Promising Ph I results with Dendreon's Neuvenge

Seattle, USA-based Dendreon Corp says an integrated analysis of two Phase I studies showed that treatment with Neuvenge (lapuleucil-T) was generally well tolerated and that the majority of side effects were mild, including infusion-related fatigue, fever and chills.

According to the firm, the median T cell proliferative stimulation index in response to the immunizing antigen increased from 1.3 at baseline to 19.7 at week four (p=0.0002), 19.4 at week eight (p < 0.0001) and 20.7 at week 16 (p=0.02). Immune monitoring performed in three of four patients who underwent repeat treatment suggested an increase in immune response following the booster treatments. Five patients had prolonged disease stabilization ranging from 48 to 94 weeks, without the addition of cancer therapy other than the continuation of bisphosphonates. In addition, one patient experienced a partial response lasting approximately six months.

"We are encouraged by the significant immune responses generated to Neuvenge in these trials, which included patients with advanced breast, ovarian and colon cancer," said John Park, associate clinical professor of medicine and neurosurgery at the University of California, San Francisco. "The therapy was well tolerated and demonstrated evidence of clinical activity, with several patients experiencing prolonged periods of disease stabilization following treatment. These findings warrant further study of this promising immunotherapy," he added.