Medolife Rx Launches Pharmacokinetic Study on Lead Drug Candidate as Next Step in Pre-IND FDA Submission
Medolife Rx, Inc., a subsidiary of Quanta, Inc. (QNTA), has initiated a pharmacokinetic (PK) study for its lead drug candidate, Escozine®, as part of the FDA’s Pre-Investigational New Drug application process. Conducted in the UK, this study aims to assess the drug's exposure in the body, crucial for determining therapeutic dosing in future trials. Escozine® is being developed as a potential treatment for COVID-19 and has received product registration in the Dominican Republic for cancer treatments. The study results are expected to advance Escozine® into Phase II clinical trials.
- Initiation of a pharmacokinetic study for Escozine®, crucial for FDA application.
- Escozine® has received product registration in the Dominican Republic for cancer treatment.
- Successful completion of the study is expected to propel Escozine® into Phase II clinical trials.
- None.
BURBANK, Calif., Aug. 03, 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 has launched a pharmacokinetic (PK) study on its lead drug candidate Escozine®. The study aims to provide the basis for determining the drug’s exposures in the body. This is part of the latest round of information requested by the United States Food and Drug Administration (FDA) for its Pre-Investigational New Drug (PIND #150335) filing on Escozine® as a potential therapeutic for the SARS-CoV-2 (COVID-19) virus.
The Company is performing a PK and a biodistribution study of Escozine® in rodents, which is being conducted by a laboratory in the United Kingdom. They are part of the requirements outlined by the FDA as next steps for the Company’s pre-IND application. The study is composed of two parts. The first part is conjugating Escozine®-containing peptides with radioactive iodine and performing a stability study of the conjugate in blood products. After the conjugation, the radioactive Escozine® will be injected sublingually into ten mice. Compared to intravenously injected mice following several time points, Escozine® levels will be determined in the blood and plasma of mice over 24 hours. Furthermore, imaging studies of mice will be performed to assess the biodistribution of Escozine in mice. These studies have several implications on the dose of Escozine®, blood-time profile, body clearance, and its biodistribution.
“An additional PK study is the next step in our FDA IND submission process and an important one as it will provide us with the data needed to formulate therapeutic dosing that we will use in our eventual human trials,” said Medolife CEO Dr. Arthur Mikaelian. “Escozine® has been shown to be effective in all of the pre-clinical proof-of-concept trials we have completed and successful completion of this study will propel the program forward into Phase II clinical trials. We decided to work with a renowned research partner as they are experts in this type of study and will be able to expedite the results so we can continue on with our next steps in the clinical program on Escozine®. We are extremely confident in Escozine® and its effectiveness and look forward to reviewing this data and using it to outline our next trial.”
Escozine® is a polarized solution of the Rhopalurus princeps scorpion peptide owned by Medolife, which has been filed with the FDA under the IND regulatory pathway as well as the Ministry of Health in the Dominican Republic (DR) where the Company has received product registration upon Escozine®. The registration enables Escozine® to be prescribed as a natural bioactive alternative medicine to be used in cancer treatments.
The Company has conducted extensive clinical studies on Escozine® as a therapeutic for both COVID-19 and multiple forms of cancer in the United States and globally. Escozine® utilizes a patented polarization technology developed by Dr. Mikaelian that increases the potency of single molecules and complex compounds. Medolife has a “first-of-its-kind” scorpion reservation in the DR, where the Company is able to safely and humanely cultivate the scorpions needed to produce the peptides that are used in the manufacturing of Escozine®. Recently, the Company has been expanding the reservation and preparing to increase capacity in order to meet the demand driven by the registration in the DR and others in the future.
About Medolife Rx
Medolife Rx, Inc. is a global biotechnology company with operations in clinical research, manufacturing, and consumer products. MedolifeRx was created through the merger of Medolife, a private company founded by Dr. Arthur Mikaelia 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 and nutraceutical products in high-impact consumer areas such as pain relief, beauty, and general wellness. QuantRx products are designed using Dr. Mikaelia’s polarization technology which applies advances in quantum biology to increase the potency of active ingredients. Currently, QuantRx supports product formulations in pain management, anti-inflammation, skincare, agriculture, nutritional supplements, and plant-based consumables. 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.
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@medolife.com
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