Drug Criteria & Outcomes

In the Pipeline

• Novogen Limited announced the start of the first trial in the United States for phenoxodiol, which targets multiple enzymes that are common to many human cancers. The patients enrolled in the Cleveland Clinic Foundation trial have late-stage, metastatic cancers of any type other than breast cancer.

• Versicor announced the start of a Phase II clinical study to evaluate the efficacy and safety of its investigational antibiotic, dalbavancin (formerly V-Glycopeptide), for the treatment of complicated skin and soft-tissue infections caused by gram-positive bacteria, usually Staphylococci. This randomized, controlled, open-label study will enroll about 60 hospitalized patients with skin and soft-tissue infections.

• Matritech announced that it has begun patient recruitment for a multi-center clinical study of its NMP66 blood test for the early detection of breast cancer. The clinical study, which will be conducted at six medical centers around the country, will enroll approximately 1,000 patients.

• Millennium Pharmaceuticals announced the initiation of a Phase II clinical trial of LDP-341 (also known as PS-341) for patients with chronic lymphocytic leukemia (CLL). This clinical trial, the third Phase II study of LDP-341 as a single agent in hematologic malignancies, is an open-label dose-finding study of LDP-341 in patients with CLL who have relapsed during or within six months of receiving treatment with a purine analog. The goal of this study is to assess the safety and response rate associated with two doses of LDP-341 in patients with B- or T-cell CLL.

• Following a meeting with the Food and Drug Administration, Antisoma plc announced its intention to extend recruitment to the Phase III SMART study of pemtumomab (formerly known as Theragyn) in the treatment of ovarian cancer. The SMART study is designed to confirm that treatment of certain ovarian cancer patients with Yttrium-90 radiolabeled pemtumomab, in addition to standard care, demonstrates a statistically significant survival benefit over standard care alone. Recruitment has reached the initial target of 300 patients.

• Guilford Pharmaceuticals announced that the FDA has accepted for review its supplemental New Drug Application to expand the labeled indication for polifeprosan 20 with carmustine implant (Gliadel Wafer) to include first-line therapy in patients newly diagnosed with malignant glioma.

• Viragen announced the commencement of pre-clinical studies to evaluate a monoclonal antibody for the treatment of many cancers. The studies are being conducted in collaboration with the National Institutes of Health in Bethesda, MD.

• SuperGen announced that is has completed patient enrollment for its second of three Phase III clinical studies of rubitecan, its oral chemotherapy compound in development for the treatment of pancreatic cancer. This study, which has enrolled more than 400 patients at 200 medical centers across the United States, compares rubitecan to the most appropriate chemotherapy as third-line therapy for patients who previously have failed multiple types of chemotherapy.

• Millennium Pharmaceuticals announced that a Phase II clinical trial has been initiated with LDP-977. The multicenter trial is a randomized, placebo-controlled, double-blind, parallel group, dose-finding study to evaluate the safety and effectiveness of LDP-977 in adult patients with chronic asthma.

• Versicor announced the start of a Phase II clinical study to evaluate anidulafungin (formerly referred to as V-Echinocandin) for the treatment of invasive candidiasis/candidemia. This randomized open-label study will enroll about 20 hospitalized patients in the United States with a documented diagnosis of candidiasis/candidemia. Patients will be examined for clinical and microbiological responses at the conclusion of therapy and two weeks following therapy.

• EntreMed announced a collaborative relationship with Aventis Pharmaceuticals for Phase II clinical studies in patients with hormone-refractory prostate cancer. The objectives of this initial study are to assess safety, dose finding, and tolerability of daily oral angiogenesis inhibitor (Panzam) in combination with weekly docetaxel (Taxotere) in prostate cancer patients and to measure PSA levels and tumor responses following Panzem/Taxotere combination treatment.

• Cellegy Pharmaceuticals announced that it filed a new drug application with the FDA requesting review of existing data on its product, nitroglycerin ointment (Anogesic), for the treatment of pain associated with chronic anal fissures. The company also announced that it has completed patient enrollment in its ongoing second Phase III anal fissure pain study.

• NeoTherapeutics announced that it has expanded its Neotrofin spinal cord injury trial to include Gaylord Hospital in Wallingford, CT. Gaylord Hospital, which is affiliated with Yale University and the University of Connecticut, is the second site participating in the 12-week, open-label study. Additional sites are expected to join the study over the next couple of months.