Prne
June 23rd, 2009
SYDNEY and AUCKLAND, New Zealand -
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(R) 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(R) in the New Zealand trial.”
LCTs Phase I/IIa clinical trial in Russia started with a low dose of DIABECELL(R). In May 2009 LCT reported preliminary data showing sustained long term clinical benefit in patients treated with the DIABECELL(R) 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(R) is designed to normalize blood glucose levels in type 1 diabetes sufferers. DIABECELL(R) 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. Current treatment options include multiple daily injections of insulin.
For further information: www.lctglobal.com. CONTACT: Dr. Paul Tan Chief Executive Officer Mob: +021-608-784 (NZ) Tel: +64-9-276-2690 ptan@lctglobal.com Mr John Cowan Finance & Administration Manager Tel: +64-9-276-2690 jcowan@lctglobal.com Prof. Bob Elliott Medical Director Mob: +64-27-292-4177 Tel:+64-9-276-2690 relliott@lctglobal.com Paul Dekkers Investor and Media Relations Tel: +612-9237-2800 pdekkers@bcg.com.au
Source: Living Cell Technologies
Dr. Paul Tan, Chief Executive Officer, Mob: +021-608-784 (NZ), Tel: +64-9-276-2690, or ptan at lctglobal.com, Mr. John Cowan, Finance & Administration Manager, Tel: +64-9-276-2690, or jcowan at lctglobal.com, Prof. Bob Elliott, Medical Director, Mob: +64-27-292-4177, Tel: +64-9-276-2690, or relliott at lctglobal.com, all of Living Cell Technologies; Paul Dekkers, Investor and Media Relations, Tel: +1-612-9237-2800, or pdekkers at bcg.com.au, for Living Cell Technologies
Filed under Clinical Trials / Medical Discoveries, FDA Approval, Government and Policy, Health, Health Care / Hospitals, Pharmaceuticals | Tags: australia, Living Cell Technologies, new zealand, Sydneyauckland, Western Europe | Comment Below
Related Press Releases Important Step Forward in Osteoarthritis Research: Bioactive Collagen Peptides Stimulate the Regeneration of Cartilage TissueSeptember 13th, 2009 MONTREAL and KIEL, Germany - Working in collaboration with Kiel University, researchers at the Kiel- based Collagen Research Institute (CRI) have demonstrated the stimulating effect of special bioactive collagen peptides (FORTIGEL(R)) in the context of cell experiments. Last weekend the CRI presented its research findings at the congress of the Osteoarthritis Research Society International (OARSI) in Montreal. Cell Biosciences Launches Unique Protein Phosphorylation Assay ServiceAugust 31st, 2009 SANTA CLARA, California -
Cell Biosciences, Inc. today launched a service program to provide phosphoprotein analysis of pre-clinical samples for pharmaceutical and biotechnology companies. Survey Reveals Diabetics Feel the Condition Impacts on Their Mood and Sex LifeAugust 26th, 2009 LONDON - A new research study carried out by The Research Partnership reveals that living with diabetes can have a major effect on people's lives, with just under half (44%) of type 2 patients reporting that the condition has impacted on either their ability or their desire to have sex. The study was conducted online amongst 2,000 patients with type 2 diabetes living in the US, UK and Germany and investigated patients' attitudes, feelings, health status, drug treatment programmes and needs for coping with life with diabetes. MacroGenics and Lilly Achieve Targeted Patient Enrollment in PROTEGE, a Global Phase 2/3 Clinical Trial of Teplizumab in Type 1 DiabetesJune 15th, 2009 ROCKVILLE, Maryland and INDIANAPOLIS - Phase 3 PROTEGE ENCORE Clinical Trial Initiated
MacroGenics, Inc. and Eli Lilly and Company (NYSE: LLY) today announced that the PROTEGE trial achieved its targeted patient enrollment. UPCI Joins ExCell Research Study Using Stem Cells for Leukemia and Lymphoma PatientsJune 14th, 2009 PITTSBURGH, Pennsylvania, and JERUSALEM, Israel - The University of Pittsburgh Cancer Institute (UPCI) and the Gamida Cell - Teva Joint Venture announced today that the Institute has joined an elite group of cancer centers in Europe, the United States and Israel that are now enrolling patients to participate in the ExCell research study. The phase III study is assessing the safety and efficacy of StemEx(R), an investigational product derived from stem cells, as an alternative treatment to bone marrow transplants for hematological malignancies, including leukemia and lymphoma. Reminder: Sanofi Aventis - Live Webcast: Breaking News From the American Diabetes Association 69th Scientific SessionsJune 4th, 2009 NEW ORLEANS - What Live Webcast: Delivering real patient benefit: Update on new clinical excellence & future company vision Live from the American Diabetes Association 69th Scientific Session When Sunday, June 7th, 2009 10:30am - 11:30am CDT (Central Daylight Time) New Orleans, Louisiana, USA 17:30pm - 18:30pm CEST (Central European Summer Time) Paris, France
How to register www.videonewswire.com/event.asp?id=59340
Password: sa2009ADA
Highlights
This webcast event will feature breaking news from real-life and clinical studies on progress in glycemic control, medication safety, cost-effectiveness, patient well-being and satisfaction. In addition, an update on the sanofi-aventis vision and strategy will further demonstrate the company's commitment to becoming a partner in diabetes healthcare. Five Cord Blood Transplant Centers in Catalonia and Valencia Join a Study to Test a New Technique to Treat Leukemia and LymphomaJune 2nd, 2009 JERUSALEM - The Gamida Cell-Teva Joint Venture announced today that five prestigious cord blood transplantations centers in Spain, three in Barcelona and two in Valencia, have joined the Excel study. Participating clinical sites include, in alphabetical order: - Hospital Clinic of Barcelona, Barcelona Principal Investigator, Dr. Poxel SAS Set up to Find Innovative Solutions for Metabolic Diseases ManagementMay 27th, 2009 LYONS, France - Poxel SAS is Set up in Lyons - France
