Drug Criteria & Outcomes: In the Pipeline
July 1, 2002
Drug Criteria & Outcomes: In the Pipeline
• Antigenics has announced that investigators have enrolled the first patient in a Phase III trial of its personalized cancer vaccine HSPPC-96 (Oncophage) for the treatment of metastatic melanoma.
• Boston Scientific Corporation has announced that the Food and Drug Administration (FDA) has authorized full enrollment of its TAXUS IV clinical trial. The prospective, randomized, double-blind trial is designed to assess the safety and efficacy of a slow-release dose formulation, paclitaxel-eluting TAXUS stent system for the treatment of coronary restenosis.
• Inspire Pharmaceuticals has announced the launch of two Phase IIa studies for INS37217 intranasal solution in a nasal spray formulation. Both studies are double-blind, placebo-controlled, dose-ranging studies. One is being conducted in 60 patients with chronic rhinitis. The other is being conducted in 90 patients with upper respiratory infections.
• Protein Design Labs has initiated a Phase II clinical trial to evaluate its humanized SMART Anti-Gamma Interferon Antibody in Crohn’s disease.
• Paris-Immuno-Designed Molecules, S.A. (IDM), and its U.S. subsidiary, IDM, have announced approval from the FDA to begin a Phase III clinical trial in the treatment of ovarian cancer using IDM’s Cell Drug Osidem (also known as IDM-1).
• Cell Therapeutics has announced that it is continuing a Phase II clinical trial of polyglutamate paclitaxel (Xyotax) in non-small cell lung cancer.
• Human Genome Sciences has announced that the FDA has cleared the company’s Investigational New Drug application to begin clinical trials of LymphoRad(131) (LymphoRad). The initial Phase I clinical trial will evaluate LymphoRad in patients with multiple myeloma.
• Oncolytics Biotech has received approval from Health Canada to initiate a Phase I/II clinical trial to investigate the use of the human reovirus (Reolysin) as a treatment for patients with recurrent malignant glioma.
• Avanir Pharmaceuticals has completed enrollment in a Phase II/III clinical trial of Neurodex in the treatment of emotional lability. Neurodex is a patented, orally administered combination of dextromethorphan (DM) and an enzyme inhibitor that sustains elevated levels of DM in the human body and allows for a 12-hour dosing schedule.
• Amylin Pharmaceuticals has initiated a dose titration study of pramlintide acetate (Symlin) in patients with Type 1 diabetes who are actively trying to improve their glucose control.
• Telikhas initiated a Phase I-IIa clinical trial of the TLK199 small molecule product candidate in patients with myelodysplastic syndrome.
• DynPort Vaccine Co., a joint venture between DynCorp of Reston, Va., and Porton International, announced that it would enter into a Phase I clinical trial for a new smallpox vaccine.
* Pharmacyclics is planning to conduct an additional Phase III clinical trial of its lead product motexafin gadolinium (Xcytrin) Injection. Last year, the company reported results of a randomized controlled Phase III trial of motexafin gadolinium in patients with brain metastases.