Enzychem Lifesciences Announces Last Patient Enrolled in Stage 2 of Phase 2 Study of EC-18 in Chemoradiation Induced Oral Mucositis
ENGLEWOOD CLIFFS, N.J., April 6, 2021 /PRNewswire/ — Enzychem Lifesciences (KOSDAQ: 183490), announced today that it has completed patient enrollment in Stage 2 of its Phase 2 clinical trial of EC-18 in chemoradiation induced oral mucositis (CRIOM). Stage 2 of the Phase 2 study successfully enrolled 80 subjects, evaluating both safety and efficacy. Database Lock (DBL) is expected in near end of 2Q 2021. After the completion of DBL, data analysis including drafting top-line summaries will begin.
EC-18, the company’s lead investigational candidate, is a novel, first-in-class, immunomodulator, which facilitates the resolution of inflammation and enhances anti-infective and tissue-healing pathways of the immune system. Enzychem received Fast Track Designation from the U.S. Food and Drug Administration for the Phase 2 study evaluating EC-18 in CRIOM.
“We are pleased to have completed enrollment and look forward to top-line results early Q3 2021,” said Ki Young Sohn, CEO and Chairman of Enzychem Lifesciences. “There is currently no FDA approved drug for the treatment of oral mucositis in head and neck cancer. We believe EC-18 has the potential to be the first approved orally delivered therapy to address this unmet medical need and improve the lives of patients with cancer.”
“For patients who are treated with chemoradiation for cancers of the head and neck, oral mucositis is often symptomatically and functionally devastating, and physiologically and fiscally costly” said Dr. Stephen Sonis, an expert in the field and a member of Enzychem’s Scientific Advisory Board. He continued that “a drug that effectively interferes with mucositis development and lessens its severity will be a huge gain for thousands of patients. I look forward with anticipation to the Phase 2 trial results”.
The Phase 2, randomized, double-blind, placebo-controlled, 2-stage study evaluated EC-18 in patients with squamous cell cancers of the mouth, oropharynx, hypopharynx and nasopharynx who plan to receive standard fractionated IMRT-delivered radiotherapy with concomitant chemotherapy (cisplatin). Stage 2 enrolled 80 patients who will be randomized in a 1:1 scheme to receive either placebo or 2000 mg of EC-18 as determined by independent Data Safety Monitoring Board in Stage 1.
CRIOM is a disease that occurs as a side effect of receiving radiation therapy in combination with chemotherapy for treating head and neck cancer patients. Due to the severe pain that accompanies, the patient’s oral function deteriorates and leads to difficulties in taking food which is likely to lead to discontinuation of the treatment.
About Enzychem Lifesciences
Enzychem Lifesciences Corp. is a global pharmaceutical company focused on developing oral small molecule therapies for patients with unmet medical needs in oncology, metabolic diseases, and inflammatory diseases. Founded in 1999, the company’s proprietary compound, EC-18 is the subject of two Phase 2 clinical trials for chemoradiation-induced oral mucositis and COVID-19. EC-18 acts as an immunomodulator, facilitating the resolution of inflammation and early return to homeostasis. For more information, please visit www.enzychem.com.
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