SAN DIEGO, March 14, 2007 (PRIME NEWSWIRE) -- Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) today reported that the U.S. Food and Drug Administration has agreed with the recommendation of the independent Data Safety Monitoring Board (DSMB) to advance Difimicin (OPT-80/PAR101) into Phase 3 clinical studies.
The DSMB reviewed the Phase 2b data and stated in their written report, "No safety issues were identified precluding continuation of the study into the Phase 3 portion as written in the protocol. This represents the final DSMB review for the study." The Board further recommended that Difimicin, which is referenced as Study PAR101.C.003, "...may proceed according to protocol without any modifications."
Difimicin, the company's lead antibiotic drug candidate, has been under evaluation in a Phase 2b/3 trial for the treatment of Clostridium difficile-associated diarrhea, or CDAD. CDAD is the primary cause of nosocomial diarrhea worldwide and affects more than 500,000 patients in the U.S. alone. When patients are treated with broad-spectrum antibiotics, C. difficile can grow in the bowel, produce toxins, and cause severe diarrhea. The Company believes that Difimicin's advantages over other antibiotic drugs are its narrow-spectrum activity, minimal systemic exposure, low resistance, convenient dosing, and limited disruption of normal gut flora.
"We are excited to advance Difimicin into the Phase 3 portion of this trial," said Michael N. Chang, Ph.D., President and CEO of Optimer. "The DSMB's recommendation to advance Difimicin into Phase 3 testing signals to us that this drug candidate has maintained the positive safety profile we saw in the earlier Phase 1 and 2a studies. We look forward to continuing this trial as well as initiating a second, parallel Phase 3 trial in Europe and North America."
Optimer plans to increase the number of study sites to approximately 100, in order to meet the targeted enrollment goal of 664 CDAD patients. "The Phase 3 protocol compares Difimicin to Vancocin(r) (oral vancomycin) with the endpoint being non-inferiority," said Howard J. Dreskin, who recently joined Optimer as Director of Clinical Operations. "Currently, oral vancomycin is the only FDA-approved drug for the treatment of CDAD. We expect data from this trial in the fourth quarter of 2007."
About Optimer
Optimer Pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products for the treatment of serious infections. Optimer currently has two late-stage anti-infective product candidates. Difimicin (OPT-80/PAR-101) is being developed for the treatment of CDAD. Prulifloxacin (OPT-99) is an antibiotic currently in a Phase 3 trial for the treatment of travelers' diarrhea, a form of infectious diarrhea. For more Company information, go to www.optimerpharma.com.
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Safe Harbor Statement
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 Difimicin, CDAD, and the timing of Clinical Trials. 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 our product research and development programs, the timing and status of our preclinical and clinical development of potential drugs and other risks detailed in Optimer's filings with the Securities and Exchange Commission.