Cell Therapeutics Stops Enrollment in Phase II/III Trial of Lisofylline for Acute Lung Injury.

SEATTLE--(BW HealthWire)--May 28, 1999--

Cell Therapeutics, Inc. (cti) (Nasdaq:CTIC) announced it has received a recommendation from a National Heart, Lung and Blood Institute (NHLBI) appointed Data Safety and Monitoring Board to discontinue enrollment in the Phase II/III trial of lisofylline (LSF) for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS).

The decision was based on predetermined criteria, which required a positive trend toward improvement in day 28 survival among the LSF recipients for the trial to continue as a phase III trial.

The trial, conducted through the NHLBI's ARDS Network, began enrollment in May 1998 and was a rolling Phase II/III pivotal study of LSF among patients who require mechanical ventilation for ALI and ARDS.

"We are disappointed by the recommendation to stop enrollment in this trial and will have a better understanding of the basis for their recommendation once we receive the data from the NHLBI," said Carolyn Paradise M.D., Head of Medical Affairs at cti.

The Company has recently completed enrollment in a pivotal phase III trial of LSF for prevention of serious infection among patients undergoing high dose induction chemotherapy for acute myeloid leukemia (AML). Results for this trial are expected later this summer.

In addition to LSF, the Company has 3 other cancer products under development: Apra(TM), the Company's novel anti-cancer drug candidate, is being investigated in two efficacy studies among patients with hormone and chemotherapy refractory prostate cancer or patients with soft tissue sarcomas. PG-TXL(TM) (polyglutamate paclitaxel), a novel version of the well-known cancer drug Taxol(R), is scheduled to enter phase I testing later this year. In preclinical animal studies, PG-TXL demonstrated significant increase in anti-tumor activity with less toxicity than paclitaxel, the active ingredient in Taxol. SC-7 is a novel oral lead candidate for preventing tumor induced new blood vessel formation, a process termed angiogenesis.

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.

This news release, and additional information of interest, is available to all investors, prospective employees and patients at cti's web site at www.cticseattle.com

This announcement 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 cti's products under development include risks associated with preclinical and clinical developments in the biotechnology industry in general and of cti's products under development in particular (including, without limitation, the potential failure of Apra(TM), LSF(TM), PG-TXL(TM), SC-7 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, and 10-Q.

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