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THE LIPOSOME COMPANY ANNOUNCES FINAL PHASE II STUDY RESULTS WITH TLC D-99

 PRINCETON, N.J., Dec. 11 /PRNewswire/ -- A high response rate and good safety profile were seen with The Liposome Company's (NASDAQ-NMS: LIPO) TLC D-99 in final results of a Phase II trial of patients with metastatic breast cancer, researchers reported at the 15th Annual San Antonio Breast Cancer Symposium sponsored by the University of Texas Health Science Center in San Antonio.
 For TLC D-99, a liposomal doxorubicin, investigators reported a 60 percent response rate in tumors that had spread to the liver, lung, and bone marrow, a figure that is "in the high range" compared to conventional doxorubicin. This suggests that targeted drug delivery by the liposomes to those tumors is effective, according to Gerald Batist, M.D., Montreal General Hospital, principal investigator.
 The 60 percent figure is higher than the response rate of 54 percent previously published in the May 1992 Proceedings of the American Society of Clinical Oncology (ASCO). The ASCO data were interim results of this Phase II study.
 In addition to the response rate, investigators found that TLC D-99 has a "favorable toxicity profile." Side effects were milder and less frequent than would be expected with conventional doxorubicin, and there was no significant clinical cardiotoxicity, the most critical side effect of doxorubicin. Furthermore, severe mucositis was uncommon with TLC D-99.
 The study was conducted at hospitals associated with McGill University.
 All women in the study had breast cancer that had metastasized to their lungs, liver, lymph nodes, skin, or bones. Because the cancer had spread beyond their breasts, these patients generally cannot be cured by surgery or radiation therapy. Chemotherapy is the treatment of choice. Unfortunately, currently available drugs are rarely, if ever, able to provide long term cures for these patients, and these drugs frequently cause side effects.
 Doxorubicin is one of the drugs most commonly used to treat advanced breast cancer. While studies vary, approximately 30 to 40 percent of women with the disease respond temporarily to treatment with doxorubicin used alone. However, the drug commonly causes side effects, such as nausea, vomiting, mucositis (ulcers of the lining of the mouth and intestines), bone marrow suppression, and hair loss. In addition, once the cumulative dose a patient receives exceeds 450 mg/m2, the chance the drug will cause life-threatening heart damage increases dramatically.
 TLC D-99 consists of doxorubicin encapsulated in liposomes, microscopic man-made fat bubbles designed to target the drug to tumors and away from healthy organs, such as the heart.
 "We are very pleased with the final results of this Phase II trial of TLC D-99," said Stephen L. Saletan, M.D., vice president of medical affairs at The Liposome Company. "Even though this was a relatively small trial of 29 evaluable patients, the response rate suggests that the rationale for liposomal drug delivery of doxorubicin is being confirmed, and that in a head-to-head trial, TLC D-99 should compare quite well with conventional doxorubicin.
 "Moreover, the fact that TLC D-99's favorable toxicity profile was reconfirmed also is good news. Eleven patients received cumulative doses of more than 450 mg/m2, with five patients receiving more than 650 mg/m2. One patient's total cumulative doxorubicin dose exceeded 1275 mg/m2, far more than would usually be possible with conventional doxorubicin. If we see such results in comparative studies with larger numbers of patients, the benefits offered by TLC D-99 could be substantial."
 A leading company dedicated exclusively to the development of liposome and lipid-based pharmaceuticals, The Liposome Company selectively develops proprietary parenteral pharmaceuticals for the treatment, prevention, and diagnosis of life-threatening diseases. It has four drugs in clinical trials. TLC ABLC is in Phase II/III studies for the treatment of systemic fungal infections, TLC G-65 is in Phase II trials in the United States and Phase III in Europe for the treatment of Mycobacterium aviumintracellulare (MAI) infections in AIDS patients, TLC D-99 is in Phase II trials for treatment of metastatic breast cancer, and TLC C-53 is in Phase I trials in preparation for studies in Adult Respiratory Distress Syndrome.
 -0- 12/11/92
 /CONTACT: Edward G. Silverman, vice president - strategic planning & business development of The Liposome Company, 609-452-7060/
 (LIPO)


CO: The Liposome Company, Inc. ST: New Jersey, Texas IN: MTC SU:

GK-LR -- NY008 -- 6135 12/11/92 09:57 EST
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Date:Nov 13, 1992
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