Advanced Cell Technology receives broad United States patent covering method of nuclear transfer for non-human mammalian cloning.

Advanced Cell Technology, Inc. (Worcester, MA; 508-756-1212) announced that the United States Patent and Trademark Office has issued a patent (5,945,577) covering an improved method of cloning non-human mammals using nuclear transfer technology. This technique, which allows scientists at the company to create identical cells and animals either with or without genetic modifications, has broad utility for numerous applications in human therapeutics and agriculture, including generation of cloned cells for transplantation and efficient production of biopharmaceuticals in transgenic animals.

The proprietary process was first disclosed by the University of Massachusetts (Amherst, MA) and Advanced Cell in January 1998, when the company announced the birth of George and Charlie, the first cloned transgenic cows produced from genetically altered bovine somatic (body) cells. Advanced Cell is the exclusive licensee of the United States patent, which was issued to The University of Massachusetts.

"This patent represents the broadest claims ever issued in the field of cloning," said Michael D. West, PhD, president and CEO of Advanced Cell. "Specifically, the patent covers clones of any non-human mammalian species, generated from any adult or fetal somatic cell, during any phase of the cell growth cycle except quiescence. We look forward to commercializing this unique method through our existing corporate partner, Genzyme Transgenics, and through licensing to additional collaborators in many and diverse applications."

Through its ongoing collaboration with Genzyme Transgenics (Cambridge, MA), Advanced Cell is applying its nuclear transfer technology to create herds of genetically identical animals capable of producing human pharmaceuticals in their milk. The results of the company's first transgenic clone studies were published in the May 22, 1998 issue of Science. Advanced Cell is also pursuing additional applications for its proprietary cloning method, including generation of genetically modified animal cells and human stem cells with improved compatibility for use in human transplant medicine. These tissues may be suitable for treating a wide range of life-threatening disorders including heart failure, diabetes and neurological diseases such as Parkinson's disease and spinal cord injury.

Claims allowed by the issued patent broadly cover an improved method of nuclear transfer involving the transplantation of any somatic (body) cell type into an oocyte, or egg cell, from which the nucleus has been removed. Transfers are performed between same species, non-human mammalian cell and egg donors. All cells, tissues and embryos created through this method are covered by patent claims, and may be genetically manipulated and multiplied subsequent to undergoing nuclear transfer. Unlike other cloning methods, which perform nuclear transfer using donor somatic cells in a quiescent state, Advanced Cell's proprietary method covers transfer of somatic cells during any non-quiescent phase of the cell cycle.

"The significance of this somatic cell technology is that it enables us to clone an animal which expresses a trait of interest, as opposed to using an embryonic cell which may or may not express a preferred trait," commented James Robl, PhD, Professor of Veterinary and Animal Science at the University of Massachusetts and Co-founder of Advanced Cell. "This patent recognizes the fundamental distinction between these two approaches." In addition to Dr. Robl, inventors on the new patent are Jose B. Cibelli, Paul J. Golueke, D. Joseph Jerry, F. Abel Ponce de Leon and Steven L. Stice.

Advanced Cell is leading the application of cloning technology for use in human medicine. Formed in 1994, the company's focus is on the development of cloned transgenic cows to produce human pharmaceuticals in milk. The company is also leading in the development of cloned transgenic animals for use in cell and tissue transplantation, and generation of cloned human stem cells for therapeutic applications in medicine.