Wednesday, May 20, 2015 9:00:46 PM
MDS Trial Observations....
In the US, the MDS patient population is ~5X the size of the MF patient population, and there are seven (7) different types of MDS diseases with each type being classified as either Low-Risk, Intermediate-Risk, or High-Risk. For reference, the seven MDS diseases are listed below.
* Refractory cytopenia with unilineage dysplasia (RCUD)
* Refractory anemia with ringed sideroblasts (RARS)
* Refractory cytopenia with multilineage dysplasia (RCMD)
* Refractory anemia with excess blasts-1 (RAEB-1)
* Refractory anemia with excess blasts-2 (RAEB-2)
* Myelodysplastic syndrome, unclassified (MDS-U)
* Myelodysplastic syndrome associated with isolated del(5q)
Dr. Tefferi's pilot study involved only MDS-RARS patients. MDS-RARS has been classified as Low-Risk, and MDS-RARS represents only ~10% of total MDS patient population.
In Peter Lebowitz's presentation (Slide 16) today, he clearly shows our upcoming MDS trial will involve both Low-Risk and Intermediate-Risk MDS patients. This is very significant for two reasons....
1) It shows Imetelstat is expected to offer benefit beyond MDS-RARS patients.
2) The combined Low-Risk and Intermediate-Risk categories represent ~70% of the total MDS patient population.
Additionally, we can see from the same slide that Janssen is already planning another MDS trial aimed at High-Risk MDS patients. Thus, in addition to today's other good news & press coverage, we've just learned Imetelstat is expected to offer benefit for a large percentage of all MDS patients.
Also of interest is the MDS trials will not be of the Refractory/Relapsed nature. Thus, it appears they plan to go for 1st line treatment via a head-to-head trial against current standard treatment.
The size of the MDS opportunity has been a lingering question, and today's information is very exciting from both patient and investor standpoint. Given the size of the MDS patient population, this insight may represent the best news of the day.
"evil flourishes when good people fail to act"
Recent GERN News
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