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ICAAC: Cancidas (Caspofungin Acetate) Shows Antifungal Activity in Candida Species TORONTO, CANADA -- September 18, 2000 -- New clinical study results showed that treatment with Cancidas™ (caspofungin acetate), an investigational medicine, resulted in a favorable response in 22 of 54 patients (41 percent) diagnosed with life-threatening invasive aspergillosis who were not responding to or were intolerant of other antifungal therapy. For patients receiving more than seven days of therapy the response rate was 49 percent (22 of 45). Cancidas is an echinocandin known as a glucan synthesis inhibitor that is being developed by Merck & Co., Inc. to treat serious fungal infections in adults. The study was presented at the 40th meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Also presented at the conference were results of a Phase I pharmacokinetic (PK) study and several in vitro studies evaluating Cancidas in Aspergillus and Candida. "We are encouraged by the results of this clinical study in this extremely difficult-to-treat systemic infection," said one of the study’s lead investigators, Dr. Thomas Walsh, chief, Immunocompromised Host Section, National Cancer Institute, Bethesda, MD. "Prognosis is usually poor in seriously ill patients with pulmonary or extra-pulmonary invasive aspergillosis who are not responding to initial therapy and with underlying conditions such as hematopoietic stem cells or organ transplantations." Patients in the multi-center, non-comparative study were immunocompromised, had documented invasive aspergillosis and were not responding to or intolerant of prior antifungal therapy. A favourable response was defined as the resolution or clinically meaningful improvement of all attributable signs and symptoms as documented by radiographs and judged by an independent expert panel of physicians. Forty-one percent (22 out of 54 who met entry criteria and had outcomes data) of patients receiving Cancidas responded favorably to treatment. The response rate for patients who were refractory was 34 percent (15 of 44) versus 70 percent (7 of 10) for those who were intolerant. Eighty-two percent (46 of 56) of patients in the study were refractory (unresponsive) to previous therapy as evidenced by either progression of disease or failure to respond to at least seven days of prior antifungal therapy. Eighteen percent (10 of 56) of the patients were intolerant, defined as having creatinine levels equal or greater than 2.5 mg/dL or other acute reactions or infusion related toxicity. Patients received 70 mg of Cancidas intravenously on Day 1, followed by 50 mg once daily thereafter, for a minimum of 28 days and for at least seven days after resolution of symptoms. Duration of treatment was based on the severity of the patient’s underlying disease, recovery from immunosuppression, and onset of clinical response. Cancidas was generally well tolerated in the study. Two serious adverse events were reported as possibly drug-related (bilateral pulmonary infiltrates and hypercalcemia). Infusion-related reactions and kidney toxicities were uncommon. Three patients (5.2 percent) discontinued use due to drug-related adverse events. Results from a Phase I study showed that the pharmacokinetics of Cancidas and itraconazole(1) did not change as a result of the two medications being administered together. The treatment regimens were explored in a 14-day, placebo-controlled, randomized, parallel-panel study of eight volunteers. Itraconazole is a potent inhibitor of cytochrome P450 3A4 (CYP3A4). The study results indicated that Cancidas was not subject to drug interactions based on CYP3A4 inhibition. Cancidas is being developed by Merck as an intravenous medicine for systemic fungal infections, such as those caused by Aspergillus and Candida. These infections, once considered unusual, have risen in number over the past 20 years according to the Centers for Disease Control and Prevention. Many fungal infections occur in hospitalised patients who represent a concentrated population of immunocompromised and critically ill patients. (1) Itraconazole (Sporanox®), Janssen Pharmaceutica (2) Amphotericin B (Abelcet®), Liposome (3) Fluconazole (Diflucan®), Pfizer Related link: Merck & Co. E-mail this page to a friend or colleague! To print, use this version