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	<title>Symptom Advice .com &#187; technology platform</title>
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		<title>NEOVACS&#160;(ALNEV)</title>
		<link>http://symptomadvice.com/neovacsalnev/</link>
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		<pubDate>Sun, 28 Nov 2010 15:34:15 +0000</pubDate>
		<dc:creator>Symptom Advice</dc:creator>
				<category><![CDATA[crohn s symptoms]]></category>
		<category><![CDATA[dose escalation]]></category>
		<category><![CDATA[dsmb]]></category>
		<category><![CDATA[rapid progress]]></category>
		<category><![CDATA[safety monitoring board]]></category>
		<category><![CDATA[technology platform]]></category>

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		<description><![CDATA[Neovacs (Paris: ALNEV)(Alternext Paris: ALNEV), &#097; biotech company focused on &#097;&#110; active immunotherapy technology platform (KinoidsTM) with applications in &#116;&#104;&#101; treatment &#111;&#102; autoimmune diseases, inflammatory diseases &#097;&#110;&#100; cancer has received DSMB authorization to proceed to &#097; higher dosage in &#105;&#116;&#115; ongoing phase I/II trial in lupus. Administration &#111;&#102; &#116;&#104;&#101; &#116;&#104;&#105;&#114;&#100; dose level in patients recruited [...]]]></description>
			<content:encoded><![CDATA[<p></p><p><img src="http://symptomadvice.com/wp-content/uploads/2010/11/1290958455-26.jpg%3Fw%3D510%26h%3D565" style="clear:both;clear:both;margin:0 15px 15px 0;width:500px" />
<p> <b>Neovacs</b><b> (Paris: ALNEV)(Alternext Paris: ALNEV), &#097; biotech company focused on &#097;&#110; active immunotherapy technology platform (Kinoids</b><b>TM</b><b>) with applications in &#116;&#104;&#101; treatment &#111;&#102; autoimmune diseases, inflammatory diseases &#097;&#110;&#100; cancer has received DSMB authorization to proceed to &#097; higher dosage in &#105;&#116;&#115; ongoing phase I/II trial in lupus.</b> </p>
<p> Administration &#111;&#102; &#116;&#104;&#101; &#116;&#104;&#105;&#114;&#100; dose level in patients recruited since September &#119;&#097;&#115; completed &#097;&#115; expected. Having reviewed &#116;&#104;&#101; data related to these patients on November 5, &#116;&#104;&#101; Data &#097;&#110;&#100; Safety Monitoring Board, &#097;&#110; independent committee which &#105;&#115; responsible for overseeing &#116;&#104;&#101; conduct &#111;&#102; &#116;&#104;&#101; study &#097;&#110;&#100; in particular for patient safety, authorized Neovacs to proceed to &#116;&#104;&#101; &#110;&#101;&#120;&#116; higher &#097;&#110;&#100; final dose &#111;&#102; INF?-Kinoid. Neovacs &#105;&#115; &#110;&#111;&#119; able to finalize recruitment &#111;&#102; patients for this phase I/II trial, &#097;&#115; &#112;&#108;&#097;&#110;&#110;&#101;&#100;. </p>
<p> &#116;&#104;&#101; DSMB&#8217;s&#8217; decision confirms &#116;&#104;&#101; good tolerability &#111;&#102; IFN?-Kinoid to date, which has &#110;&#111;&#119; been administered to patients at &#116;&#104;&#114;&#101;&#101; dose levels<i>. </i>Rapid progress has been &#109;&#097;&#100;&#101; so far in this Phase I/II trial &#097;&#110;&#100; &#116;&#104;&#101; company &#105;&#115; confident in achieving &#105;&#116;&#115; objective &#111;&#102; releasing preliminary results by &#116;&#104;&#101; end &#111;&#102; &#116;&#104;&#101; first half 2011. </p>
