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| |  AACR-EORTC-NCI: Chemical Derived From Hawaiian Mollusk Show Activity Against Prostate Cancer By Ed Susman Special to DG News MIAMI BEACH, FL -- October 31, 2001-- A chemical isolated from a Hawaiian mollusk plucked from Kahala Bay shows activity in patients with refractory prostate cancer, researchers report. "We are encouraged by these Phase I results," said Dr. Jan Schellens, a medical oncologist with the Netherlands Cancer Institute, Amsterdam, The Netherlands, "because we have seen some dramatic clinical responses even though this study was designed just to look at the toxicology of Kahalalide F. Dr. Schellens said that one of the 12 patients studied was wheelchair-bound due to painful bone metastases when he began taking the drug under the trial protocol. The doctor said the patient's pain levels decreased as did his need for pain killers. He was able to walk and didn't need his wheelchair. The effects continued for about six months until the disease began to progress. In addition to the decreased pain, the patient's PSA levels dropped by at least 50 percent, an accepted clinical marker that he was showing improvement. PSA levels also fell in two other patients in the trial who had stable disease. Dr. Schellens presented his findings at the 12th annual joint meeting of the American Association for Cancer Research, the European Organization for Research and Treatment of Cancer and the National Cancer Institute of the United States. In the trial, patients were administered kahalalide F as an intravenous infusion over one hour, during five consecutive days every three weeks. All the patients had advanced or metastatic androgen refractory prostate cancer. On the basis of the maximum tolerated dose values defined in mice, a starting dose of 20 micrograms was selected, the equivalent to a total dose of 100 micrograms of kahalalide F during the first course of treatment. Kahalalide F is one of a family of novel dehydroaminobutyric acid-containing peptides isolated from the Hawaiian herbivorous marine species of mollusk, Elysia rufescens. Dr. Schellens said kahalalide F displays both in vitro and in vivo anti-tumor activity in various solid tumor models including breast, colon, non-small cell lung, and in particular prostate cancer. In the toxicity studies, Dr. Schellens reported that the observed adverse events were rapidly reversible mild headache, fatigue, pain and local edema. "Thus far, the schedule is well tolerated," he said. "Kahalalide F is a very exciting molecule," commented Edward Sausville, MD, Ph.D., associate director for developmental therapeutics at the NCI, Bethesda, Maryland, United States. "It again shows the rich biodiversity that occurs in nature and particularly in marine creatures." Dr. Sausville said future research will likely focus on defining how kahalalide F works to achieve its activity in prostate and other cancers. "The mechanism of action of this drug is not entirely clear at this time," he commented. The study was funded by Pharmamar S.A. of Madrid, Spain, a pharmaceutical company that specializes in developing new compounds from sea creatures. Dr. Schellens said the company is working to synthesize kahalalide F because presently it takes vast numbers of the mollusks to produce the drugs used in the clinical trials.
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