...Why Big Pharma Will Want LymPro... "A rapid an
Post# of 30067
Posted On: 10/04/2014 1:05:56 PM
...Why Big Pharma Will Want LymPro...
"A rapid and economical test like LymPro could be used to improve Alzheimer's patient enrollment for future clinical trials. Right now most pharmaceutical companies are using things like PET and MRIs or MEGs to select for enrollment of a clinical program. These tests have high False Positive rates and cost upwards of $5,000 per patient. In fact, the average screen-to-enroll rate for a Phase 2 or Phase 3 clinical trial in Alzheimer’s patients is roughly 2-to-1. That means for every patient enrolled in an AD clinical program, the cost is upwards of $10,000 per patient.
To enroll 3,000 patients in an Alzheimer's Phase 3 program, a big pharmaceutical company may need to screen twice that amount. That's 6,000 patients x $5,000 per PET or MEG test, or $30 million in just enrollment costs! Under CLIA, we suspect LymPro will cost around $1,000 per test. If Amarantus can fine-tune the Sensitivity to 90% by adding additional cell lines and assay optimization without significantly sacrificing Specificity, then to enroll 3,000 patients, a big pharmaceutical company may only need to screen 3,500 subjects.
Or more likely, the big pharmaceutical company may still screen 6,000 patients, but instead of $5,000 a pop with Amyvid they may screen at $1,000 per with LymPro, eliminating 2,500 where LymPro's stimulation index predicts "Not Alzheimer's". The remaining 3,500 may then go onto have PET or an MRI. Under this scenario, using LymPro just saved that big pharmaceutical company $10 million. The other potential advantage of LymPro is the tests ability to find early-stage AD patients that have yet to develop meaningful amyloid plaque in the brain. Amyvid works by identifying plaque build-up. Early-stage AD patients may not have built-up enough amyloid plaque to be viewable on PET. This is where LymPro can really differentiate itself."
"A rapid and economical test like LymPro could be used to improve Alzheimer's patient enrollment for future clinical trials. Right now most pharmaceutical companies are using things like PET and MRIs or MEGs to select for enrollment of a clinical program. These tests have high False Positive rates and cost upwards of $5,000 per patient. In fact, the average screen-to-enroll rate for a Phase 2 or Phase 3 clinical trial in Alzheimer’s patients is roughly 2-to-1. That means for every patient enrolled in an AD clinical program, the cost is upwards of $10,000 per patient.
To enroll 3,000 patients in an Alzheimer's Phase 3 program, a big pharmaceutical company may need to screen twice that amount. That's 6,000 patients x $5,000 per PET or MEG test, or $30 million in just enrollment costs! Under CLIA, we suspect LymPro will cost around $1,000 per test. If Amarantus can fine-tune the Sensitivity to 90% by adding additional cell lines and assay optimization without significantly sacrificing Specificity, then to enroll 3,000 patients, a big pharmaceutical company may only need to screen 3,500 subjects.
Or more likely, the big pharmaceutical company may still screen 6,000 patients, but instead of $5,000 a pop with Amyvid they may screen at $1,000 per with LymPro, eliminating 2,500 where LymPro's stimulation index predicts "Not Alzheimer's". The remaining 3,500 may then go onto have PET or an MRI. Under this scenario, using LymPro just saved that big pharmaceutical company $10 million. The other potential advantage of LymPro is the tests ability to find early-stage AD patients that have yet to develop meaningful amyloid plaque in the brain. Amyvid works by identifying plaque build-up. Early-stage AD patients may not have built-up enough amyloid plaque to be viewable on PET. This is where LymPro can really differentiate itself."
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