CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)

07-25-2008

September meeting to focus on use of Zevalin as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma

Cell Therapeutics, Inc.
(CTI) (Nasdaq and MTA: CTIC) announced today that the Company has scheduled
a meeting with the U.S. Food and Drug Administration (FDA) in September to
discuss the possibility of filing a supplemental Biologics License
Application (sBLA) for use of Zevalin(R) ([90Y]-ibritumomab tiuxetan) as
consolidation therapy after remission induction in previously untreated
patients with follicular non-Hodgkin's lymphoma. The basis for the filing
would be data from the First-line Indolent Trial that CTI recently gained
access to through an agreement with Bayer Schering Pharma.

"We are pleased to have scheduled a meeting with the FDA to discuss a
label expansion for Zevalin which could broaden its availability to
patients," said James A. Bianco, M.D., President and CEO of Cell
Therapeutics. "We continue to make progress with Zevalin on multiple fronts
with clarity on reimbursement rates, deployment of our national sales team
and now the opportunity to meet with the FDA to discuss possibly expanding
the label for Zevalin."

About the Phase III First-line Indolent (FIT) Trial

The multinational, randomized phase III First-line Indolent Trial (FIT)
evaluated the benefit and safety of a single infusion of Zevalin in
patients with CD20-positive follicular non-Hodgkin's lymphoma who had
achieved a partial response or a complete response after receiving standard
first-line chemotherapy regimens. The FIT trial results were presented in
one oral and two poster presentations at the American Society of Hematology
(ASH) conference in December 2007. The FIT trial demonstrated that when
used as a first-line consolidation therapy for patients with follicular
non-Hodgkin's lymphoma, Zevalin significantly improved the median
progression-free survival time from 13.5 months (control arm) to 37 months
(p<0.0001).

The primary investigators of the study concluded that Zevalin
consolidation of first remission in advanced stage follicular non-Hodgkin's
lymphoma is highly effective, resulting in a total complete response (CR +
CRu) rate of 87 percent and prolongation of median progression-free
survival (PFS) by approximately two years, with a toxicity profile
comparable to that seen with Zevalin's use in approved indications.
Zevalin-treated patients had reversible Grade 3 or 4 hematologic side
effects including neutropenia in 67 percent, thrombocytopenia in 61
percent, and anemia in 3 percent. Nonhematologic toxicities were 24% Grade
3, 5% Grade 4, and Grade 3/4 infection was 8%.

About Zevalin(R)

Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy called
radioimmunotherapy and is indicated as part of the Zevalin therapeutic
regimen for treatment of relapsed or refractory, low-grade or follicular
B-cell non-Hodgkin's lymphoma, including patients with rituximab refractory
follicular NHL. Zevalin is indicated under accelerated approval for the
treatment of relapsed or refractory, rituximab-naïve, low-grade and
follicular NHL based on studies using a surrogate endpoint of overall
response rate. It was approved by the FDA in February of 2002 as the first
radioimmunotherapeutic agent for the treatment of NHL.

Rare deaths associated with an infusion reaction symptom complex have
occurred within 24 hours of rituximab (Rituxan(R)) infusions. Yttrium-90
Zevalin administration results in severe and prolonged cytopenias in most
patients. Severe cutaneous and mucocutaneous reactions have been reported.
The most serious adverse reactions of the Zevalin therapeutic regimen were
primarily hematologic, including neutropenia, thrombocytopenia and anemia.
Infusion-related toxicities were associated with pre-administration of
rituximab. The risk of hematologic toxicity correlated with the degree of
bone marrow involvement prior to Zevalin therapy. Myelodysplasia or acute
myelogenous leukemia was observed in 2 percent of patients (8 to 34 months
after treatment). Zevalin should only be used by health care professionals
qualified by training and experience in the safe use of radionuclides.

Patients and healthcare professionals can visit http://www.zevalin.com
for more information.

About Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of
white blood cells and normally spreads through the lymphatic system, a
system of vessels that drains fluid from the body. NHL can be broadly
classified into two main forms -- aggressive NHL, a rapidly spreading acute
form of the disease, and indolent NHL, which progresses more slowly.
According to the National Cancer Institute's SEER database there were
nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer
Society estimates that 66,120 people will be diagnosed with NHL in 2008 and
more than 19,000 are expected to die.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed
to developing an integrated portfolio of oncology products aimed at making
cancer more treatable. For additional information, please visit
http://www.celltherapeutics.com.

This press release includes forward-looking statements that involve a
number of risks and uncertainties, the outcome of which could materially
and/or adversely affect actual future results. Specifically, the risks and
uncertainties that could affect the development of Zevalin include risks
associated with preclinical and clinical developments in the
biopharmaceutical industry in general and with Zevalin in particular
including, without limitation, the potential failure of the Zevalin FIT
data to be suitable for submission or acceptable to the FDA for this
expanded indication or any other indication, determinations by regulatory,
patent and administrative governmental authorities, competitive factors,
technological developments, and costs of developing, producing and selling
Zevalin. There is also a risk that even if label expansion of Zevalin is
approved, it may not result in a significant market increase for the drug
due to the presence of other treatment options, failure to gain market
acceptance and other factors. In addition, there is a risk that we may not
be able to recognize the full expected value of Zevalin in future years.
You should also review the risk factors listed or described from time to
time in the Company's filings with the Securities and Exchange Commission
including, without limitation, the Company's most recent filings on Forms
10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend
to update or alter its forward-looking statements whether as a result of
new information, future events, or otherwise.



Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: media@ctiseattle.com
http://www.CellTherapeutics.com/media.htm

Investors Contact:
Ed Bell
T: 206.272.4345
Lindsey Jesch
T : 206.272.4347
F : 206.272.4434
E: invest@ctiseattle.com
http://www.CellTherapeutics.com/investors.htm

SOURCE Cell Therapeutics, Inc.



Related Diseases: Non-Hodgkin Lymphoma (NHL)
Related Keywords: Follicular Lymphoma
Related Glossary Terms: NHL
 
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