Press Releases
[Stockholm, Sweden, May 22, 2006.] Swedish drug development company OxyPharma today reported the successful completion of single and multiple dose phase I clinical trial in healthy volunteers on the company’s compound for the treatment of Rheumatoid Arthritis (RA).
The phase I study was designed to determine the safety, tolerability and pharmacokinetics of Rob 803 in escalating single and multiple doses. The results indicate that OxyPharma’s compound, Rob 803, is safe and well tolerated by the healthy subjects that participated in the study, which was conducted at Quintiles Guy’s Drug Research Unit in London, UK.
The study investigated seven groups of healthy male volunteers with single rising doses of a 48-fold range of dosages (12.5 to 600 mg). The pharmacokinetics demonstrated dose proportionality in terms of Cmax and AUC0-24h. No food effect was found. Three multiple dose groups have been dosed for 14 days. Loading dose of 50, 200 and 600 mg followed by a maintenance dose of 12.5, 50 and 100 mg once daily, respectively. The three multiple dose groups have been very well tolerated. In total 88 subjects have been dosed, of which 68 received Rob 803.
“We are very pleased with the phase I results, which represent a major milestone enabling us to continue investigating the use of Rob 803 for the treatment of RA. I am confident that our phase II trial will have the same attention to detail, which is very important since this will be the first Rob 803 clinical trial to include RA patients”, said Ulf Björklund, CEO, OxyPharma.
OxyPharma now turns its focus on the upcoming phase II clinical study of Rob 803, which is expected to start in October 2006. Presently the company, in consultation with its Rheumatology Advisory Board and the investigators, is finalizing the clinical end points for the phase II study.
Funding of mUSD 7.3 for Phase II Study Secured
OxyPharma recently attracted new capital from the company’s largest shareholder, Swedish investment company LLD Nybohov Invest, in the order of mSEK 55 (approx. mEUR 6; mUSD 7.3). This enables the company to initiate and complete a phase II study of Rob 803.
At present, there are no effective, safe and easily administrated drugs for the treatment of RA, a disease that affect millions of people worldwide. However, studies so far indicate that OxyPharma’s substance can be effective, easy to administrate (orally) and can be produced at low cost compared with current products. The value of the RA market is estimated at more than USD 3bn annually, and is growing rapidly.
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
