The MSG by wanghonghx

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									The MSG
Mycoses Study Group
Quarterly Newsletter
Summer 2010
Welcome to the Mycoses Study Group Quarterly Newsletter, summer 2010. This
Newsletter is intended to keep our investigators and supporters apprised of the
developments within the MSG and to encourage support and involvement in our
ongoing activities.

I. Meetings

MSG ICAAC Reception and Business Meeting (September 13,
2010)
This year’s reception and business meeting will be held on September 13, 2010 from
5:45-7:30 PM at the Seaport Hotel in the Lighthouse Ballroom. We hope each of
you will be able to join us for a MSG update!

ICAAC/MSG Co-sponsored Activities
September 13: The Cryptococcus Complex: a Model Pathogen (Symposium)
September 14: Prophylactic and Pre-emptive Antifungal Therapy: State of the Art
(Symposium)

MSG 2011 Annual Meeting
The 2011 annual meeting will be held on April 6-7th at the Courtyard by Marriott,
Downtown Philadelphia. Registration brochures will be sent out via email in January.

MSG 2010 Annual Meeting
The MSG 2010 Annual Meeting was held on April 7- 8, 2010 at the Courtyard Marriott
in Downtown Philadelphia. The CME activity, Innovations in Diagnosis and Treatment
of Invasive Mycoses, occurred on April 7th from 3:30 – 6:30 PM followed by a reception.
The business meeting with break-out sessions occurred on April 8th from 8:00 – 4:00
PM.

The CME proceedings will be available on Doctor Fungus in the form of a multimedia
production and will be available in the near future.



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Advances Against Aspergillosis
The MSG is a supporter of the AAA. The AAA4 meeting took place on February 4-6,
2010 in Rome, Italy. A special MSG lecture was given by Raoul Herbrecht, M.D.
WWW.AAA2010.org


II. Clinical Trials Update
MSG-01: A randomized, double-blind, placebo controlled trial of caspofungin
prophylaxis followed by preemptive therapy for invasive candidiasis in high risk
adults in the critical care setting.
PI: Luis Ostrosky-Zeichner
Corporate Sponsor: Merck & Co.

This study was completed on March 5, 2010 with 222 subjects enrolled. Analysis is in
progress, and we plan to submit a late-breaker abstract for IDSA with manuscript to
follow. The study is registered on Clinicaltrials.gov website.

MSG-02: Candidemia meta-analysis
PIs: Baddley, Andes, Safdar, Playford, Kullberg

Data analysis is complete for MSG 02 and a manuscript has been drafted. The abstract
of MSG 02 has been accepted to ICAAC as an oral presentation. More to follow…

MSG-03: Invasive Aspergillosis Combination Study
PI: Kieren Marr
Corporate Sponsor: Pfizer

Currently, 152 total sites, 31 domestic and 121 international are participating in this
pivotal trial. There have been 407 patients enrolled, 43 from the U.S. and 364 from
international sites. Target enrollment has been increased to 455 patients in order to
achieve 250 evaluable patients with proven/probable invasive aspergillosis.

MSG-04: Empirical Antifungal Therapy in the ICU
PI: Luis Ostrosky-Zeichner
Corporate Sponsor: Merck & Co.

The MSG Steering Committee has approved a new clinical trial entitled “A pilot
randomized, double-blind, placebo-controlled trial of caspofungin empirical therapy for
invasive candidiasis in high-risk adults in the critical care setting“. This is a feasibility
study that will assess the utility of a clinical scoring system to select ICU patients to be
included in a study comparing caspofungin vs. placebo for empiric therapy for patients
at high risk for invasive candidiasis. The trial will be conducted at U.S. and selected
international sites, and will have a target enrollment of approximately 114 patients. The
study protocol has been finalized and site selection is ongoing. Those investigators with


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an interest in participating in this trial should contact Luis Ostrosky-Zeichner or Beth
Deerman immediately. Individual site contracts are being negotiated at this time, and
enrollment is planned to begin in mid to late September.

