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Last updated on April 19, 2014 at 13:20 EDT

Adeona’s Planned Clinical Trial of Proprietary Zinc-Based Therapy in Lou Gehrig’s Disease is Hot Topic at 2011 California ALS Research Summit

September 30, 2011

ANN ARBOR, Mich., Sept. 30, 2011 /PRNewswire/ — Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today that its planned clinical trial of the Company’s proprietary zinc-based therapy for patients suffering from amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease, will be featured during the Hot Topics session at the 2011 California ALS Research Summit (ALS Summit) on Saturday, October 1, 2011. Todd D. Levine, M.D., President of PNA Center for Neurological Research (PNA), Assistant Clinical Professor at the University of Arizona, Co-Director of the Banner Samaritan ALS Center in Phoenix, Arizona and Lead Principal Investigator of the planned clinical trial will present the potential benefits of zinc therapy for ALS patients. Dr. Levine will also discuss preliminary data from PNA’s ongoing Phase I/II open label safety study of zinc therapy in ALS patients at the ALS Summit.

“I am very excited to present our theories on the potential role of zinc in the treatment of ALS. We believe that by giving high doses of zinc to ALS patients, we can decrease the amount of toxicity from unbound glutamate and prevent neurotoxicity,” said Dr. Levine. “Our goal is to improve the quality of life of patients with ALS by slowing the progression of this devastating disease.”

About Amyotrophic Lateral Sclerosis (ALS)

ALS is a devastating progressive neurodegenerative disease that affects the nerve cells in the brain and the spinal cord in people of all ages and both sexes. It is estimated that as many as 30,000 Americans may have the disease at any given time. The progressive degeneration of the motor neurons in ALS eventually leads to the death of the patient. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. When motor neurons die, the ability of the brain to initiate and control muscle movement is lost. With voluntary muscle action progressively affected, patients in the later stages of the disease may become totally paralyzed. While non-invasive ventilation and gastrostomy tubes prolong life by 6-12 months, the average lifespan from time of symptom onset is 2-5 years. Currently, RILUTEK® is the only FDA-approved drug for ALS. RILUTEK is an NMDA receptor antagonist and has been shown to prolong life in patients with ALS by 3 months. Presently, there is no cure for ALS, nor is there a known cause. For more information on ALS, please visit the ALS Association website at www.alsa.org.

About the Ongoing Phase I/II Open Label Safety Study of Zinc Therapy in ALS Patients

Currently the clinical investigators at the PNA Center for Neurological Research are conducting a Phase I/II open label study of zinc therapy in ALS patients to determine the safety of zinc in conjunction with low doses of copper. To date, no safety issues related to zinc therapy have been observed in the ALS patients. For more information on this clinical study, please visit http://www.clinicaltrials.gov/ct2/show/NCT00919555.

About PNA Center for Neurological Research

PNA Center for Neurological Research (PNA) is an independent, not-for-profit organization based in Phoenix, Arizona. PNA was established by five of the neurologists from Phoenix Neurological Associates, Ltd., who are dedicated to discovering new treatments for patients with neurological diseases. The goal of PNA is to be a hub where philanthropists, advocates, organizations, family and friends of patients with a neurological illness could make donations that can support investigator-initiated clinical trials. PNA hopes to optimize proper treatments in order to improve outcomes for patients with neurological diseases. For more information on PNA, please visit its website at www.pnaresearch.org.

About the California ALS Research Summit

The California ALS Research Summit is an annual gathering of researchers, investigators, clinicians, biotech companies, government representatives and patient advocates in ALS and related fields in the State of California. The purpose of the Summit to help increase, expedite and promote the amount and level of amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease) and related research done in California; and to foster networking, collaboration and cooperation among investigators, their peers and their colleagues to identify, develop and deliver new and effective treatments, ideas and, ultimately, a cure. For more information about the California ALS Research Summit, please visit its website at www.californiaalsresearchsummit.org.

About Adeona Pharmaceuticals, Inc.

Adeona is a pharmaceutical company focused on developing innovative medicines for the treatment of serious central nervous system diseases. The Company’s strategy is to license product candidates that have demonstrated a certain level of clinical efficacy and develop them to a stage that results in a significant commercial collaboration. Adeona is developing, or has partnered the development of, drug product candidates to treat multiple sclerosis, fibromyalgia, amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease. The Company is currently preparing to make the following products commercially available: reaZin(TM), a prescription medical food for the dietary management of zinc deficiency associated with Alzheimer’s disease, and wellZin(TM), a homeopathic over-the-counter medicine for reducing the duration and symptoms of the common cold. Adeona also operates Adeona Clinical Laboratory, a wholly owned clinical reference laboratory that provides a broad array of chemistry and microbiology diagnostic tests. For more information, please visit Adeona’s website at www.adeonapharma.com.

RILUTEK® (riluzole) is a registered trademark of sanofi-aventis U.S. LLC.

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,” “could,” “potential,” “positions,” “continue,” “expects,” “anticipates,” “intends,” “planned,” “believe,” “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 the potential role of zinc in the treatment of ALS and the belief that high doses of zinc can reduce toxicity. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Adeona’s forward-looking statements include, among others, our failure to obtain regulatory approval or market approval of drug candidates in the treatment of ALS, failure to obtain approval to conduct the planned trial, failure of the planned clinical trial to have favorable results such as a failure to show benefits of zinc therapy in ALS patients, a failure of the treatment group to have a decrease in toxicity from unbound glutamate, and other factors described in Adeona’s report on Form 10-K for the year ended December 31, 2010 and any other filings with the SEC. 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.

SOURCE Adeona Pharmaceuticals, Inc.


Source: PR Newswire