Kringle Pharma announces that positive clinical results from Phase I/II trial of recombinant human HGF, KP-100IT, in subjects with acute spinal cord injury were published in the peer-reviewed Journal of Neurotrauma (Published Online: 22 May 2020, DOI: 10.1089/neu.2019.6854).

New board members were selected at the 18th general shareholders meeting, and the board members appointed Kiichi Adachi as President and CEO.

KP-100IT, recombinant human HGF for the treatment of acute spinal cord injury, was designated as an orphan drug in Japan as of September 12, 2019, with the approval of the Minister of Health, Labor and Welfare.

Phase I/II study of recombinant human HGF, KP-100IT, for acute spinal cord injury was completed, and the clinical study report has been issued. The positive results of this study will be published later in a scientific journal and presented at academic conferences.

Clinical data from Phase I study of recombinant human HGF, KP-100IT, for the treatment of ALS were published in Journal of Clinical Pharmacology (11 DEC 2018, DOI: 10.1002/jcph.1355). It was indicated that intrathecal administration of KP-100IT was safe and tolerable. Following the Phase I study, an investigator-initiated Phase II study is currently underway to confirm therapeutic efficacy of KP-100IT against ALS.

New board members were selected at the 17th general shareholders meeting, and the board members appointed Kiichi Adachi as President and CEO.

Kringle Pharma successfully raised 200 million JPY in funding from THVP-1 Fund (General Partner: Tohoku University Venture Partners Co., Ltd.).

Kringle’s recombinant human HGF is now available as a research reagent at REPROCELL, Inc. For more information, please contact REPROCELL, Inc. through their website as follows. https://www.reprocell.com/

Kringle Pharma announces that the last subject has completed the follow-up period after dosing in the Phase I/II study of recombinant human HGF for acute spinal cord injury.

A patent entitled ‘HGF preparation suitable for treatment of nervous diseases’ was granted in Japan. Patent No. JP6281992.

Clinical data from the investigator-initiated Phase I/II of recombinant human HGF for treatment of vocal fold scar were published in Journal of Tissue Engineering and Regenerative Medicine (25 DEC 2017, DOI: 10.1002/term.2603). It was demonstrated that intracordal injection of the recombinant human HGF drug was safe, feasible, and potentially effective for vocal fold scar patients based on several evaluation methods.