Navigation Links
Optimer Pharmaceuticals Announces Lower Recurrence Rates for Fidaxomicin Versus Vancocin(R) in Subgroup Analyses from Its Phase 3 Study for the Treatment of CDI
Date:6/2/2009

SAN DIEGO, June 2 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) announced that additional results from its North American Phase 3 clinical study of fidaxomicin in patients with Clostridium difficile infection (CDI) were presented today by clinical investigator, Mark A. Miller, M.D., at the Digestive Disease Week 2009 conference in Chicago.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090413/LA97352LOGO)

The additional data presented today for the first time focused on other patient risk factors believed to be predictive of CDI recurrence following treatment. These risk factors include serum albumin levels, white blood cell (WBC) count and temperature, and non-BI (NAP1/027) strains. The data showed that fidaxomicin overall demonstrated a lower recurrence rate compared to oral vancomycin (Vancocin(R)) regardless of albumin levels, WBC count and temperature, as well as for patients with non-BI (NAP1/027) strains. Vancocin is currently the only FDA approved therapy for CDI.

Recurrence Rates by Subgroup (per protocol)

    -------------------------------------------------------------------------
    Risk Factors                         Fidaxomicin     Vancocin(R) capsules
                                         (200mg bid)         (125mg qid)
    -------------------------------------------------------------------------
    White Blood Cell Count /Temp
    -------------------------------------------------------------------------
    WBC < 15,000 uL and Temp
     < 38 degrees C                     10.7% (17/159)      22.4% (35/156)
    WBC 15-25,000 uL or Temp 38
     degrees - 39 degrees C             12.0% (3/25)        20.0% (6/30)
    WBC > 25,000 uL or Temp
     > 39 degrees C                     33.3% (1/3)         40.0% (2/5)
    -------------------------------------------------------------------------
    Albumin
    -------------------------------------------------------------------------
            < =25 mg/mL                 22.2% (8/36)        31.5% (17/54)
            26-35 mg/mL                 10.0% (9/90)        23.3% (20/86)
    -------------------------------------------------------------------------
    Strain Type
    -------------------------------------------------------------------------
        Non-BI (NAP1/027)                7.8% (8/103)       25.5% (27/106)
    -------------------------------------------------------------------------


Dr. Miller also presented the previously announced top-line results and data related to patient status (in-patient/out-patient), age (under/over 65) and the strain type BI (NAP1/027).

"The subgroup analysis shows that fidaxomicin is more effective than oral vancomycin when it comes to reducing recurrence, even in high risk patient populations such as those older than 65, hospitalized patients, and patients with very low albumin levels," said Mark A. Miller, M.D., Chief of Clinical Microbiology, Head of the Division of Infectious Diseases, Chair of the Infection Prevention and Control Unit at Jewish General Hospital and Associate Professor of Medicine and Microbiology/Immunology at McGill University in Montreal, Quebec, Canada.

Additional analyses from this study will be presented at medical conferences throughout the year.

Fidaxomicin Clinical Study Design

629 adult subjects were enrolled in this multi-center, randomized, double-blind Phase 3 clinical trial, which was the largest such trial for the treatment of CDI. Subjects with confirmed CDI received either 200 mg fidaxomicin dosed orally twice daily or 125 mg Vancocin dosed orally four times daily. This study was conducted in more than 100 clinical sites throughout North America. The objective of the study was to show that a 10-day course of fidaxomicin was at least as efficacious (non-inferior) and safe as a 10-day course of Vancocin (vancomycin hydrochloride capsules, USP) for the treatment of CDI.

The primary endpoint of the study was clinical cure defined as patients requiring no further CDI therapy two days after completion of study medication, as determined by the investigator. The secondary endpoint evaluated CDI recurrence up to four weeks post therapy with recurrence defined as the return of diarrhea associated with CDI confirmed by a positive toxin test. Global cure was defined as patients who were cured and did not have a recurrence.

About Clostridium Difficile Infection

CDI has become a growing 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 produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. CDI typically develops from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, allowing C. difficile bacteria to flourish.

Current therapeutic options for CDI include metronidazole and oral vancomycin. 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, advanced age (over 65), emerging hyper-virulent strains (BI /NAP1/027, 078, 001) of C. difficile, and previous exposure to CDI that lead to recurrence. Higher incidence, increased treatment failures, and recurrence with standard therapies have resulted in greater awareness and concern of CDI among medical professionals and public health officials.

Scheduled Conference Call

The Company will host a conference call for the investment community today beginning at 3:00 p.m. Pacific time (6:00 p.m. Eastern time) to discuss the additional fidaxomicin Phase 3 data and answer questions.