MSG-05: A re-analysis of the voriconazole versus amphotericin B followed by
other licensed antifungal therapy for invasive aspergillosis trial (Herbrecht et al.
NEJM 2002; 347: 408-15))
PI: Raoul Herbrecht
Corporate sponsor: Pfizer

This proposal was recently approved by the Steering Committee. Its purpose is to
reanalyze the existing database from the pivotal study comparing voriconazole to
amphotericin B followed by OLAT for primary treatment of invasive aspergillosis. The
analysis will use the updated EORTC/MSG disease definitions, which will certainly lead
to the reclassification of many patients in this trial, primarily based on data from stored
serum samples which have been tested for Aspergillus galactomannan (GM). It is
hypothesized that this reclassification will confirm the original observations from this
study, and support the role of voriconazole as primary therapy for IA.

Proposal for a Phaeohyphomycosis Registry
PIs: Sanjay Revankar, John Baddley
Potential corporate sponsors: Merck, Pfizer, Astellas

This proposal has been submitted as a concept and will be discussed at the next
Steering Committee conference call in late August. The project proposes to
prospectively identify 150 patients from several international sites, and collect all
relevant clinical, diagnostic, mycological and treatment/outcome information on this
uncommon disorder.

III. MSG / FDA / EMEA Galactomannan Project
The proposal for the use of galactomannan as a qualified biomarker in the context of a
clinical trial for treatment of invasive aspergillosis was judged by the FDA Biomarker
Qualification Review Team and the EMEA to have a potentially important impact on
drug development and regulatory review. Johan Maertens, Paul Verweij, Barb
Alexander, Kieren Marr, and Joe Wheat have spearheaded this effort in the US and
Europe. Our response to the FDA’s queries was submitted in June, 2009. Upon their
request, we provided additional information in April 2010. We await their final decision
concerning this proposal.


IV. The MSG Education Committee
The EC is actively working on setting the 2010 educational agenda. We are working
with Lisa Tushla (Terranova) and University of Nebraska to develop plans for the next 2-
3 years, and to approach potential sponsors for financial support of these activities.
These programs will be developed for a variety of venues including, but not limited to,
support for the MSG Annual Meeting CME Program, traditional grand rounds, regional


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seminars, national/international meetings, support of Dr. Fungus, and Web-based
educational programs. A multimedia CME activity will be launched on DoctorFungus
during late August, and more activities are in the planning stage.


V. MSG Administration
Administrative Structure

MSG Central Unit:
           Peter G. Pappas, MD, PI
           Beth Deerman, RN, Administrator
           Vicki Noles, Administrative Assistant
           Peggy Cornelius, Financial Associate

MSG Steering Committee (SC):
           Peter G. Pappas, Chair (US)
           Carol Kauffman (US) Tania Sorrell (AUS)         Bart-Jan Kullberg (NETH)
           John Wingard (US)      Jack Sobel (US)          Eric Bow (CAN)
           Tom Patterson (US)     John Perfect (US)        Marcio Nucci (BRA)
           Raoul Herbrecht (FR) Helen Boucher (US)         Thierry Calandra (SU)

            John Bennett, Jack Edwards, and Emilio Bouza will serve as non-voting
            advisors.

MSG Education Committee (EC):
          US: Susan Hadley (Chair)
          David Andes (Co-chair) Barbara Alexander           John Baddley
          John Bennett             Helen Boucher             Graeme Forrest
          Alison Freifeld          Dimitrios Kontoyiannis    Marshall Lyon
          Kieren Marr              L. Ostrosky-Zeichner      Peter Pappas
          Tom Patterson            George Thompson
          Lisa Tushla (Meeting/educational consultant)

            Europe: Olivier Lortholary (FR)   Oliver Cornely (FRG)
            Bart-Jan Kullberg (NETH)

            Latin America: Luis Thompson (CHI)      Marcio Nucci (BRA)

            Australia: David Ellis (AUS)




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