<p> &#116;&#104;&#101; study &#105;&#115; placebo-controlled, double-blind with dose-escalation &#097;&#110;&#100; randomisation at &#101;&#097;&#099;&#104; dose level. Patients must present symptoms &#111;&#102; moderate disease &#097;&#110;&#100; &#116;&#104;&#101; primary objective &#111;&#102; &#116;&#104;&#101; ongoing study &#105;&#115; to gather data on &#116;&#104;&#101; tolerability &#097;&#110;&#100; safety &#111;&#102; IFN?-Kinoid. Secondary objectives include analysis &#111;&#102; &#116;&#104;&#101; immune response &#097;&#110;&#100; measurements &#111;&#102; disease activity &#097;&#110;&#100; IFN? markers. </p>
<p> <b>About lupus</b> </p>
<p> Systemic Lupus Erythematosus (SLE) &#105;&#115; &#097;&#110; autoimmune disease in which &#116;&#104;&#101; immune system produces antibodies to cells &#119;&#105;&#116;&#104;&#105;&#110; &#116;&#104;&#101; body leading to widespread inflammation &#097;&#110;&#100; tissue &#100;&#097;&#109;&#097;&#103;&#101;. Prevalence estimates vary widely, &#097;&#110;&#100; range &#097;&#115; high &#097;&#115; 1.5 million in North America (the Lupus Foundation &#111;&#102; America) &#097;&#110;&#100; 5 million worldwide. &#116;&#104;&#101; Centers for Disease Control estimates &#097; 2005 prevalence &#111;&#102; 322,000 with definite &#111;&#114; probable SLE in &#116;&#104;&#101; US. Lupus disease may first occur at any age, though peak diagnosis &#105;&#115; &#098;&#101;&#116;&#119;&#101;&#101;&#110; &#116;&#104;&#101; ages &#111;&#102; 15 &#097;&#110;&#100; 40. &#105;&#116; &#105;&#115; far &#109;&#111;&#114;&#101; common in women &#116;&#104;&#097;&#110; men. People with SLE may experience fatigue, pain &#111;&#114; swelling in joints, skin rashes, &#097;&#110;&#100; fevers. &#105;&#116; &#099;&#097;&#110; &#097;&#108;&#115;&#111; affect &#116;&#104;&#101; lungs, kidneys, &#097;&#110;&#100; blood vessels. &#116;&#104;&#101;&#114;&#101; has been no &#110;&#101;&#119; treatment approved for lupus for &#111;&#118;&#101;&#114; fifty years. Scientists &#104;&#097;&#118;&#101; highlighted &#116;&#104;&#101; overproduction &#111;&#102; &#116;&#104;&#101; interferon alpha cytokine?as &#097; key factor in &#116;&#104;&#101; causation &#097;&#110;&#100; development &#111;&#102; &#116;&#104;&#101; disease. </p>
<p> <b>About Neovacs</b> </p>
<p> Neovacs &#105;&#115; &#097; biotechnology company focused on &#097;&#110; active immunotherapy technology platform (Kinoids?) with applications in autoimmune diseases &#097;&#110;&#100; other chronic conditions. Neovacs&#8217; current portfolio consists &#111;&#102; 3 drug candidates: TNF-Kinoid, IFN?-Kinoid &#097;&#110;&#100; VEGF-Kinoid. &#116;&#104;&#101; company&#8217;s lead immunotherapy program (TNF-Kinoid) targets TNF-mediated chronic inflammatory diseases. For TNF-Kinoid, &#097; Phase I/II clinical trial in Crohn&#8217;s disease &#097;&#110;&#100; &#097; Phase II trial in rheumatoid arthritis (RA) are ongoing. &#116;&#104;&#101; &#108;&#097;&#116;&#116;&#101;&#114; clinical study &#105;&#115; &#097;&#108;&#115;&#111; &#116;&#104;&#101; focus &#111;&#102; collaboration with &#116;&#104;&#101; French diagnostics company BMD, with &#116;&#104;&#101; goal &#111;&#102; developing theranostic tools for personalized care in RA. Patient recruitment &#105;&#115; ongoing in &#097; Phase I/II trial &#111;&#102; Neovacs&#8217; &#115;&#101;&#099;&#111;&#110;&#100; product candidate (IFN? -Kinoid, &#097;&#110; immunotherapy targeting interferon alpha) in &#116;&#104;&#101; treatment &#111;&#102; lupus. Neovacs&#8217; R&amp;D has generated &#097; broad patent estate. </p>
<p> <b>For &#109;&#111;&#114;&#101; information, visit &#116;&#104;&#101; Neovacs web site at </b><b>neovacs.com</b> </p>
<p> <b>Presse &#8211; Alize RP</b>Caroline Carmagnol+33 (0) 6 64 18 99 <b>Neovacs</b>Florence Hocd?e &#8211; Leroy+33 (0) 1 53 10 93 <b>Investors ? Actifin</b>Nicolas Meunier+ 33 (0) 1 56 88 11 </p></p>
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