• Alba Therapeutics Corp., of Baltimore, said data from its Phase IIa trial of larazotide acetate for the prevention of celiac disease reactivation by gluten challenge in celiac subjects in remission showed it did not meet its primary endpoint. In the primary study outcome, the prevention of increase in lactulose-mannitol (LAMA) ratio from Day 0 to Day 14, the treatment groups showed a dose-dependent protection from increase in intestinal permeability, however the difference was not statistically significant. In the highest dose active treatment groups of 4 mg and 8 mg, the LAMA ratio did not increase after gluten exposure when compared with placebo post-hoc analysis of change in LAMA ratio from Day 7 to Day 21. Changes in PGWBI scores and anti-tTG titers were not significant over the time course of the study. An unexpected enrollment effect resulted in a fall in intestinal permeability from Day 0 to Day 7 across all groups suggesting the need for a run-in period. Data were presented at the Digestive Disease Week meeting in San Diego.

• Ardea Biosciences Inc., of San Diego, presented positive data on its lead mitogen-activated ERK kinase inhibitor, RDEA119, demonstrating potent activity in mouse models of colitis. Phase I data evaluating the pharmacokinetics, safety and tolerability of RDEA119, as well as its ability to inhibit inflammatory cytokines, showed it has a long half-life and favorable pharmacokinetic properties, allowing for once-daily oral dosing. RDEA119 is in a Phase I study in advanced cancer patients, and the doses being evaluated have achieved systemic exposure consistent with active doses in animal models of human tumors, without drug-related toxicity.

• Cell Genesys Inc., of South San Francisco, reported encouraging interim data from the expansion cohort of the Phase I multicenter trial of CG0070 in patients with recurrent superficial bladder cancer who had failed therapy with Bacillus Calmette-Guerin. Results showed evidence of anti-tumor activity documented by a complete response at follow-up cystoscopy performed at approximately three months following administration of CG0070, which was observed in the two lowest dose cohorts at both dosing schedules. Five of six patients who received CG0070 administered once weekly, three of whom were in the lowest dose cohort, experienced a complete response; and five of 10 patients who received CG0070 once every four weeks, of whom three were in the lowest dose cohort, experienced a complete response. Patients treated at the lowest dose level all had incompletely resected tumor remaining in their bladder at the time of initial dosing. The longest response durations measured for the weekly and every-four-week schedules were continuing at 10.4 months and 7.5 months, respectively. Multidose administration of intravesical CG0070 has a generally tolerable safety profile.

• GlobeImmune Inc., of Louisville, Colo., said it completed enrollment of 120 subjects in a Phase II trial evaluating GI-5005 Tarmogen in combination with pegylated interferon plus ribavirin as a treatment for patients with chronic genotype 1 hepatitis C infection. Endpoints for the trial include improvement in early virologic response, HCV RNA kinetics, alanine aminotransferase levels, the primary biochemical marker of liver damage, end of treatment response, sustained virologic response, serum markers of liver fibrosis-necrosis and liver biopsy. GI-5005 is whole, heat-killed recombinant yeast genetically modified to express HCV-specific protein targets.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., announced positive data on Nebido (testosterone undecanoate), an investigational, long-acting intramuscular injection for the treatment of hypogonadism. The data are based on a Phase III study in which men with hypogonadism and low serum testosterone were treated with Nebido for 24 weeks showed that 94 percent of the men had their testosterone levels restored and maintained to within normal levels, and 92 percent of the men expressed satisfaction with their treatment. Data were presented at the American Urological Association annual meeting Orlando, Fla.

• Ironwood Pharmaceuticals Inc., of Cambridge, Mass. (formerly Microbia Inc.) and Forest Laboratories Inc., of New York, presented data from a Phase IIb study assessing the safety and efficacy of linaclotide in patients with chronic constipation indicating that linaclotide met its primary endpoint. Patients in the intent-to-treat population who received once-daily dosing of linaclotide showed a statistically significant change in weekly spontaneous bowel movement (SBM) frequency of 2.6 (75 mcg, p < 0.05), 3.3 (150 mcg, p < 0.01), 3.6 (300 mcg, p < 0.001), and 4.3 (600 mcg, p < 0.001) compared to 1.5 for patients receiving placebo. Increases in SBM frequency were dose-related. At all doses above 75 mcg, linaclotide-treated patients also experienced statistically significant improvements in complete SBM frequency, stool consistency, straining, bloating, abdominal discomfort and severity of constipation. Linaclotide was well tolerated at all doses.

• Jennerex Inc., of San Francisco and Ottawa, Ontario, and its partner Green Cross Corp., of South Korea, said that results of a Phase I clinical trial showed that half of the patients with cancer treated with JX-594 survived for more than eight months, well beyond their life expectancies of three to four months, and four patients with tumor responses survived for 11 to 18 months or more. The majority of the end-stage patients with solid tumors had objective tumor destruction and responses following treatment with the cancer biotherapeutic, the firm said. Jennerex noted that patients with liver and lung cancers had the most promising outcomes. The trial's results also showed that treatment with JX-594 was well tolerated. The study was published in the Lancet Oncology.

• Laboratorios Almirall SA, of Barcelona, Spain, and Forest Laboratories Inc., of New York, presented data assessing the efficacy and safety of aclidinium bromide for chronic obstructive pulmonary disease (COPD). The companies said the data demonstrated aclidinium (200 mcg and 400 mcg), administered via a multidose dry powder inhaler, significantly increased trough (24-hour) forced expiratory volume in one second (FEV1) on day 29 compared with placebo (p < 0.05 vs. placebo). There was a dose response observed for lung function improvement with once-daily aclidinium. Aclidinium was well tolerated, with no dose-dependent effect on ECG, laboratory parameters or adverse events. Aclidinium 200 mcg administered once every 24 hours was selected as the dose for investigation in the two ongoing Phase III trials, which are expected to report out during the second half of this year.

