Study Evaluated Optimum Use of AmBisome for Patients With Life-Threatening Infec

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Data Show Efficacy of Standard Dosing Regimen of AmBisome® is

Similar to High Loading Dose for Patients with Invasive Fungal

Infections

12/12/2005 9:15:00 AM EST

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AmBiLoad Study Evaluated Optimum Use of AmBisome for Patients With

Life-Threatening Infections

Gilead Sciences, Inc. (Nasdaq:GILD) today announced results from its

clinical trial known as AmBiLoad, which compared a 3 mg/kg/day

treatment course of AmBisome® (amphotericin liposome for

injection versus a 10 mg/kg/day loading regimen for the initial two

weeks of treatment in immunocompromised patients with invasive

aspergillosis and other life-threatening fungal infections. In this

study the overall rate of response for the two dosing regimens at

end of treatment were associated with similar efficacy and survival

(50 percent in the standard dosing group versus 46 percent in the

high loading-dose group). The 3 mg/kg/day dose was better tolerated

in this study. Results of the AmBiLoad clinical trial were presented

today by Oliver A. Cornely, MD, Clinic of Internal Medicine,

University of Cologne, Cologne, Germany (Poster #3222) at the

American Society of Hematology 47th Annual Meeting in Atlanta,

Georgia.

Product labeling for AmBisome varies in each of the countries in

which it is marketed. AmBisome is indicated in most countries for

the treatment of confirmed invasive fungal infections such as

aspergillosis, which primarily affects patients with impaired immune

function and can be fatal. The currently approved doses of AmBisome

for the treatment of confirmed invasive fungal infections vary from

1 to 5 mg/kg/day. Preclinical data have suggested that increasing

doses of AmBisome may be associated with improved antifungal

efficacy, and limited studies in human subjects suggested that doses

of 10 mg/kg/day could be administered without a significant increase

in adverse events.

" This study provided important insights into the optimum dose and

dosing regimen of AmBisome for established invasive fungal

infections -- data that have been lacking thus far, " said Dr.

Cornely, a principal investigator. " The results from this study

clearly confirm the efficacy of the standard dosing regimen, which

was associated with a favorable response in half of patients and a

72 percent survival rate 12 weeks after the end of treatment. These

findings are on par with response and survival rates reported in

similar studies of other licensed antifungal agents. This is

especially impressive, since patients in AmBiLoad had a high burden

of risk factors for profoundly impaired immune function. "

About the AmBiLoad Study

The multicenter, randomized, controlled study included 201

immunocompromised patients at 46 sites in Europe and Australia. All

patients had probable or proven invasive aspergillosis or other

fungal infections, as confirmed by an independent data review board.

Patients were randomized to receive either the standard dose of 3

mg/kg/day of AmBisome for the entire treatment period (n=107) or 10

mg/kg/day for the first 14 days of treatment, followed by 3

mg/kg/day until the end of treatment (n=94). Study drug was blinded

for the first 14 days of treatment. More than 70 percent of patients

in each group had neutropenia at study entry (low levels of

important infection-fighting white blood cells) and 93 percent of

patients in each group had some form of blood-related cancer.

Objectives of the study included overall response rate at the end of

treatment (EOT), survival through 12 weeks and safety and

tolerability.

The overall rate of favorable response at EOT was 50 percent in the

standard dosing group versus 46 percent in the high loading-dose

group. Survival rates at day 14 were 94 percent in the standard

dosing group and 91 percent in the 10 mg/kg/day group. At 12 weeks,

survival among patients who received 3 mg/kg/day was 72 percent

versus 59 percent for those who received the high loading dose for

the first 14 days. These differences were not statistically

significant.

