MegaPro (6827) MPB-1734 completes the phase 1 of the last patient, press release
MegaPro Biomedical Co., Ltd. (hereinafter referred to as "MegaPro", Taiwan OTC Stock Code: 6827) announced that the phase 1 of the clinical phase 1/2a trial of MPB-1734, a new anti-cancer drug formulation under its Nano-micelles technology platform, has been completed.
Dr. Hsu Yuanhung, executive vice president of MegaPro, states that regarding the clinical phase 1/2a trial approved by FDA and TFDA of MPB-1734, the first part focuses on the dose escalation assessment and the accommodation of subjects with advanced solid tumors. The maximum tolerated dose of MPB-1734 and the optimal dose for Phase 2 clinical trials is to be determined, pharmacokinetic and safety data would be collected, and the evaluation preliminary efficacy is to be completed. Relevant data are yet to be analyzed, and the results will be announced after the trial is completed. Currently, the first part of the treatment mainly treats subjects with advanced prostate cancer and head and neck cancer. Therefore, the second part is expected to focus on safety and efficacy evaluations of metastatic prostate cancer and head and neck cancer.
MPB-1734 is a new anti-cancer drug. It uses the company's Nano-micelles technology to avoid the side effects stated in the black box warning on the commercially available drug Jevtana. Jevtana is currently only approved for use on prostate cancer, and its API patent had expired in 2022. MPB-1734 has successively obtained patents for new dosage forms in the United States, Japan, and other countries, and its current expected indications are prostate cancer and head and neck cancer; (1) Prostate cancer is one of the most common health problems among men, especially the elderly (over 50 years of age), according to the latest cancer registration report from the National Health Service of the Ministry of Health and Welfare. Prostate cancer has become a common urinary tract cancer among male Taiwanese, and the global treatment market is expected to grow from US$14.767 billion in 2022 to US$28.425 billion in 2030. (2) Head and neck cancer can be further classified into oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, laryngeal cancer, etc., depending on the primary site, and it occurs in both developed and developing countries. According to the latest cancer registration report from the National Health Service of the Ministry of Health and Welfare, head and neck cancer has ascended to the top 10 most common cancers among men, and the global treatment market is expected to grow from US$1.6 billion in 2023 to US$2.9 billion in 2031.
MegaPro further states that after completing the data analysis of the first part, it will advance to the second part of the trial as soon as possible. Applications will also be made to the US FDA for rapid review of 505(b)(2) new dosage forms and new drugs in the future to speed up the process of obtaining drug certificates, hoping to benefit patients and provide them with new treatment opportunities.