ANN ARBOR, Mich., Oct. 28, 2008 (GLOBE NEWSWIRE) -- Adeona Pharmaceuticals, Inc. (AMEX:AEN), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of autoimmune and central nervous system diseases, announced today that its scientific collaborator presented new findings from a 160-patient, double-blind, placebo-controlled phase II clinical trial using oral dnaJP1 for the treatment of rheumatoid arthritis (RA) at the American College of Rheumatology (ACR) annual meeting in San Francisco, CA.
Oral dnaJP1 is an orally active epitope-specific immunotherapeutic molecule derived from a family of heat shock proteins that contribute to autoimmune inflammation in RA patients.
A presentation titled, "Susceptibility to Epitope-Specific Immunotherapy of Rheumatoid Arthritis Relies on the Expression of Co-stimulatory Molecules Associated with T-Cell Anergy and Tolerance" was given by Dr. Salvatore Albani, chairman of the Department of Rheumatology at the University of Arizona and inventor of this program (contributing authors and their respective affiliations are listed below). Findings from the phase II clinical trial demonstrated that clinical responders can be elicited in treated patients as defined by a composite score known as ACR20, which is a standard efficacy measure that requires at least a 20 percent improvement in a number of different measures of rheumatoid arthritis disease activity. ACR scores are an FDA accepted measurement of clinical efficacy. Immunological analyses in samples from patients who were clinical responders at the end of the study showed a statistically significant increase versus non-responders (p less than 0.05) in expression of PD-1, B7-H1, B7-DC, CTLA-4 and FoxP3 before the initiation of the treatment.
Dr. Albani commented, "These data suggest that an expression of a cluster of molecules associated with T-cell tolerance and anergy may be a necessary pre-requisite for clinical responses to treatment with oral dnaJP1. This knowledge may be exploited in our upcoming clinical development plan."
Nicholas Stergis, Adeona's chief executive officer, commented, "We are pleased to present these data to the scientific community. As we prepare for additional clinical trials with oral dnaJP1 for the treatment of RA, these and other data will be helpful in broadening our understanding of the mechanism of action of this molecule. Oral dnaJP1's ability to tolerize harmful T-cells to this epitope could represent a significant step forward for treating the 20 million RA patients affected worldwide."
"We intend to request a meeting with the FDA to discuss our upcoming clinical development strategy for oral dnaJP1 for the treatment of RA," Mr. Stergis continued.
Contributing authors and their respective affiliations to this research are: Theo van den Broek(1), Elissa Keogh(2), Femke van Wijk(2), Negar Ghahramani(2), Annick A.J.M van de Ven(3), Salvatore Albani(1). (1) Arizona Arthritis Center, University of Arizona, Tucson, AZ; (2) Department of Medicine, University of California San Diego, La Jolla, CA; (3) Department of Pediatric Immunology, University Medical Center Utrecht, Wilhelmina Children's Hospital Utrecht, Utrecht, Netherlands.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic inflammatory disease that leads to pain, stiffness, swelling and limitation in the motion and function of multiple joints. If left untreated, RA may produce serious destruction of joints that frequently leads to permanent disability. Although the joints are the principal body part affected by RA, inflammation may develop in other organs as well. The disease currently affects over two million Americans, almost one percent of the population, and is two to three times more prevalent in women. Onset can occur at any point in life but is most frequently manifested in the fourth and fifth decades of life, with most patients developing the disease between the ages of 35 and 50. Over 20 million people suffer from rheumatoid arthritis worldwide, and the global market is estimated at over $6.3 billion. DMARDs, including biologics such as Enbrel(r), Humira(r), Cimzia(r), and Remicade(r), accounted for nearly $5.0 billion of that figure. The global market for RA therapies has been estimated at $13 Billion.
About Oral dnaJP1
Oral dnaJP1 is an epitope-specific immunotherapy for 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 down-regulated to prevent tissue damage. The mechanisms for this regulation involve T-cells with regulatory function that are specific for hsp-derived antigens. This regulatory function is one of the key components of a "molecular dimmer" whose physiologic function is to modulate inflammation independently from its trigger. This function is impaired in autoimmunity and could be restored for therapeutic purposes.
The mechanistic hypothesis is that mucosal tolerization to oral dnaJP1 could determine immune tolerization primarily of T-cells and secondarily of APC. The effects of immune tolerance are initially peptide-specific but affect secondarily non-epitope specific pathways. Immune tolerance could translate into clinical benefit.
About Adeona Pharmaceuticals, Inc.
Adeona Pharmaceuticals, Inc. is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of autoimmune and central nervous system diseases. Adeona's strategy is to exclusively in-license proprietary, clinical-stage drug candidates and to complete the further clinical testing, manufacturing, regulatory requirements and seek marketing authorizations. Adeona is focused on treating rheumatoid arthritis (RA), dry age-related macular degeneration (AMD), multiple sclerosis (MS), and fibromyalgia. For further information, please visit www.adeonapharma.com.
This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Adeona's commercialization plans for its product candidates. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," "should," and "could," and similar expressions or words identify forward-looking statements, including statements regarding success in inducing a T-cell immunomodulatory shift and a meeting with the FDA to discuss the upcoming clinical development strategy for dnaJP1 for the treatment of RA. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Adeona is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Adeona's forward-looking statements include, among others, a failure of Adeona's product candidates to be demonstrably safe and effective, a failure to obtain regulatory approval for the company's products or to comply with ongoing regulatory requirements, a lack of acceptance of Adeona's product candidates in the marketplace, a failure of the company to become or remain profitable, Adeona's inability to obtain the capital necessary to fund its research and development activities, a loss of any of the company's key scientists or management personnel, and other factors described in Adeona's report on Form 10-Q for the quarter ended June 30, 2008. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Adeona undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.