By Kim Coghill
IntraBiotics Pharmaceuticals Inc.'s stock dropped 33 percent Monday following its announcement that Phase III clinical trials for Ramoplanin Oral will be delayed a year or more.
Ramoplanin Oral is being studied to determine whether it reduces the incidence of bloodstream infections due to vancomycin-resistant enterococci (VRE) in cancer patients known to carry VRE bacteria in their intestines. The study, which began enrollment last June, has enrolled 104 of the planned 950 patients at 20 of the targeted 51 clinical trial sites in the United States. The trial was expected to be complete at the end of this year.
A prepared statement released by the Mountain View, Calif.-based company said challenges facing enrollment are a decreased VRE prevalence at some sites compared to the earlier year, the feasibility of widespread screening for VRE at some sites, and complicated study logistics that require collaboration of both oncologists and infectious disease physicians.
No one at the company was available for comment Monday. However, IntraBiotics' officials have scheduled a conference call for interested parties today.
IntraBiotics' stock (NASDAQ:IBPI) closed Monday at $2.875, down $1.25, or 30 percent. IntraBiotics had $86 million in cash at the end of the fourth quarter.
"The announcement of a delay in the study is based on the steering committee's March 8 report," Kenneth Kelley, chairman and CEO of IntraBiotics, said in a prepared statement. "The committee reviewed progress in the trial following a principal investors' meeting held in February and considered those efforts made by the company to enhance enrollment. After reviewing all relevant information, the steering committee determined that the rate of enrollment has not been sufficiently accelerated and that the study would be delayed a year or more."
In a Phase II study of Ramoplanin, 90 percent of the patients given the product had no detectable VRE bacteria after seven days of treatment. None of those in the placebo group saw a change in VRE levels. (See BioWorld Today, July 3, 2000.)
Ramoplanin is a naturally occurring antibiotic that has shown potent activity against methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus faecium, two multidrug-resistant pathogens.
But all news of late has not been negative for IntraBiotics.
Just last week, the company issued a statement saying Phase IIa clinical trials of Protegrin IB-367 rinse showed that the product is well tolerated and demonstrates antimicrobial activity when administered to patients who are at increased risk for developing pneumonia because they require a ventilator for breathing assistance.
Ventilator-associated pneumonia (VAP) is a nosocomial (hospital-acquired) pneumonia occurring in patients who are mechanically ventilated. About 74,000 patients are placed on ventilators in the U.S. each year and presently there is no antimicrobial drug approved for the prevention of VAP.
The company currently is conducting three Phase III clinical studies, two of which are investigating Protegrin IB-367 for reduction of oral mucositis in cancer patients.
Founded in 1994, IntraBiotics went public last March, raising $112 million with the proceeds largely going to fund the clinical trials of its two lead product candidates - Protegrin IB-367 and Ramoplanin Oral. (See BioWorld Today, March 29, 2000.)
The company develops novel antibacterial and antifungal drugs for the treatment and prevention of serious infectious diseases, including those caused by multidrug-resistant microbes. The technology consists of several distinct chemical classes of antibacterials and antifungals. n