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To: Teri Garner who wrote (28469)3/19/1999 9:30:00 AM
From: Chuck  Respond to of 120523
 
Note: Negative efficacy study RE: Todays WL #10

The Liposome Company Reports Comparative Safety and Efficacy Data On Abelcet(R)

PR Newswire, Friday, March 19, 1999 at 07:17

- Study Establishes ABELCET(R)'s Superior Efficacy Versus AmBisome(R) -

SAN DIEGO, March 19 /PRNewswire/ -- The Liposome Company, Inc.
(NASDAQ:LIPO) today announced that comparative head-to-head data on
ABELCET(R) versus a competitive liposomal amphotericin B product, AmBisome(R)
(NASDAQ:NXTR), was presented at the 9th Annual Focus on Fungal Infections
meeting. The study, conducted by The University of Texas, M.D. Anderson
Cancer Center in Houston in patients with leukemia who had diagnosed or
suspected fungal infections, found ABELCET(R) to be statistically more
effective than AmBisome(R). The study also documented a lower incidence of
hepatic toxicity for ABELCET(R).
"We believe this study has demonstrated that one of the lipid-associated
formulations of amphotericin B is more effective than another," commented Dr.
J. A. Boyle, Senior Vice President, Medical and Regulatory Affairs for The
Liposome Company. "In this population of patients where the risk of dying
from invasive fungal infections can be very high, the issue of efficacy is of
primary importance. We are pleased that the research was done at one of the
world's leading cancer centers, without any financial support from The
Liposome Company."
The prospective, open-label, randomized study compared the two lipid based
formulations of amphotericin B in the treatment of leukemia patients with
either suspected or confirmed fungal infections. The 75 patients developed
82 febrile episodes that were unresponsive to antibacterial therapy and were
prospectively randomized to receive either ABELCET(R) (n=43) or AmBisome(R)
(n=39). Both drugs were dosed as follows: 3 mg/kg/day for fever of unknown
origin (FUO), 4-5 mg/kg/day for pneumonia of unknown pathogen (PUP), and 5
mg/kg/day for definite fungal infections (DFI). On an intent-to-treat basis,
the overall response to therapy was 27/43 (63%) for ABELCET(R) and 15/39 (39%)
for AmBisome(R) (p=0.03). Response rates for subcategories of infection were
FUO (100% vs. 75%), PUP (80% vs. 56%), DFI (30% vs. 29%), ABELCET(R) vs.
AmBisome(R), respectively. The response to therapy was higher for ABELCET(R)
despite the fact that AmBisome(R) treated patients received higher median
daily doses (4 mg/kg/day for AmBisome(R) vs. 3 mg/kg/day for ABELCET(R)) and
were treated with longer courses of therapy (15 day median course for
AmBisome(R) vs. a 10 day median course for ABELCET(R)). Patients randomized
to receive ABELCET(R) were more likely to be neutropenic at baseline
(93% vs. 79%, p=0.07) and therefore at greater risk of having a poor outcome.
Although AmBisome(R) treated patients had a lower incidence of acute
infusion-related toxicities (70% vs. 36%, p=NS), severe infusion-related
toxicities requiring discontinuation of therapy occurred in only 3 patients
(1 ABELCET(R) and 2 AmBisome(R)). The overall median increase in serum
creatinine was 37.5% for ABELCET(R) and 24.3% for AmBisome(R) (p=NS). A
persistent increase in serum bilirubin of >1.5 times baseline was 38% for
ABELCET(R) treated patients vs. 59% for AmBisomea treated patients (p=0.05).
ABELCET(R) (Amphotericin B Lipid Complex Injection), is marketed in the
United States for the treatment of severe, systemic fungal infections in
patients who are refractory to or intolerant of conventional therapy. In
general, the adverse events most commonly reported with ABELCET(R) are
transient chills and/or fever during infusion of the drug. ABELCET(R) is
contraindicated in patients who have shown hypersensitivity to amphotericin B
or any other component in the formulation.
The Liposome Company is a biopharmaceutical company developing,
manufacturing and marketing therapeutic products to treat cancer and related
diseases. ABELCET(R) (Amphotericin B Lipid Complex Injection), is marketed in
the United States for the treatment of severe, systemic fungal infections in
patients who are refractory to or intolerant of conventional therapy and is
the leading lipid-based formulation of amphotericin B in the United States.
In December 1998, the Company filed a New Drug Application with the U.S. FDA
for the Company's second drug, EVACET(TM) (formerly TLC D-99), liposomal
doxorubicin, to treat metastatic breast cancer. TLC ELL-12 has entered
Phase I clinical trials for the treatment of various cancers. The Company's
product pipeline includes bromotaxol and programs focused on the development
of new cancer therapies and vehicles for the delivery of gene therapy.
Except for historical information, this press release contains
forward-looking statements that involve risks and uncertainties, including but
not limited to statements regarding future sales growth prospects for
ABELCET(R), the ability of ABELCET(R) to maintain its position as the leading
lipid-based formulation of amphotericin B in the U.S., the likelihood that
EVACET(TM), TLC ELL-12 or any other product in the research pipeline can
receive regulatory approval in the U.S. or abroad or be successfully
developed, manufactured and marketed. While these statements reflect the
Company's best current judgment, they are subject to risks and uncertainties
that could cause actual results to vary, including the risk factors identified
in the Registration Statement on Form S-3 dated October 29, 1997 and from time
to time in the Company's other SEC filings.
This press release is also available at LIPO.COM(R)