Drug Criteria & Outcomes: In the Pipeline

• Adolor Corp. has announced completion of enrollment in the first Phase III clinical trial (OBD 304) for use of its product candidate, alvimopan, in managing opioid-induced bowel dysfunction.

• AnorMED has initiated a new Phase I clinical trial in cancer patients to determine the safety and potential of AMD-3100 as a new agent for stem cell transplantation. AMD-3100 blocks a specific cellular receptor, triggering the movement of stem cells out of the bone marrow and into circulating blood.

• ID Biomedical has completed enrollment for its ongoing Phase II clinical trial of FluINsure, the company’s intranasally delivered trivalent influenza vaccine.

• Inhibitex has started a Phase I clinical trial of its lead product, Veronate, for the prevention of staph infections in premature infants. Veronate is an antibody-based product that belongs to a class of drugs referred to as immune globulins.

• SuperGen has announced that decitabine has received orphan-drug designation from the FDA for the treatment of sickle cell anemia. SuperGen is developing decitabine for MDS, sickle cell anemia, and refractory chronic myelogenous leukemia as well as exploring its use in solid tumors.

• Apovia AG and its wholly owned subsidiary Apovia have announced the initiation of its first human Phase I clinical trials for its candidate malaria vaccine, MalariVax.

• Keryx Biopharmaceuticals has announced that it has filed a protocol for its Phase III trial to advance sulodexide (KRX-10), a novel treatment for diabetic nephropathy.

• Genmab A/S has announced that the FDA had approved its Investigational New Drug filing for HuMax-CD4 for psoriasis and the initiation of a Phase IIb study. This will be the fifth study carried out by Genmab with HuMax-CD4 for psoriasis or rheumatoid arthritis indications.

• Biomira and Merck KGaA have announced that investigators have enrolled the first patient in a Phase II trial of Theratope vaccine in women with metastatic breast cancer who are being treated with aromatase inhibitors or fulvestrant (Faslodex), an estrogen-receptor antagonist. Theratope vaccine contains a synthetic antigen.

• Esperion Therapeutics has initiated a second Phase I clinical study of its RLT Peptide product candidate ETC-642 in patients with existing vascular disease.

• GenVec has completed patient accrual in the Phase I study of its lead oncology product candidate, TNFerade, in patients with soft tissue sarcoma of the extremities.

• Sucampo Pharmaceuticals has begun a Phase II clinical trial with its proprietary compound RU-8811, a functional fatty acid, for the treatment of patients with non-alcoholic steatohepatitis disease.

• Angiotech Pharmaceuticals has initiated a Phase II clinical study for the use of micellar paclitaxel for Injection (Paxceed) in the treatment of patients with rheumatoid arthritis.

• Marshall Edwards has announced that its lead anti-cancer compound phenoxodiol is entering a Phase II human clinical trial in patients with leukemia.

• Antisoma plc has reached the target for patient recruitment in its Phase III study of pemtumomab for ovarian cancer.

• Antex Biologics has announced that two Phase II trials are scheduled to begin next quarter for its Helivax vaccine against Helicobacter pylori, a bacterial pathogen responsible for peptic ulcers and stomach cancers.