Friday, July 11, 2008

more changes..

On Wednesday we went in for a weekly blood check and a simple exam with the Researcher just to make sure everything is doing fine. We had a hint that something might be up when the day before we were told that we would also meet with the Director.
Blood work and exam went just fine, but the Director informed us that the ANG1005 trial Kev is participating in has been put on hold - indefinitely. Apparently the cloudy phenomenon is still problematic. It’s not the appearance, but the fact that the chemicals are precipitating out of solution that has the pharmaceutical company, MDA and FDA concerned about its effectiveness. This type of formulation problem is usually quickly resolved, and everyone expected the original plan of increasing the dilution to 1 liter to fix it, so when that and other attempts failed, the hold was implemented while the investigation continues. So the new short term course of action is to repeat brain and spine MRIs (Thurs & Fri) and meet with the Director again on Monday.

Brain MRI went fine, but Kev had a bit of an anxiety attack on the table for the spine MRI and it was aborted. (I think the meeting for Monday will stand.) Kev has also been having nightmares recently so I’ll call his Palliative Care Drs this weekend and see what they can offer up.

2 comments:

Anonymous said...

Kevin, we are so sorry for what you are going through. I worked with you on Pump Module stuff, and I had no idea how sick you were. I am so sorry.

Anonymous said...

Deneen & Kevin, sorry the trial is on hold and I hope those nightmares ease up.