In the Pipeline
March 1, 2003 4 minutes read
In the Pipeline
• Amylin Pharmaceuticals and Eli Lilly and Co. have announced the completion of enrollment for the remaining two of three Phase III trials of synthetic exendin-4 (AC2993). One study is evaluating the ability of synthetic exendin-4 to improve glucose control in people with Type 2 diabetes not currently achieving target blood glucose levels with sulfonylureas alone. The other is evaluating the ability of synthetic exendin-4 to improve glucose control in people with Type 2 diabetes not currently achieving target blood glucose levels with the combination of metformin and sulfonylureas.
• Inhibitex has initiated a Phase II clinical study of Veronate, a human polyclonal immunoglobulin containing elevated levels of antibodies to both Staphylococcus aureus and coagulase-negative staphylococci MSCRAMM proteins. Veronate is being developed for the prevention of staphylococcal infections in hospitalized premature infants.
• Genelabs Technologies has initiated its confirmatory Phase III clinical trial for prasterone (Prestara), the company’s investigational drug for systemic lupus erythematosus.
• Epimmune has received clearance from the Food and Drug Administration (FDA) to begin Phase I/II clinical trials of its EP-2101 therapeutic, multi-epitope vaccine in lung and colorectal cancer patients. Two separate Phase I/II trials will be initiated, one trial for each cancer indication, and will involve an aggregate of approximately 25 patients who have had surgery to remove the majority of the cancer cells.
• Novacea has announced that patient enrollment has begun in a Phase II trial of its lead product, calcitriol (DN-101), for the potential treatment of patients with the blood disorder myelodysplastic syndromes (MDS).
• Millennium Pharmaceuticals has initiated a Phase II clinical trial of bortezomib (Velcade) for Injection in patients with stage IIIb (locally advanced) or stage IV (metastatic) non-small cell lung cancer.
• RxKinetix has begun patient enrollment in a Phase II clinical trial of its proprietary compound, RK-0202, for oral mucositis.
• InterMune has initiated a Phase I clinical study to evaluate PEG-Alfacon, the PEGylated version of Interferon alfacon-1 (Infergen), as a potential new treatment for chronic hepatitis C virus.
• Corgentech has announced that the FDA has granted fast-track designation for the company’s second product, CGT021. The product will soon enter a Phase I/II clinical trial for the prevention of arterio-venous graft failure in end-stage renal disease patients requiring hemodialysis.
• Vion Pharmaceuticals has initiated a new multi-center Phase II trial of its ribonucleotide reductase inhibitor Triapine as a single agent in patients with advanced hormone-refractory prostate cancer.
• Antex Biologics has announced that two Phase II clinical trials for the company’s Helivax vaccine are scheduled for the first half of 2003. Helivax is an inactivated multivalent whole cell vaccine designed to prevent and treat infections caused by Helicobacter pylori.
• Alexion Pharmaceuticals has completed enrollment in its Phase IIb trial of eculizumab, a humanized monoclonal antibody C5 complement inhibitor, in rheumatoid arthritis patients.
• Attenuon LLC has announced a Phase I trial of ATN-161, which is derived from a small fragment of a human protein. The trial is expected to enroll up to 36 patients with advanced solid tumors that have not responded to treatments with traditional therapies.
• Vion Pharmaceuticals has initiated a multi-center Phase I trial of VNP40101M in patients with solid tumors. VNP40101M is a DNA-damaging alkylating agent that has broad antitumor activity in animal models.
• Micrologix Biotech, in collaboration with Fujisawa Healthcare, has completed patient enrollment in the Phase III clinical trial of MBI 226, a topical, antimicrobial peptide under development for the prevention of central venous catheter-related bloodstream infections.
• Aesgen has announced that the FDA granted fast-track designation to the company’s investigational new drug, Aesgen-14 (AES-14), for oral mucositis associated with cancer chemotherapy.
• Celgene Corp. has announced that CC-5013 (Revimid) received fast-track designation from the FDA for the treatment of relapsed or refractory multiple myeloma.
• Immtech International has completed enrollment for its Phase IIa pilot human clinical trial of the oral drug candidate DB 289 for the treatment of Pneumocystis carinii pneumonia.
The following drugs are in various stages of clinical studies and trials.
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