made and increase their benefits, while decreasing their chemical concentration.
Forward-Looking Statements
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995: This release contains statements that are forward-looking in nature which express the beliefs and expectations of management including statements regarding the Company's expected results of operations or liquidity; statements concerning projections, predictions, expectations, estimates or forecasts as to our business, financial and operational results and future economic performance; and statements of management's goals and objectives and other similar expressions concerning matters that are not historical facts. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "estimate," "plan," "project," "continuing," "ongoing," "expect," "we believe," "we intend," "may," "will," "should," "could," and similar expressions. Such statements are based on current plans, estimates and expectations and involve a number of known and unknown risks, uncertainties and other factors that could cause the Company's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. These factors and additional information are discussed in the Company's filings with the Securities and Exchange Commission and statements in this release should be evaluated in light of these important factors. Although we believe that these statements are based upon reasonable assumptions, we cannot guarantee future results. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
Contacts:
ir@medoliferx.com
818-659-8052
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