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Clinical Data For SEQUUS Pharmaceuticals' AMPHOTEC Product Suggest Safety And Efficacy In Treatment Of Fungal Infections In Bone Marrow Transplant Patients.


ASSISI, Italy--(BUSINESS WIRE)--June 27, 1996--Data from five open label trials involving 220 bone marrow transplant bone marrow transplant: see bone marrow.  patients, reviewed by Dr. Gary Noskin of Northwestern University, suggest that AMPHOTEC is safe and effective in the treatment of severe fungal infections in bone marrow transplant patients. AMPHOTEC, also known as amphotericin B colloidal colloidal

of the nature of a colloid.


colloidal bath
a bath containing gelatin, bran, starch or similar substances, to relieve skin irritation and pruritus.
 dispersion or ABCD See CompTIA. , is being developed by SEQUUS Pharmaceuticals, Inc. (Nasdaq: SEQU) to treat progressive and potentially fatal systemic fungal infections. Data derived from this retrospective analysis need to be confirmed in randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, prospective comparative trials.

This retrospective review, presented at the "9th Symposium on Infections in the Immunocompromised Host," showed an overall response rate to ABCD of 53% in 99 patients with well-documented fungal infections who received a minimum of 7 days of treatment. The response rate for Candida infections was 67%. ABCD did not cause nephrotoxicity neph·ro·tox·ic·i·ty
n.
The quality or state of being toxic to kidney cells.


nephrotoxicity(ne·fr
 in this high risk patient group, 79% of whom received allogenic transplants. There was no evidence of increased nephrotoxicity in patients receiving concurrent cyclosporine and/or aminoglycosides. Fever (12%) and chills (11%) were the most commonly reported infusion related side-effects.

Dr. Noskin's poster noted that the historical mortality rates after bone marrow transplantation Bone Marrow Transplantation Definition

The bone marrow—the sponge-like tissue found in the center of certain bones—contains stem cells that are the precursors of white blood cells, red blood cells, and platelets.
 approach 90% for pulmonary aspergillosis Aspergillosis Definition

Aspergillosis refers to several forms of disease caused by a fungus in the genus Aspergillus. Aspergillosis fungal infections can occur in the ear canal, eyes, nose, sinus cavities, and lungs.
 and invasive candidiasis candidiasis (kăn'dĭdī`əsĭs), infection of the mucous membranes caused by the fungus Candida albicans. Other terms for candidiasis are yeast infection, moniliasis (after a former name of the fungal genus), and thrush, the  and can reach 100% for disseminated aspergillosis. In contrast, patients treated with ABCD had a mortality rate of 70%. The poster also presented historical data indicating that 80% of patients treated with amphotericin B may develop renal toxicity as compared to 12% of the ABCD treated group included in the retrospective analysis.

The patients in the treatment group were evenly split among men and women (52%-48%). The average age was 34 and 21 patients under 13 years of age were included. The average daily dose was 4.1 mg/kg and the average duration of treatment was 23 days.

SEQUUS is developing AMPHOTEC for the treatment of aspergillosis and other systemic fungal infections such as candidiasis, cryptococcal meningitis and mucormycosis in patients who have failed prior therapy or are intolerant to amphotericin B. These infections primarily affect people with immune systems which have been compromised by AIDS, intensive chemotherapy or immune-suppressive drugs used in conjunction with bone marrow and solid organ transplants. AMPHOTEC, marketed as AMPHOCIL outside the U.S., is approved for use in 10 countries. A New Drug Application for this product is currently being reviewed by the U.S. Food and Drug Administration.

Founded in 1981 and headquartered in Menlo Park, California Menlo Park is a city in San Mateo County, California in the United States of America. It is located at latitude 37°29' North, longitude 122°9' East. Menlo Park had 30,785 inhabitants as of the 2000 U.S. Census.  (with offices in London, England), SEQUUS is developing proprietary pharmaceutical products for the critical care market. -0-

Note to Editors: Information about SEQUUS Pharmaceuticals, Inc. is now available on-line at http://www.sequus.com

CONTACT: SEQUUS Pharmaceuticals, Inc.

I. Craig Henderson, Scott Minick or

Donald Stewart, 415/323-9011

or

Burns McClellan, Inc.

Jonathan M. Nugent (investors) or

Liz Landy/Justin Jackson (media),
COPYRIGHT 1996 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jun 27, 1996
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