Liposome Technology Inc. said it signed an exclusive agreementwith Apache Medical Systems Inc. for review and analysis ofsafety and efficacy data from pivotal Phase III clinical trials ofAmphocil.
Apache of Washington, D.C., will be responsible for entering andanalyzing all data from three multicenter clinical trials ofAmphocil, LTI's lipid-complexed amphotericin B formulationdesigned for use in treating patients with life-threateningsystemic fungal infections.
LTI will use Apache's data to augment its own data and ensurethe quality of the Phase III data base, the soundness of theanalytical plan and the integrity of the analysis of the data,said Nick Arvanitidis, chairman and CEO.
The Menlo Park, Calif., company said it has submitted protocolsto the FDA for two open-label clinical trials. The first is arandomized comparison of two dose levels of Amphocil inpatients who have failed prior treatment with amphotericin Bfor systemic fungal infections.
The second protocol calls for treatment with 4 mg/kg per dayof Amphocil for patients with underlying renal insufficiency orwith nephrotoxicity resulting from prior therapy withconventional amphotericin B therapy.
LTI (NASDAQ:LTIZ) said it also submitted a protocol forprospectively randomized, double-blind, parallel, multicenterclinical trials to compare daily doses of 4 mg/kg of Amphocilwith daily doses of 1 mg/kg of amphtericin B in treatingimmunocompromised patients with documented invasiveaspergillosis infection.
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