The trial was conducted under Korea FDA guidelines and represents the first anti-CD19 CAR-T cell immunotherapy in Korean history
Company plans clinical trials already in 2019 with possible commercialization in 2020
Dr. Sang Mok Lee, CEO commented, "This is a major milestone for cancer treatments. Our results are extremely encouraging, and we plan to responsibly advance towards commercialization of this potentially life-saving treatment."
Vancouver, British Columbia--(Newsfile Corp. - October 16, 2018) - Biocure Technology Inc. (CSE: CURE) (OTCQB: BICTF) (the "Company" or "Biocure") announces today the successful results of the Pre-Clinical Trial of safety and toxicity of CAR-T cells based treatment for Acute Lymphocytic Leukemia.
This is the first breakthrough milestone achieved in Korea and serves as a pre-requisite by Korea FDA (KFDA) for proceeding to an IND (Investigation of a New Drug) application.
The trial results demonstrated a complete remission of the cancerous cells within 7 and 28 days from the injection of reengineered CAR-T cells into a mouse. The study further showed encouraging results as no toxicity symptoms have risen from the high-volume injection. Company believes these to be strong indicators for the next phase clinical trials.
CAR-T cells are a novel form of potential treatment for cancer by "enlisting" and strengthening the power of a patient's own immune system to attack cancerous tumors. T-Cells are the fundamental protection agent of the human immune system and plays a critical role in orchestrating the immune response and killing cells infected by pathogens.
CAR-T cells immunotherapy essentially "trains" or "engineers" T-Cells to recognize specific cancer related proteins or antigens (CD19 in this case) and thus attach themselves to that cancer cell and destroy it specifically without harming healthy cells. The T-Cells are taken from the patient's own blood, being reengineered (or "trained") and reintroduced back into the body with their new abilities to fight specific cancerous cells. The "training" entails a production of new receptors on the T-Cell surface that now will enhance the T-Cell with the ability to recognize/attach itself to the cancerous cell's surface proteins/antigens. These new T-Cell receptors are called "Chimeric Antigen Receptors" or CARs in short which coined the industry name of this novel treatment to "CAR-T".
The trial, first of its kind in the history of Korea, is a result of a wide Korean scientific collaboration. BioCure has performed the trial via its wholly owned subsidiary BiocurePharm in collaboration with Pharos Vaccine with the assistance of Osong Medical Innovation Foundations as the trial CRO (Contract Research Organization) and Croen Corp. who led the toxicity tests under GLP (Good Laboratory Practice) standards.
Biocure has successfully completed the safety test of a Biodistribution analysis study and toxicity study for single dose intravenous injection as per the Korea FDA guidelines. This milestone allows BioCure to advance into the actual production of anti-CD19 CAR-T Cell for a clinical trial.
The Company has already contracted CdmoGen Co. Ltd. and Master Cell Bank to produce a Lentiviral Vector under GMP standards necessary for advancing to the next stage of CAR-T Cell based clinical trials.
Biocure is a South Korean based Bio Pharmaceutical company specializing in the development and potential commercialization of biosimilar pharmaceutical products. Biocure is in the process of pre- clinical trials of five major biosimilar products in South Korea, including Interferon Beta 1b, PEG- Filgrastim and Ranibizumab as well as CAR-T Cell Therapy. Interferon Beta 1b is used for treating relapsing forms of multiple sclerosis ("MS") Filgrastim is used to treat neutropenia, a lack of certain white blood cells caused by bone marrow transplants, chemotherapy, and other conditions. Ranibizumab is used for treating macular degeneration. It is also used to treat a type of eye problem known as macular edema, as well as certain eye problems caused by diabetes. Biocure is also developing a foot and mouth disease vaccine, a hair growth production product and a breast cancer detection kit.
ON BEHALF OF THE BOARD OF DIRECTORS
/S/ "SANG MOK LEE"
CEO and Director
For further information, please contact:
Biocure Technology Inc. Telephone: 604-609-7149, or
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