Liposome Technology Inc. said Thursday that it has begun itsdouble-blind Phase III clinical trial of Amphocil in aspergillosispatients.
The Menlo Park, Calif., company (NASDAQ:LTIZ) is conductingthe trial in the U.S. and Europe to compare Amphocil withstandard amphotericin B therapy.
Aspergillosis is one of the most difficult to treat of the systemicfungal infections. Amphotericin B, administered by intravenousinjection, is indicated for patients with progressive, potentiallyfatal, systemic fungal infections. Its effectiveness is restrictedby dose-limiting toxicities, in particular deterioration of renalfunction.
Amphocil is being developed to reduce the toxicity andimprove the efficacy of amphotericin B for a variety ofsystemic fungal infections, including aspergillosis. Data derivedfrom treating approximately 300 patients with Amphocil, bothin clinical trials and on a compassionate-use basis, indicatedthat Amphocil is efficacious for various systemic fungalinfections and is less toxic than amphotericin B.
The double-blind aspergillosis study is the last of threeplanned Phase III clinical trials of Amphocil currently underway. LTI is also conducting Phase III open-label clinical trialsto investigate the potential benefit of Amphocil as a "rescuetherapy" for patients who have failed prior treatment withamphotericin B, and patients either with underlying renalinsufficiency or with nephrotoxicity resulting from priortreatment with amphotericin B.
All three of the Phase III clinical trials are being conductedwith product manufactured at LTI's commercial source contractmanufacturer so that subsequent studies should not berequired for product registration.
LTI is developing liposome and lipid-based pharmaceuticalproducts for the acute-care hospital market.
-- Nancy Garcia Associate Editor
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