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The news is out...
SunPharm Corporation (Nasdaq: SUNP - news) reported statistically
significant results of a Phase II, multicenter clinical trial with Diethylhomospermine (DEHOP) in AIDS patients with
uncontrolled, refractory diarrhea. Results from the trial demonstrated an overall response rate to DEHOP of slightly better than
80%.
Enrollment in the study was limited to AIDS patients who were previously unresponsive to therapy with conventional
antidiarrheal agents. The patients were hospitalized for three days prior to DEHOP therapy to establish baseline data and for
three days post-therapy to determine drug efficacy on the refractory diarrhea. The drug was administered subcutaneously once
daily at 12.5 mg or 6 mg every other day for two weeks (total of seven doses), and patients were followed with a three-month
post-drug evaluation period.
Data from the study achieved statistical significance at dose levels of 6 mg/day and 12.5 mg/day, not only for the primary
efficacy parameters of stool frequency, consistency and volume, but also at the 12.5 mg/day dose for the secondary parameter
of body weight gain at the end of the two-week treatment period when compared to baseline values. In addition, the study
confirmed the antidiarrheal effects of DEHOP observed in a Phase I trial.
In the Phase I clinical trial, 53% of AIDS-related refractory diarrhea patients responded to therapy when dosing regimens of 50
and 100 mg/day in divided doses were administered. ''Our dose-ranging studies with the compound have shown that a 6 mg or
12.5 mg dose of DEHOP every other day provides a significant clinical benefit to AIDS patients suffering with severe,
refractory diarrhea,'' said Dr. James Kesterson, Vice President of Product Development for SunPharm. ''In the Phase II study,
stool frequency decreased 46% from a baseline of 5.4/day, stool consistency improved, and stool volume decreased by 453.3
grams from a mean baseline value of 909.6 grams. We believe it is particularly important that, at the 12.5 mg/day dosage level,
the patients gained nearly two pounds of body weight during the two-week treatment period. Moreover, no significant adverse
events were reported during either the Phase I or Phase II study,'' Dr. Kesterson said. |
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