By Jim Shrine
Regeneron Pharmaceuticals Inc., in a 10-K filing this week, detailed its plans for a Phase II study of Axokine in severely obese patients. The study is expected to start this month.
The double-blind, placebo-controlled trial will be conducted in about 175 obese patients at six centers, with patients treated for up to 90 days at doses up to 2 mcg/kg/day. There is no restriction as to a subject¿s prior history of herpes cold sores.
A story in the March 8, 2000, issue of BioWorld Today mistakenly said the study would be only in subjects who are herpes simplex virus-negative. The story also was mistaken in reporting that the Phase I results showed effective doses appeared safe only in patients who were HSV-negative. The fact is, according to the SEC filing, that four doses were tested in the Phase I trial, and doses up to 2 mcg/kg/day ¿ in HSV-positive and HSV-negative patients ¿ resulted in no reports of herpes cold sore outbreaks.
The Phase II study is designed to confirm the weight loss seen in the Phase I trial and determine the lowest effective well-tolerated dose.
Regeneron, of Tarrytown, N.Y., filed this week to sell 4 million shares in a public offering. The proceeds will go toward funding development of the company¿s recently broadened pipeline, which has expanded from a focus in degenerative neurologic diseases to include candidates for obesity, rheumatoid arthritis, cancer, allergies, asthma, ischemia and other diseases and disorders. The broadened pipeline is a result of the application of its technology platforms called Targeted Genomics, Functionomics and Designer Protein Therapeutics.
Axokine, a second-generation ciliary neurotrophic factor, is being developed for obesity and its complications. Another focus is Cytokine Traps, which are antagonists for cytokines such as interleukin-1 and IL-4, which are thought to play a major role in inflammatory diseases. That program is expected to enter clinical trials by 2001.
Another program is in antagonists to vascular endothelial growth factor, which will be developed for cancer indications. VEGF Trap is expected to enter the clinic in 2001. A fourth program at Regeneron is in angiopoietins, a new family of growth factors it discovered that are specific for blood vessels and early hemotopoietic stem cells. Angiopoietins are in preclinical testing for promoting and blocking blood vessel growth, fixing leaky blood vessels and promoting the growth and mobilization of certain cells, such as stem cells and platelets.
The company¿s other two products are brain-derived neurotrophic factor for amyotrophic lateral sclerosis and neurotrophin-3, which is being developed for treating constipating disorders.
Regeneron is in an SEC-imposed quiet period and could not comment.