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Sản phẩm canxi vô định hình #Density của hãng #Amorphical, Israel đã được FDA (Cục quản lý Thực phẩm & Dược phẩm Hoa Kỳ) chấp thuận cho phép thực hiện việc kiểm định lâm sàng giai đoạn 2 đối với các bệnh nhân bị các chứng bệnh liên quan đến việc thiếu canxi, trong đó có bệnh suy tuyến giáp.
Sau khi hoàn thành giai đoạn 2, Amorphical sẽ được tiến hành luôn giai đoạn 3 mà không cần phải đợi FDA cấp phép.
Ngày mà Density được công nhận có vai trò như dược phẩm trên toàn thế giới đang đến rất gần!
The Israeli biotechnology company Amorphical has received approval from the US Food and Drug Administration (FDA) and will soon begin Phase 2 trial of a new amorphous calcium-based drug to treat patients with hypothyroidism, which causes low levels of calcium in the blood. Phase 1 trial was performed in Israel in 2014.
Amorphical, whose headquarters are located in Ness Tziona and the Arava production plant, manufactures and sells in Israel and abroad calcium produced from a shell of blue crabs that can renew it within three days.
Calcium is currently marketed as a dietary supplement, the active ingredient of which is identical to the active ingredient in the drug and is based on the same mechanism of action. This supplement is intended primarily for people with bone problems, such as osteoporosis.
The Amorphical trial, which is managed by founder Yossi Ben, will include 150 patients in 20 hospitals simultaneously, in the US, Europe and Israel According to FDA approval, if the results of the Phase 2 trial meet expectations, Amorphical can proceed directly to a clinical trial Stage 3, at the same medical centers and with the same patients, without having to submit a new application to the FDA for Phase III trials.
Amorphical has raised to date foreign investors, mainly from China, and Israelis headed by the Lahav Fund. The company last year raised $ 100 million.
The new experiment will be led by Prof. Lucia Maria Brandi of the University of Florence Medical School, a world-renowned specialist in endocrinology. Amorphical estimates that the drug will be approved for marketing within three years of the start of the trial.
Nguồn: fb Nguyễn Mỹ Hạnh