Quanta Inc (fka QNTA)

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Medolife should be good-to-go with its application for an IND.

The IND application must contain information in three broad areas:
Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).

Manufacturing Information - Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.

Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators--professionals (generally physicians) who oversee the administration of the experimental compound--to assess whether they are qualified to fulfill their clinical trial duties. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.

The information below suggests that Medolife have already met or exceeded FDA requirements for an IND.

Medolife's Therapeutic Scorpion Peptide Proves Successful in Treating COVID-19 Patients in Dominican Republic Study

January 27, 2021

Medolife" a majority owned subsidiary of Quanta, Inc. today announced In a recent study, a total of 400 patients in the Dominican Republic - where, a majority tested positive for COVID-19, and a small portion were COVID-19 symptomatic even though they tested negative for COVID-19 - reported a 100 percent improvement in symptoms after being administered Escozine®. Many of the patients participating in the study reported severe COVID-19 symptoms, such as difficulty breathing, pain and high fever, which Escozine® was able to relieve within 5 days of treatment. Even patients under ventilators were discharged within days, thanks to this novel product. Located in Santo Domingo, Dominican Republic, The Cruz Jiminian Clinic has carried out this ongoing study since August 2020, and has reported 0 COVID-19 related deaths after the clinic began administering Escozine®. Escozine®, produced by Medolife Rx, Inc., ("Medolife"), is a therapeutic consisting of small molecule peptides derived from a specific species of scorpions, Rhopalurus princeps, endemic to the Dominican Republic. After the successful study, Escozine® is on fast-track to be registered with the Ministry of Health in the Dominican Republic in Q1 2021. Medolife also submitted the study data to the US FDA, which is currently under review for permission to repeat the clinical trial in the United States. In addition to supporting the recovery of COVID-19 patients, Escozine® was registered and certified for cancer treatment by the Ministry of Health in the Dominican Republic in 2010.
"The data proving the efficacy that Escozine has on a multitude of improved patient parameters is consistent with the rapid symptom relief I experienced while on site," said Dr. Annabelle Morgan, Cell and Developmental Biologist and one of Medolife's leading scientists. She noted, "What is even more astonishing is that 100% of patients tested negative for COVID-19 within 5-10 days of treatment."
"More importantly, all COVID-19 healthcare workers, including physicians and nurses, who took Escozine as a preventative, never tested positive" said Dr. Khalid Matalka, another leading scientist at Medolife, specializing in Cancer Therapy and Immunology. "The clinical trial results indicate that Escozine could be used as monotherapy or in combination with standard therapies against COVID-19, which will accelerate the healing from the virus. Besides, observations revealed that Escozine could be used as prevention from the COVID-19 infection."

Scorpion Venom Most Expensive Liquid in the World

From treating cancer to pain management to fighting viral infections, this unique peptide has a vast range of therapeutic applications. In the last decade, a growing interest from Big Pharma companies has caused an increase in the liquid's value: costing $39 million per gallon.

Medolife's Dominican Republic Scorpion Reservation is one of the largest breeding grounds for scorpions on earth. Combined with the company's more than 15 years of research, Medolife is positioned to continue developing groundbreaking formulas and pharmaceutical-grade medications for consumer use.

Medolife Rx Announces Positive Results in Clinical Safety Study on Its Polarized Drug Candidate for the Treatment of COVID-19

