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BURBANK, CA – 
The Company performed this preclinical study in advance of its impending Pharmacokinetic (PK) study on Escozine®, the next step outlined by the FDA in its response to the Company regarding its Pre-IND submission as a COVID-19 drug. PK studies are designed to measure the body’s intake and clearing of active pharmaceutical ingredients (APIs), which in Medolife’s case is the polarized scorpion venom peptide in Escozine®. An important mechanism of action of the peptide is that it binds only to cancer cells, leaving healthy cells untouched. The peptide in Escozine® can also pass the blood-brain barrier, which allows the compound to bind with some of the deadliest types of cancers, such as glioblastomas (brain tumors). Conjugation of Escozine® with radioactive iodine allows for researchers to more clearly see where and how Escozine® is absorbed and processed in the body. Many APIs do not remain stable when conjugated with radioactive iodine, eliminating the possibility of certain types of PK studies. However, through this preclinical study, Medolife has proven the stability of Escozine® paired with radioactive iodine and is prepared to move into a full PK study per the guidelines given by the FDA.
“Beyond our successful stability result on Escozine’s peptide conjugated with radioactive iodine, we were even more excited by its potential applications in the field of diagnostics,” said Medolife CEO Dr. Arthur Mikaelian. “We hope that those who follow our company see how quickly we are moving in this process since receiving our response from the FDA. These programs generally take years and we have wasted no time since receiving the guidelines in preparing for our next steps. We are extremely confident in Escozine’s potential palliative and therapeutic benefits and look forward to updating those interested as soon as possible.”
The Company recently announced that it has received a detailed response from the FDA on its Pre-Investigational New Drug (Pre-IND) submission on Escozine® as both a potential palliative and therapeutic drug for the SARS-CoV-2 (COVID-19) virus. In the response, the FDA acknowledged the Company’s clinical trial that took place in the Dominican Republic (DR) as a proof-of-concept study and provided detailed guidelines for next steps in its approval process. Among those were the request to perform further toxicology studies on Escozine®, including a DNA toxicology study, as well as the predetermined next step of performing a PK study, which is extremely standard in clinical programs. This preclinical result enables the Company to move forward with the PK study in an expedited and efficient manner.
In addition to its usefulness in PK studies, the Company foresees additional applications for Escozine®’s peptide conjugated with radioactive iodine in the field of diagnostics. Given that the pair remains stable in the body, Escozine® conjugated with radioactive iodine could allow physicians and researchers further visualization of abnormalities in the body not previously visible without the radioactivity. Many lesions in the body can be small and difficult to identify using standard MRI imaging, but if Escozine® conjugated with radioactive iodine were introduced into the body it would be drawn to the lesions, illuminating them on imaging devices and making it easier for physicians to identify and target hard-to-see abnormalities, which could lead to a reduced recurrence of cancer. The Company plans to further investigate this hypothesis as yet another potential for Escozine® as a medical innovation and disruptor.
“Abnormality identification using MRI equipment is a less-than-perfect science and solutions are needed in order to improve their accuracy and effectiveness. Conjugating Escozine with radioactive iodine has the potential to illuminate many types of abnormalities in the body, giving physicians a better chance of identifying hard-to-see issues more quickly. This could have major applications across the spectrum of healthcare, and we are excited to pursue Escozine’s potential in this area, while simultaneously continuing our clinical program on Escozine through the FDA,” Dr. Mikaelian added.
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.
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.
Media Contact:
Kyle Porter
medolife@cmwmedia.com
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