|
Company
Plans to Submit Evaluation of Milk to FDA DEFOREST, Wis., June 26 /PRNewswire/ -- Infigen, Inc. announced today that the world's first herd of cloned dairy cows is in milk production at the company's farms. Infigen is a privately held biotechnology company merging genomics and reproductive technologies to advance both animal agriculture and human health. The milk will be evaluated and compared with milk from non-cloned Holsteins, as a part of the company's review to be shared with the United States Food and Drug Administration and the National Academy of Sciences (NAS). The 18 cloned two year old cows began production following calving, beginning in December, 2000. Several different cell lines are represented in the milking herd. One may remember the BF-15 cloned bovines as heifers on display by Infigen at World Dairy Expo in 1999. All milk from the 305-day lactation cycle will be sampled and tested but will never enter the human food chain. Complete analysis and testing is being done by two independent entities, the University of Madison and Utah State University. Results from the first lactation period will be finished by the end of this year. "This is the world's first all-clone dairy. It will be used for research and to demonstrate the viability of cloned dairy animals in a commercial environment," said Dr. Michael Bishop, President and Chief Scientific Officer of Infigen. Milk from the cloned cows has tested normally in preliminary evaluations. Infigen does not expect the components in the milk to differ since, in essence, this is exactly like milk from identical Holstein twins, to ensure there have been no new components added to the milk or any normal components subtracted due to the Nuclear Transfer (NT) process. Proteins, minerals, lactose, and fat components of the milk from the clones are broken down and then compared to the same from the control group of non-cloned cows. Milk functionality tests are also being used to determine how the milk performs when making products such as cheese. "This will be the first milk analysis ever completed in a herd of clones," said Dr. Marvin Pace, Senior Scientist and Director of Farm Operations for Infigen. This herd demonstrates that cloned animals, produced by using Infigen's patented NT process, can reach sexual maturity and be healthy, uniform, calve naturally, and perform normally in a typical dairy environment. These clones also give merit to an unlimited number of possible uses of cloned animals that are genetically identical for research and production purposes. "The uniqueness of several genetically identical animals provides the opportunity to better understand what production outcomes result from environmental factors and those that result from genetics," said Greg Mell, Livestock Manager for Infigen. To continue its educational efforts, the company has presented its plans for the demonstrational herd to the FDA and NAS to inform them that the milk product is safe and the animals are not genetically modified. Infigen officials will publish a peer-reviewed paper analyzing the data of the tests from the cloned milking herd later this summer. "We have been very proactive with the FDA and NAS," said Dr. Bishop. "Although Infigen does not believe there is any scientific basis for differences in food products from clone versus non-clone animals, we realize that we are ultimately accountable to the consumer to provide this evidence." Currently, the FDA is urging companies to submit Investigational New Drug applications (INDA) if they send any "unmodified" cloned animals to market. The FDA has signed a contract with the NAS to conduct a study to determine if the cloning of "unmodified" animals presents any food, animal or environmental safety issues. ABOUT INFIGEN, INC. AND GENMARK: Infigen, Inc., formed in August 1997, is a privately held biotechnology company commercializing its proprietary nuclear transfer cloning in the human health and animal agriculture fields. The company has other existing strategic partnerships with Pharming N.V. to produce human therapeutics from the milk of transgenic cattle and Immerge BioTherapeutics, Inc., a joint venture of Novartis Pharma AG and BioTransplant Incorporated (NASDAQ:BTRN), to develop genetically modified miniature swine for the study of xenotransplantation (transplantation between species). In 2000, Infigen was issued a U.S. patent covering critical processes for cloning any mammal, excluding humans, utilizing Nuclear Transfer. Infigen markets its agricultural products under the trademark name of Genmark. In addition to its AgriCloning(TM) products, Genmark also markets marker assisted selection, diagnostic testing, and tissue/cell harvesting and storage. For further information on Infigen and Genmark, visit http://www.infigen.com and http://www.genmarkag.com This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and other activities. http://news.excite.com/news/pr/010626/wi-infigen-clone-cows
Back to GeneticEngineering.net
|
