Navigation Links
Optimer Pharmaceuticals Phase 3 Clinical Trials show Fidaxomicin is Superior to Vancomycin in Treatment of Recurrent Clostridium difficile Infection (CDI); Data Presented at ICAAC

SAN DIEGO, Sept. 14 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) announced the presentation of new data from its North American and European fidaxomicin Phase 3 clinical trials in patients with Clostridium difficile infection (CDI) at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston.  During an oral presentation, investigator Oliver Cornely, M.D., of the University of Cologne, presented data showing that fidaxomicin was superior to vancomycin in treating a CDI recurrence and in reducing the chance of another relapse.



CDI recurrence occurs in approximately 25% of patients treated with existing therapies and there is no agreement in the medical community on the optimal treatment for a recurrence.  In the two fidaxomicin Phase 3 trials, a separate stratum was constructed of subjects who had experienced a prior CDI episode and recurred within three months of entering the study.  The 178 subjects with recurrent CDI  were randomized to be treated with either fidaxomicin or vancomycin and 128 of these subjects were subsequently evaluable for recurrence within the study. Following treatment, 35.5% (22/62) of the subjects who received vancomycin experienced another recurrence compared to 19.7% (13/66) among the subjects who received fidaxomicin (p=.045).  This equates to a 45% reduction in repeat CDI recurrence with fidaxomicin.

"The Phase 3 trials previously showed that fidaxomicin is superior to vancomycin in the prevention of recurrence.  The data presented today show that fidaxomicin is also superior to vancomycin in the treatment of CDI patients suffering a recurrence," said Sherwood Gorbach, Optimer's Chief Medical Officer and Senior Vice President of Medical Affairs.  "This is an important finding given that the medical community has not found a successful and reliable treatment for recurrent CDI.  With our recent MAA filing and anticipated NDA filing, we continue to work diligently to make fidaxomicin available to the medical community for treating acute CDI and for preventing and treating recurrences."

For a complete list of posters, please visit the Resources page on our website:

Fidaxomicin Clinical StudiesThe two fidaxomicin Phase 3 clinical studies were multi-center, randomized, double-blind trials, which enrolled a total of 1,164 adult subjects.  Subjects with confirmed CDI received either fidaxomicin (200 mg q12h) or Vancocin® (125 mg q6h), the only FDA approved product for the treatment of CDI. These studies were designed to evaluate safety and compare the response to treatment in subjects during and after a 10-day course of therapy. The primary endpoint was non-inferiority compared to Vancocin in clinical cure (defined as patients requiring no further CDI therapy two days after completion of study medication, as determined by the investigator).  If cured, subjects were monitored for a subsequent four-week period to evaluate recurrence, which was a secondary endpoint.  Global cure, also a secondary endpoint, was defined as patients who were cured and did not have a recurrence during this subsequent four-week period. In both of these studies, fidaxomicin achieved its primary endpoint of non-inferiority compared to Vancocin.  Fidaxomicin was also statistically superior to Vancocin in global cure rate and in reducing recurrences of CDI.

About Clostridium difficile InfectionCDI has become a significant medical problem in hospitals, long-term care facilities, and in the community.  It is a serious illness caused by infection of the inner lining of the colon by C. difficile bacteria, which produces toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death.  Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, and thus allowing C. difficile bacteria to flourish.

Current therapeutic options for CDI include the off-label use of metronidazole and oral vancomycin, the only FDA-approved treatment.  However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of antibiotic administration.

Primary risk factors for CDI include broad-spectrum antibiotic use (such as cephalosporins and fluoroquinolones), advanced age (over 65) and exposure to emerging hyper-virulent strains (BI/NAP1/027, 078, 001) of C. difficile. Increasing incidence, higher treatment failures and recurrence with current therapies have resulted in greater awareness and concern of CDI among medical professionals and public health officials.

About FidaxomicinFidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the death of C. difficile. The narrow-spectrum profile of fidaxomicin may eradicate C. difficile selectively with minimal disruption to the normal intestinal flora, while the alternative antibiotics to treat CDI, metronidazole and vancomycin, disrupt the flora. Fidaxomicin may facilitate the return of normal physiological conditions in the colon which may be responsible for reducing CDI recurrence.

