This Phase I/II trial explored the safety, tolerability and early signs of activity in chronic UC patients who were experiencing an acute flare in their disease. Patients were dosed for 28 days at 3 dose levels: 5 mg, 10 mg (5 bid) and 20 mg (10 bid) and Triolex was found to be safe and tolerable. Adverse events were mild to moderate and equally divided between Triolex and placebo-treated groups. The study was not powered to show statistically significant activity differences between placebo and drug-treated patients based on disease score changes. There was no clear separation between the placebo and active study arms over a one-month treatment period.
Rheumatoid arthritis Phase I safety, tolerance and drug compatibility study HE3286-0201
This Phase I safety and tolerance study was conducted in RA patients with stable disease that were concurrently taking methotrexate as maintenance therapy. A secondary objective of the study was to learn whether Triolex interfered with the action of methotrexate, which is required for concomitant dosing trials in patients with active disease. Three dose levels of Triolex were given daily to 14 subjects for 28 days along with weekly methotrexate. Three patients were dosed at 10 mg (5 mg bid), three at 20 mg (10 mg bid) and eight at 40 mg (2 mg bid) on an intent-to-treat basis.
Triolex was found to be safe and well tolerated. No disease flares or increased methotrexate toxicity were observed. Most adverse events were mild to moderate. Subject drug exposure remained dose proportional through the higher dose, and no change in methotrexate or Triolex pharmacokinetics was observed.
About Hollis-Eden Pharmaceuticals
Hollis-Eden Pharmaceuticals is a development-stage company with two product candidates in human clinical trials: Apoptone (HE3235), in the dose-escalation portion of a Phase I/II trial of patients with late-stage pros
|SOURCE Hollis-Eden Pharmaceuticals, Inc.|
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