Adeona Pharmaceuticals Inc announced today that it has initiated the US launch of its high precision diagnostic test panel for the comprehensive evaluation of zinc and copper status in patients with Alzheimer’s disease (AD) and mild cognitive impairment (MCI).
The CopperProof Test Panel™ will be offered through the company’s HartLab LLC clinical laboratory subsidiary and will provide a comprehensive look at the metabolic serum copper and zinc status of AD and MCI patients, which status has been shown to be impaired in this patient population. Defects in copper metabolism and high free copper levels are increasingly being recognized as significant factors in the progression of neurodegenerative diseases, including AD and MCI. A clinical zinc deficiency in AD patients has also been recognized for the first time in a recent Adeona-sponsored clinical study.
Adeona has hired a specialty sales force to bring the CopperProof Test Panel to neurologists, psychiatrists, gerontologists, nursing homes and other physicians that regularly treat patients with AD and MCI in selected key U.S. markets. The company will continue to build its specialty sales force with individuals having extensive experience calling on these physician practices and will expand its sales efforts to eventually cover the entire U.S. market. It is estimated that 25 million Americans suffer from Alzheimer’s disease or cognitive impairment. The Alzheimer’s Association estimates that $148 billion is spent each year caring for AD patients. Therapeutic products for AD and MCI represent an existing multi-billion dollar U.S. market. Current treatment solutions generally provide only symptomatic relief and are inadequate to halt the progression and devastating effects of AD and MCI, creating a significant market opportunity for new, potentially disease modifying solutions.
On July 9, 2009 Adeona completed the acquisition of HartLab LLC, a CLIA-certified clinical reference laboratory located in Bolingbrook, Illinois. 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 as well as elevated percent free (non-ceruloplasmin bound) serum copper levels in AD patients. The study also reported, for the first time, clinical and subclinical zinc deficiency in AD patients.
The CopperProof Test Panel, developed at HartLab, will potentially identify patients with defective serum ceruloplasmin, elevated percentages of serum free copper level as well as zinc deficiency. Adeona believes that defects in copper metabolism and elevated percentages 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 neurofibrillary tangles, the hallmark brain pathologies of Alzheimer’s disease (1-5). To learn more about the CopperProof Test Panel and HartLab, please visit www.hartlab.com.
On November 2, 2009, Adeona announced that it had received Institutional Review Board (IRB) approval to initiate a 60 patient, randomized, double-blind, placebo-controlled clinical trial of its patent pending Zinthionein™ ZC in an AD and 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. Adeona believes that Zinthionein™ ZC will prove to be beneficial to lowering high free copper levels and eliminating sub-clinical zinc deficiency in the AD and MCI populations. The company further believes correcting these free copper and zinc imbalances through dietary management may slow the progression of AD and MCI.
Max Lyon, Adeona’s CEO, stated, "We are excited to introduce our first product offering for the very under-served Alzheimer’s disease and cognitive impaired patient population. AD and MCI 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 plan to 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. We consider chronic copper toxicity and sub-clinical zinc deficiency to be a significantly under-recognized and modifiable risk factor for the progression of AD and MCI. Using our patent pending, modified oral zinc delivery technologies, we recently announced initiation of the first clinical trial of oral zinc therapy, Zinthionein™ ZC, for the once-a-day dietary management of AD and MCI."
Source: Adeona Pharmaceuticals
