Kringle Pharma Files Patent Application for Treatment of Chronic Spinal Cord Injury

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Press release

March 11, 2022

Kringle Pharma files patent application for treatment of chronic spinal cord injury

Kringle Pharma, Inc. (headquartered in Osaka, Japan; President and Chief Executive Officer, Kiichi Adachi; “KRINGLE”),

  1. late clinical-stage biopharmaceutical company, today announces that it has jointly filed a patent application with Keio University (located in Tokyo, Japan; President, Kohei Itoh) for the treatment of chronic spinal cord injury.

KRINGLE is currently conducting a Phase III clinical trial of recombinant human hepatocyte growth factor (“HGF”) in subjects with acute spinal cord injury. In parallel, KRINGLE launched in 2021 a collaborative research project with Professors Hideyuki Okano and Masaya Nakamura of Keio University School of Medicine, aimed at creating new therapies for spinal cord injuries. In this research, transplantation of neural stem/progenitor cells derived from human pluripotent stem cells (“hiPSC-NS/PC”) owned by Keio University, combined with the administration of HGF through a scaffold developed by KRINGLE, demonstrated improved function recovery in the animal model of chronic complete spinal cord injury, leading to the following new patent application:

Title of the invention Therapeutic agent for spinal cord injury

Application No. PCT/JP2022/10976

deposit date March 11, 2022

Summary Spinal cord injuries usually result from a traumatic impact on the spinal cord. In the acute phase, due to severe inflammation, secondary injury follows and aggravates the damage. As the inflammation decreases, the lesion progresses from the subacute phase to the chronic phase. In the chronic phase, the injury involves the formation of a cystic cavity and the development of scar tissue, which disables the axonal outgrowth. In this research, the HGF-containing scaffold was placed at the injury site in the thoracic spinal cord complete injury rat model, prior to hiPSC-NS/PC transplantation. As a result, we confirmed axonal outgrowth at the injury site and recovery of lower extremity motor function. Based on these results, it is suggested that the combination of hiPSC-NS/PC transplantation with HGF administration by scaffold might be a new therapeutic strategy to combat chronic spinal cord injury without treatment option. efficient, benefiting even the most severe complete spine transection subjects.

About Hepatocyte Growth Factor (HGF)

HGF was originally discovered as an endogenous mitogen for mature hepatocytes. Subsequent studies demonstrated that HGF exerts multiple biological functions based on its mitogenic, motogenic, anti-apoptotic, morphogenic, anti-fibrotic and angiogenic activities, and facilitates the regeneration and protection of a wide variety of organs. HGF exerts neurotrophic effects and enhances neurite outgrowth, and the therapeutic effects of HGF on spinal cord injury and ALS have been demonstrated in animal models by Professors Hideyuki Okano and Masaya Nakamura of Keio University School of Medicine and Professor Masashi Aoki from Tohoku University School of Medicine. , respectively. Expectations for HGF as a novel therapeutic agent are increasing for these refractory neuronal diseases.

About Human Induced Pluripotent Stem Derived from cellsNeural stem/progenitor cell (hiPSC-NS/PC) hiPSC-NS/PC is derived from human induced pluripotent stem cells and possesses the capacity for self-renewal, allowing proliferation while maintaining an undifferentiated state, as well as pluripotency, allowing differentiation into cells constituting the central nervous system such as neurons, astrocytes and oligodendrocytes. The first inhuman clinical trial of Transplantation: Regenerative Medicine using hiPSC-NS/PC to treat subacute complete spinal cord injury is currently underway at Keio University Hospital.

(For more information, please see Keio University’s January 14, 2022 press release. https://www.keio.ac.jp/en/press-releases/files/2022/1/14/220114-1.pdf)

About Spinal Cord Injury

Spinal cord injuries are caused by trauma, resulting in a variety of paralytic or painful symptoms. In decreasing order of incidence, tripping, traffic accidents and falls from heights are the leading causes of spinal injuries. Recently, due to the increase in the elderly population, tripping is becoming an increasingly common cause. In Japan, there are about 100,000 to 200,000 people with chronic spinal cord injury with an incidence of about 6,000 new cases per year*. With appropriate early post-injury treatment and specialized rehabilitation, some degree of functional recovery can be expected, but severe complex symptoms including motor paralysis, muscle spasticity, sensory paralysis, dysfunction of internal organs (rectal and bladder disorders, dysfunction of thermoregulation, decrease in respiratory, decrease in respiratory function) can often persist. For these reasons, there is therefore a strong need for the development of a new drug *Source:

Miyakoshi N et al. Spinal cord 2021 Jun;59(6):626-634. Sakai H et al. J Spine Res. 2010 1(1):41-51.

About Kringle Pharma, Inc.. https://www.kringle-pharma.com/en/

Kringle Pharma is a late-stage clinical-stage biopharmaceutical company established in December 2001 to develop novel HGF-based biologics. Currently, Kringle’s clinical programs with recombinant human HGF are: 1) ongoing phase 3 in acute spinal cord injury, 2) ongoing investigator-initiated phase 2 in ALS, 3) 2/3 in preparation in the vocal cord scar, and 4) phase 1a and 1b completed in acute renal failure. Kringle’s mission is to contribute to societal and global healthcare through the continued research, development and commercialization of the drug HGF for patients suffering from incurable diseases.

For more information please contact

Daichika Hayata

Director, Pharmaceutical Development

Kringle Pharma, Inc.

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Kringle Pharma Inc. published this content on March 11, 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unmodified, on March 11, 2022 07:25:03 UTC.

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