Monday, 24 July 2017

Enzychem Lifesciences Announces Global Phase 2 Trial Inititation of EC-18 in Patients with Chemotherapy Induced Neutropenia(CIN)

20 June 2017 | News | By BioSpectrum Bureau

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.

Enzychem Lifesciences, Corp., a Korea based life sciences company 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.

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 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.

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