| Bala Cynwyd, PA., USA and Paris, France, September 4, 2003 — Octagen Corporation, a Philadelphia area biotechnology company, and Ipsen (formerly Beaufour Ipsen), a European pharmaceutical company announced today the start of a phase I human (clinical) trial of their recombinant porcine coagulation factor VIII for hemophilia A inhibitor patients. The drug, known internally as OBI-1, is being developed jointly by Octagen and Ipsen. |    |
The phase I trial, to be conducted in up to 20 clinical centers throughout the United States of America and the United Kingdom, is designed to compare the safety and pharmacokinetics of single infusions of genetically engineered OBI-1 and the commercially available porcine factor VIII known as Hyate:C, a product derived from pig plasma and sold by Ipsen.
"A disorder that affects an estimated 350,000 people worldwide, hemophilia A is caused by a lack of a clotting factor protein known as factor VIII, a deficiency that results in periodic episodes of spontaneous bleeding" observed Richard Driansky, Octagen’s Chief Executive Officer. "These bleeding episodes are treated generally with replacement human factor VIII, which can either be genetically engineered or obtained from the pooled plasma of multiple donors. Approximately 25% of hemophiliacs develop antibodies or inhibitors to human factor VIII, which their immune systems see as foreign protein matter. As a result they can no longer be treated with human factor VIII" noted Mr. Driansky.
"Many inhibitor patients can be successfully treated with porcine factor VIII," said Dr. Alistair Stokes, Ipsen’s Executive Vice-President, Corporate Development. "The problem," added Dr. Stokes, "is that supplies of Hyate:C, the current commercial porcine factor VIII, have been constrained due to the necessity and difficulty of screening out extraneous material from the porcine plasma from which the product is derived. Since OBI-1 is a genetically engineered molecule, its production would not be hindered by that consideration" observed Dr. Stokes. "If proven safe and effective in clinical trials, OBI-1 would hold considerable promise both for hemophilia A inhibitor patients, as well as for so-called 'acquired' or 'autoantibody' patients. The latter group consists of individuals who do not have congenital hemophilia but who develop a severe and often life-threatening immune response to their own normal factor VIII" noted Dr. Stokes.
Notes to editor
Octagen
Founded in November 1997, Octagen’s mission is to develop and commercialize drugs to treat hemophilia and other disorders of the clotting process. OBI-1 was discovered by Dr. John S. Lollar, a renowned hemophilia researcher and Professor of Medicine at Emory University (Atlanta, USA). In 1998 Octagen entered into an exclusive worldwide license with Emory University to develop that drug. Later that year Octagen and Ipsen entered into an exclusive sublicense agreement, pursuant to which the two companies have been engaged in the development of OBI-1. Octagen, Ipsen, and Dr. Lollar have also been collaborating on an earlier stage project involving a recombinant and largely humanized version of factor VIII, OBI-2. That molecule is designed to reduce the incidence of inhibitor formation.
Octagen's website is www.octagen.com
Ipsen
Present in over 110 countries with a total staff of nearly 3700, the Ipsen Group had a turnover of €718 million in 2002, 27.1% outside Western Europe.
The Group is focused on developing innovative products in targeted disease areas: oncology, endocrinology, neurology and hematology. Ipsen currently has over 20 products on the market, including those marketed to specialists in disease areas that represent the main source of Ipsen’s future growth, as well as predominantly natural-based products that represent the historical base of the Group’s business in other disease areas. In 2002, 18.2% of Ipsen’s turnover was reinvested in Research and Development, carried out from 4 centers Paris, Boston, Barcelona and London by an international network of about 550 scientists.
The Group’s website is www.ipsen.com
Source: Ipsen
