In the Pipeline

• Protein Design Labs has initiated a Phase I clinical trial to evaluate the safety and tolerability of its humanized antibody visilizumab (Nuvion) in patients with ulcerative colitis.

• Baxter Healthcare Corp. has begun Phase III clinical trials in the United States and Europe for a new liquid immune globulin therapy, Immune Globulin Intravenous (Human), 10% Solution (IGIV 10%). The U.S. multi-center randomized trial evaluates safety and efficacy in patients with primary immunodeficiency.

• Exhale Therapeutics has received notice that ETX-100, its lead compound, has been granted designation as an orphan drug, for the treatment of patients with alpha-1 antitrypsin (AAT) deficiency, from the Food and Drug Administration (FDA).

• GenVec has begun a randomized, controlled Phase IIb clinical trial for its lead cancer drug, TNFerade, in patients with locally advanced pancreatic cancer.

• EntreMed has begun a Phase II clinical trial with its Angiostatin protein used in combination with paclitaxel and carboplatin for the treatment of patients with advanced non-small cell lung cancer.

• BioStratum announced that the FDA has granted fast track status to its lead drug candidate, Pyridorin (a molecule inhibitor), for diabetic kidney disease.

• Essential Therapeutics has announced that its partner, Johnson & Johnson Pharmaceutical Research & Development, LLC, has initiated Phase I clinical trials with a prodrug version of its lead cephalosporin candidate. This prodrug is converted metabolically into a cephalosporin that has broad-spectrum activity against antibiotic-resistant gram-positive bacteria such as methicillin-resistant staphylococcus, penicillin-resistant streptococcus, and vancomycin-resistant Enterococcus faecalis, as shown in in vitro testing.

• SuperGen has announced that its oral anticancer compound 9NC (Orathecin) has received orphan-drug designation from the FDA for the treatment of pediatric patients infected with human immunodeficiency virus and acquired immunodeficiency syndrome.

• CV Therapeutics has announced completion of patient enrollment in a Phase III trial of tecadenoson, or CVT-510, in patients with paroxysmal supraventricular tachycardia.

• Ilex Oncology has initiated a Phase I clinical trial to evaluate the investigational anticancer agent clofarabine (Clofarex) in adults with advanced solid tumors.

• Cell Therapeutics has started its first Phase II study with polyglutamate paclitaxel (Xyotax) for the treatment of breast cancer.

• Entropin has completed patient enrollment in its Phase II/III clinical study of its topical solution Esterom on patients who have been treated for soft-tissue afflictions resulting in impaired function of the shoulder.

• Avanir Pharmaceuticals has initiated a Phase II clinical trial of Neurodex, an orally administered combination of dextromethorphan and an enzyme inhibitor, for the treatment of pain in patients with diabetic neuropathy.

• Allos Therapeutics has completed patient enrollment in the Phase III clinical trial of efaproxiral (RSR13) in patients receiving whole-brain radiation therapy who have brain metastases.

• BioMedicines has completed enrollment in a Phase 1b clinical trial of its drug Biomed 101 in patients also receiving therapy with interleukin-2 for treatment of metastatic renal cell cancer.

• Stressgen Biotechnologies Corp. has completed enrollment for its Phase II clinical trial of HspE7 for pediatric patients suffering from a human papillomavirus (HPV)-related disease called recurrent respiratory papillomatosis, essentially warts of the upper airways.

• Vion Pharmaceuticals PHARMA has initiated a Phase I trial of VNP40101M, its initial drug candidate from the Sulfonyl Hydrazine Prodrug family of anticancer agents, for treatment of leukemia.