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For you EPO lovers, there is a new version of EPO coming out. Monkeyballs you may enjoy this one. Here is the poop thanks to CyclingNews.com. I have edited the article and the full version is available here: DynEPO: A new form of EPO undetectable by the UCI's urine test by Anthony Tan Cyclingnews.com
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DynEPO: A new form of EPO
In the ongoing battle against doping in sport, it seems there's always a new substance on the horizon that the detection bodies don't know about or can't detect. The imminent release of DynEPO, a new version of the commonly-used EPO will require another round of modifications to the current testing regime, as Anthony Tan writes.
A leading sports scientist has claimed that DynEPO - the latest drug approved by the European Union to fight kidney disease - poses a very serious threat to the cycling community. Although not wishing to be named for political reasons, the potential danger to endurance athletes, particularly within the sport of cycling, is clearly apparent:
"DynEPO is now much closer to the real thing - it looks just like normal human EPO, which means that even though it is produced via recombinant DNA techniques, the final product would not be detected by the urine test."
As the name implies, DynEPO (epoetin delta) is a variant of human erythropoietin - a hormone that stimulates "erythropoiesis", the natural production of red blood cells in the body. DynEPO has been designed for the treatment of anaemia related to chronic renal (kidney) disease - specifically for patients receiving or about to undergo dialysis, to elevate and maintain their red blood cell production.
"In theory, it would be undectectable by the urine test"
The claim that DynEPO will be undectable by the urine test developed by the French national doping laboratories in Châtenay-Malabry is of considerable concern, as the urine test has been the standard protocol for detection of EPO and its variants (such as NESP) since April 1 last year.
The good news is that the UCI is already aware of DynEPO. When Cyclingnews questioned Dr Mario Zorzoli, the high-profile Chief Medical Officer for the UCI, his response was:
"If you're talking about DynEPO, we're already on this one."
The bad news is that the UCI confirmed the urine test's inability to detect DynEPO:
"From what we have heard, DynEPO is produced naturally by human cells, not animal cells, so in theory, it would be undectectable by the urine test."
A blood test developed by the scientists at the Australian Institute of Sport has been used during the last two Olympic Games, and was instrumental in detecting the use of NESP (novel erythropoiesis stimulating protein or darbepoietin alpha, another synthetic form of EPO) by several cross-country skiers at Salt Lake City. However a quirk in the IOC rules meant they were allowed to keep their medals before subsequent testing, and were only stripped of medals won after the urine tests were also confirmed positive.
Capacity has been cited as an issue on a number of occasions. Only 10 to 15 athletes underwent the blood test for NESP at the Winter Olympics, because (according to the IOC) of the limited capacity of the laboratories - for example, over 30 hours of lab time were required to perform tests on the blood of Spanish cross-country skier Johann Muehlegg before he was declared positive.
Why create a new EPO?
If standard EPO is an effective therapy, why are pharmacological companies creating new forms? Once again, it's a question of money – not a lack of it, but everyone wanting a slice of the protein therapeutics pie that's worth over US$20 billion and growing.
Standard EPO has been in use since the 1970s to treat chronic renal failure, and the biotechnology firms that produce EPO have sought and obtained patent protection covering many of the genetic engineering techniques they use. Given the size of the market for protein therapeutics, those companies with a patent in place effectively raise the barriers of entry and at the same time, substantially increase their wealth.
A lesser reason is that conventional genetic engineering techniques for protein production may face technical limitations arising from the need to first clone the gene of interest. For certain proteins, this step adds to development times, increases costs and is technically challenging. Technical difficulties may also arise from the use of non-human production cell lines, which may result in the production of proteins that have therapeutically significant differences from those naturally produced by the cells of the human body.
Furthermore, production processes based on conventional genetic engineering may not have incorporated recent advances compared to processes originally developed over a decade ago.
In an effort to overcome these commercial barriers and technical limitations, Transkaryotic Therapies (TKT) has developed "gene activation" technology for the production of therapeutic proteins that does not rely on the manipulation of cloned genes.
