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		<title>Japan Tobacco : Top-line results of the JTT-751 Phase 3 clinical study in Japan (GBA4-1) for the treatment of hyperphosphatemiaPDF:45.5kb</title>
		<link>http://symptomadvice.com/japan-tobacco-top-line-results-of-the-jtt-751-phase-3-clinical-study-in-japan-gba4-1-for-the-treatment-of-hyperphosphatemiapdf45-5kb/</link>
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		<pubDate>Tue, 24 Apr 2012 13:34:22 +0000</pubDate>
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				<category><![CDATA[bone symptoms]]></category>
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		<category><![CDATA[hydrochloride]]></category>
		<category><![CDATA[hyperphosphatemia]]></category>
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		<description><![CDATA[04/23/2012 &#124; 03:39am FOR IMMEDIATE RELEASE Tokyo, April 23, 2012 Top-line results of &#116;&#104;&#101; JTT-751 Phase 3 clinical study in Japan (GBA4-1) &#102;&#111;&#114; &#116;&#104;&#101; treatment of hyperphosphatemia Tokyo, April 23, 2012 &#8212; Japan Tobacco Inc. (JT) (TSE:2914) and Torii Pharmaceutical &#099;&#111;., Ltd. (Torii) (TSE:4551) have announced &#116;&#104;&#101; top-line results of GBA4-1. &#116;&#104;&#105;&#115; study is a [...]]]></description>
			<content:encoded><![CDATA[<p></p><p><img src="" style="float:left;clear:both;margin:0 15px 15px 0" />04/23/2012 | 03:39am
<p> FOR IMMEDIATE RELEASE </p>
<p> <b> Tokyo, April 23, 2012 </b> <b> Top-line results of &#116;&#104;&#101; JTT-751 Phase 3 clinical study in Japan </b> <b> (GBA4-1) &#102;&#111;&#114; &#116;&#104;&#101; treatment of hyperphosphatemia </b> <b> Tokyo, April 23, 2012 &#8212; Japan Tobacco Inc. (JT) (TSE:2914) and Torii Pharmaceutical &#099;&#111;., Ltd. (Torii) (TSE:4551) have announced &#116;&#104;&#101; top-line results of GBA4-1. &#116;&#104;&#105;&#115; study is a part of &#116;&#104;&#101; Phase 3 program &#102;&#111;&#114; JTT-751 (ferric citrate), conducted in Japan, &#102;&#111;&#114; &#116;&#104;&#101; treatment of hyperphosphatemia. </b>
<p> GBA4-1 was &#097;&#110; open-label, randomized, parallel-group, active comparator study, designed to evaluate &#116;&#104;&#101; efficacy and safety of JTT-751 in comparison to sevelamer hydrochloride. &#116;&#104;&#101; study was carried &#111;&#117;&#116; over a 12 week period, among patients diagnosed with chronic kidney disease (CKD) on hemodialysis, experiencing symptoms of hyperphosphatemia. In &#116;&#104;&#101; top-line results, non-inferiority of JTT-751 to sevelamer hydrochloride was confirmed, in regard to &#116;&#104;&#101; primary endpoint of &#116;&#104;&#101; trial. In order to meet &#116;&#104;&#101; primary endpoint, &#116;&#104;&#101; levels of serum phosphorus &#102;&#114;&#111;&#109; patients were measured, comparing baseline levels with &#116;&#104;&#111;&#115;&#101; &#097;&#116; &#116;&#104;&#101; &#101;&#110;&#100; of &#116;&#104;&#101; trial. &#102;&#117;&#114;&#116;&#104;&#101;&#114;&#109;&#111;&#114;&#101;, &#116;&#104;&#101;&#114;&#101; were no clinically significant findings on safety and tolerability of JTT-751 &#119;&#105;&#116;&#104;&#105;&#110; &#116;&#104;&#101; treatment period. JT &#119;&#105;&#108;&#108; aim to submit a marketing application &#102;&#111;&#114; JTT-751 in Japan, in &#116;&#104;&#101; fiscal year ending March 31 2013, based on &#116;&#104;&#101; results of GBA4-1 and other Phase 3 studies &#102;&#111;&#114; JTT-751 which &#097;&#114;&#101; currently &#098;&#101;&#105;&#110;&#103; conducted. JT and Torii hold &#116;&#104;&#101; exclusive rights to develop and commercialize JTT-751 in Japan, which were licensed &#102;&#114;&#111;&#109; Keryx Biopharmaceuticals, Inc. in September 2007. </p>
<p> <b> About Hyperphosphatemia </b>
<p> Patients with CKD &#111;&#102;&#116;&#101;&#110; suffer &#102;&#114;&#111;&#109; hyperphosphatemia, as a result of &#108;&#111;&#119;&#101;&#114; phosphorous excretion &#102;&#114;&#111;&#109; &#116;&#104;&#101; kidney. Persisting hyperphosphatemia leads to calcareous deposition in &#118;&#097;&#114;&#105;&#111;&#117;&#115; organs, including &#116;&#104;&#101; blood vessels, heart, lung and kidney as well as periarticular tissues. In particular, a calcified blood vessel wall &#099;&#097;&#117;&#115;&#101;&#115; arterial sclerosis and increases &#116;&#104;&#101; risk of cardiac infarct and angina. &#102;&#117;&#114;&#116;&#104;&#101;&#114;&#109;&#111;&#114;&#101;, bone lesions can &#098;&#101; caused &#098;&#121; secondary hyperparathyroidism associated with &#116;&#104;&#101; increase in secretion of parathyroid hormone, negatively affecting activities of daily living and quality of life. </p>
<p> Contacts &#102;&#111;&#114; Japan Tobacco Inc.: Contact &#102;&#111;&#114; Torii Pharmaceutical &#099;&#111;., Ltd.:Hideyuki Yamamoto, General Manager &#112;&#108;&#097;&#110;&#110;&#105;&#110;&#103; Department (Public Relations) Ryohei Sugata, Associate General Manager Torii Pharmaceutical &#099;&#111;., Ltd. </p>
<p> Media and Investor Relations Division Tokyo: +81-3-3231-6814 </p>
<p> Japan Tobacco Inc. Tokyo: +81-3-5572-4292 </p>
<p> E-mail: jt.media.relations@jt.&#099;&#111;&#109; </p>
<p> Japan Tobacco Inc. is a leading international tobacco product company. Its products &#097;&#114;&#101; sold in over 120 countries and its internationally recognized cigarette brands include Winston, Camel, Mild Seven and Benson &amp; Hedges. With diversified operations, JT is also actively present in pharmaceuticals and foods. &#116;&#104;&#101; company&#8217;s adjusted net sales(*) were ?1.946 trillion (US$23,415 million(**)) in &#116;&#104;&#101; fiscal year &#101;&#110;&#100;&#101;&#100; March 31, 2011. </p>
<p> * Adjusted net sales on a consolidated basis do &#110;&#111;&#116; include excise tax and revenue &#102;&#114;&#111;&#109; &#116;&#104;&#101; imported tobacco, domestic duty free, &#116;&#104;&#101; China Division and other peripheral businesses in &#116;&#104;&#101; Japanese domestic tobacco business. &#110;&#111;&#114; does it include excise tax and revenue &#102;&#114;&#111;&#109; distribution, contract manufacturing and other peripheral businesses in &#116;&#104;&#101; international tobacco business. </p>
<p> **Translated &#097;&#116; &#116;&#104;&#101; rate of ?83.15 &#112;&#101;&#114; $1, as of March 31, 2011 </p></p>
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