Medolife Rx Completes Initial Meeting with Bioethics Committee, Preparing for Commencement of Phase II Clinical Trial on Lead Drug Candidate
BURBANK, Calif., May 20, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire – Medolife Rx, Inc. ("Medolife"), a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today that it completed its initial meetings with CONABIOS, the medical ethics committee that oversees all clinical trial programs in the Dominican Republic (DR). The meeting outlined the next steps in its clinical program on Escozine® as a treatment for the SARS-CoV-2 (COVID-19) virus and the Company is seeking approval to commence clinical trials.
The Company has completed significant preclinical safety and efficacy trials in the DR, which included more than 500 participants. The results of those studies demonstrated the efficacious nature of Escozine® in fighting viral infections, specifically in COVID-19 patients, where data showed a reduction in severity and duration of symptoms as well as a decrease in the length of positive tests. Additionally, throughout the preclinical trials, no patients experienced adverse effects to the drug candidate at any dosing level, establishing that the drug is safe and non-toxic. This data was submitted to the Ministry of Health, which led to not only the re-registration of Escozine® as a natural alternative medicine in cancer treatment, but enabled the Company to seek medical ethics committee approval to begin Phase II human trials on Escozine® as a COVID-19 therapeutic.
Upon approval from the committee, Medolife will conduct a controlled, double-blind placebo trial on humans to validate the efficacy of Escozine® as a viable treatment. This is in line with traditional regulatory approval practices, such as those in the United States, and the trial should take only a short time once approved.
“Requesting medical ethics committee approval is not just an important step – it illustrates how far along we are in the clinical trial process,” said Medolife CEO Dr. Arthur Mikaelian. “For many pharmaceutical companies, getting to a Phase II trial can take decades due to many formulation adjustments, bad outcomes and redesigning of program constructs. Our initial preclinical work was so successful that we were able to expedite the process to this point where we are ready for human trials in a controlled, double-blind placebo construct. That will entail trial participants being given either a full dose of Escozine® or a placebo, without their knowledge of which they are getting. Patients will then be observed with noticeable changes recorded, where we believe we have an extremely high chance of success. All of this is very exciting and we thank the committee in advance for their further consideration.”
Medolife is conducting clinical trials on Escozine® as a treatment for COVID-19 in both the United States and the DR. The Company has completed an Investigational New Drug (IND) filing on Escozine® through the US Food and Drug Administration (FDA) and is awaiting a response after submission of its final data set. Escozine® recently received renewed product registration in the DR, enabling it to be sold as a natural alternative medicine for the treatment of cancer throughout Latin America.
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 that makes the Company’s portfolio of pharmaceutical and nutraceutical products so effective, 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 has completed preclinical safety and efficacy research on Escozine® ® and is pursuing product registration and drug approval in various countries, including the United States and throughout Latin America.
Through its subsidiary QuantRx, Medolife manufactures and distributes consumer wellness products in high-impact consumer areas such as pain relief, beauty, and general wellness. QuantRx 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 has the opportunity to upend how commercial and pharmaceutical products are made and increase their benefits, while decreasing their chemical concentration.
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