Fantastic blog post:
http://www.thechairmansblog.com/amarantus-bio...version-2/
AAIC 2014: Understanding the Data Being Presented – LymPro Test® Version 2
Over the last 24 hours I have received several emails and inquiries from investors as it relates to understanding exactly what data will be presented by Amarantus at the Alzheimer’s Association International Conference on the 14th and 15th of July in Copenhagen. As a result, today I am providing a summary of the data we will be presenting, why we’ve chosen to present it this way, and what additional data will be presented at our #C4CT Summit on July 31st at the United Nations (www.c4ctsummit.com):
Clinical Performance – Data will be presented from in summary form from all of the published data sets on LymPro (Steiler et al, 2001 and 2012), as well as new data from a study conducted by Memory Dx (f/k/a Provista Life Sciences) in the winter of 2008. The primary focus will be on conditions for the LymPro assay used in this new study, which formed the basis for our acquisition of Version 2 of LymPro in May of this year from Memory Dx. The data, which has never been presented in any public forum, is from a 44 patient study that was tightly controlled several months prior to Memory Dx running into technical difficulties in the fall of 2008. The study evaluated Alzheimer’s patients, aged matched healthy controls, as well as vascular dementia and Parkinson’s disease dementia (together ‘other dementias’). The Company believes this Version 2 may improve upon certain critical principles established in Version 1, and make the diagnostic value of LymPro even higher than originally described;
Analytical Performance – Data will be presented from studies conducted at Becton Dickinson (BD) in 2013 and 2014 that form the basis of the current analytical performance package. The data, standard operating procedures (SOPs) and other proprietary assay parameters will facilitate transfer of the assay into our prospective partner’s laboratory for the purpose of commercialization under CLIA, a process BD has executed with our target partner several times. In this poster, we will also take into account scientific advancements in the field that underscore the analytical validity of cell cycle measurements for Alzheimer’s disease, most notably stage-independence of cell cycle and relationship between cell cycle, tau tangles and amyloid depositions;
Longitudinal Clinical Performance – Data will be presented from a follow-up patient record study of the Version 2 Clinical Performance Data mentioned above. We believe this data is the most scientifically relevant as it will add significant validity to the original Version 2 data by giving us an assessment of the change in physician’s diagnosis over time as compared to the LymPro score. Of highest potential value is whether LymPro was able to identify pre-symptomatic patients who would eventually progress to symptomatic AD (false-negatives).
Taken together, we believe this data provides a comprehensive perspective on LymPro. In addition, the Company will be presenting data at our July 31st #C4CT Summit regarding a bridging study in which the Company is comparing Version 1 and Version 2 of LymPro in a head to head study of 72 patients (AD vs. healthy control) to independently reproduce findings from the 2008 Clinical Performance study regarding greater separation in the different cohorts in Version 2 vs. and Version 1. Combined, these four data sets could provide a strong rationale for moving solely to Version 2 of the assay which the Company believes would add tremendous value to LymPro’s diagnostic value.
Dr. Louis Kirby (a recent Advisory Board addition, so not mentioned in the poster submissions which occurred in February), who is a Board-certified neurologist with a specialty in Alzheimer’s and has been the principle investigator on over 400 trials, will be present to assist in the question and answer sessions, and will be presenting data at #C4CT on behalf of the Company. We will also have a strong corporate presence, with our diagnostics, business development, regulatory and finance team onsite at AAIC and #C4CT. We believe AAIC represents a golden opportunity to let the scientific community know about LymPro’s advancements and that it will be on the market later this year (we are finding in our business development outreach that many research groups liked the concept in the Provista days, however lost track post-2008).
We have all seen reports in the media this week about a UK-based Proteomics Sciences blood test for Alzheimer’s in development, as we did several months ago regarding a lipid-based blood test from Georgetown. The reason there is such an explosion in media interest for Alzheimer’s blood tests is because everyone recognizes the massive unmet need. We would like to underscore that it is good for the field that multiple groups are moving on this concept because it reinforces that it is scientifically feasible to accomplish, and strengthens our case. We believe our approach of assessing an underlying aspect of disease biology and preparing for commercial-launch ahead of a major media push is the correct path so we can maximally capitalize on potential media attention, not only by an increase in the number of interviews I conduct, but most importantly by product sales. We continue to believe LymPro is likely superior to other non-disease biology related tests, and that our advantages are significant:
We will be first to market by years. This will allow us to appropriately establish a market for LymPro ahead of others and make LymPro the standard within the space;
Both the Proteomics and Georgetown based tests were identified through an iterative process, with no direct relation to disease biology, whereas LymPro is measuring a specific aspect to disease biology. This significantly improves the potential utility of LymPro as a companion diagnostic, which will ultimately be a massive value driver for any Alzheimer’s blood test;
LymPro has over a decade of scientific validity within the context of the cell cycle hypothesis in Alzheimer’s, with reproducibility of this finding by several independent academic group. The hypothesis has recently been expounded upon by new findings that form a rational basis to explain tau tangle formation and amyloid depositions, a huge advancement for the field. Targeting cell cycle is emerging as a new therapeutic target with significant potential because it is immediately attractive to drug developers who have anti-amyloid and anti-tau drugs as they may have activity within cell cycle, thereby furthering the rationale for pharmaceutical companies’ already massive investment. What is ultimately missing for cell cycle to takeoff as a significant ‘drugable’ target is a diagnostic that can identify cell cycle early-on in the disease process, and LymPro can fill that need as it is the most advanced cell cycle diagnostic test.
