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Immerge BioTherapeutics announces new findings addressing key safety risk in xenotransplantation

Charlestown, MA, July 14, 2003 -- In this issue of the journal Virology, (Vol. 312, Number 2, August 1, 2003) researchers from Immerge BioTherapeutics, Inc., (a BioTransplant Incorporated (Nasdaq:BTRN) /Novartis Pharma AG (NYSE:NYS) joint venture company) announced that recombination between porcine and human endogenous retrovirus was not detected when using sensitive laboratory tests, leading the authors to conclude that the creation of a new virus from the two was highly unlikely. Although the risk of recombination is purely theoretical, it has been of concern to xenotransplant researchers. This study represents an important finding and the most recent advance in the Immerge safety program, which is dedicated to addressing potential issues in the safety risk of pig-to-human xenotransplantation.

"We utilized a laboratory model to simulate PERV (porcine endogenous retrovirus) transmission by infecting human cells with the virus," said Dr Clive Patience, Director of the Safety Program at Immerge. "We found that human retrovirus elements were not detectable in the PERV particles released from the infected human cells. These results are encouraging, as we used very sensitive assays that can detect 1 out of 50,000 to 1 out of 10 million elements. Therefore, if human cells were ever to become infected by PERV, the likelihood of porcine and human viruses recombining to form a novel infectious virus is extremely remote."

PERV is a natural virus in pigs, but does not cause any disease in these animals. In certain laboratory conditions PERV can infect cells from other species, including some human cells. However, there are no indications that PERV infection has occurred in living individuals, including humans that have been treated with pig tissues or those that are in regular direct contact with living pig cells or tissues.

"The risk of cross-species spread of PERV should be balanced by the potential efficacy of the transplanted tissue," comme
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Contact: Susan Hayes
shayesconsult@earthlink.net
212-533-4472
S. Hayes Consulting
14-Jul-2003


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