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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?


To: aknahow who wrote (7950)12/6/1998 12:33:00 AM
From: Cacaito  Read Replies (2) | Respond to of 17367
 
The protocol for using TPA has several problems: Heparin and AntithrobinIII and prednisolone. All this drugs could alter the ongoing process, maybe they use all this regularly.

Heparin was used a lot in the past but there is a timing issue that is very risky, if one use it at the right time the patient could benefit, but it could bleed to death. Low dose heparin and the newest low osmolar heparins have been try, not much change. If used a little late then the clots do not dissolve and thrombi-shock continue.

Prednisolone, an steroid. Steroids use is back and forth, if lucky you put the drug early at the perfect time and it works (rarely), otherwise proven again and again to increase mortality in sepsis, some use it to improve blood pressure (dopamine is quite good)or in steroids dependent patients (not many).

TPA itself could be of help, it is more specific than heparin, and can dissolve fairly old clots (several hours old). They could probably be better off using it alone. Combination with BPI in the future is a possibility to help in the late cases were lots of clots are already form.

Antithrombin III is another drug that alters coagulation so they are adding huge complexity with so many drugs. They will need lots of patients (thousands) to prove anything.

The "open" nature of the study will kill it immediately for the FDA, (but it is already an FDA approved drug) so physicians will use it if they think it will help.

Premature newborns bleed easy in the cerebral ventricles. A recent report from London, phase I TPA study in 26 premies to dissolve clots in the cerebral ventricles, one baby bleed further. None of the babies was in septic shock, some trend toward better outcomes, nothing proven.

Some of the critics of BPI Phase II mentioned the use of TPA as better in one of the letters in the Lancet. Giroir answer back correctly about the non control and non regulated nature of the use of TPA for sepsis. Well, I went long on the previous protocol to show what Giroir complained about.

That protocol (CAVEAT: to my knowledge not necessarily the same authors that criticized BPI) is very complex, assumes that all the other drugs work (Ceftriaxone the antibiotic, the fluids, and dopamine for blood pressure are proven to help) and they use TPA as last resort, maybe to justify that everything else did not work then they go to the next step, or obviate some steps in the sicker patients which is a good choice. They probably should just stick to TPA (like Xoma's just BPI).

Robert S maybe should politely look beyond the abstracts of his persistently mentioned "reviews" so He could show that BPI is or is not one of the failure molecules mentioned in the again "reviews".