Date: 2017-12-19
Type of
information: DSMB assessment
phase: 2
Announcement: DSMB assessment
Company: Faron Pharmaceuticals (Finland)
Product: Traumakine® - FP-1201 (human recombinant interferon-beta 1a)
Action
mechanism:
- protein. FP-1201 is a human recombinant interferon-beta 1a. In acute lung injury (ALI) and acute respiratory distress syndrome (ARDS), the predominant patho-physiological result is increased vascular leakage, which has been shown to be due to the lack of adenosine, an end product of AMP degradation by 5’-nucleotidase (CD73). Adenosine acts to enhance endothelial barrier function via adenosine receptor activation. Therefore, any biological substance, which acts to increase adenosine level, will reduce vascular leakage and be of benefit in ALI/ARDS patients. Such substances are type I interferons, and especially the interferon-beta (IFN-beta). IFN-beta has been shown to up-regulate 5’-nucleotidase (also known as a CD73 molecule and expressed abundantly by normal endothelial cells) and prevent ALI in animal models (Kiss et al. (2007) Eur. J. Immunol. 37:3334).
Disease: Multi-Organ Failure (MOF), prevention of surgically operated Ruptured Abdominal Aorta Aneurysm
Therapeutic
area: Cardiovascular diseases
Country: Estonia, Finland, Lithuania, UK
Trial
details:
- The Phase II INFORAAA trial (EudraCT 014-000899-025) evaluates the efficacy and safety of FP-1201-lyo compared to placebo for the prevention of MOF following open surgery for RAAA. The trial is a double-blind, randomised (2:1), parallel group study and the same dosing is used as in the on-going INTEREST Phase III trial for the treatment of ARDS patients, who also experience MOF. Both FP-1201-lyo and placebo are administered intravenously once a day for six consecutive days post-operation in addition to intensive care. The primary end point of the INFORAAA trial is to evaluate mortality after 30 days of the first dose administration and the trial also has several secondary and explorative end points, which are related to the nature of these patients. The trial is initiated with 8 sites in Finland and is planned to be expanded to Baltic States and UK.
Latest
news:
- • On December 19, 2017, Faron Pharmaceuticals announced that it has received the first recommendation from the Independent Data Monitoring Committee (IDMC) of the INFORAAA study to continue the trial as planned using Traumakine®. The study currently has six open sites in Finland, two in Lithuania and one in Estonia. The first sites in the UK will open in the beginning of 2018. The INFORAAA study aims to treat a total of 160 post-operative Ruptured Abdominal Aorta Aneurysm (RAAA) patients and the interim results are expected in H2 2018.
- The Phase II/III INFORAAA clinical trial of Traumakine for the treatment of Multi-Organ Failure (MOF) and mortality prevention in surgically operated RAAA patients is based on a similar treatment regimen to the regimen used in patients in the Company's recently completed Phase III INTEREST trial for Acute Respiratory Distress Syndrome (ARDS).
- • On February 20, 2017 , Faron Pharmaceuticals announced the enrolment of the first patient in the Phase II INFORAAA clinical trial of Traumakine® for the treatment of Multi-Organ Failure (MOF) and mortality prevention of surgically operated Ruptured Abdominal Aorta Aneurysm (RAAA) patients. The high mortality rate of RAAA, which accounts for 4-5 deaths per 100,000 population (Karthikesalingam et al., 2014), requires new treatments to prevent post-operative reperfusion injury leading to the death of RAAA patients, which exhibits a 30-50% mortality rate post-operatively. RAAA accounts for 13-14/100,000 hospital admissions annually (Anjum et al., 2012), and is the second indication for Traumakine targeted by Faron.
- Open surgical aortic repair to treat RAAA patients is associated with a Systemic Inflammatory Response Syndrome (SIRS) affecting vital organs, especially the heart, lungs, kidneys, and intestines. The death of approximately 80% of the operated RAAA patients is caused by MOF, similar to patients with Acute Respiratory Distress Syndrome (ARDS).
- Traumakine (FP-1201-lyo) is currently in a European Phase III clinical trial for the treatment of ARDS, with encouraging Phase I/II data. The Directors consider that data seen to date supports the rationale for extending the use of Traumakine in similar conditions to potentially treat single, and multiple, organ failures. For example, during the Traumakine phase I/II study, there was a reduced need for haemodialysis (an indication of improved kidney function) among the ARDS patients on Traumakine.
Is
general: Yes
