SOURCE: Adeona Pharmaceuticals, Inc.

Adeona Pharmaceuticals, Inc.

November 13, 2009 08:09 ET

Adeona Announces Publication of Results of 160 Patient Phase 2 Clinical Trial of Oral dnaJP1 for Rheumatoid Arthritis

Results Published in Journal, Arthritis & Rheumatism; Oral Peptide Capable of Inducing Immune Tolerance to Key Antigen Expressed by 75% of RA Patients; Adeona Actively Seeking Corporate Partners for This Program

ANN ARBOR, MI--(Marketwire - November 13, 2009) - Adeona Pharmaceuticals, Inc. (AMEX: AEN) announced today the publication in the journal Arthritis & Rheumatism of results of a 160-patient, six-month, double-blind, placebo-controlled Phase 2 clinical trial using the company's oral dnaJP1 for the treatment of rheumatoid arthritis (RA). The results of the study were originally presented at the 2008 American College of Rheumatology Annual Meeting. The study was sponsored by the National Institutes of Health (NIH).

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.

The publication entitled, "Epitope-specific immunotherapy of rheumatoid arthritis: Clinical responsiveness occurs with immune deviation and relies on the expression of a cluster of molecules associated with T cell tolerance in a double-blind, placebo-controlled, pilot phase II trial," can be found in the current issue of Arthritis & Rheumatism, Vol. 60(11), pages 3207-3216, with related editorial at page A21.

The Clinical Trial:

The clinical trial was an 11 center, randomized, double-blind, placebo-controlled trial of daily oral dnaJP1 (25mg capsule) versus placebo in 160 rheumatoid arthritis patients with active disease, disease onset of less than 5 years and that also demonstrated reactivity to the dnaJP1 peptide by in vitro analysis.

Results of the published study showed the following:

1. dnaJP1 appeared to be safe and well-tolerated;

2. There was a significant reduction in the percentage of T cells producing the porinflammatory cytokine tumor necrosis factor alpha (TNF-alpha) (p < 0.0007);

3. The primary efficacy end point (meeting the American College of Rheumatology 20% improvement criteria at least once on day 112, 140, or 168) showed a difference between treatment groups (p=0.09) that became significant in post hoc analysis using generalized estimating equations (p=0.04).

4. Differences in clinical responses were also found between treatment groups on day 140 and at follow up, indicative a durable response following discontinuation of therapy.

5. Post hoc analysis showed that the combination of dnaJP1 and the commercially available RA agent, hydroxychloroquine (HCQ), was superior to the combination of HCQ and placebo, demonstrating potential synergistic of dnaJP1 with HCQ.

Max Lyon, Adeona's President and Chief Executive Officer, commented, "We are pleased that this important study is receiving the scientific attention it deserves and believe that dnaJP1 has significant potential to improve the course of treatment for RA patients. We are currently engaged in a variety of activities required to support further clinical trials of dnaJP1 while simultaneously actively seeking U.S. and international licensing and corporate partnerships for this potentially important new therapy for RA."

Business Development Opportunity

Adeona is actively seeking U.S. and international corporate partners interested in assisting in the further development and commercialization of this novel and potentially important new therapeutic approach for RA. Interested parties should contact Max Lyon, Chief Executive Officer and President at (734) 332-7800 x 36 or by email at mlyon@adeonapharma.com.

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®, Humira®, Cimzia®, and Remicade®, 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 and 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 functions 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. (AMEX: AEN) is a specialty pharmaceutical company dedicated to the awareness, diagnosis, prevention and treatment of zinc deficiency and chronic copper toxicity in the mature population. Adeona believes that these conditions may contribute to the progression of debilitating degenerative diseases, including, Dry Age-Related Macular Degeneration (Dry AMD), Alzheimer's disease (AD) and mild cognitive impairment (MCI) in susceptible persons. Using Adeona's proprietary, modified oral zinc delivery technologies, Adeona is preparing to initiate the first clinical trial of oral zinc therapy for the once-a-day dietary management of AD and MCI. Adeona is also developing a number of late-stage clinical drug candidates for the treatment of rheumatoid arthritis and multiple sclerosis. Adeona recently launched its Copperproof™ Test Panel through its HartLab subsidiary, which is intended to provide accurate and timely information to physicians regarding the copper and zinc metabolic status of their Alzheimer's disease and cognitive impairment patients. For further information, please visit www.adeonapharma.com or www.hartlab.com.

This release includes forward-looking statements on Adeona's current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding designing additional clinical trials for its oral zinc therapies, dnaJP1, Zinthionein, Zinthionein ZC, flupirtine, or Trimesta. Adeona is at an early stage of development and may not ever have any products that generate significant revenue. Adeona's Hartlab subsidiary is generating modest revenues and its future success will likely depend upon its ability to successfully introduce and market new specialty diagnostic assays to generate additional revenues. 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, regulatory limitations relating to the company's ability to promote or commercialize its products for awareness, prevention, diagnosis or treatment of zinc deficiency and chronic copper toxicity, a lack of acceptance of Adeona's product candidates in the marketplace, a failure of the company to become or remain profitable, that we will continue to meet the continued listing requirements of the American Stock Exchange (which, unlike other exchanges, does not require us to maintain any minimum bid price with respect our stock but does require us to maintain a minimum of $4 million in stockholders' equity during the current year, for example), our inability to obtain the capital necessary to fund the company's 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-K for the year ended December 31, 2008, Forms 10-Q for quarters ending in 2009 and any other filings with the SEC. 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.

Contact Information

  • For Further Information Contact:
    Max Lyon
    Chief Executive Officer and President
    (734) 332-7800 x36