Wake up, CTIC holders. CTIC has finished its first phase III trial.
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Friday January 23, 5:06 pm Eastern Time
Company Press Release
Cell Therapeutics Completes First Phase III Trial of
Lisofylline
SEATTLE--(BW HealthWire)--Jan. 23, 1998--Cell Therapeutics Inc. (cti) (Nasdaq: CTIC - news)
today announced that the last patient completed treatment and the subsequent 100-day evaluation
period in its first pivotal Phase III trial of lisofylline.
The trial was a multi-center, randomized, double-blind, placebo-controlled trial designed to
assess the effect of lisofylline in patients with advanced hematological malignancies undergoing
high dose radiation and/or chemotherapy accompanied by bone marrow transplantation (BMT) from
related (sibling) donors. Enrollment in the trial totaled 132 patients.
''This trial is one of the largest studies in BMT recipients, and we are anxious to see if the
results are comparable to those of the similarly designed Phase II trial we previously reported.
Since one of our primary endpoints is survival at 100 days post BMT, we needed to wait for the
last patient to reach that evaluation point before finishing data clean up and validation,''
said James A. Bianco, MD, president and CEO. ''We are on target to release preliminary results
of this first pivotal lisofylline trial by the end of the first quarter of 1998 as planned.''
Lisofylline is being developed to prevent or reduce the incidence of serious and fatal
infections, mucositis and treatment-related mortality among cancer patients receiving radiation
and/or chemotherapy. The Company also has an ongoing pivotal Phase III trial among patients
undergoing induction chemotherapy to treat acute myeloid leukemia. A third pivotal Phase III
trial is ongoing for patients receiving ablative radiation and/or chemotherapy followed by BMT
from unrelated donors. Both patient groups are at high risk for serious and fatal infections.
cti anticipates completing enrollment in these two trials later this year.
This news release includes forward-looking statements that involve a number of risks and
uncertainties, the outcome of which could materially adversely affect actual future results.
Specifically, the risks and uncertainties that could affect the development of lisofylline and
related compounds includes risks associated with preclinical and clinical development in the
biotechnology industry in general and of lisofylline and related compounds in particular
(including, without limitation, the potential failure of lisofylline and related compounds to
prove safe or effective for treatment of disease), determinations by regulatory, patent, and
administrative governmental authorities, competitive factors, technological developments, costs
of developing, producing, and selling lisofylline and related compounds, 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 Registration Statement on Form S-1, and
the Company's most recent reports on Forms 10-K, 8-K and 10-Q.
Cell Therapeutics Inc. focuses on the discovery, development and commercialization of small
molecule drugs that selectively regulate the metabolism of oxidized lipids and phospholipids
relevant to the treatment of cancer and inflammatory and immune diseases.
Contact:
Cell Therapeutics Inc.
Lee M. Parker, 800/664-CTIC
invest@ctiseattle.com
www.cticseattle.com
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Cell Therapeutics Inc (Nasdaq:CTIC - news)
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