Mycamine - Micafungin sodium - een stofje uit medicinale paddestoelen en een betaglucaan krijgt van FDA erkenning als medicijn ter preventie en behandeling tegen candida infecties bij patiënten die stamcel- en beenmergtransplantaties ondergaan

In The health benefits of medicinal mushrooms from Mark Stengler een Engelstalig boek over medicinale paddestoelen wordt beschreven hoe de paddestoelen moeten worden klaargemaakt en gegeten. Raadpleeg wel altijd een deskundig arts hiervoor.

20 maart 2005: Antimicrob Agents Chemother. 2000 Jun;44(6):1728-30.

Mycamine - Micafungin sodium - een stofje uit medicinale paddestoelen en een betaglucaan krijgt van FDA erkenning als medicijn ter preventie en behandeling tegen candida infecties bij patiënten die stamcel- en beenmergtransplantaties ondergaan en ter bestrijding van een slokdarmcandida, welke vaak uitmondt in slokdarmkanker. Achtereenvolgens een kort persbericht van Medscape over FDA toestemming en daarna abstract van studie met muizen met Mycamine - Micafungin sodium - bij muzien met 100% resultaat en citaat uti resultaten van volledig studieverslag. Maar als sluitstuk van deze artikel over mycafungi ook een gerandomiseerde studie bij 70 patienten welke hoog significante resultaten - 70 % genezing - gaf in bestrijding van o.a. slokdarmcandida en van verschillende soorten Aspergillus gerelateerde infecties.

Een interessante ontwikkeling mede ook omdat ook PSK en PSP en de Maitake paddestoel volop in de belangstelling staan als gebruik in een behandeling va n kanker

U.S. FDA Approves New Antifungal Agent

LOS ANGELES (Reuters) Mar 17 - A unit of Japan's Fujisawa Healthcare, Inc., said on Wednesday U.S. regulators had approved its antifungal drug Mycamine (micafungin sodium) for preventing Candida infections in patients undergoing bone marrow transplants and for treating esophageal candidiasis.

"Micafungin is a member of a new class of antifungal agents, the echinocandins, which inhibit cell-wall synthesis," according to Fujisawa. "The novel mechanism of action of echinocandins specifically targets the wall of fungal cells to treat the infection."

"Mycamine will allow us to expand our depth in the anti-fungal market and offer patients another treatment option to fight or prevent a life-threatening candida infection," Hideo Fukumoto, chief executive of Deerfield, Illinois-based Fujisawa Healthcare Inc., said in a statement.

According to a recent study, invasive candidiasis kills between 10% and 40% of infected patients whose immune systems are compromised, the company said.

Side effects of Mycamine include isolated cases of serious hypersensitivity and anemia as well a changes in liver and kidney function.

Hier een studie met muizen met Mycamine (micafungin sodium) waarbij Mycamine zorgt voor 100% resultaat en geen enkele muis stierf aan candidainfectie. Eerst het abstract en daarna citaat uit volledig studieverslag. Het volledige studie verslag is hier te lezen, inclusief tabellen en grafieken enz.

Efficacy of FK463, a (1,3)-beta-D-glucan synthase inhibitor, in disseminated azole-resistant candida albicans infection in mice. Maesaki S, Hossain MA, Miyazaki Y, Tomono K, Tashiro T, Kohno S. The Second Department of Internal Medicine, Nagasaki University School of Medicine, Nagasaki 852-8501, Japan. The efficacy of FK463, a new (1,3)-beta-D-glucan synthase inhibitor, against azole-resistant Candida albicans strains has been studied. The MIC of FK463 was lower than those of azoles and amphotericin B against CDR1-expressing C26 and CaMDR-expressing C40 strains. All mice treated with FK463 (1 mg/kg) survived disseminated murine candidiasis. The fungal burden in the kidney after 6 days was markedly reduced after therapy with FK463 and amphotericin B sodium deoxycholate, and plasma (1,3)-beta-D-glucan concentration was found to be lower in FK463-treated mice. In our study, FK463 was found to be a potent antifungal agent against disseminated infection with azole-resistant C. albicans. PMID: 10817741 [PubMed - indexed for MEDLINE] Het volledige studie verslag is hier te lezen, inclusief tabellen en grafieken enz.