In summary, we are excited to be presenting the Company’s first data sets on LymPro to the scientific community at AAIC. We have noted recent interest in Alzheimer’s blood diagnostics from competing labs, and continue to believe that we have the most advanced diagnostic blood test in terms of commercial readiness due to the rigor we endeavored upon with Becton Dickinson, and scientific fundamentals. We are well positioned to transfer LymPro to a commercial lab where our protocols will be implemented according to commercial standards under CLIA. We believe the data sets presented next week will provide the basis for initial LymPro sales to pharmaceutical companies and Key Opinion Leaders who are continually seeking to improve their diagnostic paradigms. Ultimately, we intend to gather data with our partners on several thousand patients through strategic collaborations and commercial sales (as all other prospective tests will have to do), which will ultimately allow for submission to the FDA for approval. The data will be produced in a commercial setting, adding significant validity to the results from an FDA standpoint (In Vitro Diagnostics regulations are quite stringent) and providing the marketing credibility needed to accelerate sales along the way. We believe the future for LymPro is very, very bright and are excited to soon be offering new options to physicians and patients struggling to cope with the massive burden that Alzheimer’s presents.
Thank you for taking the time to read this blog. This is an exciting time for Amarantus as we look forward to the coming days at AAIC and especially to our #C4CT Summit at the United Nations. We invite all interested parties to sign up to attend #C4CT Summit at http://www.c4ctsummit.com/registration/.
Warmest Regards,
Gerald E. Commissiong
President & CEO
http://www.thechairmansblog.com/amarantus-bio...version-2/
AAIC 2014: Understanding the Data Being Presented – LymPro Test® Version 2
Over the last 24 hours I have received several emails and inquiries from investors as it relates to understanding exactly what data will be presented by Amarantus at the Alzheimer’s Association International Conference on the 14th and 15th of July in Copenhagen. As a result, today I am providing a summary of the data we will be presenting, why we’ve chosen to present it this way, and what additional data will be presented at our #C4CT Summit on July 31st at the United Nations (www.c4ctsummit.com):
Clinical Performance – Data will be presented from in summary form from all of the published data sets on LymPro (Steiler et al, 2001 and 2012), as well as new data from a study conducted by Memory Dx (f/k/a Provista Life Sciences) in the winter of 2008. The primary focus will be on conditions for the LymPro assay used in this new study, which formed the basis for our acquisition of Version 2 of LymPro in May of this year from Memory Dx. The data, which has never been presented in any public forum, is from a 44 patient study that was tightly controlled several months prior to Memory Dx running into technical difficulties in the fall of 2008. The study evaluated Alzheimer’s patients, aged matched healthy controls, as well as vascular dementia and Parkinson’s disease dementia (together ‘other dementias’). The Company believes this Version 2 may improve upon certain critical principles established in Version 1, and make the diagnostic value of LymPro even higher than originally described;
Analytical Performance – Data will be presented from studies conducted at Becton Dickinson (BD) in 2013 and 2014 that form the basis of the current analytical performance package. The data, standard operating procedures (SOPs) and other proprietary assay parameters will facilitate transfer of the assay into our prospective partner’s laboratory for the purpose of commercialization under CLIA, a process BD has executed with our target partner several times. In this poster, we will also take into account scientific advancements in the field that underscore the analytical validity of cell cycle measurements for Alzheimer’s disease, most notably stage-independence of cell cycle and relationship between cell cycle, tau tangles and amyloid depositions;
Longitudinal Clinical Performance – Data will be presented from a follow-up patient record study of the Version 2 Clinical Performance Data mentioned above. We believe this data is the most scientifically relevant as it will add significant validity to the original Version 2 data by giving us an assessment of the change in physician’s diagnosis over time as compared to the LymPro score. Of highest potential value is whether LymPro was able to identify pre-symptomatic patients who would eventually progress to symptomatic AD (false-negatives).
