SOURCE: Adeona Pharmaceuticals, Inc.

Adeona Pharmaceuticals, Inc.

November 02, 2009 07:47 ET

Adeona Receives IRB Approval to Initiate Clinical Trial of Once-Daily Oral Zinthionein ZC in Alzheimer's Disease

Study Represents First Controlled Trial of Oral Zinc Therapy for Alzheimer's Disease; Study to Be Conducted at Prominent Alzheimer's Center in Clearwater, Florida; Conference Call Scheduled for 12:00 p.m. EST Today

ANN ARBOR, MI--(Marketwire - November 2, 2009) - Adeona Pharmaceuticals, Inc. (AMEX: AEN), a specialty pharmaceutical company dedicated to the awareness, diagnosis, prevention and treatment of zinc deficiency and chronic copper toxicity in the mature population, today announced that it has received Institutional Review Board (IRB) approval to initiate a 60 patient, randomized, double-blind, placebo-controlled clinical trial of its patent pending Zinthionein™ ZC-GS150 in an Alzheimer's disease (AD) and mild cognitive impairment (MCI) patient group.

The clinical trial, titled "CopperProof 2," will test, for the first time, the effects of a novel gastro-retentive, sustained release zinc/cysteine combination tablet on the amelioration of sub-clinical zinc deficiency, and elevated percentage serum free copper, associated with Alzheimer's Disease.

A teleconference call has been scheduled for 12:00 p.m. EST today to present further details of the clinical trial and its potential significance for AD and MCI. Participants may listen to the teleconference by dialing toll free (888) 417-8525 (for callers outside the U.S. (719) 325-2370) and utilize passcode 1924645 just prior to 12:00 p.m. EST. A replay of the teleconference will be available on Adeona's website for at least 15 days following the call.

"Adeona is pleased to be working with the recognized Alzheimer's expert, Dr. Diana Pollock, Associate Director, Neuroscience Research Unit, Morton Plant Mease Hospital, in Clearwater, FL," commented David Newsome, M.D., President of Adeona's HealthMine subsidiary and discoverer and pioneer of oral zinc therapy for age-related macular degeneration (AMD), another chronic neuro-degenerative disease affecting approximately 17 million mature adults in the U.S. "The CopperProof 2 study is very reminiscent of the first study of oral zinc therapy that I conducted for AMD which showed the value of zinc therapy. The findings of my study were later confirmed by the NIH in their landmark AREDS study and zinc therapy is now the standard of care for the 15 million U.S. patients with dry AMD. Our findings earlier this year, in the CopperProof 1 study, of notable subclinical zinc deficiency in AD patients also matches my findings of a similar condition in AMD patients, in which oral zinc therapy proved highly beneficial clinically. The success of oral zinc therapy in AMD, and the notable zinc and copper imbalances observed in our CopperProof 1 study, as well as in the CSF of AD subjects, gives me considerable confidence that dietary management of AD and MCI with Zinthionein ZC-GS150 may prove to have a disease modifying impact in this patient population." Oral zinc preparations for AMD currently represent a $350 million market annually and are required to be taken twice per day. Currently marketed high dose oral zinc therapies also suffer from poor tolerability with reported rates of nausea and gastric irritation of up to 90%. Zinthionein ZC-GS150 is only required to be taken once daily and the company believes it will significantly lessen the rates of nausea and gastric irritation that are common with other high dose oral zinc therapies.

The new study will screen and enroll 60 AD and MCI patients with clinically confirmed serum zinc/copper imbalances with the goal of demonstrating the increased tolerability of Zinthionein over current high dose zinc therapy as well as the ability of dietary management with Zinthionein ZC-GS150 to correct the copper and zinc imbalances identified in the study by the use of the CopperProof Test Panel. Near term comparative data will be generated and made available in the first part of the study and randomized blinded clinical parameters will also be evaluated in the second part of the study following six months of treatment with Zinthionein ZC-GS150 versus placebo. Zinthionein ZC-GS150 is a patent pending once-a-day gastro-retentive sustained release formulation containing 150mg of elemental zinc and other ingredients that are considered "generally regarded as safe" (GRAS). Adeona believes that Zinthionein ZC-GS150 demonstrates significantly improved bioavailability and tolerability for the patient which would permit the convenience of once-a-day dosing. Zinthionein ZC-GS150 is intended to be marketed as a medical food for the dietary management of AD and MCI and available by a physician prescription, with use under medical supervision.

