Partner Pays Collateral $4M for Gene Products
President George W. Bush’s decision to limit funding for stem-cell research leaves one UCSD scientist puzzled and another one disappointed.
“The president’s decision was an important step forward, but I wish it would have been bigger,” said UCSD biologist Larry Goldstein.
Dr. Mark Tuszynski, director of UCSD’s Center for Neural Repair, called the decision a “mistake.”
The president’s televised decision of Aug. 9 followed weeks of wrangling with fundamental questions such as whether frozen embryos constitute human life, and whether should they be thrown out or allowed to be used for research that could save lives.
In the end, Bush settled midway by funding research on more than 60 genetically diverse stem cells lines while banning the use of new embryos.
But rather than ending the debate, the decision sparked a whole slew of new questions.
For one, Goldstein said, there is the question of whether there are actually 60 stem cell lines in exitence. He said he only knows of some 10 to 15 such lines.
“All of us are puzzled where the (cell) lines are, what their properties are, how to get to them and (if) they are any good,” Goldstein said.
He is worried that these lines may be inadequate to answer key scientific questions. He said more genetic variety may be needed to answer fundamental questions.
Then there is the issue of access.
Since many of these cell lines are in private hands, access will be limited and challenging.
“There is concern that private companies will place restrictions on what you can do or not,” said Goldstein.
There is an inherent conflict between private research, which tends to be product-oriented, and public research, which is information-driven, Goldstein said.
Furthermore, if private companies can dictate which areas researchers can pursue, it will slow down the discovery and development process, Goldstein said.
“If you use a cell line that is generated from a company (it) allows you to use it for a defined purpose, but if you discover something new (it can be an unwieldy process to get permission to follow up on it),” he said.
It is likely that academic researchers will find cell lines of better quality in the future, but won’t be able to use them for their own research.
In this light, Tuszynski said it is unfortunate that researchers will no longer be able to use cells created through in vitro fertilization.
“Stem cells exist in large numbers as a consequence of in vitro fertilization (they will be) simply discarded from now on,” he said.
Embryonic stem cells, clusters of eight to 16 cells, can grow into any type of cell that may be used to repair damaged tissue resulting from such diseases as Alzheimer’s and Parkinson’s, he said.
Fertility clinics ask couples whether they want to store left-over embryos or discard them, he said. Most fertility clinics prefer to destroy them to avoid legal problems in the future.
But everyone agrees the stem cell debate is far from being over: That includes patent and property issues of cell lines, scientific concerns, and how much money the National Institutes of Health, which funds the effort, will make available to stem cell research and when.
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Collateral’s collaborate pays dues:
Collateral Therapeutics, Inc. said it has received a $4 million milestone payment from its German development partner, Schering AG, for bringing two gene therapy products into the next stage of development.
Collateral said it will move an experimental gene therapy to treat chest pain resulting from coronary artery disease from Phase I/II into Phase IIb/III trials, and another gene therapy product targeting peripheral vascular disease from animal testing into humans, said Lora Pike, spokeswoman for Collateral.
Pike couldn’t say when the studies will actually begin.
She said however, that the Phase IIb/III should last between 18 and 24 months and will encompass up to 1,000 patients.
The Phase I/II trial should encompass 130 patients and will take place in 6 countries at 10 major sites.
Both trials will be fully funded by Schering, Pike added.
Collateral of San Diego is developing gene therapy products for the treatment of cardiovascular disease.
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