Citaat:

In our study, FK463 showed efficacy against murine disseminated candidiasis caused by infection with azole-resistant C. albicans strains. Treatment with FK463 led to 100% survival in therapy for murine candidiasis caused by both C26 and C40 strains. AmB was also potent against azole-resistant C. albicans infection; however, 30% of mice died on the first day, immediately after injection. As was suspected, these mice died due to the acute toxicity of D-AmB. However, further studies are needed to compare the safety of FK463 and to the safety of D-AmB. FK463 significantly reduced the numbers of yeast cells in the kidney, as was also observed in the D-AmB-treated mice. This data suggested that FK463 has a fungicidal efficacy for the therapy of the azole-resistant C. albicans infections. In this study, the efficacy of FK463 was evaluated in immunocompetent mice. However, the disseminated Candida infection often occurs in immunocompromised patients. The comparative study of the efficacy of FK463 and AmB for the therapy of disseminated Candida infection in immunocompromised mice is under consideration for the assessment of the effects of immunosuppression on the efficacy of FK463.

In order to reduce candidiasis-related morbidity and mortality, early diagnosis and definitive treatment are essential. The blood culture is often negative and takes several days, as does measurement of disseminated candidiasis. Methods for the serodiagnosis of deep mycosis, including detection of (1,3)-â-d-glucan, are helpful for the diagnosis of Candida infections (6). Monitoring the concentration of (1,3)-â-d-glucan in the plasma from the patients with Candida infections has been found to be useful for diagnosis, as has the evaluation of the efficacy of the antifungal treatment (8). In our murine model of disseminated Candida infection, the concentration of (1,3)-â-d-glucan in plasma from the untreated mice was elevated. The concentration of (1,3)-â-d-glucan was notably lower in the plasma following treatment with FK463. These results also suggested that FK463 could effectively inhibit the growth of the cells in mice, resulting in suppression of the production and release of (1,3)-â-d-glucan from the yeast cell wall.

In the present study, FK463 was found to be an effective antifungal agent against azole-resistant strains of C. albicans. The results also revealed FK463 might add to the armamentarium for the treatment of infection by azole-resistant C. albicans. Hier de studie met 70 patiënten behandeld met mycafungi:

Scand J Infect Dis. 2004;36(5):372-9.

A multicenter, open-label clinical study of micafungin (FK463) in the treatment of deep-seated mycosis in Japan.

Kohno S, Masaoka T, Yamaguchi H, Mori T, Urabe A, Ito A, Niki Y, Ikemoto H.
Section of Molecular and Clinical Microbiology, Department of Microbiology and Immunology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. s-kohno@net.nagasaki-u.ac.jp

The efficacy and safety of micafungin (FK463), which is a new lipopeptide antifungal agent of the echinocandin class and is active against both Aspergillus and Candida species, were investigated in patients with deep-seated mycosis in this study. 70 patients were treated with micafungin 12.5-150 mg/d intravenously for up to 56 d. The overall clinical response rates were 60% (6/10) in invasive pulmonary aspergillosis, 67% (6/9) in chronic necrotizing pulmonary aspergillosis, 55% (12/22) in pulmonary aspergilloma, 100% (6/6) in candidemia, and 71% (5/7) in esophageal candidiasis. The response rates for patients with prior antifungal treatment which was considered ineffective or toxic, were similar to rates for patients without prior treatment. Mycological eradication was observed in patients infected with Aspergillus fumigatus, Aspergillus flavus, Aspergillus terreus, Aspergillus niger, Candida albicans, Candida glabrata, or Candida krusei. Adverse events related to micafungin were reported in 21 patients (30%), and there was no dose-related occurrence of any adverse event. It is concluded that treatment with micafungin as monotherapy seems to be effective and safe in patients with deep-seated mycosis. PMID: 15287383 [PubMed - indexed for MEDLINE]