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.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.