Biotech Values

[exwannabe]

CTIC Pixantrone PR, more from Comedy Central.

Before reading the PR, here is the background.

Pixantrone:

A dox. varient that is designed to reduce the cardiac toxicity. Seams like a reasonable candidate, but as usual CTIC tries to shortcut the trial process.

EXTEND trial:

"The EXTEND clinical trial is a phase III single agent trial of pixantrone for patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines" N=320

What happened:

The trial enrollment started slowly and came to a near stop (single agent?). The trial was just now terminated at N=140

The PR: http://biz.yahoo.com/prnews/080325/aqtu505.html?.v=3

"Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) announced today that enrollment is complete in the phase III EXTEND (PIX301) clinical trial of pixantrone (BBR2278) for patients with relapsed diffuse large B cell non-Hodgkin's lymphoma (NHL). An analysis of the data is expected in the second half of 2008. Based on prior discussions with the U.S. Food and Drug Administration (FDA) the data could provide a registration path for pixantrone if final study results are adequate for submitting a New Drug Application (NDA) with the FDA in early 2009 with a potential approval in 2009. A total of 140 patients were enrolled in the study, 97 patients are currently evaluable according to Histological Intent to Treat, or HITT, criteria and will be included in the final analysis of the study."

Right.

P.S., these guys could set a record for time between successive reverse splits.