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Posted On: 01/14/2019 4:13:18 PM
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(10.01.2019) Heavily homeland, financial crisis in the USA, defective devices - an Alzheimer's blood test developed in Leipzig could have been on the market for a long time.
Classically, you get the definite diagnosis "Alzheimer's" only after death. Because only postmortem the pathologist can detect amyloid plaques and neurofibrillary tangles, the typical signs of the disease, in the patient's brain tissue.
Although amyloid-positron-emission-tomography, amyloid-PET for short, is a method for early diagnosis, it is very expensive and only available in large medical centers. Would not it be nice to have a simple, non-invasive test that you could do at home or at the family doctor? In fact, this could happen soon, but the way there was long and muddled.
Alzheimer's lymphocytes are different
It all began about 20 years ago when Leipzig neuroscientists around Thomas Arendt made an extraordinary observation. Lymphocytes of Alzheimer's patients behave differently than the immune cells of healthy people. "It has also been reported in other organs over and over again that non-neuronal cells in a disease of the central nervous system mitreagieren," says Arendt in the Labor Journal interview. "In depression, for example, you also see changes in peripheral immune cells."
In the case of Alzheimer's lymphocytes react less strongly to a mitogenic stimulus than control cells, which are first activated and then multiply. Alzheimer's lymphocytes apparently have a problem with proliferation. This observation fits well with a hypothesis that tries to explain the clinical picture of Alzheimer's - the " Cell Cycle Dysregulation " hypothesis. This states that neurons, which normally no longer divide and remain in the G0 phase of the interphase, suddenly reenter the cell cycle. However, they do not go through the cycle completely, but become stuck in the G2 phase (just before the core split).
Mechanism unknown
The cell cycle thus appears to be disturbed both in the neurons and in the immune cells of Alzheimer's patients. "What is at the root of this and what mechanisms provide this answer, which we simply use phenomenologically, is still unknown," says Arendt. However, the mechanisms of the diagnostic test from Leipzig, the LymPro test, are clear: "Ultimately, it is an activation test with peripheral blood lymphocytes," summarizes the scientist. "The test is based on patient blood sampling, which is considered non-invasive - any form of invasive early diagnosis is always problematic. Then the lymphocytes are mitogen stimulated. There are different possibilities, right now we are at Phytohaemagglutinin. This activates them and this activation pattern can be quantified by measuring surface molecules that form on the lymphocyte as a result of activation. "Currently, the assay uses the" early activation antigen CD69 "as a marker.
So far so easy, but it gets more complicated in the commercialization of the test. As early as 2004, a US company was interested in the further development of LymPro. "GW Medical had taken over the first licenses, but then more or less lost in the turmoil of the American financial crisis," recalls Arendt. "The financial crisis has led to significant market turbulence in the US, which has had a negative impact on the flow of capital so that product development has stopped. As a result, we lost a lot of time. We lost at least 10 years."
Sale, delay, confusion
The crisis hit GW Medical so hard that in 2007 they had to sell to Provista Life Sciences. The next year did not go much better for the blood test in Leipzig. Provista was on the verge of completing a clinical trial of the test, as measuring instruments broke down and the results could no longer be reliably evaluated. NIH funding fell through this delay. The company also decided that in the future it wanted to focus more on its breast cancer diagnostic (also a blood test). The development of LymPro was outsourced to a subsidiary called MemoryDx.
In turn, MemoryDx sold rights to another US company, Amarantus Bioscience , to which it has been a subsidiary since April 2014. Confused? It still goes on. Amarantus Bioscience's subsidiary, Amarantus Diagnostics, merged with Avant Diagnostics in 2016, and the licenses were also transferred to Avant. Only last year, Amarantus took back the rights of Avant back and to a new exclusive license directly from the University of Leipzig. "These are the usual strategies," Arendt says dryly, adding, "Amarantus will continue to advance that now - I hope so."