Taken together, we believe this data provides a comprehensive perspective on LymPro. In addition, the Company will be presenting data at our July 31st #C4CT Summit regarding a bridging study in which the Company is comparing Version 1 and Version 2 of LymPro in a head to head study of 72 patients (AD vs. healthy control) to independently reproduce findings from the 2008 Clinical Performance study regarding greater separation in the different cohorts in Version 2 vs. and Version 1. Combined, these four data sets could provide a strong rationale for moving solely to Version 2 of the assay which the Company believes would add tremendous value to LymPro’s diagnostic value.
Dr. Louis Kirby (a recent Advisory Board addition, so not mentioned in the poster submissions which occurred in February), who is a Board-certified neurologist with a specialty in Alzheimer’s and has been the principle investigator on over 400 trials, will be present to assist in the question and answer sessions, and will be presenting data at #C4CT on behalf of the Company. We will also have a strong corporate presence, with our diagnostics, business development, regulatory and finance team onsite at AAIC and #C4CT. We believe AAIC represents a golden opportunity to let the scientific community know about LymPro’s advancements and that it will be on the market later this year (we are finding in our business development outreach that many research groups liked the concept in the Provista days, however lost track post-2008).
We have all seen reports in the media this week about a UK-based Proteomics Sciences blood test for Alzheimer’s in development, as we did several months ago regarding a lipid-based blood test from Georgetown. The reason there is such an explosion in media interest for Alzheimer’s blood tests is because everyone recognizes the massive unmet need. We would like to underscore that it is good for the field that multiple groups are moving on this concept because it reinforces that it is scientifically feasible to accomplish, and strengthens our case. We believe our approach of assessing an underlying aspect of disease biology and preparing for commercial-launch ahead of a major media push is the correct path so we can maximally capitalize on potential media attention, not only by an increase in the number of interviews I conduct, but most importantly by product sales. We continue to believe LymPro is likely superior to other non-disease biology related tests, and that our advantages are significant:
We will be first to market by years. This will allow us to appropriately establish a market for LymPro ahead of others and make LymPro the standard within the space;
Both the Proteomics and Georgetown based tests were identified through an iterative process, with no direct relation to disease biology, whereas LymPro is measuring a specific aspect to disease biology. This significantly improves the potential utility of LymPro as a companion diagnostic, which will ultimately be a massive value driver for any Alzheimer’s blood test;
LymPro has over a decade of scientific validity within the context of the cell cycle hypothesis in Alzheimer’s, with reproducibility of this finding by several independent academic group. The hypothesis has recently been expounded upon by new findings that form a rational basis to explain tau tangle formation and amyloid depositions, a huge advancement for the field. Targeting cell cycle is emerging as a new therapeutic target with significant potential because it is immediately attractive to drug developers who have anti-amyloid and anti-tau drugs as they may have activity within cell cycle, thereby furthering the rationale for pharmaceutical companies’ already massive investment. What is ultimately missing for cell cycle to takeoff as a significant ‘drugable’ target is a diagnostic that can identify cell cycle early-on in the disease process, and LymPro can fill that need as it is the most advanced cell cycle diagnostic test.
In summary, we are excited to be presenting the Company’s first data sets on LymPro to the scientific community at AAIC. We have noted recent interest in Alzheimer’s blood diagnostics from competing labs, and continue to believe that we have the most advanced diagnostic blood test in terms of commercial readiness due to the rigor we endeavored upon with Becton Dickinson, and scientific fundamentals. We are well positioned to transfer LymPro to a commercial lab where our protocols will be implemented according to commercial standards under CLIA. We believe the data sets presented next week will provide the basis for initial LymPro sales to pharmaceutical companies and Key Opinion Leaders who are continually seeking to improve their diagnostic paradigms. Ultimately, we intend to gather data with our partners on several thousand patients through strategic collaborations and commercial sales (as all other prospective tests will have to do), which will ultimately allow for submission to the FDA for approval. The data will be produced in a commercial setting, adding significant validity to the results from an FDA standpoint (In Vitro Diagnostics regulations are quite stringent) and providing the marketing credibility needed to accelerate sales along the way. We believe the future for LymPro is very, very bright and are excited to soon be offering new options to physicians and patients struggling to cope with the massive burden that Alzheimer’s presents.
Thank you for taking the time to read this blog. This is an exciting time for Amarantus as we look forward to the coming days at AAIC and especially to our #C4CT Summit at the United Nations. We invite all interested parties to sign up to attend #C4CT Summit at http://www.c4ctsummit.com/registration/.
Warmest Regards,
Gerald E. Commissiong
President & CEO
