Press Releases
[Stockholm, Sweden, July 27, 2007.] Swedish drug development company OxyPharma today announced the initiation of its phase II clinical trial of Rob 803, the company’s orally administered compound for treatment of moderate or severe active Rheumatoid Arthritis (RA).
OxyPharma has received regulatory clearance to commence a phase II trial of its immunomodulator, Rob 803, in patients with moderate to severe active RA. OxyPharma expects to start enrollment of patients within a few days, starting in Latvia and Lithuania. The phase II study will be carried out in Belgium, Bulgaria, Latvia, Lithuania, Romania, Serbia, Sweden and the UK by Pharm-Olam International, a multi-national contract research organization. Principal Investigator is Prof. Lars Klareskog, Head of Rheumatology Unit at Karolinska Hospital, Stockholm, Sweden.
OxyPharma’s primary objective is to evaluate the clinical response rate of Rob 803 when added to a stable dose of methotrexate in 224 patients with moderate or severe active RA. Rob 803 will be given orally once daily for 12 weeks.
The placebo-controlled trial is intended to evaluate the compound’s tolerability, to determine the appropriate dosage and to provide laboratory results with indication of an anti-inflammatory effect of Rob 803. The trial is expected to be completed by March 2008.
OxyPharma’s phase I program to test the safety, tolerability and absorption of Rob 803 in healthy volunteers, demonstrated that Rob 803 was well tolerated with good oral absorption. These results support the move into the phase II program, an important milestone in OxyPharma’s drug's development program.
“The start of the first clinical trial in patients with our RA compound Rob 803 is a key milestone in the development of OxyPharma and our product portfolio”, said Ulf Björklund, CEO, OxyPharma.
There are presently no effective, safe and easily administrated drugs for the treatment of RA. The value of the global RA market is estimated at more than USD 3bn annually.About OxyPharma:
OxyPharma is a Swedish drug development company developing new drugs primarily for the treatment of Rheumatoid Arthritis (RA) and Multiple Sclerosis (MS). The development programs are primarily carried out in collaboration with the Karolinska Institute in Stockholm, Sweden and contract research organizations (CRO’s) in England, Sweden and Israel. OxyPharma was founded in 2002 and is based in Stockholm, Sweden. The company’s largest shareholder is innovator and entrepreneur Leif Lundblad (mainly through his investment company LLD Nybohov Invest). Ulf Björklund is OxyPharma’s CEO.
For additional information please contact:
Ulf Björklund
CEO, OxyPharma AB
Phone: +46 8 726 17 02 or +46 70 667 04 40
Email: ulf.bjorklund@oxypharma.com
or
Peter Karaszi
Press Officer, OxyPharma AB
Phone: +27 21 439 8806 or +27 83 243 5797
Email: peter.karaszi@oxypharma.com