About Optimer PharmaceuticalsOptimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing hospital specialty products to treat serious infections and address unmet medical needs. Optimer has two anti-infective product candidates in development. Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). Optimer has completed two Phase 3 trials of fidaxomicin for the treatment of CDI demonstrating that fidaxomicin was statistically superior to vancomycin in global cure rate (defined as cure with no recurrence within four weeks of completing therapy) as well as statistically superior in reducing recurrences of CDI by up to 50% when compared with vancomycin, the only FDA approved product for CDI. Optimer has also successfully completed two Phase 3 trials of Pruvel™ a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea. Additional information can be found at

Forward-looking Statements Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to the ability of fidaxomicin to treat CDI and address current treatment limitations, expectations regarding regulatory filings and the potential to bring fidaxomicin to the market. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to: the timing, progress and likelihood of success of its product research and development programs, the timing and status of its preclinical and clinical development of potential drugs, Optimer's ability to complete its NDA submission in a timely manner, whether regulatory authorities will review or approve Optimer's applications for marketing approval, the timing of any marketing approvals, Optimer's ability to commercialize any products for which it receives marketing approval and other risks detailed in Optimer's filings with the Securities and Exchange Commission. ContactsOptimer Pharmaceuticals, Inc.Christina Donaghy, Corporate Communications ManagerJohn D. Prunty, Chief Financial Officer & VP Finance858-909-0736Canale Communications, Inc.Jason I. Spark, Senior Vice President619-849-6005

SOURCE Optimer Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Optimer Pharmaceuticals Reports Third Quarter 2009 Financial Results
2. Optimer Pharmaceuticals to Present at September 2009 Investor Conferences
3. Optimer Pharmaceuticals Announces Presentations of Additional Phase 3 Fidaxomicin and Prulifloxacin Data at Upcoming ICAAC Annual Meeting
4. Optimer Pharmaceuticals Reports Second Quarter 2009 Financial Results
5. Optimer Pharmaceuticals to Present at the Canaccord Adams 29th Annual Global Growth Conference
6. Optimer Pharmaceuticals to Present at June 2009 Investor Conferences
7. Optimer Pharmaceuticals Announces Lower Recurrence Rates for Fidaxomicin Versus Vancocin(R) in Subgroup Analyses from Its Phase 3 Study for the Treatment of CDI
8. Optimer Pharmaceuticals Reports First Quarter 2009 Financial Results
9. Edimer Pharmaceuticals and CMC Biologics Announce Agreement to Manufacture EDI200 Recombinant Protein
10. Transdel Pharmaceuticals to Present at Rodman & Renshaw 12th Annual Healthcare Conference
11. Amylin Pharmaceuticals to Present at Morgan Stanley Global Healthcare and Baird Global Healthcare Conferences
Post Your Comments:
(Date:11/25/2015)... November 25, 2015 Studies reveal ... human plaque and pave the way for more effective treatment ... cats     --> ... diagnosed health problems in cats, yet relatively little was understood ... collaborative studies have been conducted by researchers from the WALTHAM ...
(Date:11/25/2015)... 25, 2015 Orexigen® Therapeutics, Inc. (Nasdaq: ... a fireside chat discussion at the Piper Jaffray 27th ... . The discussion is scheduled for Wednesday, December 2, ... .  A replay will be available for 14 days ... , Julie NormartVP, Corporate Communications and Business Development , ...
(Date:11/24/2015)... 2015 Cepheid (NASDAQ: CPHD ) today ... following conference, and invited investors to participate via webcast. ...      Tuesday, December 1, 2015 at 11.00 a.m. Eastern Time ...      Tuesday, December 1, 2015 at 11.00 a.m. Eastern Time ... New York, NY      Tuesday, December 1, 2015 ...
(Date:11/24/2015)... 24, 2015 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ:  AEZS) (TSX: ... behalf of the Toronto Stock Exchange, confirms that as ... no corporate developments that would cause the recent movements ... --> About Aeterna Zentaris Inc. ... --> Aeterna Zentaris is a specialty biopharmaceutical company ...
Breaking Biology Technology:
(Date:11/12/2015)... 11, 2015   Growing need for low-cost, ... has been paving the way for use of ... discrete analytes in clinical, agricultural, environmental, food and ... used in medical applications, however, their adoption is ... to continuous emphasis on improving product quality and ...
(Date:11/10/2015)... Nov. 10, 2015 About ... that helps to identify and verify the identity ... considered as the secure and accurate method of ... a particular individual because each individual,s signature is ... especially when dynamic signature of an individual is ...
(Date:11/4/2015)... ALBANY, New York , November 4, 2015 /PRNewswire/ ... According to a new market report published by Transparency ... Size, Share, Growth, Trends and Forecast 2015 - 2022", ... value of US$ 30.3 bn by 2022. The market ... during the forecast period from 2015 to 2022. Rising ...
Breaking Biology News(10 mins):