• Acacia Pharma Ltd., of Cambridge, UK, reported Phase II data showing that APD421 significantly reduced the incidence of nausea and vomiting compared to placebo in adult surgical patients at moderate to high risk of suffering postoperative nausea and vomiting (PONV). Data from the 223-patient trial showed that the drug was highly significantly superior to placebo at preventing PONV, the optimal dose about halving the PONV rate, from 67 percent in the placebo group to 36 percent in the treatment group (p = 0.04). The incidence and severity of nausea also were significantly reduced. APD421 comprises a new use for a marketed dopamine D2/D3 antagonist.

• Advaxis Inc., of Princeton, N.J., completed enrollment in a 110-patient, randomized Phase II trial of ADXS-HPV in women with recurrent/refractory cervical cancer who have failed cytotoxic therapy. The trial, being conducted in India, will assess whether ADXS-HPV can be safely used with and without cisplatin chemotherapy. The primary endpoint is overall survival. Preliminary data from the study will be presented at the upcoming American Society of Clinical Oncology meeting in Chicago.

• Bio-Path Holdings Inc., of Houston, said it completed treatment of the third dosage cohort of three patients in its Phase I trial of BP-100-1.01 (liposomal Grb-2), a systemic treatment for blood cancers, including acute myeloid leukemia, chronic myelogenous leukemia, acute lymphoblastic leukemia and myelodysplastic syndrome. The drug's safety profile continues to be favorable, with no treatment-related serious adverse events reported. Data also continue to suggest some possible antileukemia activity.

• ChemoCentryx Inc., of Mountain View, Calif., presented Phase I data at the European Renal Association – European Dialysis and Transplant Association meeting in Paris establishing a targeted dosing level for the firm's ongoing Phase II study of CCX168, an oral C5aR inhibitor, in anti-neutrophil cytoplasmic antibody-associated renal vasculitis. Phase I data also showed that the compound was well tolerated and caused no serious adverse events.

• Medivir AB, of Stockholm, Sweden, said a Phase I trial has been initiated for MIV-711, a cathepsin K inhibitor to treat bone disorders such as osteoporosis, osteoarthritis and bone metastases. MIV-711 will be administered as single-ascending oral doses to healthy volunteers, followed by daily doses for seven days. Besides exploring the safety, tolerability and pharmacokinetics of the drug, the trial will look at its effect on biomarkers relevant for bone and cartilage degradation. MIV-711 also will be studied in postmenopausal women following once-daily oral dosing for 14 days. Study results are expected in the first quarter of 2013.

• Ocera Therapeutics Inc., of San Diego, reported preliminary data from an open-label Phase II study evaluating the effectiveness and safety of OCR-002 (ornithine phenylacetate) for the treatment of cirrhosis of the liver and upper gastrointestinal bleeding. An interim analysis of the first cohort of patients demonstrated that OCR-002 is well tolerated and provided a rapid, durable ammonia reduction after 36 hours of treatment. The data were presented at the International Symposium for Hepatic Encephalopathy and Nitrogen Metabolism in Grenaa, Denmark. The second phase of the ongoing trial is double-blinded, placebo-controlled and will measure ammonia plasma concentration as the primary endpoint with improvement in hepatic encephalopathy as a secondary endpoint. OCR-002 has orphan and fast-track status in the U.S. and orphan drug status in Europe.

• Oncos Therapeutics Ltd., of Helsinki, Finland, said it started a Phase I study of CGTG-102, an oncolytic adenovirus, in development for solid tumors. The first patients already have completed the safety assessment part of the trial.

• Marshall Edwards Inc., of San Diego, said the first patients were dosed in a Phase I trial of ME-344, the company's lead mitochondrial inhibitor candidate, in patients with refractory solid tumors. The dose-escalation trial is expected to enroll up to 24 patients in up to five cohorts with final safety and pharmacokinetic data expected in the first half of 2013. The Phase I trial is evaluating the safety and tolerability of intravenous ME-344 in escalating dose cohorts while characterizing the compound's pharmacokinetic profile and observing any preliminary clinical antitumor activity.

• RedHill Biopharma Ltd., of Tel Aviv, Israel, and IntelGenx Corp., of Saint Laurent, Quebec, reported data from a pivotal bioequivalence study, which met its specified endpoints showing that RHB-103, an oral thin-film formulation of rizatriptan for acute migraine, met bioequivalence parameters when tested against Maxalt-MLT (rizatriptan, Merck & Co. Inc.), the leading 5-HT1 receptor agonist. RedHill said, after receiving the final data, it will file a new drug application for RHB-103, which is based on IntelGenx's immediate-release VersaFilm technology.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Sanofi SA, of Paris, reported additional Phase II data showing that SAR236553/REGN727 reduced LCL-cholesterol (LDL-C) from baseline across the four dosing regimens tested for 12 weeks, with 28.9 percent to 67.9 percent in the treatment groups showing decreased LDL-C vs. 10.7 percent in the placebo group (p < 0.05). In the most intense dose regimen tested, where the greatest LDL-C reduction was observed, 93.8 percent of patients achieved LDL-C levels lower than 100 mg/dL, compared to 13.3 percent of patients on placebo. SAR236553/REGN727 is a subcutaneously delivered fully human antibody targeting PCSK9. Data were published in The Lancet.

• Soricimed Biopharma Inc., of Toronto, said the FDA and Health Canada have cleared its investigational new drug application to start testing on SOR-C13, a targeted peptide designed to inhibit the nonvoltage gated calcium channel found in epithelial cancers. The planned Phase I study will assess safety and tolerability in patients with advanced cancer tumors, with a weighting on ovarian cancers. The study also will evaluate pharmacokinetics, biomarkers and initial evidence for efficacy.

• Spectrum Pharmaceuticals Inc., of Henderson, Nev., said it started patient enrollment in a Phase I study testing RenaZorb (SPI-014), a lanthanum-based nanotechnology compound with phosphate-binding properties, in healthy volunteers. The trial is designed to evaluate the product's safety and phosphate-binding capacity, with a primary endpoint measuring capacity to bind phosphorous ingested with food by comparing the difference in urine and fecal phosphorous levels measured before and after RenaZorb dosing.

• Tranzyme Pharma Inc., of Research Triangle Park, N.C., and Norgine BV, of Amsterdam, the Netherlands, said top-line results from the primary analysis of ULISES 008, the second of two pivotal Phase III trials evaluating ulimorelin in postoperative ileus, failed to meet the primary and secondary endpoints, with no statistical difference between the ulimorelin and placebo groups. The double-blind, multinational, placebo-controlled study evaluated ulimorelin in accelerating GI recovery in patients who had undergone partial bowel resection. In March, the companies reported the first Phase III, ULISES 007, failed to demonstrate efficacy compared to placebo, driving Tranzyme's shares down 43 percent. The stock (NASDAQ:TZYM) lost 12 centsTuesday, to close at $3.12. Tranzyme said it has halted new drug application activities for ulimorelin to focus on TZP-102 for diabetic gastroparesis. (See BioWorld Today, March 13, 2012.)