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| |  AACR-NCI-EORTC: Responses Seen in Solid Cancers With Investigational Dolastatin Analogue By Ed Susman BOSTON, MA -- November 20, 2003 -- The investigative dolastatin analog ILX651 appears to show activity in patients with advanced lung, colon and renal cell cancers, researchers reported here November 20th at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. "We observed prolonged stable disease in patients with non-small-cell lung cancer in which a patient achieved 47% shrinkage of tumours over seven cycles of treatment," said Lisa Hammond, MD, a medical oncology consultant with ILEX Oncology, Inc., San Antonio, Texas, United States. Each drug cycles was four weeks in duration. The study was funded by ILEX. Dr. Hammond also said patients with advanced colorectal cancer experienced stabilization of disease through three and four cycles, and a patient with renal cell carcinoma had stable disease through six cycles of treatment. She reported on the treatment of 25 patients in the preliminary study. "We have been encouraged enough with these phase 1 and pharmacokinetic studies to begin phase 2 studies of the drug's usefulness in melanoma and lung cancer," Dr. Hammond said. In the study, patients were administered ILX651, a synthetic compound derived from dolastatin 15, a small peptide isolated from the sea hare, Dolabella auricularia. The compounds inhibit tubular polymerization. That process is aimed at disrupting cell division and growth. ILX651 is administered through a 30-minute intravenous infusion once a week for three weeks in a four-week cycle. Dr. Hammond said that treatment produced side effects that were manageable, reversible and non-cumulative. "No major gastrointestinal symptoms, prominent nausea, hypertension, liver toxicity, peripheral neuropathy or alopecia have been reported so far," she said. The dose-limiting toxicity of the drug is neutropaenia. That appeared at dosages of 62.2 mg/m2 a day in patients with minimal pretreatment, and at 54.5 mg/m2 in patients who were heavily pretreated.
[Study title: A Phase I and Pharmacokinetic (PK) Study of ILX651, a Third-Generation Dolastatin 15 Analog Administered IV Weekly x 3 Weeks Every 4 Weeks in Patients With Advanced Solid Malignancies. Abstract A264]
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