Poxel is a research integrated pharmaceutical Company (RIPCO), spun out from Merck Serono a division of Merck KGaA, Germany, following the decision of Merck Serono to no longer invest in diabetes research and development. It aims to advance promising assets for cardio-metabolic diseases (with a primary focus on Type 2 diabetes) from Research to Phase 2 Clinical Proof-of-Concept, before out-licensing these projects to major pharmaceutical companies. Ambe Medical Group Revolutionises Diabetes StrategyMay 20th, 2009 KEMSING, England - Price of Blood Glucose Test Strips to the NHS to be cut by 50%
- "My Lords, I Cannot say why They are so Expensive" (Baroness Thornton House of Lords June 23 2008)
- NHS Spends 10% of Annual Budget on Treating Diabetes
Living with diabetes involves keeping a close eye on blood glucose levels. This is done by putting a drop of blood onto a small but expensive device called a test strip. Orcrist Bio Inc. Receives Approval From European Competent Authority to Initiate its Planned Phase I, Open-label, Single-ascending-dose, Safety Study of HYC750April 5th, 2009 CALGARY, Canada - Orcrist Bio Inc. (ORC) a biotechnology company developing stem cell-mobilizing pharmaceuticals, announced today the approval of its Phase I, open-label, single-ascending-dose, safety study of HYC750 in healthy male volunteers, by the European Competent Authority in Seville, Spain.
Related News Fast acting erectile disorder drug goes on trial againFebruary 15th, 2009 WASHINGTON - A new fast-acting oral drug for erectile dysfunction (ED) is ready for a crucial trial phase. It's going to be a multicentre, randomised, double-blind, placebo-controlled trial that will evaluate the safety and efficacy of Avanafil in the treatment of ED in men with type-1 or type-2 diabetes. GVK Biosciences forms clinical research alliance with Excel PharmaStudiesApril 14th, 2009 HYDERABAD - GVK Biosciences (GVK BIO), Asia's leading integrated research services provider and Excel PharmaStudies (Excel), a leading Chinese Clinical Research Organization announced a strategic alliance to conduct clinical trials in Asia. The alliance provides clinical trial sponsors access to the scientific skills, talent pool, flexible resourcing, and cost-effectiveness of both India and China. Contrave - Weight-Loss Drug Trials Meet GoalsJuly 21st, 2009 Contrave is an experimental weight-loss drug developed by Orexigen Therapeutics Inc. It has been shown to significantly aid weight loss
in three late-stage clinical trials according to Associated Press reports. MakroCare announces workshop on Advanced GCP on May 15May 6th, 2009 HYDERABAD - MakroCare, a global clinical services firm, provides clinical research support to pharmaceutical, biotechnology, and medical device industries, is taking a lead in the training of professionals for the clinical research industry by providing series of informational through workshop and seminars. Advanced GCP workshop will be held at CHITRAMAYEE Auditorium, State Arts Gallery, Kavuri Hills, Madhapur, Hyderabad on May 15. Tier Technologies increases size of buyback plan to $20 million from $15 millionSeptember 1st, 2009 Tier Technologies ups buyback plan to $20 millionRESTON, Va. — Payment processing company Tier Technologies Inc. Indian clinical research company to set-up unit in Kuala LumpurJuly 27th, 2009 NEW DELHI - The Ahmedabad-based Veeda Clinical Research organization is entering Malaysia's medical sector by setting up its advanced research unit at the Ampang Hospital in Kuala Lumpur by the year-end. India's fastest-growing clinical research organisation has selected the Ampang Hospital to conduct first phase clinical trials on humans under a quasi-commercial agreement with the Malaysian Health Ministry, The Star Online reports. Developmental drug effective against radiation damageApril 23rd, 2009 WASHINGTON - A drug, currently under development, has been found effective in providing protection against damaging effects of radiation exposure. The research team from University of Pittsburgh School of Medicine has found that experimental drug JP4-039 protects cells from being damaged by radiation exposure. Kiwi inmates told to build their own jail cellsJune 21st, 2009 WELLINGTON - In a bid to deal with a "dangerously high" prison population, inmates in New Zealand could be forced to build their own jail cells from shipping containers. Prime Minister John Key's government has asked Corrections, a state sector organisation of New Zealand, to produce options to cope with the burgeoning prison muster, which has increased by 700 so far this year, reports The Sunday Star Times. An Indian diabetic cure for Hollywood star Halle BerryApril 18th, 2009 NEW DELHI - With an Oscar statuette under her belt, Hollywood is at Halle Berry's feet. However, life has never been a bed of roses for this brilliant actress, as she has had to battle one of the world's most common illnesses - diabetes. Pilot's death sees New Zealand investigators seeks clearer rules on in-flight cell phone callsApril 23rd, 2009 New Zealand wants clear rules on pilot phone callsWELLINGTON, New Zealand — Crash investigators in New Zealand called for clearer rules for in-flight phone use by pilots after a probe found that distractions from cell phone calls and text messaging were key causes of a fatal 2007 crash of a crop duster. Pilot Andrew Wilde, 38, was killed after his crop duster crashed into some trees on a farm on North Island.
|
|