The most commonly reported adverse events in both treatment groups

were hypokalemia (abnormally low potassium levels in the blood),

elevated creatinine levels, nausea and elevated liver function

values. Statistically significant differences between treatment

groups were found in the incidence of nephrotoxicity (elevated

creatinine levels) and hypokalemia, which were higher in the 10

mg/kg/day treatment group (31 percent versus 14 percent for

nephrotoxicity, p less than 0.01; and 30 percent versus 16 percent

for hypokalemia, p less than 0.015). Discontinuations due to adverse

events were statistically greater in the 10 mg/kg/day group (36 of

111) versus the 3 mg/kg/day group (23 of 115; p=0.035). Drug

discontinuations in both groups were primarily due to hypokalemia,

elevated creatinine levels and/or liver function test values. No

unusual or previously unreported safety signals were seen in either

treatment group.

About Invasive Aspergillosis

Invasive aspergillosis is a life-threatening infection caused by the

fungus Aspergillus. Aspergillosis and other invasive fungal

infections are a major health risk for patients with low white blood

cell counts (neutropenia) due to chemotherapy or underlying disease,

as well as for patients receiving stem cell or solid organ

transplantations. Ubiquitous fungal organisms such as Aspergillus

frequently infect the lungs of immunocompromised patients and can

spread throughout the body. Prompt diagnosis and initiation of

antifungal therapy are imperative to patient survival.

" Aspergillosis is increasingly common and there is a great need for

well-designed, prospective studies to determine the most effective

treatment strategies for these potentially deadly infections, " said

Dr. Cornely. " AmBiload further defines the definitive effectiveness

of AmBisome in severely immunocompromised patients. "

About AmBisome

AmBisome is a liposomal formulation of amphotericin B that is

administered by intravenous injection. Amphotericin B, the active

ingredient, is incorporated in a single bilayer liposomal delivery

system. The approved indications and product labeling vary in each

country in which AmBisome is marketed. In the United States,

AmBisome is approved for empirical therapy for presumed fungal

infection in febrile, neutropenic patients; the treatment of

cryptococcal meningitis in HIV infected patients; the treatment of

Aspergillus species, Candida species and/or Cryptococcus species

infections refractory (non-responsive) to conventional amphotericin

B, or in patients where renal impairment or unacceptable toxicity

precludes the use of conventional amphotericin B; and the treatment

of visceral leishmaniasis. The recommended initial dose for

empirical therapy of presumed fungal infections in febrile

neutropenia patients varies from 1 to 3 mg/kg/day.

AmBisome has a demonstrated superior safety profile compared to

conventional amphotericin B for the empirical treatment of febrile,

neutropenic patients. In clinical trials, nephrotoxicity and

infusion-related reactions were observed. Side effects associated

with the use of AmBisome include, but are not limited to, chills,

diarrhea, nausea and vomiting.

Gilead and Astellas Pharma US co-promote AmBisome in the United

States for the treatment of life-threatening systemic fungal

infections. Astellas has sole marketing rights to AmBisome in

Canada. Sumitomo Pharmaceuticals maintains marketing rights to

AmBisome in Japan. Gilead retains exclusive marketing rights to

AmBisome in the rest of the world.

About Gilead

Gilead Sciences is a biopharmaceutical company that discovers,

develops and commercializes innovative therapeutics in areas of

unmet medical need. The company's mission is to advance the care of

patients suffering from life-threatening diseases worldwide.

Headquartered in City, California, Gilead has operations in

North America, Europe and Australia.

This press release includes forward-looking statements, within the

meaning of the Private Securities Litigation Reform Act of 1995,

that are subject to risks, uncertainties and other factors. These

risks and uncertainties could cause actual results to differ

materially from those referred to in the forward-looking statements.

Risks are described in detail in the Gilead Annual Report on Form 10-

K for the year ended December 31, 2004 and in Gilead's Quarterly

Reports on Form 10-Q, all of which are on file with the U.S.

Securities and Exchange Commission. All forward-looking statements

are based on information currently available to Gilead and Gilead

assumes no obligation to update any such forward-looking statements.

AmBisome is a registered trademark of Gilead Sciences, Inc.

For more information on Gilead, please call the Gilead Public

Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit

www.gilead.com.

CONTACT:

Gilead Sciences, Inc. Hubbard, 650-522-5715 (Investors)

Edgley, 650-522-5635 (Media)