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Biotech / Medical : Biotransplant(BTRN) -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (1177)	1/3/2002 3:50:46 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 1475

Thursday January 3, 3:40 pm Eastern Time Press Release SOURCE: Immerge BioTherapeutics Inc. U.S. Researchers Successfully Clone First Knockout Miniature Swine - Study Represents Important Step Towards Animal-to-Human Organ Transplantation - COLUMBIA, Mo., Jan. 3 /PRNewswire/ -- Researchers from the University of Missouri-Columbia and Immerge BioTherapeutics Inc. (a BioTransplant Incorporated (Nasdaq: BTRN - news)/Novartis Pharma AG (NYSE: NYS - news) joint venture company) reported they have successfully cloned the world's first miniature swine with a specific gene ``knocked out'' of their DNA. This particular knockout moves scientists closer to making animal-to-human organ transplantation a reality, offering additional hope to the more than 75,000 Americans currently awaiting organs, 16 of whom die each day while waiting. The pigs were born on September and October 2001, and are reported online today by the journal Science at the Science Express web site (www.sciencexpress.org). ``The greatest challenge in xenotransplantation -- or the transplanting of a cell, tissue or organ from one species to another -- is overcoming the body's massive immune response after it perceives a 'foreign' organ,'' said Randall Prather, Ph.D., MU Distinguished Professor of Reproductive Biotechnology. ``This modification eliminates the gene that triggers this response, opening the door for further advances.'' The aggressive (hyperacute) rejection response seen in previous research occurs when human antibodies attach to sugar molecules on the surface of the transplanted pig organ's cells. Once they attach, the antibodies kill the cells. In this particular line of miniature swine, however, the gene that produces this sugar molecule, called alpha-1,3-galactosyltransferase or GGTA1, has been eliminated. Without the sugar, the antibodies can't attach, and therefore the rejection process can't begin. Today's report represents the first targeted modification of the pig genome and only the second in any large animal. It also is the first nuclear transfer-derived miniature swine. The choice of pig line is another unique feature of this study and represents advancement towards an important safety hurdle for xenotransplantation. ``We have been actively developing a line of miniature swine that offers many advantages as a potential donor for xenotransplantation, including their organ size, which is appropriate for human recipients,'' said Julia Greenstein, Ph.D., CEO and President, Immerge BioTherapeutics Inc., whose company knocked out the GGTA1 gene. ``Another advantage is that preliminary research shows that cells from this line of pigs, in contrast to most other cells tested, don't have the capacity to spread porcine endogenous retrovirus to human cells in culture.'' Endogenous retroviruses are part of the natural genetic makeup of all mammals and are not believed to cause any illness to the species that they inhabit. Although the risk of any harm posed by PERV to xenotransplant recipients may be purely theoretical, use of this line of miniature swine would help minimize this particular risk of this new technology. ``Based on the success reported today, we can now proceed with pig strains chosen solely for their advantages in xenotransplantation rather than their large-scale availability,'' said Robert Hawley, Ph.D., Associate Director of Animal Genetic Engineering, Immerge BioTherapeutics Inc. ``We believe this line of miniature swine offers the greatest potential for clinical use in humans, and we're working closely with the University of Missouri-Columbia and our commercial partner, Infigen Inc., to develop these swine with this goal in mind.'' The University of Missouri-Columbia has a long-standing research collaboration with Immerge BioTherapeutics and BioTransplant Incorporated in the field of porcine genetic engineering. The current collaboration is supported by a National Institutes of Health Small Business Innovative Research grant. Immerge BioTherapeutics was formed on September 26, 2000, as a joint venture between Novartis Pharma AG and BioTransplant Incorporated. The company, which began operations on January 2, 2001, focuses its research efforts toward developing therapeutic applications for xenotransplantation. The name of the company derives from its use of immunology to address the challenges of conducting transplants between species. SOURCE: Immerge BioTherapeutics Inc.

To: Icebrg who wrote (1177)	1/4/2002 5:33:31 PM
From: Icebrg	Read Replies (1) \| Respond to of 1475

PPL Therapeutics licks its wounds over pig cloning accusation By David Firn in London Published: January 4 2002 18:52 \| Last Updated: January 4 2002 18:56 Cloned pigs that produce organs for human transplant may well go down in history as one of the biggest medical achievements of the 21st century. But PPL Therapeutics has walked into a storm of criticism over its claims to have won the race to unveil cloned pigs with a key for organ rejection removed. The Scottish biotechnology company on Friday was licking its wounds after accusations from leading scientists that it put out the news with little regard for scientific convention, merely to claim victory over its US rival Immerge BioTherapeutics. PPL's piglets offer hope to hundreds of thousands of people who need organ transplants - a market worth up to $5bn. However, its shares, which soared 46 per cent to 77½p on Wednesday, fell 15.8 per cent to 62p on Friday, after it emerged that PPL had been beaten by its rivals, who had waited for independent scientific confirmation before revealing their achievement. Glenn McGee, editor of the American Journal of Bioethics, said growing disregard for the peer-review process was turning basic science into a circus, with cute cloned pigs and human embryos as the acts. Art Caplan, director of the University of Pennsylvania Center for Bioethics said there was a danger that without peer reviews, bogus research could be presented as truth, threatening scientific progress. PPL's decision to circumvent the rules of the scientific establishment highlights a dilemma for companies operating at the forefront of research. Traditionally, scientific breakthroughs reach the world through the filter of peer review journals. A thorough analysis of the data by leading scientists working in the field is supposed to ensure the results are robust. Even for academics, the wait is fraught with fears that rival groups may win kudos by publishing faster but companies face the added complication that discoveries are price sensitive information. Keeping them out of the market may put them in breach of Stock Exchange rules. PPL denies it attempted to scoop its competitors. It said it had made a deliberate decision to announce its breakthroughs directly to the press and stock market in 1997, after it was criticised by the financial community for waiting seven months to reveal the existence of Dolly in the journal Nature. Dolly was created in collaboration with the Roslin Institute, a public sector establishment. "Scientists talk to each other. People do find out what you've done, so you can't wait to publish in a peer review journal," the company said. That Dolly's creation was price sensitive is beyond doubt. PPL shares leapt 66 per cent to an all time high of £5.55 when her birth was finally reported. PPL says its scientists had checked that the five piglets really were genetically modified before making an announcement. However, Richard Smith, editor of the British Medical Journal, says he is suspicious of any claims that were not backed up by relevant data. "If you are another scientist whowants to review what they have done, you have nothing to go on if there is only a press release." he says. Melanie Toyne-Sewell, a life sciences specialist at Financial Dynamics, a PR agency, says companies are wary of releasing data about their discoveries because it can jeopardise chances of subsequent publication in a journal. "Peer review publications are an important marketing tool, because of their independence," she says. "But keeping important news it secret may breech the FSA rules." Ruth Matthews, a professor of immunology who also runs NeuTec Pharma, a Manchester drug development company, says there is another argument for releasing news of breakthroughs. "When you work in a hospital seeing people dying every day, you want to get news out as quickly as possible," she says. PPL is not the first company to eschew peer review for its discoveries and despite the howl of disapproval it will not be the last. With the completion of the Human Genome Project and the emergence of biotechnology as the drug discovery powerhouse of the pharmaceutical industry, research results are becoming a more important tool for raising funds. PPL does not have enough money to commercialise its xenotransplant work and is seeking a backer for the technology. The company's spin doctors may have raised hackles in the scientific community but they undoubtedly caught the attention of financiers. news.ft.com