Drug Criteria & Outcomes: In the pipeline
• Cardiome Pharma Corp. has commenced patient dosing of oxypurinol in a Phase II/III study of patients with congestive heart failure.
• SuperGen has announced that patient enrollment has been completed in an open-label, randomized Phase III clinical study of decitabine, an investigational treatment for advanced myelodysplastic syndrome.
• Telik has initiated a randomized, controlled Phase III registration trial of TLK286, administered as a single agent in ovarian cancer patients whose disease has progressed following platinum-based chemotherapy and one second-line treatment.
• Vion Pharmaceuticals has initiated a Phase I trial of Triapine, an inhibitor of ribonucleotide reductase, in combination with cytarabine (Ara-C) in patients with advanced leukemia.
• Barrier Therapeutics has announced that enrollment has begun in Phase III clinical trials for Seboride in both Europe and the United States. Seboride, a combination topical agent containing ketoconazole, an antifungal agent, and desonide, a steroid, is a patented gel formulation. The trials have been designed to show that the agent is effective in seborrheic dermatitis with a treatment regimen of once per day for two weeks.
• Schering AG, Berlin has announced that its novel experimental agent PTK787/ZK 222584, which is being developed in collaboration with Novartis AG, has entered Phase III clinical trials for treatment of metastatic colorectal cancer.
• Barrier Therapeutics has begun enrolling patients in its final Phase III clinical trial for its lead product, Zimycan, a topical ointment containing 0.25% of the antifungal miconazole, in a zinc oxide and petrolatum base. If approved, Zimycan would be the first and only product approved for use in Candida-associated diaper dermatitis.
• Access Pharmaceuticals has begun a Phase I clinical study to evaluate AP5346, a DACH Polymer Platinate. Upon successful completion of the Phase I study, a Phase IIA study will be conducted in ovarian cancer patients to determine the initial efficacy of AP5346.