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News update

News

2019

October 2019 a new scientific article about the 2STEP study has been accepted in Pediatric Research, "Pharmacokinetics and short-term safety of the selective NOS inhibitor 2-iminobiotin in asphyxiated neonates treated with therapeutic hypothermia".

Summer: follow up visits 2 years old patients 2STEP study

2018

Q4 2018: Start 3e cohort Out of Hospital Cardiac Arrest study
May 2018: New CEO, Eveline Hogenkamp-van Velp
Summer 2018: Release clinical batches GMP Production

2017

December 2017: Successful completion of second cohort of TIBOHCA study
November 2017: DSMB approval of 2-STEP study Formulation patent granted in Russia and South Korea
June 2017: DSMB approval and start of second cohort of TIBOHCA study. Successful completion of second cohort of 2-STEP study

2016

October 2016: Successful completion of first cohort of TIBOHCA study
September 2016: DMSB approval and start of second cohort of 2-STEP study
March 2016: Start of first cohort of investigator-initiated Phase II study at AMC Amsterdam exploring safety and pharmacokinetics of 2-IB in adults after out of hospital cardiac arrest (TIBOHCA)

2015

August 2015: Formulation patent granted in US, China, Australia and New Zealand. In the US a continuation-in-part has been filed.
July 2015: Start of investigator-initiated ​Phase II study at UMC Utrecht exploring safety and pharmacokinetics of 2-IB given in addition to hypothermia in neonates with perinatal asphyxia (2-STEP study).

2014

September 2014: Completion of hospitalisation phase of first Phase II clinical open label pilot study in Turkey.

2012

February 2012: Approval of Paediatric Investigational Plan (PIP) by the European Medicines Agency (EMA).

2011

June 2011: Successful completion of Phase I clinical study.

2010

June 2010: Protocol advice received from the European Medicines Agency (EMA) in London for the first Phase II clinical study.
May 2010: Formulation patent application filed.
January 2010: Granting of Orphan Drug designation in the European Union by the European Commission.

2009

February 2009: Granting of Orphan Drug Designation by the US FDA.

2008

September 2008: Start of formal preclinical development of 2-IB (manufacturing and safety studies).
July 2008: Pre-IND meeting with the US FDA.
April 2008: Acquisition of the 2-IB patent family, originally filed by University Medical Center Utrecht.

Neurophyxia B.V. was incorporated on April 20th, 2008 with the founders and private investors as shareholders