The Leipzig scientist is very happy about the cooperation with the US company, "it works quite well," he says. In an ongoing clinical trial with Amarantus, which is also taking place in Leipzig, the LymPro test now has to compete with other gold standards in Alzheimer's diagnostics such as amyloid PET. In addition, the test should be further simplified. He is currently running a FACS system, but Arendt has other ideas. "If you have a bit of imagination, you might think of a test strip, like the pregnancy test or the diabetes test. That's science fiction now. "
No interest from Germany
The test in its current form is now being further developed in the US and brought to market. Was not there any interest from German companies? "Not at all", laughs Arendt and adds in a more serious voice: "Germany is very heavy". At least two things speak for the US. For one thing, there's a lot of venture capital, and the other is the FDA ( Federal Drug Administration ). "If the FDA would allow such an early diagnostic test, then in principle it is approved around the world," says Arendt. "All other national authorities are guided by these decisions. The FDA is, so to speak, the gateway to the world market. "
And that's where Amarantus wants to go, because the potential is enormous. The company believes that at least $ 500 million a year can be earned in the US alone with an Alzheimer's blood test such as LymPro. Therefore one wants to be also " first to market ", thus the unrivaled first offerers.
Maybe that's why everything is now faster than expected. Anyway, in April, Amarantus named a new Chief Medical Advisor who's mainly concerned with getting LymPro on the "best possible path". And in December, the company entered into a joint venture with Todos Medical, an Israeli firm specializing in cancer blood test diagnostics.
Every now and then, Arendt has also thought about founding his own company and marketing "his baby", the LymPro-Test himself. But then science would have come too short - and there is still so much to explore at the Paul Flechsig Institute for Brain Research in Leipzig, whose director is Arendt. "We are scientists after all, of course we want to understand the mechanisms better. Why do the lymphocytes react differently, does that have any consequences on the immune system? Is there a crosstalk with CNS cells? What is behind it? And we will continue to work in that direction. "
Kathleen Gransalke
https://translate.google.com/translate?hl=en&...1669.lasso
(10.01.2019) Heavily homeland, financial crisis in the USA, defective devices - an Alzheimer's blood test developed in Leipzig could have been on the market for a long time.
Classically, you get the definite diagnosis "Alzheimer's" only after death. Because only postmortem the pathologist can detect amyloid plaques and neurofibrillary tangles, the typical signs of the disease, in the patient's brain tissue.
Although amyloid-positron-emission-tomography, amyloid-PET for short, is a method for early diagnosis, it is very expensive and only available in large medical centers. Would not it be nice to have a simple, non-invasive test that you could do at home or at the family doctor? In fact, this could happen soon, but the way there was long and muddled.
Alzheimer's lymphocytes are different
It all began about 20 years ago when Leipzig neuroscientists around Thomas Arendt made an extraordinary observation. Lymphocytes of Alzheimer's patients behave differently than the immune cells of healthy people. "It has also been reported in other organs over and over again that non-neuronal cells in a disease of the central nervous system mitreagieren," says Arendt in the Labor Journal interview. "In depression, for example, you also see changes in peripheral immune cells."
In the case of Alzheimer's lymphocytes react less strongly to a mitogenic stimulus than control cells, which are first activated and then multiply. Alzheimer's lymphocytes apparently have a problem with proliferation. This observation fits well with a hypothesis that tries to explain the clinical picture of Alzheimer's - the " Cell Cycle Dysregulation " hypothesis. This states that neurons, which normally no longer divide and remain in the G0 phase of the interphase, suddenly reenter the cell cycle. However, they do not go through the cycle completely, but become stuck in the G2 phase (just before the core split).
