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LIPOSOME COMPANY PHASE III TRIALS OF MAITEC FOR MAI

Executive Summary

LIPOSOME COMPANY PHASE III TRIALS OF MAITEC FOR MAI are expected "to begin...within the next several months," Senior VP-Strategic Operations Edward Silverman told the Wheat First Securities/Butcher & Singer Healthcare Conference Oct. 26 in New York City. Maitec (TLC G-65), a liposomal gentamicin, is being developed for the treatment of Mycobacterium avium-intracellulare in AIDS patients. Results of a Phase II trial completed earlier this year in 21 MAI patients were published in the Journal of Antimicrobial Agents and Chemotherapy in September. Silverman said that the "patients were very sick with an average CD4 count of six. As the cumulative dose of Maitec increases, the level of infection decreases... The colony forming units in the blood were reduced significantly, and there was also a reduction in key symptoms of fever, night sweats and rigors." However, "Maitec did fall short of complete eradication of the infection." Based on these results, "additional trials were initiated that intensified the dose, increased the treatment period and used combination therapy," Silverman said. There is a Phase IIb trial under way in the U.S. and a Phase III trial ongoing in Europe. The company is preparing two pivotal Phase III trials of ABLC (liposomal amphotericin B) in neutropenic patients, Silverman said. These trials, which will begin "late this year or very early next year," will be the basis for a U.S. NDA submission. Silverman said the company has nearly completed a Phase II/III randomized comparative trial of ABLC and nonliposomal amphotericin B in candidiasis. He expected patient enrollment to be completed by year-end. The neutropenia trials will "give us the labeling we'll need to participate in the largest part of the potential market for ABLC," Silverman said. Based on European ABLC studies of over 500 patients, the company will begin to make submissions by year end in several European countries for the treatment of systemic mycoses, Silverman added. Additional Phase III and Phase IV trials also have been initiated in Europe. Four Phase III trials are under way for Liposome Technology's liposomal amphotericin B Amphocil, VP-Finance Peter Leigh told the Wheat First conference. These studies include: one in patients who have failed conventional therapy with Apothecon's injectable amphotericin B, Fungizone; one in patients with preexisting kidney disease or Fungizone-induced renal insufficiency; a trial comparing Amphocil and Fungizone in empiric therapy for fever of unknown origin; and a randomized, double-blind comparison of Amphocil and Fungizone in aspergillosis. Leigh indicated that Liposome Technology would like to file an NDA in the second half of 1994 for fever of unknown origin, but that FDA would probably insist on a registration package demonstrating efficacy in a specific fungal infection. "That is difficult in fungal infections because often the first time a diagnosis is made...is on autopsy," he said. If a specific pathogen such as aspergillosis has to be identified in the submission, then "it looks more likely that the filing will be in the first half of 1995," Leigh predicted. On Oct. 28, The Liposome Company reported a third quarter net loss of $7.3 mil. on sales of $3.5 mil. Through nine months, the company reported a loss of $14.5 mil. on sales of $9.9 mil. The company had $127 mil. in cash as of Sept. 30. Liposome Technology reported a loss of $6.1 mil. on revenues of $731,000 for its second quarter. The company had $41.5 mil. in cash as of the end of June.
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