The Liposome Co. Inc. said Thursday it has launched a two-partPhase III clinical trial to test its amphotericin B LipidComplex (ABLC) for the treatment of life threatening fungalinfections.The first part will involve patients with aspergillosis whohave not responded to standard therapy or who were unable totake conventional amphotericin B because of its toxicity. Thesecond part will be a comparative test to judge the effectivenessof ABLC vs. conventional amphotericin B in the treatment offungal infections in patients receiving cancer chemotherapy orbone marrow transplants.The trials are aimed at testing the efficacy of ABLC and itsability to protect patients against the toxic side effects ofconventional amphotericin B.According to Liposome, amphotericin B is considered the"gold standard" treatment against infections, such as candidiasis,cryptococcal meningitis and aspergillosis. However, serious sideeffects, particularly kidney toxicity and anemia, have limitedthe drug's use.The Princeton, N.J.-based company said its clinical trials showthat by incorporating amphotericin B in a lipid complex, ABLCmay reduce the toxicity of conventional amphotericin B and enablepatients to receive larger dosages.Earlier trials have involved compassionate or emergency testingof ABLC and those studies are continuing. In all cases the patientshad not responded to conventional therapy or were unable to useamphotericin B because of toxic side effects.On June 3 at a European Hematology Association meeting inBrussels, Belgium, the company released results from patientstreated with ABLC in the emergency use protocol for infections thatincluded candidiasis and aspergillosis. The company said 67 percentof the first 111 evaluable patients either improved or were curedof their infections.Last week, at an International Immuno-compromised Host Societyconference in Davos, Switzerland, test results were released fortreatments of 41 patients with candidiasis. That study showed73 percent were either cured or improved.Brooks Boveroux, Liposome's chief financial officer, said thatif the Phase III trials are successful, the company plans to filea new drug application with the FDA at the end of this year or inearly 1996. The company already has filed for marketing approval in sixEuropean countries.Liposome's stock (NASDAQ: LIPOZ) closed Thursday at $16.63, up 25 cents. n
-- Charles Craig
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