Medolife" a global integrated bioceutical company with R&D, manufacturing, and consumer product distribution, which is a majority owned subsidiary of Quanta, Inc. announced today positive results in a safety and toxicity study conducted on its polarized drug candidate derived from a small molecular peptide found in scorpions, designed to treat patients with the SARS-CoV-2 virus, also known as COVID-19. The results showed no signs of toxicity in any of the patients involved in the study who were given the drug Escozine®, which is a polarized solution of the Rhopalurus princeps scorpion peptide owned by Medolife.
The study, which was conducted in Santo Domingo of the Dominican Republic under the supervision of medical principal investigators, was conducted on over 500 patients, where data from one group of patients was used in the Company’s FDA pre-IND filing. Each patient was given Escozine® sublingually four times a day. During and after administration, a complete blood count (CBC) was conducted on each patient where the researchers measured various parameters to evaluate if the drug candidate was safe, such as hemoglobin (Hb), hematocrit (HCT), and red blood cells (RBCs) levels. There were no significant differences observed before or after administration. Additionally, there were no significant differences observed in white blood cells (WBCs), neutrophils, lymphocytes, monocytes, or eosinophils, concluding that the drug candidate was safe and non-toxic.
“A successful safety study is a pivotal step in the clinical development program for a new drug candidate and we could not be more enthusiastic about our results,” said Medolife CEO Dr. Arthur Mikaelian. “While our near-term goal is to work with the Ministry of Environment of The Dominican Republic to bring this drug to market, we are able to use this data in our programs around the world, including with our submissions to the United States Food and Drug Administration. While there is significant research that suggests the potential therapeutic benefits of extracted scorpion peptide, when paired with our proprietary polarization technology that increases efficacy and bioavailability in the body, we believe our product Escozine® could be a true breakthrough in the field of medicine with applications in a variety of focus areas and indications.”
The Company is currently involved in various clinical studies on Escozine® around the world. It is seeking product registration in the Dominican Republic for treatment of COVID-19 where this study took place, while simultaneously seeking approval in the United States, where it has filed data on Escozine® with the US Food and Drug Administration (FDA) as a Pre-Investigational New Drug (PIND #150335) as a COVID-19 therapeutic. Registration in the Dominican Republic would act as a proof-of-concept on the drug that would propel it forward in its path to market.

Medolife’s patented polarization technology increases the potency of single molecules and complex compounds. This technology is already used in various Medolife products, ranging from supplements to drug candidates.

Medolife Rx Submits Final Data Set to FDA for IND Filing on Lead Drug Candidate

April 13, 2021

The Company assembled detailed information regarding the manufacturing of Escozine®, clarity on dosing, as well as both previous and new safety and efficacy data derived from an on-going human study taking place in the DR. The study has been conducted on over 500 participants and intends to demonstrate the safety and efficacy of Escozine®. 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 DR where the Company is seeking product registration. Previous clinical data was submitted to the FDA including preliminary results of the safety study, which has now been expanded upon. This data, as well as the batch of Escozine® that was produced specifically for the FDA, has now been submitted. After the review of the data and barring any further inquiries or requests, the FDA will designate IND status for Escozine®, essentially allowing the drug to be distributed in the US. After such designation, the Company will pursue other clinical applications of Escozine®, including as a potential cancer therapeutic where the Company has already released positive clinical results.
“The FDA-approved therapeutic drug market is the gold standard globally and should we receive IND designation from the FDA, it would catapult our other research across the world,” said Medolife CEO Dr. Arthur Mikaelian. “Submission to the FDA is never easy, but we are generating such positive clinical trial results that we are confident the regulatory body will take notice. They have been reviewing our submission for some time, requesting various other information that we have now submitted. I believe this could be the last request ahead of approval, which would be tremendous not only for our Company, but for patients who are in need of a solution where one does not currently exist. An approval from the FDA would also propel interest from the scientific community on the potential therapeutic benefits of the natural peptides we are studying, including investment and partnership interest.”
The Company has conducted extensive clinical studies on Escozine® as a therapeutic for both COVID-19 and multiple forms of cancer in the US and globally. It is seeking product registration in the DR for treatment of COVID-19 through its exclusive relationship with the Ministry of Health. Escozine® utilizes a patented polarization technology developed by Dr. Mikaelian that increases the potency of single molecules and complex compounds.
https://www.otcmarkets.com/stock/QNTA/news/story?e&id=1862474