CTIC
This week, (10th February) the FDA’s Oncologic Drugs Advisory Committee will be meeting to review the filings from Cell Therapeutics ($CTIC) and ChemGenix ($CXSPY) for pixantrone and omacetaxine, in relapsed refractory NHL and CML, respectively.
I’ve just taken a few minutes to read the briefing documents and here are my initial thoughts.
Cell Therapeutics, a Seattle based biotech company, are going to have a very tough morning on Wednesday in DC for the following reasons:
1. The pivotal study had a very poor accrual with only 140 out of 320 patients enrolled.
2. Substantial cardiac and hematologic toxicities.
Risk:benefit trade-offs are always going to be a question for debate in the third-line setting, but CTI may well have shot themselves in the foot by closing enrollment early. This led the FDA to raise an important question about the study and whether there was sufficient information:
read full article: FDA and ODAC to review $CTIC’s pixantrone and $CXSPY’s omacetaxine
pharmastrategyblog.com
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: Cell Therapeutics : FDA and ODAC to review $CTIC’s pixantrone and $CXSPY’s omacetaxineTags: cardiac, cell therapeutics, Cell Therapeutics drug data, Cell Therapeutics Inc, Chemgenix, chronic myeloid leukemia, CML, ctic, ctic message board, ctic stock, CTIC US Drug, CXSPY', FDA, FDA and ODAC, Food And Drug, kia superbowl commercial, lymphoma drug, Nhl, Non-Hodgkin's Lymphoma, ODAC, super bowl shirts 2010, U.S. Drug, US FDA
Why if heart failure is the effect of pixantrone don’t they use the heart strengthener?,cant remember the name of it right now-but it comes from a plant and strengthens the heart muscle oh digatalis is the name-of the heart strengthen chemical-it works from what I have heard-it really does work!Ben
Could it be correct to assume Digitalis would be a good drug to use with Pixantrone-to help the heart stay stronger while the pixantrone effect this weakebing the heart?Ben
Could it be correct to assume Digitalis would be a good drug to use with Pixantrone-to help the heart stay stronger while the pixantrone effect this weakening the heart?Ben