By Lisa Seachrist
WASHINGTON — Anergen Inc. reported that final Phase II results of its rheumatoid arthritis vaccine, AnervaX , strengthened and confirmed positive findings of interim data. The Redwood, Calif.-based company is searching for a corporate partner to aid in the expansion of the drug's clinical development .
"The final data analysis confirms that AnervaX is safe and results in important clinical improvement in patients with rheumatoid arthritis in this study," Barry Sherman, president and CEO of Anergen, said in a statement. "AnervaX has the potential to safely arrest the disease at a very early step in the autoimmune process. We plan to initiate an additional Phase II study as soon as possible."
AnervaX is a synthetic 20-amino acid peptide designed to block the stimulation of T cells specifically involved in causing rheumatoid arthritis and halt the progression of the disease. Rheumatoid arthritis (RA) is one of the world's most prevalent and destructive chronic autoimmune diseases, affecting approximately 2.5 million Americans.
The completed Phase II trial was intended to evaluate safety and define the effect AnervaX had on biological processes. The study included 53 patients with active RA whose joints were painful, tender and swollen despite the use of methotrexate with or without steroids.
The company tested two different doses and two different dosing intervals against placebo for up to six months. Patients who produced antibodies against AnervaX received only one more booster, to avoid any unwanted immune responses.
The company pooled the data for the dosing regimens and evaluated signs of clinical improvement. Patients dosed at six-week intervals clearly experienced a greater reduction in their symptoms than those in the placebo or eight-week interval group. Six weeks following the last injections 44 percent had an improvement of their disease severity score of at least 20 percent, ranging from 21 percent to 42 percent with a mean of 34 percent.
The six-week group experienced 46 percent improvement in the number of painful joints and a 50 percent improvement in the number of swollen joints. Twelve weeks out, 35 percent of the patients had a 20 percent improvement in their disease severity score.
"This study wasn't powered to show clear clinical benefit," said Michael Schulman, vice president of medical affairs at Anergen. "We are very encouraged by these results. The next trial will be powered to detect a difference between treated patients and placebo."
AnervaX showed no evidence of causing generalized immune suppression, which is often caused by drugs used to treat RA.
The company's stock (NASDAQ:ANRG) closed Thursday at $1.50 up $0.41. *