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Other Disclosures4582SymBio Pharmaceuticals LimitedPharmaceuticals

First Patient In (FPI) Achieved in Phase 3 Clinical Trial of IV BCV for AdV Infections Following Hematopoietic Stem Cell Transplantation

The first US patient has been enrolled in the global Phase 3 trial of injectable brincidofovir (IV BCV) for adenovirus infections following hematopoietic stem cell transplantation. The trial will proceed with enrollment of a total of 180 patients, with enrollment completion targeted by the end of 2027 and regulatory filing targeted by the end of 2028.

Worth reading
69In focus
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Direction
Improvement
Direction inferred from the company’s description.
Scale
180
Example
Wording
Conditional
How definitive the wording is.

Announced details

IV BCV (injectable brincidofovir)
Applicable field (uses covered by this announcement)

Adenovirus (AdV) infections following hematopoietic stem cell transplantation

What the company reported numerically
Quantitative Effects

Extremely high efficacy demonstrated in a Phase 2 clinical trial, achieving proof of concept (POC) for antiviral activity

Usage history

First Patient In (FPI) achieved

Relationship between the counterparty and the company
SymBio Pharmaceuticals Limited4582
Relationship with the Company

Clinical trial site. Michael Grimley, the site's medical director, achieved first patient enrollment.

CounterpartyCincinnati Children's Hospital Medical Center

A medical center in Ohio, US. Its Cancer and Blood Diseases Institute includes a Bone Marrow Transplantation and Immune Deficiency division.

Registration number and expiry date

Clinical trial registration number NCT07387367

Location (as indicated in this announcement)

Cincinnati Children's Hospital Medical Center, Ohio, US

A total of 80 sites and enrollment of 180 patients planned
Impact on Business Performance

No impact on consolidated results for the fiscal year ending December 2026

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

Press release dated 30 June 2025; Phase 2 clinical trial

Announced details
ItemDetails
Names of Products / Services CoveredIV BCV (injectable brincidofovir)
CounterpartyCincinnati Children's Hospital Medical Center
Counterparty overviewA medical center in Ohio, US. Its Cancer and Blood Diseases Institute includes a Bone Marrow Transplantation and Immune Deficiency division.
Relationship with the CompanyClinical trial site. Michael Grimley, the site's medical director, achieved first patient enrollment.
Applicable areaAdenovirus (AdV) infections following hematopoietic stem cell transplantation
Registration number and expiry dateClinical trial registration number NCT07387367
LocationCincinnati Children's Hospital Medical Center, Ohio, US
Location scaleA total of 80 sites and enrollment of 180 patients planned
Quantitative EffectsExtremely high efficacy demonstrated in a Phase 2 clinical trial, achieving proof of concept (POC) for antiviral activity
Usage historyFirst Patient In (FPI) achieved
Impact on Business PerformanceNo impact on consolidated results for the fiscal year ending December 2026
SourcePress release dated 30 June 2025; Phase 2 clinical trial
Items this document does not state (6)
Contract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying body

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.

There are no effective treatments for adenovirus infections following hematopoietic stem cell transplantation, and the mortality rate is high, creating an urgent need for the development of effective treatments.

How to read this page

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First Patient In (FPI) Achieved in Phase 3 Clinical Trial of IV BCV for AdV Infections Following Hematopoietic Stem Cell Transplantation | SymBio Pharmaceuticals Limited (4582) timely disclosure | Komori