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UPDATE 1-Oxford Bio says FDA supports TroVax plans

Mon Jul 6, 2009 3:43am EDT

Stocks

   

* FDA invites plans to develop drug in colorectal cancer

* FDA clears TroVax of causing more deaths in failed trial

* Shares rise 6.4 pct (Adds details and analyst comments)

LONDON, July 6 (Reuters) - British gene therapy specialist Oxford BioMedica (OXB.L) said on Monday that a ruling by U.S. regulators has cleared the way for it to develop its lead drug in a range of cancers, following a review of a failed trial.

TroVax, which is being developed with Sanofi-Aventis (SASY.PA), missed a key goal in a Phase III renal cancer trial in July last year, causing a key safety board to stop its development. [ID:nL11567522]

Now, the U.S. Food and Drug Administration (FDA) has completed a review of the renal cancer data, and has supported the company's proposals to develop TroVax in other cancers, including colorectal cancer.

The regulator acknowledged that confounding factors may have contributed to the increased number of deaths in the renal trial, and said there was no evidence that could attribute the imbalance of deaths to TroVax.

The result clears the way for partner Sanofi to develop the drug for colorectal cancer.

"TroVax is not dead and is an ignored asset with value," said Ian Wainwright, managing director life sciences specialist sales at brokerage Canaccord Adams, in an email.

By 0707 GMT shares were up 6.4 percent to 12.75 pence per share.

(Reporting by Ben Deighton; editing by Simon Jessop)



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