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| Recombinant B Domain Deleted Porcine Factor VIII | ||||||||
| Octagen is developing recombinant B domain deleted porcine (pig) factor VIII (rpfVIII) for the approximately twenty-five percent of severe Hemophilia A patients with neutralizing antibodies or "inhibitors" to replacement human factor VIII. Such inhibitors preclude further treatment with human factor VIII. The Company is also developing rpfVIII for the treatment of a rare but life threatening autoimmune condition caused when an individual not born a hemophiliac suddenly develops inhibitors to his own factor VIII, so called "acquired hemophiliacs" or "autoantibody" patients. RpfVIII is now in Phase II clinical trials both in the U.S. and in Canada. A summary of the current Phase II trial can be found at (Clinical Trials). By way of background, Hemophilia A patients lack sufficient factor VIII, often requiring periodic infusions of "replacement" human factor VIII to halt the spontaneous bleeding associated with that condition. Replacement human factor VIII may be derived from the pooled plasma of thousands of donors or, as is the case with newer products, may be of recombinant form manufactured using the techniques of genetic engineering. Approximately twenty-five percent of those treated with replacement human factor VIII eventually develop neutralizing antibodies to that product, since their immune systems recognizes the replacement human factor VIII as foreign protein to be attacked and inactivated. Those hemophiliacs, known as inhibitor or "alloantibody" patients, can no longer be treated with human factor VIII. In the past, these patients have often been treated with a variation of factor VIII known as porcine factor VIII, a product until recently sold commercially under the name Hyate:C and derived from the plasma of pigs. While Hyate:C had often proven to be effective in the treatment of both alloantibody and autoantibody patients, its availability had been severely and chronically limited due to its difficulty of manufacture. The long time marketer of Hyate:C, French drug maker Ipsen, has teamed with Octagen in an effort to develop and commercialize a genetically engineered, recombinant form of porcine factor VIII, known internally as "OBI-1." |
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© 2003-2005. Octagen Corporation. Legal Notice
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