Targanta Presents Preclinical In Vivo Data Demonstrating Activity of Oritavancin Against Clostridium Difficile Infection
Targanta Therapeutics Corporation (NASDAQ: TARG) today released the in vivo data from a preclinical study comparing the activity of its antibiotic drug candidate, oritavancin, to vancomycin in a hamster model of Clostridium difficile infection. Results are being presented in a poster (B-067) today at 12:15 pm EDT entitled, “Efficacy of Oritavancin against Clostridium difficile (CD) infection in the Hamster Model of CD infection (CDI)” at the combined annual meetings of the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the 46th Infectious Disease Society of America (IDSA), taking place in Washington, DC.
In the study, oritavancin activity at 10, 50 and 100 mg/kg/day and a pegylated (PEG400) formulation of oritavancin at 100 mg/kg/day were compared to vancomycin activity at 50 mg/kg/day against clindamycin-induced C. difficile infection in Golden Syrian hamsters. The Golden Syrian hamster model is widely recognized as the gold standard for C. difficile infection. The hamsters were treated orally for 5 days and their progress measured for a total of 20 days.
Results showed that all doses of oritavancin were highly effective in prolonging survival compared to untreated controls, and prevented relapse longer than treatment with vancomycin at equivalent dose. Oritavancin at 100 mg/kg exhibited superior efficacy to vancomycin at day 12: 100% survival was observed for animals treated with oritavancin compared to 0% survival with vancomycin. The PEG400 formulation of oritavancin protected all hamsters from relapsing, yielding 100% survival out to day 20, compared to vancomycin (0% survival).
These data are consistent with previously presented results from in vitro gut model studies demonstrating that, while both oritavancin and vancomycin were effective in treating clindamycin-induced C. difficile infection, only oritavancin appeared active against the spore forms of the bacteria, suggesting that oritavancin may prevent recurrence of disease.
Targanta plans to continue advancing this program and initiating additional studies that would possibly enable the testing of orally-administered oritavancin for the treatment of C. difficile in the first half of 2009.
About C. difficile
C. difficile are anaerobic, gram-positive, spore-forming bacteria that are a major cause of morbidity in the hospitalized elderly. Recent studies estimate that currently there may be as many as 500,000 cases of C. difficile infection occurring annually in the United States, contributing to between 15,000 and 30,000 deaths.(1) C. difficile infection is associated with production of toxins in the colon, resulting in disease ranging from uncomplicated diarrhea to severe pseudomembranous colitis. The later more severe disease can be complicated by toxic megacolon, requiring removal of the colon, and sometimes results in death. It is postulated that after the normal gut flora balance is compromised or eradicated by the use of antibiotics, C. difficile spores refractory to current antimicrobial therapies persist, causing recurrent infections.
Oritavancin is a novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of Gram-positive bacteria. In its intravenous (IV) formulation, the product candidate has been tested in over 2,400 individuals and has completed two Phase 3 studies for the treatment of complicated skin and skin structure infections (cSSSI) in which the primary endpoints were met. Targanta submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in February 2008 seeking to commercialize oritavancin for the treatment of cSSSI; the FDA accepted the NDA submission for standard review, establishing an action date of December 8, 2008. Targanta’s Marketing Authorization Application (MAA) for oritavancin was accepted for review by the European Medicines Agency (EMEA) in June 2008. Targanta is also developing an oral version of oritavancin for the possible treatment of Clostridium difficile.
About Targanta Therapeutics
Targanta Therapeutics Corporation (Nasdaq: TARG) is a biopharmaceutical company focused on developing and commercializing innovative antibiotics to treat serious infections in the hospital and other institutional settings. The Company’s pipeline includes an intravenous version of oritavancin, a semi-synthetic lipoglycopeptide antibiotic currently awaiting U.S. and EU regulatory approval, and a program to develop an oral version of oritavancin for the treatment of Clostridium difficile. The Company has operations in Cambridge, MA, Indianapolis, IN, and Montreal, Quebec, Canada. For more information on Targanta, visit www.targanta.com.
(1) CDC Congressional Testimony, United States Senate Committee on Health, Education, Labor and Pensions, Tuesday, June 24, 2008
Safe Harbor Statement
This press release contains “forward-looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These are statements that are predictive in nature, that depend upon or refer to future events or conditions or that include words such as “potential,”"may,”"will,”"expects,”"projects,”"anticipates,”"estimates,”"believes,”"intends,”"plans,”"should,”"seeks,”"hope” and similar expressions. Such statements include, but are not limited to the suggestion that oritavancin may prevent recurrence of C. difficile infection, and the possible testing of orally-administered oritavancin for the treatment of C. difficile infection in the first half of 2009. Forward-looking statements involve known and unknown risks and uncertainties that may cause actual future results to differ materially from those projected or contemplated in the forward-looking statements. Forward-looking statements may be significantly impacted by certain risks and uncertainties described in Targanta’s filings with the Securities and Exchange Commission. The risks and uncertainties referred to above include, but are not limited to, delays in obtaining or a failure to obtain regulatory approval for Targanta’s product candidates; unfavorable clinical trial results; Targanta’s potential inability to initiate and complete pre-clinical studies and clinical trials for its product candidates; the possibility that results of pre-clinical studies are not necessarily predictive of clinical trial results; and those other risk factors that are described more fully in the Company’s filings with the Securities and Exchange Commission. Targanta does not undertake any obligation to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release.