Pipex Pharmaceuticals, Inc, a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of central nervous system and autoimmune diseases, has acquired an oral, once-daily candidate for the treatment of rheumatoid arthritis (RA), which has completed a 160 patient, multi-center, double-blind, randomized, placebo-controlled phase-II clinical trial for the treatment of rheumatoid arthritis (RA). Rheumatoid arthritis is an autoimmune disease which affects approximately 20 million people worldwide.

Oral dnaJP1 has been developed using computer-aided, rational drug design techniques, which resulted in a short synthetic peptide derived from a heat shock protein dnaJ. Heat shock proteins and dnaj are upregulated during cellular stress, including inflammation and autoimmune diseases. Heat shock protein responses have been found in several other autoimmune diseases other than RA, including Juvenile idiopathic arthritis (JIA), multiple sclerosis (MS) and inflammatory bowel disease (IBD). The mechanism of action of dnaJP1 relies on selectively inducing an immune shift of a T-cell function from inflammatory to regulatory, thus inhibiting disease-related inflammation and inducing a tolerogenic immunologic response. Oral dnaJP1 is a new chemical entity (NCE), which is covered by issued US and international patent filings including composition of matter and methods of use patents. This phase-II clinical program was supported by a $5 million grant from the National Institutes of Health (NIH).

Dr Salvatore Albani, chairman of the Arizona Arthritis Center at the University of Arizona and inventor of this program, commented, "Due to its oral activity and plausible long term durable response rate seen in RA patients in the initial multi-center, placebo controlled phase-II clinical trial, oral dnaJP1 may have an important clinical advantage over current injectable RA treatments which have significant toxicities. Our preliminary studies also strongly suggest that the mechanism of action of dnaJP1 is complementary to current biologics, thus providing the opportunity to develop combination therapies which may improve currently used regimens. The long term statistically significant improvement in clinical scores as seen by ACR20 and ACR50 following cessation of drug therapy further suggests that this technology may be inducing a tolerogenic response."

Nicholas Stergis, Pipex's chief executive officer, stated, "We are pleased to have broadened our therapeutic pipeline of products with the acquisition of this innovative program. Oral dnaJP1 certainly complements our existing clinical stage immunology programmes which include TRIMESTA, our oral phase II/III clinical programme in multiple sclerosis and our CD4 inhibitor technology. We have been equally impressed with the rigor and quality of the scientific data, along with the level of grant funding this programme has received over the years from the NIH. We look forward to reporting additional clinical data from this study later this year."

Oral dnaJP1 is a once-daily epitope specific immunotherapy for rheumatoid arthritis (RA) patients. Oral dnaJP1 is a heat shock protein (hsp)-derived peptide which was previously identified as a contributor of T cell mediated inflammation in RA Immune responses to hsp are often found at sites of inflammation and have an initially amplifying effect that needs to be downregulated to prevent tissue damage.

Rheumatoid arthritis is a chronic inflammatory disease that leads to pain, stiffness, swelling and limitation in the motion and function of multiple joints. If left untreated, rheumatoid arthritis can produce serious destruction of joints that frequently leads to permanent disability.

Pipex Pharmaceuticals, Inc (Pipex) is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of central nervous system and autoimmune diseases. Pipex's strategy is to exclusively in-license clinical-stage drug candidates for the treatment of unmet medical diseases.