Biogen Inc. and Elan Corp. plc presented solid endpoint results from their Antegren Phase II study in Crohn¿s disease at the annual meeting of the American Gastroenterological Association during the Digestive Disease Week meetings, held in Atlanta.
Elan, of Dublin, Ireland, and Cambridge, Mass.-based Biogen are collaborating on Antegren, a humanized monoclonal antibody designed to prevent migration of inflammatory cells from blood vessels to the site of inflammation. The placebo-controlled Phase II study enrolled 244 moderate-severely active patients with Crohn¿s disease and was conducted at 38 sites in eight countries. Patients were randomized into four treatment groups and followed for 12 weeks. Patient assessment was based on the Crohn¿s Disease Activity Index (CDAI) and changes in quality of life as determined by the Inflammatory Bowel Disease Questionnaire (IBDQ).
The data included a statistically significant difference in clinical response ¿ defined as a decrease of more than 70 points in CDAI ¿ in patients by week two and maintained through week 12. The highest response was 74 percent, seen in the 3 mg/kg dose, compared to 38 percent in the placebo group. Remission ¿ a CDAI score of less than or equal to 150 ¿ was recorded by 46 percent of patients in the 3 mg/kg dose arm vs. 27 percent in the placebo group. Also, a statistically significant difference in the change from baseline IBDQ score in patients receiving two infusions of Antegren, compared to placebo, was seen at weeks six and 12.
Last week, Elan and Biogen met with the FDA to discuss Crohn¿s disease Phase III studies and they expect to begin the trials this year. Antegren also is in Phase II trials for multiple sclerosis and should move to Phase III this year.
In other news from the Digestive Disease Week meeting:
¿ Cell Pathways Inc., of Horsham, Pa., presented research from a study showing cyclic GMP phosphodiesterase 5, an anticancer target, was overexpressed in 77 percent of human pancreatic carcinomas examined. There was little expression of the enzyme in normal pancreatic tissue. The enzyme was originally identified by Cell Pathways. Also, Cell Pathways¿ candidate, CP461, which targets cGMP PDEs overexpressed in cancers, demonstrated in laboratory research its ability to induce apoptosis in two human pancreatic cancer cell lines. The company¿s stock (NASDAQ:CLPA) gained $1.18 Wednesday, or 17 percent, to close at $8.07.
¿ Enzo Biochem Inc., of Farmingdale, N.Y., presented data from a preclinical study showing its immune regulation medicines could be used to manage autoimmune diseases such as Crohn¿s disease and colitis. The study demonstrated that when mice with experimentally induced colitis were given specific cell products by oral administration, an amelioration of the symptoms was seen. Based on the data, Enzo said it expects to begin clinical trials in the near future.