Portion of Jason Napodano, CFA new update concerning LymPro Monday, January 27, 2014 :
LymPro Update
In October 2013, Amarantus announced positive analytical performance data for the LymPro Test. The data produced by the Custom Technology Team at Becton, Dickinson and Company (BD) demonstrates that CD69 was increased in response to mitogenic stimulation with both pokeweed mitogen (PWM) and phytohaemagglutinin (PHA) across all control samples. Amarantus is now in a position to embark on long-term stability controls of the assay to ensure commercially-acceptable reproducibility, as well as enter into agreements with leading clinical sites to obtain additional clinical performance data for LymPro. Ultimately, we believe it makes sense to try and develop an ELISA-based version of LymPro instead of the mitogenic stimulation assay. However, what the analytical performance data tells us is that the cell cycle hypothesis and previous data generated from the 2005 (n=88) study published in Neurobiology of Aging (Volume 33, Issue 2) holds true.
Results from the Phase 1 study show the scoring model was able to differentiate between AD subjects and other demented subjects (e.g. with PDD or MCI) with co-positivity (sensitivity) up to 91% and co-negativity (specificity) up to 92% relative to the clinical diagnosis of AD.
Between AD subjects and non-AD subjects we found a co-positivity of 88% and a co-negativity of 82%. The separation between AD and OD was particularly apparent, with a SI score at 0.55. This can be seen in the graph below where red bars represent patients with probably AD and the blue bars represent patients with another form of dementia (in this case Parkinson’s disease dementia). The study investigators also found a 95.6% correlation on AUC relative to clinically diagnosed AD compared to OD. Source: Stieler at el; Neurobiology of Aging 33 (2012) 234–241
A comparison of the LymPro results with the Mini Mental Status Exam showed independence from dementia severity. The study investigators concluded that this was logical because the defect measured precedes the dementia and continues throughout the course of the disease. The R-squared value indicates that the LymPro score and the dementia severity are 90% independent.
Amarantus tells us they are now in the process of going back and doing a 7-year follow-up analysis of the 88 patients studied in the Phase 1 trial above. This will be an incredibly important longitudinal analysis for the validation of LymPro. Investors need to understand, the “Gold Standard” for Alzheimer’s disease diagnosis is an autopsy. Obviously this limits data validation while the patient is still alive. Therefore, data from the Phase 1 study was compared to the physician’s diagnosis. The 88 patient Phase 1 study was conducted in subjects with mild-to-moderate dementia previously diagnosed as having probably AD (n=32) or dementia with PD (n=26), vs. a healthy control (n=30). In-between the initial physician’s diagnosis and autopsy (patient death) are follow-up examinations. LymPro compared well to the physician’s initial diagnosis. However, actual real-world follow-up data from the 58 subjects diagnosed with AD or PDD will give a definitive answer to the question, “Does LymPro work?”
Investors previously believed that Amarantus will seek a development partner for LymPro shortly after the preparation of the analytical performance package. However, Amarantus now plans to analyze the data from the 7-year longitudinal analysis prior to forming a developmental partnership because confirmation of the impressive accurate [(sensitivity x prevalence) + (specificity x 1-prevalance)] of LymPro represents a major valuation inflection for the company. We agree. Why partner LymPro in the second quarter 2014 before this 7-year data validation, when validation means a partnership at multiples of what LymPro is worth today?
Once the data has been validated, the next step is to establish long-term analytical performance to support commercial launch in 2015 (note: management guidance is “second half of 2014”). Amarantus expects to be in a position to submit the necessary data package to CLIA to support the intended use statement: "Aid in the diagnosis of Alzheimer's disease," and commercial launch of LymPro as a Laboratory-Developed Test (LDT) through CLIA. Following clearance under CLIA, Amarantus will focus on gaining U.S. FDA approval for multi-lab use. This could occur in 2015. Once enough clinical utility data has been generated, Amarantus can approach the Center for Medicare and Medicaid Services (CMS) and gain reimbursement for broad-scale use. This is an important step, especially in light of the fact that CMS has denied reimbursement for Eli Lilly’s Amyvid given a lack of clinical and pharmaco-economic evidence.
Amarantus believes it has identified CPT codes relating to cell cycle dysfunction and Alzheimer’s disease that might facilitate reimbursement for LymPro under CLIA or commercial sale. This would be an enormous advantage for the company, and something worth looking deeper into by management. This is yet another reason to push partnering talks out a quarter or two because progress added significant value.
The ultimate goal for Amarantus with LymPro is to gain approval as a companion diagnostic paired with a therapeutic for the treatment of Alzheimer’s disease. However, as noted on the most recent conference call by the CEO, therapeutic developments for the treatment of Alzheimer’s disease are the rate-limiting step. Therefore, we believe Amarantus has the right strategy in pursing CLIA approval in late 2014. We think CLIA approval can be achieved with as little as $5 million investment.
We see a significant market need for an Alzheimer's diagnostic product like LymPro. Specifically, the goal of any Alzheimer's disease diagnostic should be to distinguish between patients with Alzheimer's disease and other degenerative dementias, such as Parkinson's disease dementia (PDD) or psychosis, and mild cognitive impairment (MCI) or age-related memory loss (AAMI). A simple and economical test that can accurately and reliably do such would have a number of benefits, including:
1) Significantly expedite diagnosis, allowing for earlier treatment in the primary practice setting. 2) Significantly simplify the diagnosis process, allowing for meaningful economic savings to the healthcare system. 3) Improve outcomes by allowing for a more focused treatment based on the type of cognitive impairment, and 4) Distinguish between patients for clinical trials and therapeutic development.
For additional detail on LymPro, we encourage investors to read the company’s LymPro White Paper outlining the history and clinical data to data published in October 2013.
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Monday, January 27, 2014 Meeting With Amarantus Confirms Fundamental Turnaround By Jason Napodano, CFA
We recently sat down with Amarantus Bioscience Holdings (AMBS) CEO, Gerald Commissiong. The meeting confirmed our belief that Amarantus is in the midst of a fundamental turnaround and has significant growth potential over the next two to three years. Below we highlight the four key variables with respect to Amarantus future – MANF, LymPro, Eltoprazine, and the balance sheet....... http://bionapcfa.blogspot.ca/2014/01/meeting-with-amarantus-confirms.html
"All Truth, In The Long Run, Is Only Common Sense Clarified. ~ Thomas H. Huxley "Facts Do Not Cease To Exist Because They Are Ignored." ~ Aldous Huxley
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