Feb. 20 /PRNewswire/ -- BioTransplant Incorporated (Nasdaq: BTRN - news), Immerge BioTherapeutics Inc. and Massachusetts General Hospital (MGH) announced today the issuance of the US patent 6190861 entitled ``Molecular Sequence of Swine Retrovirus and Methods of Use.'' The patent is exclusively licensed to BioTransplant and Immerge BioTherapeutics, its joint venture with Novartis Pharma AG. It is based on work by Jay Fishman, M.D., a physician in Infectious Disease and Transplantation at MGH, and an Associate Professor of Medicine at Harvard Medical School. This work provides key tools for further documenting the safety of pig to human xenotransplantation.
The patent describes a method for screening cells or tissue to look for the presence or expression of swine or miniature swine retrovirus. The patent also includes a screening method to check the presence of retroviruses in porcine genome. These methods can assess the potential risk of porcine endogenous retrovirus (PERV) infection associated with the transplantation of a graft from a porcine donor into a human recipient. These procedures may eventually provide the capability for screening and/or treating a human subject for the presence or expression of PERV, which has important ramifications for the success of xenotransplantation.
``The MGH has an important research program in transplantation,'' says Fishman. ``The cloning of porcine endogenous retrovirus is a part of an effort to assess potential risks associated with xenotransplantation from swine to humans. Hopefully, our studies will ultimately contribute to the safety of clinical xenotransplantation. Studies of this family of viruses have also evolved into an exciting new area of biomedical research.''
There is a critical shortage of human donor organs used to treat end-stage organ failure. Xenotransplantation is thought to be a potential answer to address this overwhelming clinical need. Pigs have been identified as the animal donor species best suited for use in xenotransplantation. The removal of the constraint of organ availability by xenotransplantation will mean that transplants can be planned and performed when the patient is in an improved state of health, because pig organs of high medical quality will be available when the patient needs them. If xenotransplantation is successful, these organs will be available on demand in sizes to meet patient needs. Not only are thousands of lives expected to be saved, but also a significant improvement in quality of life for recipients is anticipated.
Julia L. Greenstein, Ph.D., President and CEO of Immerge BioTherapeutics says: ``The issuance of this patent illustrates our commitment to the safety issues involved in xenotransplantation. Additionally, this important patent will serve as a basis for our future development of therapeutic and diagnostic approaches useful to xenotransplantation.''
The immune response of the recipient is the major barrier to clinical xenotransplantation. To overcome this barrier, attention has recently turned to the possibility of using genetically modified pigs as a source of cells and organs. Work is being actively done both to add genes to control the immune response to the transplanted tissue and to remove porcine genes that are responsible for this reaction. The ability to quantitate quickly and efficiently a risk factor for the transplantation of porcine organs into humans using technology covered in this patent represents a milestone in the advancement of xenotransplantation toward the clinical arena.
Fishman's work augments a portfolio of data supporting clinical applicability of xenotransplantation. Previously, Dr. Clive Patience of BioTransplant presented data at the International Congress of the Transplantation Society in Rome (August, 2000) that suggested the company may have characterized a proprietary breed of miniature swine that does not produce PERV that is capable of productively infecting human cells.
Immerge BioTherapeutics, a new company formed as a joint venture between BioTransplant and Novartis Pharma AG, integrates the work previously done by both parent organizations in xenotransplantation. The creation of Immerge signals the joint commitment of Novartis and BTI to achieve clinical and commercial success for xenotransplantation based on their ongoing multi-year collaborations. Its research is focused on the development and therapeutic applications of xenotransplantation of cells, tissues and organs using miniature swine as potential donors.... |
