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Clinical Trials
Phase II Clinical Trial With TRIOLEX In Type 2 Diabetes Patients
Phase I/II Clinical Trial With TRIOLEX In Ulcerative Colitis
Based upon published observations with TRIOLEX in preclinical models widely used by the pharmaceutical industry and academia to test agents as potential treatments for ulcerative colitis, in 2008, we commenced a Phase I/II clinical trial with TRIOLEX in ulcerative colitis patients. This Phase I/II dose ranging study evaluated the safety, tolerance, pharmacokinetics and activity of TRIOLEX when administered orally for 28 days to patients with active, mild-to-moderate ulcerative colitis. TRIOLEX at the doses studied was found to be safe and well tolerated but offered no indication of a treatment advantage in this acute inflammatory setting when compared to placebo. Triolex is staged for long-term clinical trials directed towards the control of the chronic inflammatory processes associated with this disease, a clinical setting believed to be consistent with the pharmacological properties of the compound.
Phase I/II Clinical Trial With TRIOLEX in Rheumatoid Arthritis
Based upon the published studies in rodent models of collagen-induced and collagen antibody-induced arthritis where TRIOLEX demonstrated activity, a Phase I clinical trial was initiated with TRIOLEX in 2008 in rheumatoid arthritis patients. A 28-day oral dose ranging study assessed the safety, pharmacokinetics and potential for drug-drug interactions in stable rheumatoid arthritis patients also receiving methotrexate. TRIOLEX was found to be safe and well tolerated. No drug-drug interaction was found. TRIOLEX is now positioned to enter clinical studies in patients with active rheumatoid arthritis.
Phase I/II Clinical Trial With APOPTONE In Prostate Cancer
Harbor BioSciences is conducting a Phase I/II clinical trial with APOPTONE in prostate cancer. This Phase I/II dose ranging study will evaluate the the safety, tolerance, pharmacokinetics and potential activity of APOPTONE when administered twice daily for 28 days to late-stage prostate cancer patients who have failed hormone therapy and at least one round of chemotherapy treatment.
For information on the clinical trial, including enrollment information, click here:
http://clinicaltrials.gov/ct2/show/NCT00716794?term=he3235&rank=1