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EXHIBIT 99.1
Contact: Susan O. Moore, Executive Vice President,
Corporate Communications
Cell Therapeutics, Inc.
(206) 282-7100 or (800) 664-CTIC
[email protected]
www.cticseattle.com
or Susan Callahan
KNCB Dave
(206) 794-4706
[email protected]
CELL THERAPEUTICS, INC. RECEIVES FDA APPROVAL FOR TRISENOX TO TREAT ACUTE
PROMYELOCYTIC LEUKEMIA
70% of Patients With Relapsed/Refractory APL Achieved Complete Remission of
Their Disease
September 26, 2000 Seattle-- Cell Therapeutics, Inc. (CTI) (Nasdaq:CTIC)
announced TRISENOX (arsenic trioxide) injection was approved today by the U.S.
Food and Drug Administration to treat patients with a severe form of leukemia
whose disease has recurred or who have failed to respond to standard therapy.
Acute promyelocytic leukemia (APL) is a malignant disorder of the white blood
cells which can affect patients of any age. In the United States, APL represents
10-15% of the more than 10,000 patients who are diagnosed with acute myeloid
leukemia each year.
"For patients with APL whose disease has recurred following initial treatment,
the use of salvage therapy is highly toxic and rarely curative," said Carolyn
Paradise, M.D., Vice President of Clinical Development at CTI. "Results of the
clinical trials using TRISENOX demonstrated that a significant number of those
patients who suffered multiple relapses were able to achieve a complete
remission, or a disappearance of all visible leukemia cells. The majority of
patients who achieved complete remission were still alive and disease-free with
a median follow-up time of 16 months. This new treatment represents a
significant advance for patients with this disease."
A pivotal trial involving 40 patients with relapsed/refractory APL unresponsive
to standard therapies was conducted at nine institutions, including Memorial
Sloan-Kettering Cancer Center in New York City and other leading cancer centers
across the United States. Seventy percent of these patients achieved a complete
remission, with the majority achieving molecular eradication of the genetic
abnormality associated with APL. Complete remission was achieved on average
within two months after initiation of TRISENOX.
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"We are impressed at both the high rate of complete remission and the relapse-
free survival in this high risk population of APL patients whose previous
treatment failed to eradicate their disease," said Steven Soignet, M.D.,
investigator of Developmental Chemotherapy Service at Memorial Sloan-Kettering
Cancer Center in New York City.
Most patients experienced some drug-related toxicity. Acute toxicities
associated with arsenic trioxide therapy are well defined and when monitored and
treated appropriately are manageable. Serious adverse events (SAEs) reported
include APL-differentiation syndrome symptoms (fever, weight gain, shortness of
breath, and musculoskeletal pain) in 23% of the patients, and hyperleukocytosis
(increased levels of white blood cells) in 50% of the patients. Common
toxicities include gastrointestinal (nausea, vomiting, diarrhea, and abdominal
pain), fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching,
headaches, and dizziness. These adverse effects have not been observed to be
permanent or irreversible nor do they usually require interruption of therapy.
Another important adverse event was QT prolongation - a change in the time it
takes for the heart to relax after each beat. One serious case of QT
prolongation evolved into an abnormally rapid heartbeat. This episode resolved
spontaneously, and the patient was retreated with TRISENOX without recurrence of
the event.
In contrast to the side effects prevalent with use of standard chemotherapy,
hair loss, mucositis (mouth sores and ulcers) were uncommon.
TRISENOX is administered intravenously in two phases: induction therapy
consisting of daily injections of 0.15 mg/kg until the bone marrow is cleared of
leukemic cells, for up to a maximum of 60 days, and consolidation therapy using
the same dose for 25 days beginning three weeks after bone marrow remission is
evident.
A management conference call will be held on Wednesday, September 27 at 8:30
a.m. (EST). The call-in number is for domestic and for international
callers.
For more information on product availability, interested parties may contact
CTI's Customer Service at 1-888-305-2289.
CTI is committed to developing an integrated portfolio of oncology products
aimed at making cancer more treatable.
This announcement 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 CTI's products under development include risks
associated with preclinical and clinical developments in the biopharmaceutical
industry in general and of CTI's products under development in particular
(including, without limitation, the potential failure of TRISENOX and related
compounds to prove safe and effective for treatment of disease), determinations
by regulatory, patent and administrative governmental authorities, competitive
factors, technological developments, costs of developing, producing and selling
CTI's products under development, and 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
registrations on Forms 10-K, 8-K, S-3 and 10-Q.
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Cell Therapeutics, Inc. 201 Elliott Ave West Suite #400, Seattle, WA 98119
