Monday, May 08, 2006 9:55:18 PM
In the right solvent and under the right conditions, Rose Bengal has been found to confine its destructive effects almost
exclusively to tumor tissue. The conditions that exist in tumor cells that allow a saline solution of Rose Bengal to cross the
cell membrane are not fully understood. However, key elements may be that membrane fluidity is higher in diseased cells
than in healthy cells. This solution does not penetrate the membranes of healthy cells, as shown in Figure 2. In addition,
any of the drug that is not taken up by cells is rapidly cleared from normal tissue.
Enrollment [in Phase 1 study] began in August 2005. Reported interim results from the first patient cohort that received treatment with a
low-dose regimen indicated that the Provecta was well tolerated. Preliminary efficacy data were also positive and in line
with those observed in preclinical models; that is, tumors were destroyed within seven to 14 days, there were no serious
adverse events and there was no evidence of systemic toxicity.
The Phase 1 study is scheduled for completion in July 2006. If the results are positive, Provectus plans to begin before the
end of 2006 the first of what is expected to be two Phase 2 trials.
Caradoc
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