Norwegian biotechnology firm A-Viral AS has enrolled the first six patients in a Phase II clinical study of an AIDS candidate drug called AV-1101.
The company plans to recruit 40 subjects in total, CEO Einar Stokke told BioWorld International, but capacity restraints will limit the number of patients it can treat to four per week.
¿We hope to produce a preliminary report when we reach 10 to 12 patients because all 40 will take some time,¿ Stokke said. If these early results prove positive, the company plans to broaden the Phase II trial before seeking a licensing agreement with a larger partner. The company is looking at viral load reduction as its primary endpoint. AV-1101 is a hydroxylated derivative of oxyphenbutazone, which, according to the company, acts on HIV infection through a novel mechanism.
The company picked the Philippines as the location for its clinical studies. ¿We evaluated many places, and we decided that we could not afford to go into any industrialized countries because of the costs,¿ Stokke said. In addition, working in the Philippines enables the company to enroll ¿virgin¿ patients who have not had previous access to other AIDS treatments, he said.
The study is being performed at the University Hospital in Manila, one of Southeast Asia¿s leading centers for treatment of HIV and AIDS, according to the company.
A-Viral, which was founded in 1996, has maintained a virtual organization throughout its existence. Initially, it got contract research services from the Norwegian Institute of Public Health in Oslo.
This year it entered a strategic relationship with the Dutch research organization CLB, of Amsterdam, which is supplying contract research services to A-Viral¿s AIDS program and supplying research and innovation services, including any intellectual property developed, to a new autoimmune disease program. In return, CLB, which is part of the Dutch Sanquin Blood Supply Foundation, has received a 10 percent stake in A-Viral.
The company has so far raised NOK35 million (US$3.5 million) in private equity funding.
Stokke, who previously spent 21 years at Andersen Consulting and rose to head its European health care practice, said A-Viral will seek between NOK 100 million and NOK200 million in venture capital funding next year.