AACR-NCI-EORTC:
New Cancer Drug, Apra, Promising Without Conventional Chemo Toxicities

WASHINGTON, DC -- November 24, 1999 -- New data on Apra(TM), Cell Therapeutic's (cti) novel anti-cancer drug, looks promising in treating chemotherapy-resistant sarcomas without the traditional toxicities that accompany conventional anti-cancer agents. Sarcomas, a type of soft tissue malignant tumor, are diagnosed in more than 7800 patients in the United States each year and standard chemotherapy is not curative.

This data was presented in a late breaking presentation at the AACR-NCI-EORTC International Conference in Washington, DC by researchers from the Columbia University Presbyterian Hospital, NY and the Dana-Farber Cancer Institute of Harvard Medical School. "This was a strong showing for Apra at this important clinical cancer meeting," said Dr. James Bianco, president and CEO of cti. "Seeing Apra advance to its next stage of development is exciting. With the identification of a novel target, investigators are eager to explore the use of this agent in combination with conventional cancer drugs since there is potential to provide greater anti-tumor effects without increased toxicity, " Dr. Bianco added.

The Phase II clinical trial, which was initiated in May 1999, was scheduled to enroll 40 patients with sarcoma who had failed conventional chemotherapy or for whom chemotherapy is known to be ineffective. The patients were randomized to one of two drug infusion schedules. Per the study protocol, if 1 of 20 patients in a given treatment arm had evidence of a response, an additional 20 patients were to be added to that arm. Based on preliminary response rates observed to date, the Company is expanding the study to include additional centers and will increase enrollment to 60 to 80 patients.

"The preliminary data are encouraging and demonstrate evidence of clinical activity when Apra is administered as a single agent for treating sarcoma, " said Dr. Carolyn Paradise, Head of Clinical Research at cti. "Of the clinical activity noted in this trial, one major response was in a patient with a highly resistant type of sarcoma that had spread to the liver. This patient continues to have a significant response more than 5 months after treatment began. Since the first stage of the study has met its objectives, we have a sound basis for expanding enrollment on the most active arm," Dr. Paradise added. Additional centers that specialize in the treatment of soft tissue sarcomas will join the study.

In a separate but related presentation, company scientists reported they have identified the molecular target through which Apra exerts its killing effects on cancer cells. This target is an enzyme important to cellular membrane development. Because of differences in phospholipid metabolism between tumor cells and normal cells, tumor cells are more sensitive and therefore more responsive to the effects of Apra than are normal cells. By altering the phospholipid composition of tumor cells, Apra appears to have activity against a broad variety of cancers, including those that are resistant to conventional chemotherapeutic drugs.

The company has a second ongoing phase II study of Apra in hormone and chemotherapy refractory prostate cancer and anticipates initiating a study of Apra in combination with conventional chemotherapy for lung cancer early next year.

Reprinted from: All contents Copyright (c) 1999 P\S\L Consulting Group Inc. All rights reserved.