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Cubist Pharmaceuticals Announces the End of Patient Dosing in HepeX-B(TM) Hepatitis B Phase 2 Trial.


LEXINGTON, Mass. -- Plans to Review Data with the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 

Cubist Pharmaceuticals, Inc. (Nasdaq: CBST CBST Center for Biophotonics Science and Technology
CBST Congregation Beth Simcha Torah (NYC)
CBST Complete Binary Search Tree
) today announced that Cubist and XTLbio have ended patient dosing in the second of two Phase 2 hepatitis B Hepatitis B Definition

Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the most common chronic
 clinical trials of HepeX-B(TM). Cubist plans to review data from this trial with the FDA as part of a discussion of design elements of a Phase 3 trial. A Data Safety Monitoring Board recently reviewed safety data from all patients in the second Phase 2 trial and no concerns were raised.

About Hepatitis B (HBV HBV hepatitis B virus.

HBV
abbr.
hepatitis B virus
)

Hepatitis B is most commonly caused by the Hepatitis B virus, which, according to Datamonitor, has infected over 2 billion people around the world. Although a vaccine against HBV was introduced in 1982, globally, 350 million people are infected chronically with the disease and approximately 1 million people die each year as a result of complications from HBV infection. Current treatment regimens for chronic HBV often include use of interferon alpha or an antiviral drug. Despite these treatment options, chronic HBV can lead to severe liver damage and patients may require liver transplantation To prevent re-infection of the new liver with HBV, patients are currently treated with hepatitis B immune globulin (HBIg) combined with an antiviral compound, such as lamivudine. The global market for HBIg is estimated to be about $100 million annually.

About HepeX-B(TM)

HepeX-B(TM) is a combination of two fully human monoclonal antibodies, selected using XTLbio's pre-clinical Trimera(TM) model, that target HBV surface antigens. It is currently in evaluation for the prevention of infection by HBV in liver transplant patients who have been maintained on HBIg. HepeX-B(TM) has already been granted Orphan Drug Status in both the U.S. and the European Union.

About Cubist

Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development and commercialization of antiinfective products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN(R) (daptomycin for injection), the first antibiotic in a new class of antiinfectives called lipopeptides. CUBICIN is currently the only once-daily bactericidal bactericidal /bac·te·ri·ci·dal/ (bak-ter?i-si´d'l) destructive to bacteria.
Bactericidal
An agent that destroys bacteria (e.g.
 antibiotic approved in the U.S. with activity against both methicillin-susceptible and methicillin-resistant Staphylococcus aureus methicillin-resistant Staphylococcus aureus Methicillin-aminoglycoside resistant Staphylococcus aureus, MRSA An organism with multiple antibiotic resistances–eg, aminoglycosides, chloramphenicol, clindamycin, erythromycin, rifampin, tetracycline,  (MSSA MSSA Methicillin-Sensitive Staphylococcus Aureus
MSSA Microscopy Society of Southern Africa
MSSA Maryland Saltwater Sportfishermen's Association
MSSA Military Selective Service Act
MSSA Mid-South Sociological Association
MSSA Minnesota Social Service Association
 and MRSA MRSA Methicillin-resistant Staphylococcus aureus. See MARSA. ) in complicated skin and skin structure infections. The Company has announced that its Phase 3 Staphylococcus aureus (S. aureus The aureus (pl. aurei) was a gold coin of ancient Rome valued at 25 silver denarii. The aureus was regularly issued from the 1st century BC to the beginning of the 4th century AD, when it was replaced by the solidus. ) endocarditis endocarditis (ĕn'dōkärdī`tĭs), bacterial or fungal infection of the endocardium (inner lining of the heart) that can be either acute or subacute.  and bacteremia bacteremia: see septicemia.
bacteremia

Presence of bacteria in the blood. Short-term bacteremia follows dental or surgical procedures, especially if local infection or very high-risk surgery releases bacteria from isolated sites.
 trial of CUBICIN(R) (daptomycin for injection) at 6 mg/kg once daily met its primary endpoints of non-inferiority in the intent-to-treat (ITT ITT Initial Teacher Training (UK)
ITT I Think That
ITT Invitation To Tender
ITT Individual Time Trial (professional cycling)
ITT Intention-To-Treat
ITT In This Thread (forums) 
) and per protocol (PP) populations. Cubist expects to file a supplemental New Drug Application (sNDA) before year-end 2005 seeking priority review for approval to add S. aureus endocarditis and bacteremia to the indication statement for CUBICIN. Cubist's pipeline includes HepeX-B(TM), a monoclonal antibody biologic being evaluated to determine its potential for the prevention of infection by the Hepatitis B virus (HBV) in liver transplant patients, and research efforts focused on novel members of the lipopeptide class of molecules and on natural products discovery. Cubist is headquartered in Lexington, MA.

About XTLbio

XTL XTL Crystal
XTL Xpress Train Limited
XTL Anything-To-Liquids (synthetic fuels)
XTL XML Template Language
XTL Xml Transformation Language
XTL Extensible Transformation Language
XTL Executable Temporal Language
 Biopharmaceuticals Ltd. (XTLbio) is a biopharmaceutical company developing drugs against hepatitis. Established in 1993, XTLbio became a public company in 2000 and its ordinary shares are listed on the Official List of the UK Listing Authority and are traded on the London Stock Exchange London Stock Exchange

London marketplace for securities. It was formed in 1773 by a group of stockbrokers who had been doing business informally in local coffeehouses.
 under the symbol XTL and in the Tel Aviv Stock Exchange Tel Aviv Stock Exchange

Israel's only stock exchange.
, Israel.

Cubist Safe Harbor Statement

Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and such statements are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements made by Cubist. These factors include, but are not limited to: (i) the level of acceptance of CUBICIN by physicians, patients, third-party payors, and the medical community generally; (ii) Cubist's ability to continue to develop, secure additional regulatory approvals for, and successfully market, CUBICIN; (iii) Cubist's expectations regarding our ability to continue to manufacture sufficient quantities of CUBICIN in accordance with current Good Manufacturing Practices; (iv) commercialization of products that are competitive with CUBICIN; (v) Cubist's ability to discover or in-license drug candidates; (vi) Cubist's ability to successfully develop drug candidates in its pipeline, including HepeX-B; (vii) Cubist's ability to successfully commercialize any product or technology developed by Cubist; (viii) Cubist's ability to establish and maintain successful manufacturing, sales and marketing, distribution, and development collaborations; (ix) legislative or regulatory changes adversely affecting Cubist or the biopharmaceutical industry; (x) Cubist's expectations regarding the future market demand and medical need for CUBICIN; (xi) Cubist's ability to protect its intellectual property and proprietary technologies; and (xii) Cubist's ability to finance its operations . Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Cubist's recent filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings.

Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.; HepeX-B is a trademark of XTL Biopharmaceuticals Ltd.

Additional information can be found at Cubist's web site at www.cubist.com
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Aug 9, 2005
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