A Medical Device Daily
Providing a corporate update during the first annual shareholders meeting of Arbios Systems (Los Angeles) last Thursday, CEO Amy Factor said the company would be starting a clinical trial to assess the safety, tolerability and indications of clinical utility of its SEPET (selective plasma filtration therapy) liver-assist and blood-purification device.
She said Arbios recently received Institutional Review Board approval from Albert Einstein Medical Center (Philadelphia) for the clinical trial to be held at that institution. As part of the trial process, the company has set up a data safety monitoring board and is working toward completion of the manufacturing of devices for the trial.
“We will now train the staff and initiate the trial at Albert Einstein Medical Center,” Factor said. “For a patient to be enrolled in the trial, they must be experiencing an acute episode of a chronic liver condition.”
The second site in the two-site, 15-patient study is Cedars Sinai Medical Center (Los Angeles).
Factor also updated shareholders on the company’s HepatAssist-2 bioartificial liver program, noting that a meeting with members of firm’s scientific advisory board was held recently to discuss the clinical trial design for that program. Arbios plans to reactivate its IND for a Phase III clinical trial and plans to meet with the FDA to review the clinical program for the HepatAssist-2.
She also reported that during the past year, the company has strengthened its management team and board of directors, adding expertise in the areas of manufacturing, operations, marketing and sales. “This pool of talent will be invaluable as the company continues to progress its novel liver-assist devices closer to market introduction,” she said.
“2004 was an important year for the company in regard to building its infrastructure and putting the necessary processes in place to advance its product pipeline,” Factor said. “I now look forward to moving . . . into the next phase of its development.”
Shareholders approved the re-incorporation of Arbios from Nevada to Delaware, which also will result in the consolidation of its operations with those of its operating subsidiary, along with an increase in the number of authorized shares of common stock from 25 million to 60 million. The company intends to complete the re-incorporation consolidation of operations within the next few days.