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Article 1




An Auckland professor has won official approval to resume clinical trials for implanting insulin-producing pig cells into diabetics.


Health regulators blocked Professor Bob Elliott's initial controversial research over fears that the animal transplants could introduce pig viruses into humans.
Today the listed company for which Prof Elliott is medical director said it had all the necessary approvals for new New Zealand trials.
Living Cell Technologies (LCT) chief executive Paul Tan said the company had obtained all the regulatory and ethics approvals required by Health Minister Pete Hodgson for the trials.
LCT - which is already carrying out similar trials in Russia - said it was the only company to obtain clinical trial approval for a pig cell transplant without suppressing a patient's immune system.
Auckland's regional medical ethics committee has approved the company's clinical trial protocols.
LCT planned to resume implanting pig cells in New Zealanders by the end of the year.
The company has said it hopes to commercialise its DiabeCellB pig cell transplants by 2012, targeting a global market of 24 million type-1 diabetes patients.
About 11,000 New Zealanders have type-1 diabetes, which is different from obesity-linked type-2 diabetes.
Type-1 diabetes can start in childhood, and leave patients unable to produce much insulin, which the body uses to process glucose.
They need regular injections of synthetic insulin, but if millions of pig cells inserted into their abdomens can manufacture extra "natural" insulin, their dependence on injections would be reduced.
The company said today it expected Mr Hodgson to accept the regulatory approvals in the next few weeks, so that it could start inserting pig cells into eight type-1 diabetics at Auckland's Middlemore Hospital.
In June it implanted cells from the pancreas of specially-bred New Zealand pigs into the abdomens of six Russians - all adults who had had type-1 diabetes for at least 10 years.
That trial is being held at the Sklifasovsky Institute in Moscow and is being managed by Boston-based GenyResearch Group.
This year, LCT received regulatory approvals from medicines regulator Medsafe and the Gene Technology Advisory Committee, and in May it became the first company to have an internationally-accredited laboratory for testing to ensure the absence of infectious viruses and micro-organisms in pig tissue and a system for monitoring recipients of pig cell implants.
LCT has been working with Medsafe, and the Ministry of Health on setting up a register of xenotransplant recipients and an archive for biological samples, as recommended by the ethics committee.
The national Bioethics Council called in 2005 for transplants of animal tissue into humans to be registered, and for any subsequent medical treatment to be recorded.
People with type-1 diabetes are not able to produce their own insulin because their pancreas cells are not functioning.
LCT has enclosed its pig pancreatic islet cells - which secrete insulin in response to signals from the patient's blood glucose levels - in a gel made from seaweed and branded the product as DiabeCellB.
The two key parts of the research are the seaweed gel stops the "foreign' cells triggering the patient's immune system, and its use of a breeding line of pigs which has been out of contact with "modern" pig diseases for over a century.
Other trials - such as implanting pancreatic cells from brain-dead humans - have required heavy use of immuno-suppressive drugs to avoid rejection by the patient's immune system. Human islet cell transplants cost about $US300,000 ($NZ430,000) a patient.
After two low doses of the pig islet cells over a 12-month period, the Auckland and Moscow patients will be studied for a further year to check the therapeutic effect.
"If the trial is successful, a major stride in developing a better treatment for diabetes will have been accomplished," said Prof Elliott.
One of the six NZ patients he injected with pig islet cells in 1996, Michael Helyer, of Auckland, was still gaining insulin from them when he was tested again last year.
Those trials were halted by then Health Minister Annette King because of fears that pig viruses could infect people.
Since then, LCT, which is listed on the Australian stock exchange, has acquired a ready supply of "safe" cells from two herds of quarantined pigs bred from animals isolated from human and modern pig diseases for 200 years on sub-Antarctic islands.
Dr Tan said regulators had led an international review of the health status of the pig herd and certified its manufacturing plant to standards for supplying medical grade pig cells for use in humans

Article 2







Manuel Elkin Patarroyo (born November 3, 1947) is a Colombian pathologist who developed the world's first synthetic vaccine for malaria, a disease transmitted by mosquitos that affects millions of people in the Third World every year. The vaccine was evaluated in clinical trials carried out by the WHO in Gambia, Tanzania and Thailand, and had mixed results

However, the vaccine has been proven effective at around 30 percent of the times and could save an estimated 1 million lives out of an annual death toll of 3 million; which is the most effective vaccine against malaria to this day.
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