Cell Therapeutics and R.W. Johnson Pharmaceutical Research Institute Expand Their Collaboration For Lisofylline Development to Include Acute Myeloid Leukemia.

SEATTLE --(BW HealthWire)--Sept. 22, 1997-- Cell Therapeutics Inc. (Nasdaq:CTIC) today announced that, the R.W. Johnson Pharmaceutical Research Institute (PRI) and Ortho Biotech Inc., both Johnson & Johnson Companies, (NYSE:JNJ) have elected to expand their lisofylline collaboration agreement with Cell Therapeutics (cti) to include development of cti's lead drug candidate to treat patients receiving induction chemotherapy therapy for acute myeloid leukemia (AML).

This decision was based in part on an analysis and review by PRI of a recently completed Phase II randomized double-blind, placebo-controlled trial of lisofylline among patients undergoing high dose induction chemotherapy to treat AML. In that trial, there was a 50 percent reduction in the incidence of serious neutropenic infections among lisofylline patients when compared to placebo recipients (p=0.043). In addition, fungal infections were seen in 14 percent of placebo recipients whereas no patients (0 percent) receiving lisofylline developed a fungal infection (p=0.01). A strong trend in reducing infection related deaths was also observed.

Cti President and Chief Executive Officer James A. Bianco, MD, stated: "We are excited by the consistency of the effects of lisofylline in both our earlier bone marrow transplantation trial and the recent AML Phase II trial. We believe this drug candidate holds significant potential for cancer patients receiving high dose radiation therapy and/or chemotherapy. These results suggest that reducing serious infections is more clinically meaningful than just reducing days of fever and low white blood cell counts; the endpoints affected by blood cell growth factors. Demonstration that lisofylline may have activity in induction chemotherapy for AML expands the application of this drug candidate to broader populations of cancer patients. We are excited by the potential benefits a product like this might hold for cancer patients and their families." Bianco added, "I believe I speak for both companies when I say that we are extremely pleased with the progress of our collaboration thus far."

Including lisofylline development for the AML indication marks a significant expansion of the collaboration. Initial funding commitments were for the development and commercialization of lisofylline for preventing serious infections and mortality following high dose radiation and/or chemotherapy accompanied by bone marrow transplantation, with PRI funding 60 percent of the development costs. Under the expanded agreement, PRI will also fund 60 percent of the development costs related to achieving additional marketing approval from the FDA for using lisofylline in AML patients. Under the terms of the agreement, cti and Ortho Biotech will co-promote lisofylline for all indications in the U.S. and share equally in profits and losses. Ortho Biotech and its affiliates will exclusively commercialize lisofylline in the rest of the world excluding Canada and will pay cti royalties on sales. BioChem Therapeutics Inc., of Laval, Quebec, a subsidiary of BioChem Pharma Inc., has marketing rights to lisofylline in Canada.

The lisofylline collaboration, initiated in November 1996, focuses on the development and commercialization of cti's lead drug candidate, lisofylline. Lisofylline is being developed to reduce the incidence and severity of the side effects such as serious infection, mucositis and mortality associated with the use of high-dose radiation and/or chemotherapy to treat cancer patients.

The agreement calls for J&J to pay cti a $1 million milestone payment for the expansion of the joint development agreement for lisofylline to include the AML indication. The agreement specifies additional milestones and equity payments upon cti's achievement of certain development and regulatory events.

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. is a Seattle-based biopharmaceutical company focused on the development of a new class of small-molecule drugs that selectively regulate the metabolism of lipid peroxides and phospholipids in intracellular signaling pathways relevant to cancer and inflammatory and immune diseases.

CONTACT: Cell Therapeutics Inc.

Lee M. Parker, 206/282-7100 or 800/664-CTIC

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