NewG Lab "US NewG Lab Pharma's Anticancer Treatment Preclinical Trials 'Progressing Smoothly'... FDA Clinical Trials Accelerating"

[Asia Economy Reporter Yoo Hyun-seok] NewG Lab announced on the 6th that its U.S. subsidiary, NewG Lab Pharma Inc., is in the final stages of preclinical and FDA clinical trial design work for its anticancer technology KAT (Ko Anticancer Therapy) and plans to officially begin clinical trials in the U.S. this year.

According to NewG Lab Pharma, through animal experiments on mice, pigs, and others, the anticancer efficacy of KAT has been proven, and verification of safe dosage ranges was completed long ago. Additionally, in preclinical studies conducted in collaboration with the University of Maryland School of Medicine, KAT monotherapy significantly reduced tumors without toxicity, confirming its potential as a standalone treatment.

Furthermore, since September last year, NewG Lab Pharma has accelerated clinical progress by signing a contract with Covance, the world's leading Contract Research Organization (CRO).

Founded in 1996, Covance is a global leading CRO known for conducting clinical and non-clinical research related to new drugs for global pharmaceutical companies and for producing the world's best large animals (Beagle Dogs). In 2018, it ranked first worldwide in the CRO sector. Covance has branches in the Asia-Pacific region, South America, and Eastern Europe to secure its own network of Clinical Research Associates (CRA) and provides end-to-end new drug development services from early clinical stages to approval.

NewG Lab Pharma plans to rapidly enter clinical trials by closely cooperating with Covance, the world's top-level CRO, from the preclinical stage to enhance the reliability of clinical data and results and to prove safety and efficacy according to international standards.

Preclinical studies, which confirm drug efficacy in animals and cells, must comply with stringent international standards and guidelines in data management (DM) and statistics. The company explained that preclinical studies are an essential and very cautious phase conducted immediately before administering drugs to humans, especially considering recent contamination incidents in clinical trials by some pharmaceutical companies.

A company official stated, “The premium value of a new drug can be influenced by how highly reliable data is built and whether research is conducted with trustworthy institutions during preclinical and early clinical stages or license agreements. Covance, with its extensive experience and know-how, handling CRO services for 49 out of the top 50 global pharmaceutical sales, is expected to further enhance the reliability of NewG Lab Pharma’s clinical data.”

He added, “Currently, the FDA clinical trial design for KAT targeting liver cancer, breast cancer, bladder cancer, and melanoma in the U.S. is in its final stages. Since data from animal experiments and numerous actual treatment cases in humans have already been secured, once the design work is successfully completed, we expect to quickly proceed to clinical trials.”

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