Go Big or Go Home - Pt 2

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Go Big or Go Home - Pt 2

Post by kmall » Sun May 31, 2020 4:50 am

Go Big, or Go Home - Pt 2

In conjunction with Imetelstats future marketplace is emerging evidence of a booming and sometimes misrepresented patient population around the world. Countries such as China and India could easily have up to 5x or more then that of the US patient population when factoring in environmental conditions being linked to certain hematologic malignancies and median patient age reductions of 10 years or more. I will primarily focus on MDS for now, since the bulk of my research centered on the IMerge P3 clinical trial. I do have some findings on marketplace data for MF and AML as well, but that will come later on when we delve into potential revenue streams for Imetelstats target indications.

During my patient support group outreach endeavor for the then upcoming P3 clinical trial of IMerge - “Operation Kmall” – I came across quite a bit of research on patient populations in MDS and abstracts pertaining to. From what I could gather, it seems as if global patient populations are widely underestimated. Several factors contribute to this:

1. Non-registry

2. The overall increase in life expectancies globally

3. Pollution; exposure to pesticides, fertilizers, insecticides and certain chemicals in manufacturing processes (Benzene exposure in rubber and plastic production plays a significant role here – as well as Agent Orange exposure in Vietnam Veterans)

4. Poverty / Economic Conditions

5. Remote and rural locations where cases of MDS in “undeveloped” countries are occurring in greater numbers and with significantly lower average patient age ranges

6. And finally the misdiagnosis of MDS itself.

As far as hematologic diseases go, MDS is a relatively new kid on the block; not being regarded as a separate, distinct disorder until 1976. Treatment of which, first began in 2004 with FDA approval of Vidaza. This drug can retard progression of MDS and prolong survival but it causes a temporary drop in blood counts during the treatment period requiring dose adjustments. Vidaza, distributed by Celgene, was the first approved drug therapy for MDS. - https://rarediseases.org/rare-diseases/ ... syndromes/

Let’s breakdown some of the above points with supporting research and abstracts:

1. Non-Registry / Data Collection - This 2017 abstract from the Lazio region in Italy is a prime example of the commonalities found globally with regards to non-registry and a lack of data reporting. Mind you, this is from Italy, a “developed” nation. Throughout less developed countries in areas like South America, Asia and Africa this becomes compounded exponentially.

“Data on Myelodysplastic Syndromes (MDS) are difficult to collect by cancer registries because of the lack of reporting and the use of different classifications of the disease.” (2017) - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5499502/

2. Increase in Global Life Expectancy – A 2010 study deals with not only an increased aging population as it pertains to MDS, but also other health related issues that coexist throughout MDS patients.

"As the U.S. population continues to age, MDS will become a more prominent medical problem with a significant impact on the health care system," says Dr. Goldberg."

"The study also showed for the first time that MDS patients are at much higher risk for heart attack, diabetes and other serious complications than other seniors, and that their health care costs are far higher." - https://www.sciencedaily.com/releases/2 ... 182000.htm

3. Pollution / Exposure – Around the globe studies, abstracts and articles confirm not only this being a major factor in new incidences, but as a result it has driven down the average MDS patient age by 10 years or more – some as high as 20. This will play a significant role in the sharp increase in MDS populations worldwide.

EGYPT - (2012) – “Mean age of presentation of MDS in Egypt is lower than developed countries. Pollution of water and use of insecticides and smoking are high risk factors for MDS among Egyptians”
https://www.omicsonline.org/myelodyspla ... p?aid=7382

INDIA – (2017) - “The median age of patients (MDS) in India is a decade younger than the western population.”
https://www.mjhid.org/index.php/mjhid/a ... 7.048/html

CHINA – (2017) – “In this study population, we observed statistically significant associations between benzene and MDS”

CHINA – (2013) – “MDS is commonly found in young individuals (<60 years) in Asia” “In Asia (e.g., Japan, Thailand and South Korea), MDS has been reported to occur more frequently in younger individuals, with the median age of 50–60 years at diagnosis [6]–[8]. Chen et al. [9] and Li et al. [10] released two independent analysis regarding 508 and 351 cases of de novo MDS in the Chinese population respectively, with the median age of 49 and 45 years, respectively.” - https://journals.plos.org/plosone/artic ... ne.0057392

VIETNAM / USA – (2016) – “Vietnam-Era Vets Sought for Study to Determine Links Between Agent Orange and Rare Bone Marrow Cancer”
“The Aplastic Anemia and MDS International Foundation (AAMDSIF) is proud to support a unique study by Dr. David Steensma, MD, on Agent Orange exposure and its potential link to myelodysplastic syndromes (MDS) in Vietnam-era veterans.”
https://www.aamds.org/article/new-study ... ent-orange

EAST ASIA – (2010) - “Even though MDS can occur at any age, most patients are older. The median age at diagnosis is 71 years,3,5,8 and 72% of patients are age 70 or older.3 The prevalence increases with age, to a rate of 36 per 100,000 in those age 80 and older.9 However, in areas of East Asia, it occurs at ages almost 2 decades younger than in the rest of the world.5”

-5. Ma X, Does M, Raza A****, Mayne ST. Myelodysplastic syndromes: incidence and survival in the United States. Cancer 2007; 109:1536–1542

****look at the 2nd author above….our beloved Dr. Raza !!! ****


USA – (2016) – “Benzene exposure is one of the few well‐established risk factors for myeloid malignancy. We evaluated occupational and residential chemical exposures as risk factors for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) using population‐based data.” - https://onlinelibrary.wiley.com/doi/ful ... /ijc.30420

USA – (2014) - “You’re still seeing elevated risks of leukemias and lymphomas among occupational groups exposed to benzene”
https://publicintegrity.org/environment ... n-tragedy/

Cont.......Go Big or Go Home Pt 2. 2.0

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