To participate in the live call by telephone, please dial (877) 419-6590 from the U.S., or (719) 325-4893 from outside the U.S. The conference call will be webcast live under the Investors section of Optimer's website at www.optimerpharma.com.

About Fidaxomicin

Fidaxomicin is the first in a new class of antibiotics called macrocyclics, which inhibit the bacterial enzyme RNA polymerase, resulting in the death of Clostridium difficile. The narrow spectrum profile of fidaxomicin may eradicate Clostridium difficile selectively with minimal disruption to the normal intestinal flora. This may facilitate the return of the normal physiological conditions in the colon and reduce the probability of CDI recurrence.

About Optimer Pharmaceuticals

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products to treat serious infections and address unmet medical needs. Optimer has two late-stage anti-infective product candidates under development. Fidaxomicin, formerly known as OPT-80, is the only antibiotic therapy currently in Phase 3 worldwide clinical development for Clostridium difficile infection. Prulifloxacin is an antibiotic which has completed two Phase 3 clinical trials for the treatment of travelers' diarrhea, a form of infectious diarrhea. Additional information can be found at http://www.optimerpharma.com.

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 address current treatment limitations and the presentation of future clinical trial results. 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 and other risks detailed in Optimer's filings with the Securities and Exchange Commission.

    Contacts

    Optimer Pharmaceuticals, Inc.
    John Prunty, CFO & VP, Finance
    Christina Donaghy, Corporate Communications Manager
    858-909-0736

    Porter Novelli Life Sciences
    Jason I. Spark, Vice President
    619-849-6005


'/>"/>
SOURCE Optimer Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Optimer Pharmaceuticals Reports First Quarter 2009 Financial Results
2. Vion Pharmaceuticals Pays Interest on 7.75% Convertible Senior Notes
3. China Biopharmaceuticals Holdings Announces Second Quarter 2007 Financial Results
4. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
5. XTL Biopharmaceuticals Announces Financial Results for the Six Months Ended June 30, 2007
6. Cadence Pharmaceuticals Reports Second Quarter 2007 Financial Results
7. Nabi Biopharmaceuticals to Present at Upcoming Industry Conferences
8. Anadys Pharmaceuticals Appoints Steve Worland, Ph.D. as President and Chief Executive Officer
9. Poniard Pharmaceuticals Announces Participation in Upcoming Conferences
10. NovaQuest Advances Virtual Development Model With Strategic Investment in TOPIGEN Pharmaceuticals
11. Drug Royalty Corporation (DRC) Announces Acquisition Regarding PEG-INTRON(R) From Enzon Pharmaceuticals, Inc. (ENZN)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... CALABASAS, Calif. , Jan. 19, 2017 /PRNewswire/ ... Mathias Schmidt , Ph.D., as chief executive ... board of directors. Dr. Schmidt brings to ArmaGen more ... on the research and development of biotherapeutics and ... biopharmaceutical executive with the diverse experience and skillset ...
(Date:1/19/2017)... Linda, Ca (PRWEB) , ... January 18, 2017 ... ... virtual events for tech innovators, engineers, and scientists from around the world, was ... American News. The awards program is based entirely on merit and decided upon ...
(Date:1/19/2017)... YORK , Jan. 18, 2017 ... to reach USD 92.9 billion by 2025, according ... Inc. Pharmaceutical industry has been adaptive of the ... as early as 2002. Among the services outsourced, ... forerunners. For instance, Johnson & Johnson was the ...
(Date:1/19/2017)... -- BD (Becton, Dickinson and Company) (NYSE: BDX ), ... a live webcast of its Annual Meeting of Shareholders on Tuesday, ... webcast can be accessed from the BD corporate website at ... 2017. ... BD BD is a global medical technology company that is ...
Breaking Biology Technology:
(Date:1/12/2017)... 2017 A new report by Allied Market Research, titled, "Global ... technology market is expected to generate revenue of $10.72 billion by 2022, with an ... Reading ... Allied Market Research Logo ...      (Logo: http://photos.prnewswire.com/prnh/20140911/647229) In the year ...
(Date:1/6/2017)... 5, 2017  SomaLogic announced today that it ... established by iCarbonX, the China ... "Global Digital Health Ecosystem that can define each ... individual,s biological, behavioral and psychological data, the Internet ... companies, SomaLogic will provide proteomics data and applications ...
(Date:1/3/2017)... 2017 Onitor, provider of digital health technology ... an innovative biometric data-driven program designed to aid weight ... the 2017 Consumer Electronics Show (CES) in ... U.S., the World Health Organization (WHO), have identified lifestyle ... who are overweight or obese. WHO also states that ...
Breaking Biology News(10 mins):