ENZYCHEM LIFESCIENCES ANNOUNCES INITIATION OF GLOBAL PHASE 2 TRIAL OF EC-18 IN PATIENTS WITH CHEMOTHERAPY INDUCED NEUTROPENIA(CIN)
FORT LEE, N.J., June 19, 2017 /PRNewswire/ — Enzychem Lifesciences, Corp. (konex:183490), the largest life sciences company by market capitalization in South Korea’s KONEX Stock Exchange, announced the initiation of the dose-escalation stage of a global phase 2 trial of EC-18 today, a synthetic palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol (Mosedipimod), intended for patients with Chemotherapy-Induced Neutropenia (CIN).
This multicenter Phase 2 study of EC-18 (Mosedipimod), the world’s first oral medicine candidate to prevent and treat Chemotherapy-Induced Neutropenia (CIN), will begin dosing its first patient in the Asan Medical Center of Seoul, Korea.
“Efficiently progressing this study into Phase 2 is an important milestone for the development of EC-18,” said Alexander Fleming, M.D., Chief Technology Officer of Enzychem Lifesciences. “Having established the Phase 2 study in Korea and the U.S., we are now focused on augmenting proof of concept data for EC-18 in management of severe chemotherapy-induced neutropenia patients with advanced breast cancer.”
Unlike the current standard care for CIN, G-CSFs, EC-18 will be produced in the form of soft oral gelatin capsules, which is intended to considerably enhance the convenience of regularly taking the medicine.
Currently approved formulations of G-CSFs for the treatment of CIN are administered intravenously as injectables. This is one of the primary contributors to the high cost of therapy. The expense of these biologics, even though partially reimbursable, can create a significant burden on patients owing to the expenses that they must pay as part of their copayments. The expense also creates a great burden on the government or commercial health insurance companies. Enzychem expects chemically synthesized EC-18, on the other hand, to significantly reduce the cost of current treatment.
Furthermore, owing to different mechanism of action (MoA) of EC-18, which is controlling inflammation through neutrophil modulation, Enzychem expects EC-18 to address medical needs unmet under current treatment. Presently, the most serious adverse reactions reported in patients taking G-CSF products are splenic rupture, bone pain, serious allergic reactions and potential for tumor growth stimulatory effects on malignant cells. Per FDA’s prescribing information, “The G-CSF receptor through which pegfilgrastim and filgrastim act has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type cannot be excluded.” EC-18’s unique mechanism of action is designed to no longer initiate these side-effects.
It is Enzychem’s hope that EC-18 may be able to help combat cancer growth and inflammation, as well as immune diseases including psoriasis, rheumatoid arthritis, asthma, atopic dermatitis, and sepsis. Enzychem Lifesciences is preparing to submit an investigational new drug application (IND) for the indication of chemotherapy and radiation induced oral mucositis (CRIOM) during June.
Enzychem Lifesciences’s intellectual property portfolio comprises use and process patents, and patent applications that the company believes are necessary for the development and commercialization of EC-18. In aggregate, Enzychem owns over 169 active patents and patent applications with over 85 of the granted patents coming worldwide, especially in the U.S., Europe, and Japan.
Enzychem Lifesciences Chief Executive Officer Ki-young Sohn said, “Enzychem is investing 30% of the company’s total annual sales into R&D. Enzychem Lifesciences won the award for best R&D Company at the Korean Venture Business Association in 2017, and it will become a leading global biopharmaceutical company through new drug development.”
Enzychem is also hopeful that EC-18 will eventually be approved by the FDA. The phase 2 trial being announced today is one step towards that ultimate goal. Enzychem looks forward to the day when EC-18 is available to physicians and patients so that the formula can decrease costs and prevent painful side effects. Enzychem expects the step announced today to be instrumental in moving forward the date where EC-18 will be available to patients suffering from immune diseases.
About Enzychem Lifesciences Corporation
Enzychem Lifesciences, Corp. (konex:183490) is a global new drug development biopharmaceutical company founded in 1999. With R&D driven approach and corporate mission of “Saving Human Lives by Overcoming Unmet Medical Needs”, Enzychem is developing innovative treatments which can address significant unmet medical needs. Enzychem is the largest life sciences company by market capitalization in South Korea’s KONEX Stock Exchange. The company is headquartered in Seoul, South Korea.
For more information on Enzychem Lifesciences, visit http://www.enzychem.com/
This discussion may include predictions, estimates or other information that might be considered forward-looking. While these forward-looking statements represent Enzychem’s current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this announcement. Please keep in mind that Enzychem is not obligating itself to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events.
The information included in this press release concerns a drug use that has not been approved by the Food and Drug Administration.