<SEC-DOCUMENT>0001144204-11-022253.txt : 20110415
<SEC-HEADER>0001144204-11-022253.hdr.sgml : 20110415
<ACCEPTANCE-DATETIME>20110415103058
ACCESSION NUMBER:		0001144204-11-022253
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20110414
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20110415
DATE AS OF CHANGE:		20110415

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ADEONA PHARMACEUTICALS, INC.
		CENTRAL INDEX KEY:			0000894158
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				133808303
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-12584
		FILM NUMBER:		11761320

	BUSINESS ADDRESS:	
		STREET 1:		3930 VARSITY DRIVE
		CITY:			ANN ARBOR
		STATE:			MI
		ZIP:			48108
		BUSINESS PHONE:		734-332-7800

	MAIL ADDRESS:	
		STREET 1:		3930 VARSITY DRIVE
		CITY:			ANN ARBOR
		STATE:			MI
		ZIP:			48108

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	PIPEX PHARMACEUTICALS, INC.
		DATE OF NAME CHANGE:	20061214

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SHEFFIELD PHARMACEUTICALS INC
		DATE OF NAME CHANGE:	19970730

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SHEFFIELD MEDICAL TECHNOLOGIES INC
		DATE OF NAME CHANGE:	19940606
</SEC-HEADER>
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<TYPE>8-K
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Adeona&#8217;s Clinical Study of <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">TM</font> Meets Primary Outcomes of</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-STYLE: italic; FONT-FAMILY: Times New Roman">-- Conference Call Scheduled for Friday, April 15, 2011 at 2:00 p.m. (EDT) --</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Ann Arbor, MI, April 14, 2011 &#8211;</font> Adeona Pharmaceuticals, Inc. (AMEX:AEN - News), a developer of innovative medicines for serious central nervous system diseases, announced today top-line results from its clinical study evaluating <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> for the dietary management of Alzheimer&#8217;s disease (AD) and mild cognitive impairment (MCI). The clinical study met the primary outcome of increasing serum zinc and decreasing serum free copper. In addition, secondary outcomes of mental status as measured by three standardized cognitive tests all favored the treatment group versus the placebo group.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">The clinical study data was presented today at the Annual Meeting of the American Academy of Neurology (AAN) in Honolulu, Hawaii at 2:00 p.m. (HAST)/8:00 p.m. (EDT) by Diana Pollock, M.D., Lead Principal Investigator of the study at Morton Plant Neuroscience Institute on the campus of Morton Plant Hospital. The poster titled "Clinical Trial Results of the First Controlled Clinical Trial of Zinc-Based Therapy for Alzheimer&#8217;s Disease and Mild Cognitive Impairment" included findings from 42 of 57 subjects evaluable at the end of the study.&#160;&#160;The results are as follows:</font></div>