Mechanism unknown
The cell cycle thus appears to be disturbed both in the neurons and in the immune cells of Alzheimer's patients. "What is at the root of this and what mechanisms provide this answer, which we simply use phenomenologically, is still unknown," says Arendt. However, the mechanisms of the diagnostic test from Leipzig, the LymPro test, are clear: "Ultimately, it is an activation test with peripheral blood lymphocytes," summarizes the scientist. "The test is based on patient blood sampling, which is considered non-invasive - any form of invasive early diagnosis is always problematic. Then the lymphocytes are mitogen stimulated. There are different possibilities, right now we are at Phytohaemagglutinin. This activates them and this activation pattern can be quantified by measuring surface molecules that form on the lymphocyte as a result of activation. "Currently, the assay uses the" early activation antigen CD69 "as a marker.
So far so easy, but it gets more complicated in the commercialization of the test. As early as 2004, a US company was interested in the further development of LymPro. "GW Medical had taken over the first licenses, but then more or less lost in the turmoil of the American financial crisis," recalls Arendt. "The financial crisis has led to significant market turbulence in the US, which has had a negative impact on the flow of capital so that product development has stopped. As a result, we lost a lot of time. We lost at least 10 years."
Sale, delay, confusion
The crisis hit GW Medical so hard that in 2007 they had to sell to Provista Life Sciences. The next year did not go much better for the blood test in Leipzig. Provista was on the verge of completing a clinical trial of the test, as measuring instruments broke down and the results could no longer be reliably evaluated. NIH funding fell through this delay. The company also decided that in the future it wanted to focus more on its breast cancer diagnostic (also a blood test). The development of LymPro was outsourced to a subsidiary called MemoryDx.
In turn, MemoryDx sold rights to another US company, Amarantus Bioscience , to which it has been a subsidiary since April 2014. Confused? It still goes on. Amarantus Bioscience's subsidiary, Amarantus Diagnostics, merged with Avant Diagnostics in 2016, and the licenses were also transferred to Avant. Only last year, Amarantus took back the rights of Avant back and to a new exclusive license directly from the University of Leipzig. "These are the usual strategies," Arendt says dryly, adding, "Amarantus will continue to advance that now - I hope so."
The Leipzig scientist is very happy about the cooperation with the US company, "it works quite well," he says. In an ongoing clinical trial with Amarantus, which is also taking place in Leipzig, the LymPro test now has to compete with other gold standards in Alzheimer's diagnostics such as amyloid PET. In addition, the test should be further simplified. He is currently running a FACS system, but Arendt has other ideas. "If you have a bit of imagination, you might think of a test strip, like the pregnancy test or the diabetes test. That's science fiction now. "
No interest from Germany
The test in its current form is now being further developed in the US and brought to market. Was not there any interest from German companies? "Not at all", laughs Arendt and adds in a more serious voice: "Germany is very heavy". At least two things speak for the US. For one thing, there's a lot of venture capital, and the other is the FDA ( Federal Drug Administration ). "If the FDA would allow such an early diagnostic test, then in principle it is approved around the world," says Arendt. "All other national authorities are guided by these decisions. The FDA is, so to speak, the gateway to the world market. "
And that's where Amarantus wants to go, because the potential is enormous. The company believes that at least $ 500 million a year can be earned in the US alone with an Alzheimer's blood test such as LymPro. Therefore one wants to be also " first to market ", thus the unrivaled first offerers.
Maybe that's why everything is now faster than expected. Anyway, in April, Amarantus named a new Chief Medical Advisor who's mainly concerned with getting LymPro on the "best possible path". And in December, the company entered into a joint venture with Todos Medical, an Israeli firm specializing in cancer blood test diagnostics.
Every now and then, Arendt has also thought about founding his own company and marketing "his baby", the LymPro-Test himself. But then science would have come too short - and there is still so much to explore at the Paul Flechsig Institute for Brain Research in Leipzig, whose director is Arendt. "We are scientists after all, of course we want to understand the mechanisms better. Why do the lymphocytes react differently, does that have any consequences on the immune system? Is there a crosstalk with CNS cells? What is behind it? And we will continue to work in that direction. "
Kathleen Gransalke
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