PR Newswire; Tuesday December 9, 9:09 am EST

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.

AIDS-related diarrhea is a serious complication that affects a significant percentage of AIDS patients and nearly doubles the cost of AIDS patients' healthcare. According to IMS America's HIV Insight(R), a database that has followed 5,000 HIV-positive and AIDS patients with their consent since 1991, the prevalence of AIDS-related diarrhea is 28%, while the prevalence of this condition among all HIV-positive patients is 24%. "Experts continue to be surprised that the prevalence of diarrhea is remaining unchanged over time despite the adoption of triple antiretroviral therapy," commented Stefan Borg, President and Chief Executive Officer of SunPharm. "HIV Insight(R) reveals a mean duration of 92 days for AIDS-related diarrhea, underscoring the chronic nature and severity of this condition. Clearly this is a significant healthcare challenge," he added. "We intend to work closely with the Food and Drug Administration on a multicenter, pivotal study to expedite further development of DEHOP for the treatment of AIDS-related diarrhea."

DEHOP belongs to a new and novel class of pharmaceutically active agents that are analogs of naturally occurring, essential intracellular polyamine compounds. Preclinical pharmacology studies have shown that DEHOP inhibits both the secretory and motility aspects of diarrhea. The product is currently in Phase I clinical trials for cancer and ulcerative colitis. In addition, clinical studies of DEHOP in AIDS-related non-Hodgkin's lymphoma and cancer chemotherapy diarrhea are scheduled to initiate as soon as Institutional Review Board approval is obtained.

SunPharm, based in Jacksonville, Florida, is engaged in the design and development of small molecule pharmaceutical products, derived from novel polyamine analogues and metal chelators, for the treatment of gastrointestinal and viral disorders, cancer, and other proliferative disorders. The technology was invented by Dr. Raymond Bergeron at the University of Florida and licensed exclusively to the Company for the development of products to treat severe and chronic disorders.

Certain statements in this news release regarding the potential therapeutic utility of polyamine analogues and SunPharm's development plans may be regarded as forward-looking statements and involve risk and uncertainties which could cause actual results to differ materially from the statements made, including the success and timing of product approvals, the establishment of new corporate alliances, and other risks listed from time to time in SunPharm's SEC filings, including those described in SunPharm's most recently filed annual report on Form 10-KSB. These forward-looking statements represent SunPharm's judgment, as of the date of this release, and SunPharm disclaims any intent or obligation to update these forward-looking statements.

HIV Insight(R) is marketed by IMS America and is owned by APACHE Medical Systems, Inc.

SOURCE: SunPharm Corporation

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