On July 15, 2009, Adeona presented the results of the CopperProof 1 Study, a prospective observational study comparing serum parameters of copper and zinc status in patients with Alzheimer's disease, Parkinson's disease and normal subjects, at the 2009 International Conference on Alzheimer's Disease (ICAD) in Vienna, Austria. This study showed a strong correlation between Alzheimer's disease and impaired serum copper binding (p = 0.00008) as well as an elevated percentage of free (non-ceruloplasmin bound) serum copper levels in AD patients (p = 0.045). The study also reported, for the first time, clinical and subclinical zinc deficiency in AD patients (p = 0.015).

On July 9, 2009 Adeona completed the acquisition of HartLab LLC a CLIA-certified clinical reference laboratory located in Bolingbrook, Illinois. Through its HartLab subsidiary, Adeona is preparing to launch the CopperProof Test Panel, a diagnostic panel intended to provide a comprehensive evaluation of the metabolic serum copper and zinc status of patients with Alzheimer's disease (AD) and mild cognitive impairment (MCI). Adeona believes that defects in copper metabolism and elevated levels of serum free copper (non-ceruloplasmin bound) predisposes certain persons to enhanced susceptibility to the neurotoxic effects of copper, which include the aggregation, and reduced clearance, of oxidative copper in the beta amyloid plaques and tangles, the hallmark brain pathology of Alzheimer's disease.(1-5)

Max Lyon, Adeona's CEO, stated, "We are excited to begin the first study to evaluate the use of high dose oral zinc therapy in the AD and MCI populations. These two diseases have been resistant to other therapeutic approaches, leaving many patients, and their caregivers, with little hope of stopping the continued progression of the patient's cognitive decline. We hope to be able identify those patients with copper and zinc imbalances and to provide therapeutic alternatives, such as high dose zinc therapy, which can correct these imbalances and may have a positive effect in slowing the progression of disease."

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. For further information, please visit

For further background on the role of zinc and copper imbalance in Alzheimer's disease and mild cognitive impairment interested persons are directed to and the following references:

1. Sparks D. and Schreurs, B., Trace amounts of copper in water induce
   beta-amyloid plaques and learning deficits in a rabbit model of
   Alzheimer's disease. Proc. Natl. Acad. Sci. (2003) 100: 11065-11069.
2. Sparks DL, Friedland R, Petanceska S, Schreurs BG, Shi J, Perry G, Smith
   MA, Sharma A, Derosa S, Ziolkowski C, Stankovic G., Trace copper levels
   in the drinking water, but not zinc or aluminum influence CNS Alzheimer-
   like pathology, J Nutr Health Aging. (2006 Jul-Aug);10(4):247-54.
3. Deane R, Sagare A, Coma M, Parisi M, Gelein R, Singh I, Zlokovic B, A
   novel role for copper: Disruption of LRP-dependent brain Aß clearance,
   Neuroscience 2007, Society for Neuroscience (Nov. 2007), Pres. 857.2
4. Kitazawa M, Cheng D, Laferla FM., Chronic copper exposure exacerbates
   both amyloid and tau pathology and selectively dysregulates cdk5 in a
   mouse model of AD., J Neurochem. (Mar. 2009);108(6):1550-60.
   Epub 2009 Jan 22.
5. Morris MC, Evans DA, Tangney CC, et al., Dietary copper and high
   saturated and trans fat intakes associated with cognitive decline., Arch
   Neurol. (2006) 63: 1085-1088.
7. Committee on Copper in Drinking Water, Copper in Drinking Water,
   National Research Council, National Academy Press (2000).
8. Squitti R, Bressi F, Paswualetti P, Bonomini C, Ghidoni, R, Binetti G,
   Casetta E, Moffa F, Ventriglia M, Vernieri F, Rossini P., Longitudinal
   prognostic value of serum "free" copper in patients with Alzheimer's
   disease,  Neurology, (Jan. 2009) 72: 50-55.

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, 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. Zinthionein™ ZC-GS150 is a patent pending modified release formulation containing 150mg of elemental zinc and other ingredients that does not contain zinc-monocysteine. Zinthionein is a trademark of Adeona Pharmaceuticals, Inc.

Contact Information

  • For Further Information Contact:

    Max Lyon
    Chief Executive Officer and President
    (734) 332-7800 x36