Sunday, December 10, 2006

Reneuron Seeks FDA OK For Human Stem Cell Trials

Stem cell specialist Reneuron (RENE.LN) said Wednesday it's seeking approval from the U.S. Food and Drugs Administration to start testing its stroke therapy, ReN001, on human patients.

The Surrey, U.K.-based company, which has a market capitalization of less than GBP15 million, wants to conduct the trials on 12 humans. Trials on paralyzed rats showed that they regained some movement after treatment.

The trials would involve the injection of stem cells - taken from an aborted foetus - directly into the patients' brains. The tests would be carried out the Medical Centre at the University of Pittsburgh, with the patients under local anasthetic.

The news, which has sparked much ethical debate, drove ReNeuron shares almost 30% higher in early trading on London's Alternative Investment Market, AIM. At 1002 GMT, they were up 31%, or 4.6 pence, at 19.50 pence.

Chief Executive Michael Hunt said the company has already had "extensive" talks with the regulator and is "pretty confident".

Hunt believes the company will be able to meet concerns they FDA may have over the therapy's safety.

He said his team had sourced all the tissue it needed from one foetus.

"We're open about what we do. Clearly, there's an ethical issue here - but we have no need to extract more tissue, it was done with full maternal consent and it's also important to look at the patient benefit angle."

The use of embrionic stem cells - immature cells that have yet to have a function - destroys the embryo, and research in this area has sparked fierce ethical and moral debate. A different type of stem cell, known as adult cells, can be sourced from umbilical cords and bone marrow.

Hunt said the company will be tapping the market for further cash in the coming year.

The U.K. is seen as a supportive environment in which to conduct stem cell research, and the sector has received considerable Government support.

The Australian Parliament Wednesday lifted its ban on cloning human embryos for stem cell research, despite opposition from the prime minister and other party leaders. However, the anti-stem cell research in the U.S. remains very vocal. In 2001, President George Bush vetoed the use of public funds for stem cell research.

Reneuron has had a bumpy ride on the stock exchange. Founded in 1997 by scientists at London's Kings College, the company initially listed in 2000, valued at around GBP60 million, only to be taken private in 2003 for GBP3.6 million. The group subsequently relisted in 2005 at 25 pence per share.

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