Prolor Biotech Inc. (AMEX: PBTH; TASE: PBTH) today reported positive results in the preclinical comparative trial longer-acting version of the hemophilia drug Factor IX (Factor IX-CTP) in Factor IX-depleted hemophilic mice. The study was designed to measure the potential increase in clotting activity and duration of therapeutic effect of drug compared with commercially available recombinant Factor IX. Factor IX is indicated for the treatment of acute bleeding episodes and as therapy for prevention of bleeding in hemophilia B patients.
Prolor's Factor IX-CTP, demonstrated a significantly longer duration of clotting activity in the hemophilic mice model compared with commercially available Factor IX. Bleeding episodes were also significantly shorter and less intense for the group treated with Factor IX-CTP. In addition, none of the animals treated with Factor IX-CTP had any spontaneous re-bleeding events, compared with a 50% incidence of re-bleeding events for the group treated with commercial Factor IX and an 83% incidence of re-bleeding events for the untreated group.
The new study results support previous preclinical studies that demonstrated significant improvements in the half-life of Factor IX-CTP compared with commercially available Factor IX.
Prolor president Shai Novik said, "We believe that this study further validates CTP as a leading platform for developing long-acting therapeutic proteins, demonstrating that the fundamental ability of CTP to extend duration of therapeutic effect while increasing biological activity is consistent across various types of proteins.
"The utility of CTP has previously been validated for non-enzyme proteins, such as Merck's hormone therapy Elonva and Prolor's human growth hormone, interferon beta and erythropoietin. With this successful Factor IX study, we have now additionally confirmed the applicability of CTP technology for the development of biobetter enzymes."
Prolor CEO Dr. Abraham Havron said, "We believe that these results further confirm the clinical potential of Factor IX-CTP to become an important long-acting therapy for the treatment of acute bleeding episodes and for prevention of bleeding in hemophilia B patients. We are moving forward with our plan to initiate our first clinical study of Factor IX-CTP in hemophilia in early 2012."
Prolor's share price rose 3.6% at the opening on the American Stock Exchange today to $5.77, giving a market cap of $308 million, after falling 0.2% on the TASE to NIS 21.32.
Published by Globes [online], Israel business news - www.globes-online.com - on February 2, 2011
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