Biotech Values

[srsmgja]

Jbog - Thank you for posting the article, but I had already seen it. You highlight (rebif) although the article makes no mention of the drug.

The article is interesting on a number of issues:

1. The risk of leukemia with Novantrone is much greater than originally thought.... 0.74% in this study

2. Surprise, surprise .......... "The patients who developed acute myeloid leukemia (AML) received a significantly greater number of mitoxantrone (Novantrone) administrations and a greater cumulative dose of the drug than did those who do not develop leukemia"............ Any first year medical study could have told you the same, without seeing the trial results.

3. Cladribine produced a rate of cancer in its one phase 3 trial of approx. 5/800 or about 0.63% Gee, that's no too far off from the 0.74% with Novantrone. Novantrone and Cladribine are different class of drugs, yet they share similiar characteristics. They both are cytotoxic and interfere with DNA synthesis and repair.

4. Now Novantrone (thankfully) can only be given for a total of approx 2-3 years of dosing because of cardiotoxicity. But Cladribine doesn't have a cardiac limiting dose. Can you guess what will probably happen to those cancer rates as you increase the cumulative dose?? Answer - it aint going to be pretty.


5. If a dim-wit ophthalmologist like myself can figure this out, you can be sure those sharp, safety minded FDA reviewers can also understand the considerable cancer risk to these YOUNG, MS patients with near normal life expectancies.


6. Reinforces my belief than Cladribine has no chance of passing FDA review WITHOUT much greater, longer safety data.


7. BTW, I bet neurologists are going to be a bit more resistent to place patients on Novantrone without a much longer and detailed informed consent regarding the leukemia risk. Some might take another look at the Tysabri alternative.
6.