Liposome Technology Inc. (LTI) announced Monday that it isdelaying the launch of Amphocil, its lipid-based formulation ofamphotericin B, in the United Kingdom. LTI Vice PresidentPeter Leigh said the company was "looking at possibly a 90-day delay."
LTI (NASDAQ:LTIZ) of Menlo Park, Calif., said the delay "willallow LTI to apply more appropriate evaluation standards to aportion of the previously submitted clinical data to ensure theconsistency of all data prior to filing a European multistateapplication."
Leigh explained that the company's medical group decided toreclassify 14 of the 104 patients with fungal infectionsincluded in LTI's filing with the U.K. regulatory authorities. Hesaid seven of these patients were originally classified as havingbeen cured by Amphocil, but the medical group concluded thatthey were non-evaluable since it was not absolutely clear thatthey had fungal infections.
The Amphocil response rate was determined to be 61 percentin LTI's original filing, Leigh said. By changing the evaluation of14 patients, the overall response rate was reduced to 52percent.
In addition, Leigh noted that an additional cohort of 62 patientshad a response rate of 65 percent. This cohort received ahigher dose of Amphocil, 4 mg/kg, compared with the originalgroup, which received 1 mg/kg to 4 mg/kg.
Taking this additional cohort into consideration, Leigh said theoverall response rate for Amphocil is 57 percent. Based on thisinformation the company decided to delay the launch, whichhad been scheduled for the new year.
Amphocil was approved in the U.K. in August for treatment offungal infections in cases where toxicity or renal failureprecludes the use of conventional amphotericin B or in caseswhere prior systemic anti-fungal therapy has failed. It is alsoavailable in Israel, Austria and Ireland on a "named-patientbasis" (essentially a compassionate-use program).
Vestar Inc.'s amphotericin B liposomal formulation, AmBisome,is already on the market in the U.K. The Liposome CompanyInc. declined to comment about whether it has soughtmarketing approval in the U.K. for its amphotericin B lipidcomplex, ABLC.
Leigh noted that LTI plans to file a new drug application forDoxil, a lipid-based formulation of doxorubicin, in the firstquarter of 1994. This is the company's second liposomeproduct.
-- Brenda Sandburg News Editor
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