[Asia Economy Reporter Jang Hyowon] Mecox Curemed, a new drug development specialist company in which Kosdaq-listed Medicox holds a majority stake, has initiated Phase 1 clinical trials of the oral anticancer drug Mecbentu.
On the 21st, Mecox Curemed announced that it had completed the first patient registration for the Phase 1 trial of Mecbentu and officially started the clinical trial. The company stated that with the full-scale patient registration underway, it aims to complete Phase 1 clinical trials within this year through accelerated clinical progress.
The Mecbentu Phase 1 trial, conducted on 30 patients with low-grade B-cell lymphoma at Seoul St. Mary's Hospital and Yeouido St. Mary's Hospital, both recognized as top five hospitals worldwide in hematologic cancers, will compare the drug’s safety, pharmacokinetic properties, and clinical efficacy against the existing injectable drug Bendamustine, the company explained.
Mecox Curemed also plans to submit an IND for the European Phase 2 clinical trial of Mecbentu within this year. After signing a comprehensive service contract with the European multinational CRO OPIS in March regarding Mecbentu’s clinical trials, Mecox Curemed has completed drafting the Phase 2 clinical trial plan following reviews of EMA regulations and identification of key investigators in participating countries.
Since July 2020, Mecox Curemed has been producing Mecbentu for global clinical trials through Haupt Pharma Amareg GmbH, a global pharmaceutical manufacturer based in Germany. The company expects to accelerate the sequential global clinical trials planned in Europe, the United States, Australia, and other regions.
CEO Ilgu Lee of Mecox Curemed said, “Mecbentu is an oral anticancer drug that enhances safety, efficacy, convenience, and cost-effectiveness.” He added, “The commencement of domestic clinical trials and the upcoming European Phase 2 trial will serve as important milestones for global technology transfer.”
Mecbentu is a novel anticancer drug that changes the administration route of the existing hematologic cancer treatment Bendamustine from injectable to oral, significantly improving patient convenience. It primarily targets a broad range of hematologic cancers including follicular lymphoma, lymphocytic leukemia, and multiple myeloma. Notably, it applies a drug delivery system (DDS) using cyclodextrin, one of Mecox Curemed’s proprietary drug delivery technology platforms.
The company expects that this technology can be applied to convert other injectable drugs to oral forms or to drugs with reduced stability, potentially expanding the pipeline to indications such as gastric cancer and solid tumors.
Medicox invested approximately 3 billion KRW raised through a paid-in capital increase last year into Mecox Curemed’s pipeline R&D, including the Phase 1 clinical trial of the oral anticancer drug Mecbentu and the Phase 2 clinical trial of the natural product-based arthritis treatment Bozanics.
Market research firm Polaris Market Research forecasts that the global hematologic cancer treatment market will grow to about 87 billion USD (approximately 107 trillion KRW) by 2025.
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