Using its proprietary technology, TKT has succeeded in producing therapeutic proteins in human cells by bypassing regulatory DNA sequences set in the "off position" with regulatory DNA sequences set in the "on position" in order to activate the gene of interest (click here for a diagrammatic explanation).
Gene targeting is a technology by which DNA fragments can be "cut and pasted" precisely at pre-selected locations within the cell's genome. Gene targeting can be thought of as molecular surgery, with the surgical tools literally functioning at the molecular level.
Via gene targeting, cells have the capacity to align two homologous DNA sequences (two sequences that are quite similar) and exchange one with the other - allowing the cell to exchange the new active sequences in place of the old inactive ones. The new sequences must be introduced precisely in order to allow the proper initiation of gene expression.
The ability to detect use of these cloned cells will be the next challenge for the detection agencies
Legal wrangling delays global release
On March 26, 2002, the European Commission granted Transkaryotic Therapies (TKT), the biopharmaceutical company that has developed DynEPO, marketing authorisation for the fifteen countries of the European Union.
In a collaborative agreement, Transkaryotic Therapies will engage the services of Aventis Pharma, the pharmaceutical company of Aventis Worldwide, to propagate and market DynEPO for full-scale commercial production.
However TKT and Aventis are currently involved in litigation with both Amgen Inc and Kirin-Amgen Inc relating to the commercial production and sale of DynEPO.
California based Amgen is the world's largest biotechnology company, and are the proprietary owners for Epogen (Epoetin Alfa) - a substance much the same as Erythropoietin (EPO) - and Aranesp (NESP). Amgen developed EPO, Epogen and NESP to enable cancer and kidney disease patients to fight anemia.
Last year, the U.S. District Court for the District of Massachusetts concluded that DynEPO infringed several claims of patents asserted by Amgen, and the High Court of Justice in the United Kingdom ruled that DynEPO infringed one claim of a patent asserted by Kirin-Amgen.
In both the U.S. and U.K., TKT and Aventis have filed appeals with decisions expected by 2003. With appeals pending in both the U.S. and U.K., a launch of DynEPO has not yet been planned.
>>>
The above article was reprinted for entertainment only.
FHG
<<<
DynEPO: A new form of EPO
In the ongoing battle against doping in sport, it seems there's always a new substance on the horizon that the detection bodies don't know about or can't detect. The imminent release of DynEPO, a new version of the commonly-used EPO will require another round of modifications to the current testing regime, as Anthony Tan writes.
A leading sports scientist has claimed that DynEPO - the latest drug approved by the European Union to fight kidney disease - poses a very serious threat to the cycling community. Although not wishing to be named for political reasons, the potential danger to endurance athletes, particularly within the sport of cycling, is clearly apparent:
"DynEPO is now much closer to the real thing - it looks just like normal human EPO, which means that even though it is produced via recombinant DNA techniques, the final product would not be detected by the urine test."
As the name implies, DynEPO (epoetin delta) is a variant of human erythropoietin - a hormone that stimulates "erythropoiesis", the natural production of red blood cells in the body. DynEPO has been designed for the treatment of anaemia related to chronic renal (kidney) disease - specifically for patients receiving or about to undergo dialysis, to elevate and maintain their red blood cell production.
"In theory, it would be undectectable by the urine test"
The claim that DynEPO will be undectable by the urine test developed by the French national doping laboratories in Châtenay-Malabry is of considerable concern, as the urine test has been the standard protocol for detection of EPO and its variants (such as NESP) since April 1 last year.
The good news is that the UCI is already aware of DynEPO. When Cyclingnews questioned Dr Mario Zorzoli, the high-profile Chief Medical Officer for the UCI, his response was:
"If you're talking about DynEPO, we're already on this one."
The bad news is that the UCI confirmed the urine test's inability to detect DynEPO:
"From what we have heard, DynEPO is produced naturally by human cells, not animal cells, so in theory, it would be undectectable by the urine test."