• Medarex Inc., of Princeton, N.J., announced positive safety data from two Phase I trials that support the Phase II development program of MDX-1100, a fully human monoclonal antibody that targets CXCL10 for the treatment of inflammatory diseases. An open-label pilot study to evaluate safety (primary endpoint) and preliminary efficacy of escalating single doses of MDX-1100 in 11 patients with moderate to severe UC showed that single doses (ranging from 0.3 to 10 mg/kg) were safe and well tolerated. A separate placebo-controlled study conducted to determine safety and pharmacokinetics of escalating single doses (ranging from 0.01 to 10 mg/kg) of MDX-1100 in 50 healthy volunteers showed dose-proportional pharmacokinetics, and a potential pharmacodynamic effect that signaled a decrease in the production of CXCL10 at 10 mg/kg. There were no infusion reactions, and the drug was non-immunogenic.

• NeoPharm Inc., of Lake Bluff, Ill., said it has enrolled its first patient in its Phase I clinical trial for LE-DT, a liposomal delivery system of docetaxel, which is used for the treatment of patients with metastatic solid cancer. The open-label, dose-escalation, Phase I study is designed to determine the maximum tolerated dose of LE-DT in patients with metastatic solid cancer who have failed conventional therapy. Up to five dose levels will be studied at up to three investigational sites, The secondary objectives of the study are to evaluate the pharmokinetics of docetaxel following intravenous administration of LE-DT.

• Osiris Therapeutics Inc., of Columbia, Md., said it treated the first patients in a Phase II trial of Prochymal, a mesenchymal stem cell therapy, in moderate to severe chronic obstructive pulmonary disease (COPD). The 60-patient study will test Prochymal in conjunction with standard of care for improving pulmonary function. Patients will be randomized to either Prochymal or placebo on a 1-to-1 ratio, and pulmonary function tests, exercise capability and quality of life will be measured, while exacerbations and hospitalizations due to COPD will be monitored for both safety and efficacy. Patients will be evaluated over the course of two years following initial Prochymal or placebo infusion.

• PTC Therapeutics Inc., of South Plainfield, N.J., announced data suggesting that the quantification of cough frequency may offer a clinically meaningful outcome measure in cystic fibrosis. Using its VivoMetrics LifeShirt, which integrates cough signals from chest wall motion transducers and a throat microphone and stores the data for computer analysis, PTC discovered that patients with CF cough an average of 643 times per day, compared to an average of 16 times per day for those without CF. Data will be presented at the annual European Cystic Fibrosis Society Conference in June.

• QuatRx Pharmaceuticals Co., of Ann Arbor, Mich., reported further positive data from a pivotal Phase III study of Ophena (ospemifene tablets) in postmenopausal women with symptoms of vulvovaginal atrophy, showing that women treated with Ophena experienced improvements in vaginal dryness and dyspareunia, two of the most frequent symptoms. Data were presented at the World Congress on Menopause in Madrid, Spain. The company previously reported top-line results in January, showing that the drug demonstrated statistical significance in each of the four co-primary endpoints. (See BioWorld Today, Jan. 4, 2008.)

• Romark Laboratories LC, of Tampa, Fla., said it has completed enrollment of its 60-patient Phase II clinical trial, known as STEALTH C-2, evaluating the safety and efficacy of nitazoxanide in combination with peginterferon and ribavirin in U.S. patients with chronic hepatitis C genotype 1 who have previously failed to respond to the standard-of-care therapy. The company said it expects to announce interim data results at a medical meeting this fall.

• Sunesis Pharmaceuticals Inc., of South San Francisco, initiated a Phase II REVEAL-1 (Response Evaluation of Voreloxin in Elderly AML) trial to test voreloxin (SNS-595) in about 55 previously untreated elderly patients with acute myeloid leukemia who are are unlikely to benefit from standard induction therapy. The study's primary objective is to evaluate the drug's anti-leukemic activity as a single agent, measured as either complete remission or complete remission without full platelet recovery. It also will measure the duration of those responses. Voreloxin is a naphthyridine analogue, structurally related to the quinolone class of compounds.

• Telik Inc., of Palo Alto, Calif., started two Phase II studies of Telintra tablets - one in myelodysplastic syndrome and one in cancer patients at risk for chemotherapy-induced neutropenia. The 86-patient MDS study will aim to determine the hematologic improvement rate in erythroid or red blood cell precursors in each treatment group using International Working Group criteria as its primary endpoint. The CIN study will enroll about 135 non-small-cell lung cancer patients who are being treated with standard front-line combination chemotherapy. Ninety patients will receive chemotherapy followed by a starting dose of Telintra in twice-daily doses until white blood cell count recovery, and another group of 45 patients will receive chemotherapy alone. That study's objective is to evaluate the effect of Telintra on accelerating hematologic recovery from chemotherapy.

• Tioga Pharmaceuticals Inc., of San Diego, said results of a Phase IIb study of its oral kappa opioid receptor agonist, asimadoline, demonstrated statistically significant results in the treatment of irritable bowel syndrome. It produced significant improvement in diarrhea-predominant and alternating patients across multiple parameters including the primary endpoint of pain, as well as secondary endpoints of urgency, frequency and bloating in both males and females. In D-IBS patients, therapeutic benefit was observed within the first month of treatment and was sustained for the three month duration of the trial. Asimadoline appeared to be well tolerated with no adverse events occurring. Data were presented at the Digestive Disease Week annual meeting in San Diego.