By Mary Welch
IntraBiotics Pharmaceuticals Inc. is enrolling patients in a Phase III trial of Ramoplanin Oral for the treatment of vancomycin-resistant Enterococcus (VRE).
Patients who carry VRE bacteria in their intestines are vulnerable to a bloodstream infection of VRE bacteria when they undergo procedures such as chemotherapy. Ramoplanin will be administered as an oral solution to cancer patients known to carry VRE in their intestines who are about to undergo chemotherapy.
The single pivotal trial is designed to demonstrate whether treatment with Ramoplanin reduces the incidence of bloodstream infection due to VRE.
The trial will enroll at least 1,000 patients in more than 50 sites across the U.S. Results may be ready in the second half of next year.
"Ramoplanin is poised to become the first safe and effective preventative of VRE bloodstream infections," Kevin Tang, senior biotech analyst with Deutsche Banc Alex. Brown, of New York, wrote in a research paper. "We believe that Ramoplanin, a novel antibiotic, represents a potential breakthrough in the prevention of VRE bloodstream infections. We estimate that this product possesses sales potential in excess of $200 million."
The therapy could be ready for market in the second half of 2002, Tang wrote.
So far, more than 100 people have received Ramoplanin treatment in earlier tests. In a Phase II study, 90 percent of the patients given Ramoplanin had no detectable VRE bacteria after seven days of treatment. None of those in the placebo group saw a change in their VRE levels.
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.
IntraBiotics holds the exclusive right to the drug in the U.S. and Canada under a license from Biosearch Italia SpA, of Milan, Italy.
IntraBiotics, of Mountain View, Calif., advanced its first product, Protegrin IB-367 Oral Rinse, into pivotal trials last month for oral mucositis. A second Phase III for the treatment of patients with head and neck cancer undergoing radiotherapy should begin soon. (See BioWorld Today, May 5, 2000, p. 1.)
Protegrin IB-367 is an analogue of a naturally occurring antibiotic originally purified from white blood cells of pigs. It is a synthetic peptide based on a class of antimicrobial peptides called protegrins.
Founded in 1994, IntraBiotics went public in March, raising $112 million, with the proceeds largely going to fund the clinical trials of its two lead product candidates. (See BioWorld Today, March 29, 2000, p. 1.)
IntraBiotics' stock (NASDAQ:IBPI) closed Friday at $26.69, up $1.19.