Cell Therapeutics Reports Results of Lisofylline Phase II Trial Among Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing High Dose Induction Chemotherapy.

SEATTLE--(BW HealthWire)--July 16, 1997--Cell Therapeutics, Inc. (NASDAQ: CTIC) today announced preliminary results from a Phase II trial of its lead drug candidate, lisofylline (LSF), among patients with newly diagnosed acute myeloid leukemia (AML). The randomized, double-blind, placebo-controlled trial was conducted at the University of Texas MD Anderson Cancer Center in Houston, Texas. The Principal Investigator was Elihu Estey, MD.

In this trial, seventy patients, ages 19 to 70 years, were randomized to receive either LSF (3mg/kg), or placebo, along with high dose induction chemotherapy for the treatment of AML. Thirty-five patients received LSF and 35 received placebo. Trial endpoints included examining the effect of LSF on the incidence of neutropenia-associated (both serious and non-serious) infections, and early mortality (including infectious- and non-infectious-related deaths), in the first 60 days following chemotherapy.

LSF recipients experienced 50% fewer serious neutropenic infections than placebo recipients. Six patients (17%) in the LSF arm developed seven serious neutropenic infections, compared with 12 placebo recipients (34%), who developed 16 serious neutropenic infections (p=0.043). No patients (0%) in the LSF group developed fungal infections, compared with five placebo patients (14%), who developed six fungal infections (p=0.01).

While a difference in all-cause mortality was not observed between the two treatment arms, there was a strong trend toward reducing fatal infections among LSF recipients. Seven (20%) patients receiving placebo developed fatal infections in the first 60 days following chemotherapy, compared with three (8.6%) LSF recipients, who died from infections (p=0.19). A trend in the reduction of all (serious and non-serious) neutropenic-related infections was also observed. Thirteen LSF recipients had 16 infections compared to 17 placebo recipients, who experienced 25 infections (p=0.29). LSF had no observable effect on the acquisition of non-serious infections. No serious side effects due to LSF administration were observed.

Cell Therapeutics President and CEO James A. Bianco, MD stated: "This is our second randomized, placebo-controlled Phase II trial where we have observed a significant reduction in serious neutropenic infections. These results are consistent with those of our other Phase II trial with cancer patients undergoing bone marrow transplantation (BMT), which we reported at the American Society of Hematology meetings last December. In that study, we observed a significant reduction in the incidence of neutropenic-related serious and fatal infections following BMT. We believe being able to reduce the incidence of serious infections that occur during neutropenia, or that period when a patient's infection-fighting white blood cells are reduced by cancer treatment, is a clinically meaningful and beneficial endpoint for the patient, and one that usually correlates with outcome. We believe that LSF may be lowering the rate of serious and fatal infections by acting to reduce or prevent the breakdown of mucosal barriers in the gastrointestinal tract that typically occurs following chemotherapy"

This news release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of lisofylline and related compounds includes risks associated with pre-clinical and clinical development in the biopharmaceutical and biotechnology industries 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 most recent Registrations on Forms 10-K, 8-K and 10-Q.

Lisofylline is being developed and commercialized in collaboration with the R.W. Johnson Pharmaceutical Research Institute and Ortho Biotech Inc. of Raritan, N.J., both are Johnson & Johnson Companies. Cell Therapeutics Inc. is a Seattle-based biopharmaceutical company focused on the development of a new class of small-molecule drugs that seeks to selectively regulate the metabolism of phospholipids in intracellular signaling pathways relevant to cancer and inflammatory and immune diseases.

CONTACT: Cell Therapeutics Inc.

Lee M. Parker, 800/664-2846

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