Cell Therapeutics, Inc. Initiates Phase I Trial of Lisofylline for Prevention and Treatment of Mucositis.

SEATTLE--(BUSINESS WIRE)--Oct. 20, 1998--Cell Therapeutics, Inc. (cti) (Nasdaq:CTIC) today announced that it has initiated a Phase I trial of the company's lead supportive care oncology agent, lisofylline, among patients receiving combined radiation and chemotherapy to treat advanced head and neck cancers. The single center study will be conducted at the H. Lee Moffitt Cancer Center in Tampa, Florida, a lead center for the Radiation Therapy Oncology Group (RTOG).

Lisofylline is being developed to prevent or reduce the incidence and severity of mucositis, the breakdown of the epithelial cells which line the mouth and gastrointestinal tract. Mucositis affects an estimated 60,000 - 75,000 cancer patients each year in the U.S. Lisofylline is also under investigation to reduce serious and fatal infections and treatment-related mortality among cancer patients receiving radiation and/or chemotherapy.

The majority of patients receiving combined radiation and chemotherapy for head and neck cancers develop severe mucositis of the mouth, throat and esophagus, which requires use of a feeding tube to provide nutrition. Because mucositis may last for months after the radiochemotherapy is completed, significant weight loss is common, contributing to the pain and discomfort of this frequent side effect of cancer therapy. Currently, there are no effective therapies to prevent or treat mucositis.

The trial is designed as an open label dose-ranging study utilizing a new infusion schedule of lisofylline. Unlike ongoing studies of lisofylline, where the drug is administered four times a day over a 10-minute infusion, this trial will examine the safety and potential effectiveness of lisofylline administered as a continuous infusion. The drug will be started just prior to chemotherapy and will be continued during the entire 8 - 11 week period of cancer treatment. Four dose levels will be investigated. If dose limiting toxicities are observed, patients will be allowed to switch to the standard 4 times daily dosing regimen of lisofylline. Approximately 12-20 patients are expected to be enrolled in this Phase I trial.

"This study is expected to provide us with important information about alternative lisofylline dosing schedules available to oncologists and patients which may more readily accommodate the large mucositis outpatient population we are treating," said Carolyn Paradise, M.D., Head of Medical Affairs at cti. "Once we have an acceptable dose schedule, we intend to roll the study over into a randomized efficacy trial," she added.

"Data from a number of leading research institutions continues to provide strong support for lisofylline in applications for reducing serious side effects of cancer treatments and for preventing acute lung injury," noted James A. Bianco, M.D., President and CEO of cti. "Earlier this year at the PRISM conference, researchers from the Harvard School of Dental Medicine presented data demonstrating a significant effect of lisofylline on reducing the severity and duration of mucositis in relevant animal models."

Lisofylline is currently in pivotal Phase III trials for adult myeloid leukemia (AML) and bone marrow transplant (BMT) and under sponsorship of the National Heart Lung and Blood Institute, for acute lung injury (ALI). "Initiating the mucositis trial fills out the third leg of our oncology development strategy for lisofylline. Together with our ongoing pivotal trials in (AML) and (BMT), if successful, lisofylline will provide oncologists and their patients a way to manage the serious side effects associated with cancer treatment," noted Dr. Bianco.

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 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 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 reports on Forms 10-K, 8-K and 10-Q.