By Kim Coghill
WASHINGTON ¿ Ever since BresaGen Inc. announced in mid-summer that it had isolated four human stem cell lines, the Athens, Ga., company has been approached by numerous companies searching for collaborative deals.
And the offers are expected to continue following the government¿s release Monday of 10 organizations worldwide whose embryonic stem cell lines are expected to qualify for federal funding for research.
BresaGen, an Australian-based company that opened its U.S. office in December, isolated its four stem cell lines in the last few months, Chris Juttner, the company¿s vice president of clinical development, told BioWorld Today. ¿We believe it is important to isolate more stem cells, particularly because of the issue of xenotransplantation,¿ he said.
But any derivation process that started after 9 p.m. on Aug. 9 will not be eligible for federal money. At that time in a televised address, President Bush told the nation that the 64 or so existing stem cell lines would qualify for federal funding for research. The decision changed ex-President Bill Clinton¿s executive order from a year ago that allowed federal funding of embryonic stem cell research, as long as a private company collected the stem cells.
Aside from BresaGen, other U.S. organizations on the list are CyThera Inc., of San Diego; the University of California, San Francisco; and the Wisconsin Alumni Research Foundation (WARF) in Madison, Wis.
Geron Corp., of Menlo Park, Calif., funded the research at WARF that resulted in the derivation of stem cells in 1998. WARF has filed a lawsuit against Geron questioning the company¿s option to negotiate certain rights. Representatives from Geron could not be reached for comment Monday, but immediately following the Bush decision, Thomas Okarma, Geron¿s president and CEO, released a prepared statement saying, ¿We are very pleased that academic and government laboratories will be able to gain access to these pluripotent cells and explore a broad range of research opportunities. We expect to be collaborating with some of those laboratories.¿
WARF was issued the patent on human pluripotent embryonic stem cells and negotiated a commercial license for a limited number of cell types to Geron.
Juttner said BresaGen has licenses to the Wisconsin blastocysts. ¿In our view, this is going to be an area where the development of successful therapies is going to produce a large amount of intellectual properties. There will be a lot of commercial cross-licensing going on before any products are developed.¿
Stem cells are the master cells for human development and scientists believe that the cells could be critical in developing cures for diseases and conditions, including juvenile diabetes, Parkinson¿s, Alzheimer¿s, cancer, heart disease and spinal cord injury.
Juttner said BresaGen¿s interest is in Parkinson¿s, spinal cord injury and potentially stroke and Alzheimer¿s.
CyThera¿s initial focus will be on the development of functional islet cell transplants for insulin-dependent diabetics, a statement from the company said.
CyThera¿s nine derivations have not been fully characterized, according to the company, but when they are, CyThera said it will make them available to the research community.
Under the president¿s new regulations, stem cell lines eligible for funding must have been collected from an embryo that was created for reproductive purposes and was no longer needed. Also, informed consent must have been obtained for the donation of the embryo and the donation must not have involved payment.
The National Institutes of Health in Bethesda, Md., released a statement Monday that said the 64 existing stem cell lines are viable, show characteristic stem cell morphology, can be maintained frozen, as well as in culture, and have undergone at least several population doublings.
A majority of the cells were reported to express all of the markers known to be associated with human embryonic stem cells, including stage-specific embryonic antigens (SSEA-3 and SSEA-4), the enzyme, alkaline phosphatase, and tumor rejection antigen 1 (TRA-1 60 and TRA-1-81), the NIH said. The cells reportedly can be frozen and thawed and continue to grow while maintaining their karyotype. In many cases, the NIH said, the laboratories reported they had assayed the cells for pluripotency by injecting the cells into immune-deficient mice and showing the formation of ectodermal, endodermal and mesodermal tissues.
The NIH intends to create a registry that will list human embryonic stem cells that meet eligibility requirements.