OxyPharma's patented RA candidate drug, Rob 803, will enter into phase I clinical studies with the objective to complete the studies by February 2006. The Phase I clinical trial is designed to test the pharmacokinetics and tolerability of Rob 803 in escalating single and multiple doses.
80 healthy subjects will participate in the study, which is being conducted at Quintiles Guy's Drug Research Unit in London, UK. Phase IIa clinical studies of the compound are scheduled to start in mid 2006.
OxyPharma recently completed its preclinical safety evaluation of Rob 803. The safety and toxicity studies were designed and successfully carried out in accordance with international requirements for the safety evaluation of human pharmaceuticals.
Rob 803 has been developed from OxyPharma's patented lead compound B-220, from which OxyPharma has developed several analogue substances, including Rob 895, which has been selected as a candidate drug for the treatment of multiple sclerosis (MS).
"Our Phase I clinical program will evaluate the safety and pharmacokinetic profiles of Rob 803 in human volunteers", said Ulf Björklund, CEO, OxyPharma. "Once these studies are completed, we will initiate efficacy studies in patients. "
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, preclinical studies 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.
OxyPharma will participate in the upcoming Swedish Biotech Mission in the USA, organized by Invest in Sweden Agency (ISA). Existing and potential partners, potential investors and members of the press are welcome to meet OxyPharma in Raleigh, N.C., San Diego, CA., and/or San Francisco, CA., October 21st- 26th. Please contact Mr. Björklund to set up meetings (see contact information below).
For additional information please contact:
CEO, OxyPharma AB
Phone: +46 8 726 17 02 or +46 70 667 04 40
Press Officer, OxyPharma AB
Phone: +27 21 439 8806 or +27 83 243 5797