The first fully human TNF antibody was now in phase III studies, said Dr Steven Fischkoff (senior director, medical oncology and immunology, Knoll) at a press briefing during the conference.
Dr Fischkoff said that studies to date had shown that D2E7 gave a sustained clinical response in 60 to 80 per cent of patients. It was also likely to arrest radiographic progression. Phase II trials of 283 patients had found that D2E7 20-80mg, given by self-injection once weekly for three months, was significantly superior to placebo. The drug could be given by intravenous or subcutaneous injection.
Knoll says that fully human antibodies are less likely to be recognised by the body as foreign substances than antibodies derived from non-human proteins. The company's new antibody, D2E7, is unique in that it was "the only fully human TNFa antibody, in contrast to the other TNF antagonists which recently entered the market".
Apart from a reduced potential for allergic reactions, the company claims other advantages of D2E7 over current anti-TNF therapies. It may have superior long-term "durability" because it has a lower potential for antibody formation which could affect its long-term efficacy. D2E7 also has a long half-life so would require less frequent administration than etanercept, Knoll says. Unlike infliximab, which is used in combination with methotrexate, it is expected that D2E7 could be used either with or without methotrexate.
Knoll says that D2E7 is expected to be available in 2002/2003.
Other highlights include: |