Re: Living Cell Technologies' diabetes clinical trial authorized by New Zealand Government

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Posted by nzDoctor on 09:05:41 2009/06/24

In Reply to: NZ Approval for LCT Clinical Trials now Final posted by Medical News

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New Zealand Doctor Online - Medical News for GPs function GoHandlerHome(evt){var isNS4 = (navigator.appName=='Netscape')?1:0;if(!isNS4){if (evt.keyCode == 13){__doPostBack('MenuQuicklinks1$lbSearch','');return false;}}else{if(evt.which == 13){__doPostBack('MenuQuicklinks1$lbSearch','');return false;}}} Contact Advertising Specifications Free Classified Advertising Publishing Schedule 2009 Classified Advertising Display Advertising Advertising Rate Card 2009 Advertising Options Profile Print Archives Subscribe Home » Search Website Find a GP Colleague Handy Clinical Stuff Recent Print Issues TIP OFF .grayBox{ width: 118px; min-height: 18px; text-align: right; background-color: #FFF; text-transform: uppercase; padding-top: 5px; background: url(images/bg-leftNav-bottom.gif) repeat-x left top; /*background-color: #CDCDCE; border: solid 1px #9A9A9A; text-align: center; font-size: 10px; color: Black;*/ } .grayBox a{ font-weight: normal; color: #323334; line-height: 12px; text-decoration: none; } .grayBox a:visited{ color: Black; font-size: 10px; } -- Free Classifieds VIEW ADS: -- » Locums Wanted » Locums Available » Practices » General » Practice Nurses » Buy + Sell » Place an Ad What's in your locum kitbag? -- Professional Classifieds DOCTOR@LARGE (enewsletter) GP Subscription to NZ Doctor Blog -- -- Swine flu DOWNLOADS Home Your Subscriber ID Home Delivery Print Archives (free to subscribers) Daily News Archive Media Releases Reports Archive Find a GP Extra Coverage Bits & Pieces References Noticeboard Wilcox Reviews PHO Stuff PEARLS MEDOKU The Write Stuff Popular Podcasts A-Z Health Links SEARCHMEDICA Clinical GP Groups Patients Overseers Business Practice Websites Everybody Pharmacy Today Goodfellow 25 June Waikato practice in the spotlight As one investigation into a Hamilton general practice closes, another opens » read full story News Feed MEDIA RELEASE 24 JUNE 2009 Living Cell Technologies’ diabetes clinical trial authorized by New Zealand Government Media release from Living Cell Technologies Limited Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) today announced that the New Zealand Minister of Health, the Honourable Tony Ryall, has authorized LCT’s New Zealand Phase I/IIa clinical trial of DIABECELL® for insulin dependent diabetes. The authorization confirms the conditions announced on 19 June 2009. One condition of the new authorization limits participation in the trial to patients with poorly controlled (brittle) diabetes. The remaining conditions are procedural rather than substantive in nature and LCT and the Middlemore Hospital clinical team conducting the trial, have requested the Regional Ethics Committee formally accept the changes required by the Minister. LCT CEO Dr Paul Tan said: “We are pleased that the conditions have been finalized and LCT looks forward to commencing the trial within the next two months with the acceptance of the changes by the Ethics Committee.” Professor Bob Elliott, LCT Founder and Medical Director added, “The New Zealand diabetes trial is another major milestone for LCT. With two diabetes patients not requiring insulin following implants with encapsulated pig islet cells in our first study in Russia, we expect to see further benefit in more patients as we use higher doses of DIABECELL® in the New Zealand trial.” LCTs Phase I/IIa clinical trial in Russia started with a low dose of DIABECELL®. In May 2009 LCT reported preliminary data showing sustained long term clinical benefit in patients treated with the DIABECELL® implant with no remarkable adverse events. Remarkably, two of seven patients given implants are now off insulin injections. The New Zealand trial allows LCT to extend its Phase I/IIa clinical data with eight patients, four of whom are to receive double the initial dose used in Russia followed by four patients to receive triple the dose. Dr John Baker, Clinical Director and Diabetes Physician at Middlemore Hospital, Auckland, who will be conducting the trial said, “There are many patients with poorly controlled diabetes who would qualify for this trial.” DIABECELL® is designed to normalize blood glucose levels in type 1 diabetes sufferers. DIABECELL® comprises encapsulated porcine insulin-producing cells which can be administered without the need to use immunosuppressive drugs. Type 1 diabetes occurs when the body's own immune system destroys the insulin-producing cells of the pancreas (called beta cells). Five to 10 percent of the more than 200 million diabetics worldwide have insulin dependent type 1 diabetes. Type 1 diabetes is associated with kidney failure, blindness, nerve damage, life-threatening cardiovascular disease and limb amputations. 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Re: Hopes For Start To Pig Cell Implant Trials In Two Months - Voxy 09:10:32 2009/06/24 (0)
Re: Living Cell Technologies' Clinical Trial Authorized By NZ Government - Twitter 09:08:00 2009/06/24 (0)

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