• Adherex Technologies Inc., of Durham, N.C., and the International Childhood Liver Tumour Strategy Group (SIOPEL) initiated enrollment in the UK for a Phase III trial of sodium thiosulfate (STS) to prevent hearing loss in children treated for hepatoblastoma. SIOPEL centers in up to 33 other countries also are expected to participate in the multicenter, prospective, randomized Phase III clinical study of about 100 evaluable children with hepatoblastoma being treated with cisplatin. Patients will be randomized to receive either cisplatin alone, a platinum-based drug associated with frequent hearing loss used to treat hepatoblastoma, or cisplatin plus STS. The study will compare the level of hearing loss, or ototoxicity, associated with cisplatin alone vs. the combination of cisplatin plus STS, as well as the safety, tolerability and anti-tumor activity in both arms of the study. Adherex has received orphan drug status from the FDA for the use of STS to prevent platinum-induced ototoxicity in pediatric patients.

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., started a Phase I study of EZN-2968, an HIF-1 alpha antagonist, in about 30 patients with advanced solid tumors or lymphoma. The trial will evaluate the drug in a daily for five days dosing schedule. HIF-1 (hypoxia-inducible factor-1) alpha is a regulator of genes important in cancer biology, including angiogenesis, cell proliferation, apoptosis and cell invasion. Enzon licensed rights to ENZ-2968 in July 2006 from Santaris Pharma A/S, of Copenhagen, Denmark, in a potential $200 million deal that also included a Survivin antagonist and six other product candidates. (See BioWorld Today, July 28, 2006.)

• Inovio Biomedical Corp., of San Diego, said partner Tripep AB, of Huddinge, Sweden, has begun enrolling patients for its Phase I/II clinical study of a novel DNA vaccine designed to treat chronically infected hepatitis C virus patients. The trial will test Tripep's DNA vaccine, ChronVac-C, administered using Inovio's MedPulser DNA delivery system, in 12 subjects already infected with HCV. The trial is being conducted in Sweden at the Karolinska Institute. The main purpose of the study is to show that the treatment is safe, but also to test if the treatment boosts patients' immune response to hepatitis C.

• Novacea Inc., of South San Francisco, said the firm, along with Schering-Plough Corp., of Kenilworth, N.J., is finalizing the protocol for ASCENT-2, a Phase III clinical trial of Asentar (DN-101) for the treatment of patients with androgen independent prostate cancer or AIPC, with the FDA. The study is comparing the benefits of weekly Asentar plus Taxotere (docetaxel) to the current standard of care in the treatment of AIPC. The Joint Development Committee of Novacea and Schering-Plough in August submitted to the FDA a protocol amendment for the companies' ASCENT-2 Phase III clinical trial of Asentar in AIPC. Pending completion of the formal amendment process, the sample size for the new ASCENT-2 protocol will increase from 900 to 1,200 subjects and the statistical power will increase from 85 percent to 90 percent. The primary efficacy endpoint is overall survival, defined as the time from the date of randomization to the date of death from any cause.

• Sciele Pharma Inc., of Atlanta, and Plethora Solutions Holdings plc, of London, started patient enrollment for the Phase III trials in the U.S. for PSD502 for the treatment of premature ejaculation. In May 2007, Sciele signed an exclusive licensing agreement for PSD502 with Plethora for PSD502, a proprietary formulation of two marketed drugs - lidocaine and prilocaine - dispensed by a metered-dose aerosol.

• Tranzyme Pharma, of Research Triangle Park, N.C., started a Phase IIb trial with the intravenous ghrelin agonist TZP-101 for the management of severe gastroparesis. TZP-101 is a first-in-class prokinetic agent under development for the treatment of selected GI motility disorders. In July 2007, Tranzyme began enrollment in a Phase IIb clinical trial for postoperative ileus. The severe gastroparesis Phase IIb trial, under way in the U.S., Denmark and Sweden, is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to assess efficacy and safety. In July 2007, TZP-101 received fast-track designation from the FDA for the treatment of severe gastroparesis based on Tranzyme's positive Phase IIa clinical data.