LONDON (ShareCast) - (ShareCast News) - Clinical stage biopharmaceutical company 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 and mortality prevention of surgically operated ruptured abdominal aorta aneurysm patients on Monday.
The AIM-traded company said the high mortality rate of ruptured abdominal aorta aneurysm, which accounts for between four and five deaths per 100,000 people, requires new treatments to prevent postoperative reperfusion injury leading to the death of patients, which exhibits a 30-50% mortality rate.

It has been claimed that ruptured abdominal aorta aneurysm accounts for 13-14/100,000 hospital admissions annually, and is the second indication for Traumakine targeted by Faron.

Open surgical aortic repair to treat ruptured abdominal aorta aneurysm patients is associated with a systemic inflammatory response syndrome affecting vital organs, especially the heart, lungs, kidneys, and intestines.

The death of approximately 80% of the operated ruptured abdominal aorta aneurysm patients is reportedly caused by multi-organ failure, similar to patients with acute respiratory distress syndrome.

Traumakine is currently in a European Phase III clinical trial for the treatment of ARDS, with encouraging Phase I/II data.

The directors of Faron said they considered that the data seen to date supported the rationale for extending the use of Traumakine in similar conditions to potentially treat single, and multiple, organ failures.

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, the board added.

"We are delighted to start the trial with the first patient enrolled in the Phase II INFORAAA trial for the reduction of post-operative ruptured abdominal aorta aneurysm patient mortality," said Faron CEO Markku Jalkanen.

"The main cause of death for these patients is multi-organ failure following a postoperative reperfusion injury of ischemic organs including kidneys, liver, brain and intestines."

Dr Jalkanen said the company believes Traumakine shows significant efficacy for the recovery of operated ruptured abdominal aorta aneurysm patients.

"Furthermore, there is a possibility that a positive outcome of both the INFORAAA and INTEREST trials could result in the INFORAAA trial fulfilling Phase III trial requirements.

"The clinical data of ruptured abdominal aorta aneurysm patients treated with FP-1201-lyo during the INFORAAA trial could also provide us with valuable information on the recovery of ischemic single organ injuries and planning further trials to treat these injuries."

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