LIVING CELL JUMPS 64% ON NZ XENOTRANSPLANT TRIAL APPROVAL
October 23rd 2008 09:28
Tuesday October 21, 2008
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECHS UP: LIVING CELL UP 43%, CYTOPIA DOWN 8%
* LIVING CELL JUMPS 64% ON NZ XENOTRANSPLANT TRIAL APPROVAL
* US PATENT ALLOWANCE FOR ALCHEMIA’S SYNTHETIC HEPARIN
* NOVOGEN’S GLYCOTEX COLLABORATES WITH ADVANCED MEDICAL
* KARMELSONIX APPARATUS GRANTED AUSTRALIAN PATENT
* AVANTOGEN CEO DR WILLIAM ARDREY JOINS HAWAII BIOTECH BOARD
* CHEMGENEX VOTES ON DIRECTORS, FEES, $17.9m REDUCTION
* BONE VOTES ON $75m ‘ACCOUNTING ENTRY’, DIRECTORS’ SHARES
* VIRALYTICS VOTES ON 6m DIRECTORS’ INCENTIVE OPTIONS
* NANOSONICS VOTES ON 1.5m CEO ‘INCENTIVISATION’ OPTIONS
* NORWOOD ABBEY VOTES ON SHARES, OPTIONS, CONVERTIBLE NOTES
* CORRECTION: GBS VENTURE PARTNERS
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LIVING CELL TECHNOLOGIES
New Zealand Health Minister, David Cunliffe, has approved Living Cell’s application for a phase I/IIa trial of its Diabecell porcine islets of Langerhans for type 1 diabetes.
Living Cell jumped 64.3 percent to 23 cents on the announcement.
Living Cell founder and medical director Prof Bob Elliott told Biotech Daily the recruitment process effectively had begun and the company expected to dose the first patient early in 2009.
Living Cell’s chief executive officer Dr Robert Caspari said the approval to begin the clinical trial was “a major milestone for the company and also makes it easier … to obtain approvals in other countries”.
“Porcine insulin has been used therapeutically for 80 years to treat type 1 diabetes,” Dr Caspari said.
“Early data shows that utilizing our proprietary encapsulation technology with islet cells may significantly reduce daily insulin requirements in type 1 diabetics,” Dr Caspari said.
“The Minister’s approval is the culmination of a thorough regulatory process under the Medicines Act 1981, involving detailed consideration of clinical and ethical issues by a wide range of expert bodies over a two year period, and public consultation,” he said.
“Approval is subject to extensive conditions designed to safeguard the health and safety of the trial’s participants and the wider public and will be monitored on an ongoing basis by the Ministry of Health,” Dr Caspari said.
Living Cell’s chief operating officer Dr Paul Tan said the company was “delighted to be able to get this clinical trial underway in New Zealand, the place where the Diabecell concept was initially conceived by Prof Bob Elliott”.
“The conditions of the Minister’s approval allow us to proceed with commencing the trial and work with an independent international expert to assure the Minister that the world’s first safety procedures set up by LCT are adequate,” he said.
Living Cell began a phase I/IIa clinical trial of Diabecell in Russia in June 2007 and continues to enroll patients into the program.
The Russian component of phase I/IIa development was designed to include only the lowest dose, 5,000 islet equivalents (IEQ/kg) of Diabecell, but as a result of positive preliminary results, it was expanded to include a higher dose of 10,000 IEQ/kg, which is now being studied.
Living Cell said in July that the six participants who received Diabecell in the Russian trial all derived clinical benefit with no significant adverse events (see Biotech Daily July 22, 2008). The company said the approval allowed it to extend its phase I/IIa clinical data.
The New Zealand trial will enroll eight patients, four of whom are to receive the dose of 10,000 IEQ/kg followed by four patients to receive the high dose of 15,000 IEQ/kg.
The trial will be conducted by the clinical director and diabetes physician at Auckland’s Middlemore Hospital, Dr John Baker.
Prof Elliott said the company was “now able to formally access volunteers and intend to start work on this with Middlemore Hospital immediately”.
Diabecell is an encapsulated porcine insulin-producing cell product, in development for the treatment of type 1 diabetes without the use of immunosuppressive drugs.
Five to 10 percent of the more than 200 million diabetics worldwide have insulin-dependent type 1 diabetes with 30,000 cases of diabetes diagnosed each year in the US, of whom approximately 40 percent are children.
Type 1 diabetes is associated with kidney failure, blindness, nerve damage, cardiovascular disease and amputations. Treatment options include multiple daily injections of insulin.
Living Cell closed up six cents or 42.86 percent to 20 cents with 362,700 shares traded.
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