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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Comparisons of the average changes in cognitive scores at baseline and 6 months are presented below. Although the individual p-values of the cognitive scores did not achieve statistical significance (p &lt; 0.05), all three of these cognitive measures favored the treatment group versus the placebo group.</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Mini Mental State Examination (MMSE), an average net improvement of 0.19 points in favor of the treatment group versus placebo (p &lt; 0.42)</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Results reported from Part 2 of this clinical study demonstrated that <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> was safe and well tolerated by subjects in the treatment group and dropouts were equivalent across the treatment and placebo groups. These results confirm the previously reported results from Part 1 of the clinical study (April 14, 2010) that demonstrated <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> was well tolerated and superior to Galzin&#174;, an FDA-approved zinc preparation.</font></div>
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">A copy of the poster presented at the AAN meeting is available using the following URL: <font style="DISPLAY: inline; COLOR: #0000ff; TEXT-DECORATION: underline">www.adeonapharma.com/AANposter.pdf</font>.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&#8220;We are highly encouraged by the results from this clinical study, especially achieving the primary outcome with the statistically significant change in the free copper to zinc ratio in the treatment group over the placebo group,&#8221; stated George J. Brewer, M.D., Adeona&#8217;s Senior Vice President of Research &amp; Development. &#8220;Also, of ultimate importance with respect to a potential treatment for Alzheimer&#8217;s disease patients, the composite score supports cognitive benefit in the treatment group versus the placebo group.&#8221;</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Dr. Pollock also commented on the clinical study, &#8220;In my clinical experience, this zinc therapy appears to have been extremely well tolerated and may represent a new mechanism of action to address the cognitive deficits in Alzheimer's patients. This potential treatment deserves further study in larger clinical trials.&#8221;</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&#8220;Based on the favorable results presented from this clinical study, we intend to further the commercial development of <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> as a prescription medical food for the dietary management of Alzheimer&#8217;s disease and mild cognitive impairment,&#8221; stated James S. Kuo, M.D., M.B.A., Adeona&#8217;s Chief Executive Officer. &#8220;In addition, we will be reviewing the results from our clinical study with our scientific advisors to determine what further clinical studies might be warranted to support additional labeling claims.&#8221;</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">About Adeona Conference Call/Audio Webcast</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Adeona will hold a conference call/audio webcast to discuss the results from the clinical study evaluating <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> for the dietary management of Alzheimer&#8217;s disease and mild cognitive impairment on Friday, April 15, 2011, at 8:00 a.m. (HAST)/2:00 p.m. (EDT). James S. Kuo, M.D., M.B.A., Adeona&#8217;s Chief Executive Officer and Diana Pollock, M.D., Lead Principal Investigator of the study at Morton Plant Neuroscience Institute on the campus of Morton Plant Hospital, will host the call. Interested parties should call toll free<font style="DISPLAY: inline; FONT-WEIGHT: bold">&#160;</font>1-800-860-2442 (U.S.) or 1-866-605-3852 (Canada), or from outside North America +1 412-858-4600, fifteen minutes before the start of the call to register and identify themselves as registrants of the &#8216;Adeona&#8217; Conference Call. Any registered caller on the toll free line may ask to be placed in the queue for the Question &amp; Answer session. The call will be simulcast on the web at <font style="DISPLAY: inline; COLOR: #0000ff; TEXT-DECORATION: underline">http://www.videonewswire.com/event.asp?id=78671</font>. If you are unable to participate during the live call, the webcast will be available for replay at <font style="DISPLAY: inline; COLOR: #0000ff; TEXT-DECORATION: underline">www.adeonapharma.com</font> for 30 days after the call.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">About <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> Clinical Study</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Two scientific observations support Adeona&#8217;s hypothesis that correcting zinc and free copper abnormalities could benefit AD patients as measured by cognitive scores. The first observation is derived from studies conducted by Dr. Squitti and her group that have shown the following: 1) AD patients have elevated levels of serum free copper<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">2</font> and 2) the elevated levels of free copper correlate with lower cognitive function<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">3</font> and, over time, a decline in cognitive function<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">4</font>. The second observation is the finding that AD patients are zinc deficient compared to age-matched control patients<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">5</font>.These findings suggest that elevated free copper is toxic to the brain of AD patients. Therefore, based on these scientific observations, Adeona&#8217;s therapeutic strategy for the <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> clinical study is to correct zinc deficiency and to lower serum free copper in AD patients. Based on findings in Wilson&#8217;s disease (a disease characterized by toxic levels of free copper), oral zinc is known to lower serum free copper.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">The prospective, randomized, double-blind, placebo-controlled clinical study represents the first controlled clinical study evaluating the safety and efficacy of a zinc and cysteine-based therapy (<font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font>) for Alzheimer&#8217;s disease. Study subjects were randomized into the active treatment group or the placebo group and were assessed at baseline, 3 months and 6 months. Primary outcome measures include serum zinc and serum free copper. Secondary outcomes include cognitive measures using ADAS-Cog, CDR-SOB and MMSE.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">About <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> Product Candidate</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font>, formerly named Zinthionein, is a proprietary, gastroretentive, sustained release, once-daily oral tablet formulated from zinc (150 mg) and cysteine (100 mg), an amino acid with potent anti-oxidant properties. <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> was developed by Adeona to achieve the following: 1) the convenience of a once-daily dose, 2) high bioavailability (the quantity or fraction of the ingested dose that is absorbed by the body) and 3) the ability to minimize gastrointestinal side effects of oral zinc therapy.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">About Adeona Pharmaceuticals, Inc.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Adeona is a pharmaceutical company developing innovative medicines for the treatment of serious central nervous system diseases. The Company&#8217;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. Currently, Adeona is developing, or has partnered the development of, the following product candidates: a prescription medical food for Alzheimer&#8217;s disease, and drugs for multiple sclerosis, fibromyalgia and age-related macular degeneration. For more information, please visit Adeona&#8217;s website at <font style="DISPLAY: inline; COLOR: #0000ff; TEXT-DECORATION: underline">www.adeonapharma.com</font>.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-STYLE: italic; FONT-FAMILY: Times New Roman">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," &#8220;positions,&#8221; "continue," "expects," "anticipates," "intends," "plans," "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 use of zinc as a potential treatment for cognitive deficits in Alzheimer&#8217;s patients and our intent to further commercialize development of reaZin as a prescription&#160;&#160;medical food. 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 successfully commercialize reaZin for the treatment of Alzheimer&#8217;s disease, the failure of reaZin to be accepted as a treatment for Alzheimer&#8217;s disease,&#160;&#160;failure of future clinical trials studying&#160;&#160;reaZin to have favorable results, 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.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">1 </font>O&#8217;Brien, P.C., &#8220;Procedures for Comparing Samples with Multiple Endpoints,&#8221;<font style="DISPLAY: inline; FONT-WEIGHT: bold">&#160;</font><font style="DISPLAY: inline; FONT-STYLE: italic">Biometrics</font>, 40, 1079-1087, 1984.</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">2</font> Squitti, R., Pasqualetti, P., Dal Forno, G., et al., &#8220;Excess of serum copper not related to ceruloplasmin in Alzheimer disease,&#8221; <font style="DISPLAY: inline; FONT-STYLE: italic">Neurology</font>, vol. 64, no. 6, pp 1040-1046, 2005.</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">3 </font>Squitti, R., Barbati, G., Rossi, L., et al., &#8220;Excess of nonceruloplasmin serum copper in AD correlates with MMSE, CSF [beta]-amyloid, and h-tau,&#8221; <font style="DISPLAY: inline; FONT-STYLE: italic">Neurology</font>, vol. 67, no. 1, pp 76-82, 2006.</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">4 </font>Squitti, R., Bressi, P., Pasqualetti, R, et al., &#8220;Longitudinal prognostic value of serum &#8220;free&#8221; copper in patients with Alzheimer&#8217;s disease,&#8221; <font style="DISPLAY: inline; FONT-STYLE: italic">Neurology</font>, vol. 72, no.1, pp 50-55, 2009.</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">5 </font>Brewer, G.J., Kanzer, S.H., Zimmerman, E.A., et al., &#8220;Subclinical zinc deficiency in Alzheimer&#8217;s disease and Parkinson&#8217;s disease,&#8221; <font style="DISPLAY: inline; FONT-STYLE: italic">American Journal of Alzheimer&#8217;s Disease and Other Dementias</font>, vol. 25, no. 7, pp 572-575, 2010.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">For further information, please contact:</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">James S. Kuo, M.D., M.B.A.</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Chief Executive Officer</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">(734) 332-7800</font></div>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
