Enzychem Lifesciences Corp., a South Korean biotech company, is closer to penetrating overseas markets with its independently developed investigational oral compound EC-18 to prevent and treat chemo-radiotherapy induced oral mucositis.
A phase II study is underway for the compound after receiving approval from the U.S. Food and Drug Administration (FDA), the company said. The company expected that once its global sale is approved, the drug would generate more than 3 trillion won ($2.6 billion) in sales as it would be the first oral cancer therapy. Currently, the related global market including its related immune disorders is valued at about 74 trillion won ($64.2 billion).
“We are expecting that this immune modulating drug will prevent oral mucositis. We successfully synthesized this molecule in 2005 and anticipate completing the phase II development as the world`s first oral therapy for cancer patients next year,” Sohn Ki-young, chairman and CEO of Enzychem Lifesciences, said during a recent interview with Maeil Business Newspaper.
EC-18 is designed from synthesis of palmitic acid extracted from palm trees and linoleic acid from safflower seeds and acetic acid on the backbone of glyceride. Early data showed EC-18 is proven effective in preventing severe neutropenia associated with side effects of chemotherapy, the company claimed.
One of the drug`s key target indications is for oral mucositis caused by the DNA injury of the immune system during chemoradiotherapy. The disease causes mouth ulcers and extreme pain, making it difficult for a patient to swallow food and continue cancer treatment and may cause infection and furthermore sepsis .
The company obtained “AA” and “A” grades for its new concept and first-in- class immune modulating treatment technology of EC-18, respectively, from independent Korean evaluators eCredible and Korea Enterprise Data. Patents are already registered in Korea and the U.S., the company said.
Enzychem Lifesciences is the largest company in market capitalization on the Konex, a stock exchange for small-to-medium sized companies in Korea. The company is prepping to move its stocks to the country`s secondary Kosdaq market, which is larger than the Konex, to ensure sufficient funds to finance the development of EC-18. Stocks are due to be traded on the Kosdaq market in December this year.
“EC-18 will be a first-in-class drug, and contribute to promoting Korea`s pharma and biotech sector. New findings from the development process will be released through peer-reviewed one of the world best professional journals,” said Sohn.