PRNewswire
SEATTLE, Jan. 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI)
(Nasdaq and MTA: CTIC) announced today results of a study published by
Esmaeli, et al. online on January 15, 2009 in the Annals of Oncology
demonstrating that rituximab followed by single agent Zevalin (ibritumomab
tiuxetan) in a front-line setting for patients with MALT lymphoma and low-
grade follicular lymphoma that primarily involved the conjunctiva or orbit
produced a complete response rate of 83 percent.
Ocular adnexal lymphoma (OAL) defined as lymphoma affecting the orbit,
eyelid and conjunctiva is the most frequent primary malignant tumor of the
orbit in adults, accounting for approximately 55 percent of all orbital
tumors. MALT lymphoma is the most common histologic subtype of OAL, followed
by low-grade follicular lymphoma. External-beam radiotherapy (EBRT) has been
the most frequently used modality and is considered the gold standard for
treating OAL that present with local disease. However, EBRT does not address
systemic sites of involvement in OAL in patients with multifocal disease and
therefore, systemic targeted radioimmunotherapy with Zevalin might offer an
alternative to treating OAL.
"This study demonstrates the potential for Zevalin to provide an
alternative to EBRT, the current standard of therapy for MALT lymphoma, which
may result in lower ocular toxicity than EBRT and equivalent or better
disease control," noted Jack Singer, M.D. and Chief Medical Officer of CTI.
In the study 9 patients with MALT lymphoma of conjunctiva or orbit and 3
patients with low grade follicular lymphoma of the orbit received rituximab
and Indium-111 Zevalin and then approximately 1 week later received a second
infusion of rituximab followed by single dose of Yttrium-90 Zevalin.
Results demonstrated an initial response rate for patients of 100 percent
with 83 percent achieving a complete response. There were no cases of
extraorbital relapse, with a median follow-up time of 20 months. All 12
patients experienced grade I or II transient pancytopenia during the first 3
months. Two patients had platelet transfusions, and one patient had blood
transfusions due to myelosuppression. There were no episodes of grade III or
IV toxicity.
The authors conclude that Zevalin may represent a reasonable alternative
for front-line treatment of early-stage extranodal OAL, producing response
rates similar to those with EBRT with one-tenth the absorbed radiation dose.
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 also 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 in the
United States 66,120 people are expected to be diagnosed with NHL in 2008.
Additionally, approximately 19,160 are expected to die from this disease in
2008.
About RIT Oncology, LLC
Cell Therapeutics and Spectrum Pharmaceuticals are the sole members of the
LLC, whose sole purpose is to commercialize Zevalin in the United States. The
LLC is governed by a Board of Managers comprised of an equal number of members
from both companies. Both parties are to equally provide for the future
capital requirements of the LLC and share equally in the profits and losses of
the LLC.
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 for Zevalin to be proved safe and effective for the
treatment of additional indications as noted in this publication or any other
indication, determinations by regulatory, patent and administrative
governmental authorities, competitive factors, technological developments, and
costs of developing, producing and selling Zevalin. 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: [email protected]
http://www.CellTherapeutics.com/press_room
Investors Contact:
Ed Bell
T: 206.272.4345
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: [email protected]
http://www.CellTherapeutics.com/investors