FDA Accepts COVID-19 Clinical Study and Advises on Next Steps for Pre-IND Filing by Medolife Rx
Medolife Rx, a subsidiary of Quanta (OTC PINK: QNTA), received a positive FDA response regarding its Pre-IND filing for the COVID-19 treatment, Escozine®. The FDA recognized the clinical trial in the Dominican Republic as a proof-of-concept study and provided specific guidelines for further development. To proceed, Medolife must conduct two additional toxicology studies focusing on DNA-level impacts. The FDA's detailed roadmap aims to expedite future U.S. clinical trials, enhancing the likelihood of Escozine's approval as an effective therapeutic option against COVID-19.
- FDA acknowledged the clinical trial as a proof-of-concept for Escozine's therapeutic potential.
- Received clear guidelines from the FDA for the next steps in the approval process.
- FDA's detailed roadmap for future U.S. clinical trials is expected to expedite the timeline.
- FDA mandated two additional toxicology studies, which may delay the process.
- New FDA protocols require data analysis at the DNA level, adding complexity to the studies.
BURBANK, Calif., June 23, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire – Medolife Rx, Inc. ("Medolife"), a global integrated biopharmaceutical company with R&D, manufacturing, and consumer products, which is a majority owned subsidiary of Quanta, Inc. (OTC PINK: QNTA), announced today that the Company has received a response from the U.S. Food and Drug Administration (FDA) relating to its Pre-Investigational New Drug (Pre-IND) filing on its lead drug candidate Escozine® for the treatment of the SARS-CoV-2 (COVID-19) virus. The response validated the Company’s clinical study conducted in the Dominican Republic (DR) and outlined next steps for its approval process in the US.
As the Company expected, it received a detailed response from the FDA on its Pre-IND originally filed on April 27, 2020. The response included: recognition from the FDA on the therapeutic effects of Escozine®, validation of the Company’s clinical trial as an informal proof-of-concept study, and laid out very specific guidelines for the next steps required by the regulatory body in order to garner approval for Escozine® as a treatment for COVID-19.
Subsequent to the acknowledgement of the trial, the FDA has requested that the Company complete two additional toxicology studies in animals. Since adoption of COVID-19 vaccinations, the FDA altered its protocol for measuring toxicology to include studying it at the DNA level. As this is a newer development, the agency has asked Medolife to provide data in this regard. Medolife has the product and protocol necessary to complete these studies in short-order.
“We could not be more pleased with the response from the FDA, in its acknowledgment of our clinical trials on Escozine and its potential therapeutic benefit, as well as the very clear guidelines set forth in the response for moving our program forward,” said Medolife CEO Dr. Arthur Mikaelian.
The acknowledgment by the FDA of the clinical trial conducted in the DR as a proof-of-concept for Escozine®’s therapeutic potential as a COVID-19 therapeutic is an important aspect of the response.
“Given the ever-changing landscape of COVID-19, we are pleased that the FDA recognizes that our original proposed study was a proof-of-concept design under our original Pre-IND submission,” said Christina DiArcangelo, CEO and Founder of Affinity Bio Partners, a contracted clinical consultant for Medolife.
DiArcangelo has 24 years of experience in the global biotechnology, pharmaceutical, device, and nutraceutical industries and has worked on products that have received FDA approval on 25 pharmaceutical drugs.
While both the palliative and therapeutic potential of Escozine® were highlighted in the filing, the FDA recognized the potential therapeutic benefits of the drug, alluding to its ability to fight the COVID-19 virus, another important aspect of the response.
“Another interesting aspect of this Pre-IND filing is that we included both the therapeutic and palliative potential of Escozine in treating COVID-19,” noted Medolife advisory board member and clinical adviser Dr. Annabelle Morgan. “This means that the drug could help reduce symptoms in patients who have the virus in addition to its potential benefit in fighting the virus itself. I am optimistic that the response seemed to point to its potential therapeutic benefit as well as its palliative.”
Lead researcher on the Escozine® clinical trial program, Dr. Khalid Matalka, stated: “I am very pleased that the FDA acknowledged the results of our clinical trial on Escozine® as a COVID-19 therapeutic in the DR. It was an extremely positive outcome, where we saw that after four to five days of taking Escozine as a monotherapy, all COVID-19 positive clinical participants had a significant improvement and tested negative for the virus within a week time. The drug contains four small molecular peptides that block ion channels causing a multi-action effect on the SARS-CoV-2 pathogenesis as both a therapeutic and palliative potential drug.”
“It is understandable that the FDA is paying close attention to the toxicological aspects of new drug applications, because excessive studies from vaccinations caused the FDA to be more cautious about the side-effects of the drugs, especially how they affect the body on a genetic level,” added Dr. Mikaelian. “Fortunately, these additional studies will not add more time to our program than originally anticipated.”
Also included in the response was a very detailed roadmap for the next phases of U.S. clinical trials with specific protocols. The amount of detail given in the guidelines will dramatically expedite the Company’s timeline for preparing for the next steps of the clinical program.
“The FDA regularly provides the level of detail provided in our response to companies who have already passed the Pre-IND stage. We believe this is an indication of the level of confidence the FDA has in Escozine’s potential for approval and will allow for more time in the market approval process,” stated Dr. Mikaelian.
Christina DiArcangelo added: “The FDA has provided us with clinically meaningful endpoints and assistance in the design of future trials, including minor diversity and pediatric patients. By doing so, we have a clear understanding as to how to proceed forward, not only with our next study but with the development of the entire Escozine clinical program. This information is so valuable and will help us to expedite our program in a meaningful way. We are very grateful for the FDA’s thorough guidance.”
The Company plans to commence the additional toxicity studies requested in the response in the coming weeks with a short completion timeline. After that, the Company will file the data to the FDA, once again seeking approval of its Pre-IND, moving the Company closer to approval.
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
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Contacts:
Tom Nelson
https://ir.quantrx.com/
480-326-8577
Kyle Porter
medolife@cmwmedia.com
858-264-6600
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