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Cancidas (Caspofungin Acetate) Resolves Serious Candida Fungal Infections With Fewer Side Effects

MONTREAL, QC -- December 18, 2002 -- A new clinical study published in the December 19 issue of the prestigious The New England Journal of Medicine showed that Cancidas® (caspofungin acetate) resolved serious Candida fungal with fewer drug-related side effects. The study evaluated the investigational use of caspofungin acetate for the treatment of invasive candidiasis (an infection that spreads to organs), including candidemia (an infection of the bloodstream).

"Invasive candidiasis is a serious, life-threatening disease that is associated with a high mortality rate in hospitalized patients. Since patients can be infected by any one of a variety of different Candida strains, there is a need for new antifungal therapies that not only treat a broad range of Candida strains but are also well-tolerated," said Dr. Michel Laverdière, a study investigator, Medical Microbiologist and Infectious Diseases Specialist, Head of the Department of Microbiology, Maisonneuve-Rosemont Hospital. "The results from this study provide critical insights for clinicians on alternative - and better tolerated - treatment options for serious Candida infections."

First time study demonstrates efficacy
The randomized, multi-national, double-blinded study is the first time that an echinocandin antifungal (caspofungin acetate) has been compared to amphotericin B for the primary treatment of invasive candidiasis and candidemia. A total of 239 adults with proven invasive candidiasis - 80 percent of whom had candidemia - were enrolled in the study. Patients received either intravenous caspofungin acetate (a 70-mg loading dose followed by 50-mg daily dose) or intravenous amphotericin B (daily doses ranging between 0.6-1.0 mg/kg of body weight). Patients were treated with antifungal therapy for at least 14 days after the last positive Candida culture.


Overall response to treatment was assessed on results from two pre-defined patients groups: the modified intention-to-treat (MITT) population and the evaluable patients populations (patients meeting the predefined criteria for evaluation. The MITT group was the primary efficacy population for this study. In the (MITT) analysis, caspofungin acetate demonstrated 73.4 percent efficacy in the treatment of invasive candidiasis at the end of intravenous therapy. Study results revealed that amphotericin B showed 61.7 percent efficacy in the MITT group. Patients included in the MITT group had documented evidence of invasive Candida infection and received at least one day of intravenous antifungal therapy (224 out of 239 patients). In the evaluable patients analysis, caspofungin acetate demonstrated 80.7 percent efficacy at the end of intravenous therapy. Efficacy results for amphotericin B were 64.9 percent. The evaluable-patients group met the predefined criteria for evaluation, which required inclusion in the MITT, receipt of five or more days of intravenous therapy and no concomitant antifungal therapy or other major protocol violations (185 out of 239 patients).

Fewer drug-related side effects
Overall, 75 percent of the patients receiving amphotericin B were reported as having at least one drug-related side effect. Forty-two percent of patients receiving caspofungin acetate had at least one drug-related side effect. In particular, kidney-specific side effects were seen in 25 percent of patients on amphotericin B. Eight percent of patients on caspofungin acetate experienced similar side-effects. Three percent of patients treated with caspofungin acetate dropped out of the study due to drug-related serious side effects. The drop out rate for patients on amphotericin B due to drug-related serious side effects was 23 percent.

The most common drug-related side effects seen with use of caspofungin acetate in this study included fever, chills, phlebitis/ thrombophlebitis (irritation or inflammation at the intravenous site of caspofungin acetate administration), and vomiting.

Invasive infections caused by Candida strains
Strains of the fungus Candida account for over 80 percent of all serious systemic fungal infections encountered in hospitalized patients. Invasive Candida infections are particularly serious because of their tendency to spread throughout the bloodstream to other major body organs, ultimately resulting in death, if untreated. Invasive infections caused by the different Candida strains can develop in all body sites, including the bloodstream, abdominal organs, the eye, and other tissues.

In those hospitalized patients having undergone a major surgical procedure or having received either cancer chemotherapy or multiple antibiotics for other bacterial infections, Candida is the most common cause of fungal infections. Candida albicans is the predominant cause of invasive candidiasis. However, recent studies show an increase in the proportion of infections with other strains of Candida.

In this study, the strains of Candida responsible for infection were similar across both treatment groups, with the exception of C. albicans-which was more common in those patients who received amphotericin B. Caspofungin acetate resolved 63.9 percent of C. albicans infections while amphotericin B resolved 57.6 percent.

Non-albicans strains of Candida accounted for 55 percent of all infections, and mostly included, in order of occurrence, C. parapsilosis, C. tropicalis, C. glabrata, and C. krusei. Non-albicans infections where isolated in 64.4 percent of patients in the caspofungin acetate treatment group and 45.8 percent of patients in the amphotericin B treatment group. Caspofungin acetate resolved 80 percent of non-albicans infections, while amphotericin B resolved 68 percent.

Important information about Cancidas®
Cancidas® (caspofungin acetate) is the first of a class of antifungal drugs called echinocandin (a glucan synthesis inhibitor) from Merck Frosst that is indicated for the treatment of invasive aspergillosis in patients who do not respond to or cannot tolerate other antifungal treatments (i.e., amphotericin B, lipid formulations of amphotericin B, and/or itraconazole).

Caspofungin acetate is not currently approved in Canada for the treatment of invasive candidiasis. Merck Frosst does not recommend the use of any product in any manner other than as described in the prescribing information.

Merck Frosst Canada & Co. is one of the country's leading research-based pharmaceutical companies. The Merck Frosst Centre for Therapeutic Research, one of the largest biomedical research facilities in Canada, has a mandate to discover new therapies for the treatment of respiratory, inflammatory and other diseases. Discoveries such as VIOXXÒ (rofecoxib) and SINGULAIRÒ (montelukast sodium) were made in Canada by our researchers. In 2001, the company invested nearly $120 million in research and development in Canada. For its part, Merck Frosst Canada Ltd. markets a broad range of innovative products to improve human health. Merck Frosst Canada & Co. and Merck Frosst Canada Ltd. are affiliated companies of Merck & Co., Inc. of Whitehouse Station, New Jersey. Merck & Co., Inc. is a publicly traded company on the New York Stock Exchange under the symbol MRK.

®Registered trademark Merck & Co., Inc. Used under license.


SOURCE: Merck Frosst Canada Ltd

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