From today' s PR 11/1/2021:
In recent months, the Company has demonstrated tremendous progress in both its clinical development program as well as its direct-to-consumer nutraceutical product portfolio. It is in the process of completing a pharmacokinetic (PK) study on its lead drug candidate Escozine® per an instructional response from the US Food and Drug Administration (FDA) as it relates to the Company’s pre-Investigational New Drug (Pre-IND) application for Escozine®. Additionally, it has ramped up its sales and marketing initiatives on its consumer products including the attendance and sponsorship of the Tony Hawk Vert Alert event, where it showcased its revolutionary line of pain relief products and introduced its Immunapen™ line of products.
From August 3, 2021 PR:
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.
