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CTIC - If we release it late, maybe they won't notice!

I hope nobody still owns shares of this company... In case there is any doubt this is bad news, please note:

(1) It was released at 8pm on a Friday night
(2) There is no scheduled conference call for Monday.

Friday November 3, 8:00 pm ET

Cell Therapeutics, Inc. (CTI) Temporarily Suspends Enrollment on PIONEER Lung Cancer Clinical Trial; Current Patients Continue to Be Treated

Company to Amend XYOTAX(TM) PIONEER Trial Based on Guidance from FDA Regarding Primary Endpoint Selection and Analysis

Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) reported today that enrollment on its PIONEER lung cancer clinical trial has been temporarily suspended while the Company awaits follow up data of recently enrolled patients. After consultation with the Company and the study's steering committee, the Data Safety Monitoring Board (DSMB) recommended and CTI agreed to suspend enrollment on the trial to allow maturity of the data and assessment of differences in early cycle deaths observed between arms of the study. Translation: People are dying faster in the Xyotax arm so the DSMB is getting nervous and wants to stop to see if it will balance out While most of the deaths were attributed to disease progression Translation: Whew, we managed to dodge the docs attributing the deaths to Xyotax at least, more complete data is required to analyze this difference. Also according to the recommendation of the DSMB, all patients who are currently on the trial will continue to be treated per the protocol.

In addition, as a planned follow up to its May meeting with and following recommendations from the U.S. Food and Drug Administration (FDA), the Company reviewed the demographic and estrogen data of the patients on the PIONEER study and plans to amend the current study while enrollment is suspended. The study will be amended to focus on the primary efficacy endpoint of survival Translation: This is what the FDA told us to do in the first place and since we've stopped enrollment we might as well listen in women with normal estrogen levels; the subset of patients that demonstrated the greatest survival benefit in the STELLAR trials. actually, the subset of patients that demonstrated the best treatment were those that were treated in Russia, but who's counting at this point...

"Following our meeting with the FDA, we decided to use the initial enrollment in this study to determine whether the proportion of patients who have normal estrogen levels is equivalent to what was expected based on our experience in the STELLAR trials," said James A. Bianco, M.D., President and CEO of CTI. "Given that only approximately one-half of patients sampled have normal estrogen levels in the PIONEER trial compared to approximately two- thirds of patients for which estrogen data was available in our prior STELLAR trials, we decided it would be prudent to amend the protocol to focus the primary endpoint analysis on the subgroup of patients in which we saw the greatest survival difference in our STELLAR trials -- patients with normal estrogen levels." Translation: We thought that we could skate through enrolling just women, but the DSMB analysis hosed that idea so we might as well try something else

The PIONEER study was initiated in December 2005 using pre-menopausal age to stratify patients. Based on feedback from the FDA, CTI will utilize the Agency's recommendation to amend the protocol to use estrogen level as a stratification factor and as the primary efficacy endpoint of the study. The Company expects to submit an amendment to the FDA under a Special Protocol Assessment request as soon as practicable. The Company anticipates the change to the protocol will push the interim analysis of the PIONEER trial back by at least six months.

Yeah, six months. Sure.