Treatment satisfaction with ITCA 650, a novel drug-device delivering continuous exenatide, versus twice-daily injections of exenatide in type 2 diabetics using metformin.

Aims: To evaluate treatment satisfaction in patients with type 2 diabetes (T2D) not adequately controlled by metformin, randomized to ITCA 650 (continuous exenatide in osmotic mini-pump) vs twice-daily exenatide injections (Ex-BID).

Materials And Methods: The Diabetes Medication Satisfaction Tool (DM-SAT) was administered and assessments were made at baseline, Week 8 and Week 20 during a 24-week open-label phase 2 trial. In Stage I (Weeks 1-12), 155 patients, comprising the ITT population, were randomized to 3 groups: ITCA 650 20 μg/day, ITCA 650 40 μg/day and Ex-BID 10 μg BID.

Antiviral activity of CHO-SS cell-derived human omega interferon and other human interferons against HCV RNA replicons and related viruses.

The fully glycosylated human omega interferon produced from CHO-SS cells (glycosylated IFN-omega) has been shown to be well-tolerated in man and to induce a sustained virologic response in patients infected with hepatitis C virus (HCV). We examined the antiviral activity of glycosylated IFN-omega and various human IFNs (IFN-alpha, -beta, -gamma and non-glycosylated bacterial (Escherichia coli) recombinant IFN-omega (non-glycosylated IFN-omega)) against HCV RNA replicons and several viruses related to HCV. Since none of the IFNs displayed cytotoxicity we compared their activities based on the effective concentration of the IFN that inhibited virus growth by 50% (EC50).

Safety pharmacology, toxicology and pharmacokinetic assessment of recombinant human omega-interferon produced from CHO-SS cells.

Human omega-interferon (IFN-omega) has been shown to be well-tolerated in man and to induce reductions of hepatitis C virus RNA levels in a series of human clinical trials. Here we provide an overview of our preclinical safety evaluation of the fully-glycosylated human IFN-omega produced from CHO-SS cells that is currently being evaluated clinically. IFN-omega was not associated with any biologically-relevant adverse effects in a series of 10 safety pharmacology experiments, in the Ames mutagenicity test, in the micronucleus test, or in intraarterial, intravenous, paravenous or subcutaneous local tolerance studies.