New drug, ON 01910. Na, for MDS in Phase I trial

[Birgitta-A]

Hi all,
Now they have started a Phase I trial with a new drug for MDS, ON 01910. Na. http://tinyurl.com/3l8vtl
Kind regards
Birgitta-A

[Jun]

Hi,

This is a first visit for me in this forums.
I heard that Estybon has started to estimate in Phase III.
Have there been any information about the trial ?
Effectiveness will be superior to other agents or Vidaza or so ?

Kind regards,

[Birgitta-A]

Hi Jun,
The Estybon Phase III trial is only for MDS patients with Intermediate1-2, or High Risk with the chromosome aberration Trisomy 8.
http://clinicaltrials.gov/ct2/show/N...estybon&rank=1

We don't know how effective Estybon is compared to Vidaza or Dacogen since they have only published one report about Estybon in patients who had failed Vidaza or Dacogen.
http://www.eventure-online.com/event...ongressId=4634
Kind regards
Birgitta-A

[Birgitta-A]

Hi All,
Here are very early results from a study of oral Rigosertib (ON 01910). As far as I understand 2 out of 12 patients had Complete Responses and 4 patients had red blood cell responses.
http://ash.confex.com/ash/2011/webpr...aper38326.html
Kind regards
Birgitta-A

[Alice P]

I am pretty certain that ON 01910.Na, from the drug company Oncanova, is the same as Estybon. My husband was in the Phase one ON 01910.Na trial for Trisomy 8 patients at NIH last spring. Unfortunately, his disease progressed and he was dropped from the trial.

[Birgitta-A]

Hi Alice,
You know Estybon, Rigosertib and ON 01910 are different names of the same drug - I should have written Estybon in my latest post.
http://www.businesswire.com/news/hom...%C2%A001910.Na

Too bad that your husband didn't respond. Perhaps he is getting another drug now?
Kind regards
Birgitta-A

[Jun]

Hello there,

The MDS Beacon said that "Estybon may be effective".

http://www.mdsbeacon.com/news/2011/1...ith-trisomy-8/

I feel uneasy that they said "May Be"
The results of the trial are very complicated for me...

Jun

[Birgitta-A]

Hi Jun,
I have tried to make the results more easy to understand - if there are some difficult words you can ask again.

Results 13 patients:
4 patients achieved a complete bone marrow response – no dysplasia.
1 patient experienced a partial bone marrow response.
3 patients maintained stable disease.
5 patients experienced disease progression, including 4 patients who developed AML.

Response to Estybon treatment was seen in all risk types of MDS.
Of the 6 patients with trisomy 8, 2 patients maintained stable disease. They experienced a reduction in the number of cells with the trisomy 8 mutation (65 percent to 15 percent in one patient, and 80 percent to 13 percent in the other patient).
Kind regards
Birgitta-A

[Jun]

Hi Birgitta-A,

Thank you for your easy-to-follow explanation.

This trial is "Best supportive care" vs "Best supportive care +　Estybon"
Still wondering if "Best supportive care + Estybon" is superior to "Best supportive care" because the results of "Best supportive care" have never been shown (I think).

Jun

[Birgitta-A]

Hi Jun,
"Best supportive care" is different in different clinics - there is no standard. That's why they always have a control group so they can compare if Estybon makes any difference.

Some clinics for example give blood or platelet transfusions or Neupogen for the WBCs when the counts are low and other clinics wait until the counts are very low. Some clinics give antibiotics often and others are very restrivtive.
Kind regards
Birgitta-A