A blood test developed by the scientists at the Australian Institute of Sport has been used during the last two Olympic Games, and was instrumental in detecting the use of NESP (novel erythropoiesis stimulating protein or darbepoietin alpha, another synthetic form of EPO) by several cross-country skiers at Salt Lake City. However a quirk in the IOC rules meant they were allowed to keep their medals before subsequent testing, and were only stripped of medals won after the urine tests were also confirmed positive.
Capacity has been cited as an issue on a number of occasions. Only 10 to 15 athletes underwent the blood test for NESP at the Winter Olympics, because (according to the IOC) of the limited capacity of the laboratories - for example, over 30 hours of lab time were required to perform tests on the blood of Spanish cross-country skier Johann Muehlegg before he was declared positive.
Why create a new EPO?
If standard EPO is an effective therapy, why are pharmacological companies creating new forms? Once again, it's a question of money – not a lack of it, but everyone wanting a slice of the protein therapeutics pie that's worth over US$20 billion and growing.
Standard EPO has been in use since the 1970s to treat chronic renal failure, and the biotechnology firms that produce EPO have sought and obtained patent protection covering many of the genetic engineering techniques they use. Given the size of the market for protein therapeutics, those companies with a patent in place effectively raise the barriers of entry and at the same time, substantially increase their wealth.
A lesser reason is that conventional genetic engineering techniques for protein production may face technical limitations arising from the need to first clone the gene of interest. For certain proteins, this step adds to development times, increases costs and is technically challenging. Technical difficulties may also arise from the use of non-human production cell lines, which may result in the production of proteins that have therapeutically significant differences from those naturally produced by the cells of the human body.
Furthermore, production processes based on conventional genetic engineering may not have incorporated recent advances compared to processes originally developed over a decade ago.
In an effort to overcome these commercial barriers and technical limitations, Transkaryotic Therapies (TKT) has developed "gene activation" technology for the production of therapeutic proteins that does not rely on the manipulation of cloned genes.
Using its proprietary technology, TKT has succeeded in producing therapeutic proteins in human cells by bypassing regulatory DNA sequences set in the "off position" with regulatory DNA sequences set in the "on position" in order to activate the gene of interest (click here for a diagrammatic explanation).
Gene targeting is a technology by which DNA fragments can be "cut and pasted" precisely at pre-selected locations within the cell's genome. Gene targeting can be thought of as molecular surgery, with the surgical tools literally functioning at the molecular level.
Via gene targeting, cells have the capacity to align two homologous DNA sequences (two sequences that are quite similar) and exchange one with the other - allowing the cell to exchange the new active sequences in place of the old inactive ones. The new sequences must be introduced precisely in order to allow the proper initiation of gene expression.
The ability to detect use of these cloned cells will be the next challenge for the detection agencies
Legal wrangling delays global release
On March 26, 2002, the European Commission granted Transkaryotic Therapies (TKT), the biopharmaceutical company that has developed DynEPO, marketing authorisation for the fifteen countries of the European Union.
In a collaborative agreement, Transkaryotic Therapies will engage the services of Aventis Pharma, the pharmaceutical company of Aventis Worldwide, to propagate and market DynEPO for full-scale commercial production.
However TKT and Aventis are currently involved in litigation with both Amgen Inc and Kirin-Amgen Inc relating to the commercial production and sale of DynEPO.
California based Amgen is the world's largest biotechnology company, and are the proprietary owners for Epogen (Epoetin Alfa) - a substance much the same as Erythropoietin (EPO) - and Aranesp (NESP). Amgen developed EPO, Epogen and NESP to enable cancer and kidney disease patients to fight anemia.
Last year, the U.S. District Court for the District of Massachusetts concluded that DynEPO infringed several claims of patents asserted by Amgen, and the High Court of Justice in the United Kingdom ruled that DynEPO infringed one claim of a patent asserted by Kirin-Amgen.
In both the U.S. and U.K., TKT and Aventis have filed appeals with decisions expected by 2003. With appeals pending in both the U.S. and U.K., a launch of DynEPO has not yet been planned.
>>>
The above article was reprinted for entertainment only.
FHG
