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Other Disclosures4884Kringle Pharma,Inc.Pharmaceuticals

Notice of Public Disclosure of Registration Information for the Additional Phase III Clinical Trial of HGF (Hepatocyte Growth Factor) in Acute Spinal Cord Injury

Registration of the additional Phase III clinical trial of Oremepermin alfa (recombinant human HGF protein) for acute spinal cord injury has been completed on jRCT and ClinicalTrials.gov, and an overview of the trial has been published. Final preparations are currently underway to begin patient enrollment.

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Announced details

Oremepermin alfaHGF (hepatocyte growth factor)
Applicable field (uses covered by this announcement)

Patients with acute spinal cord injury

Launch dateFinal preparations are underway to begin patient enrollment (start date undisclosed)
Registration number and expiry date

jRCT2031260281, NCT07722962 (expiration date undisclosed)

In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.

Source (materials cited by the company)

Miyakoshi N et al. Spinal Cord 2021 Jun;59(6):626-634.

Shingu Hikosuke (新宮彦助), “Prevention of Spinal Cord Injury,” Journal of the Japanese Paraplegia Medical Society 13:48-49, 2000

Sakai Hiroaki (坂井宏旭), “Epidemiological Survey,” Comprehensive Rehabilitation 36:969-972, 2008

Announced details
ItemDetails
Names of Products / Services CoveredOremepermin alfa, HGF (hepatocyte growth factor)
Launch dateFinal preparations are underway to begin patient enrollment (start date undisclosed)
Applicable areaPatients with acute spinal cord injury
Registration number and expiry datejRCT2031260281, NCT07722962 (expiration date undisclosed)
SourceMiyakoshi N et al. Spinal Cord 2021 Jun;59(6):626-634., Shingu Hikosuke (新宮彦助), “Prevention of Spinal Cord Injury,” Journal of the Japanese Paraplegia Medical Society 13:48-49, 2000, Sakai Hiroaki (坂井宏旭), “Epidemiological Survey,” Comprehensive Rehabilitation 36:969-972, 2008
Items this document does not state (13)
CounterpartyCounterparty overviewRelationship with the CompanyContract ValueOffering priceContract DateAward/certification nameAwarding / certifying bodyLocationLocation scaleQuantitative EffectsUsage historyImpact on Business Performance

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

To publish an overview of the trial and advance development with the aim of ensuring a smooth launch and enrolling patients at an early stage.

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Notice of Public Disclosure of Registration Information for the Additional Phase III Clinical Trial of HGF (Hepatocyte Growth Factor) in Acute Spinal Cord Injury | Kringle Pharma,Inc. (4884) timely disclosure | Komori