About 120 healthy adult volunteers will be enrolled in the open-label trial, which will evaluate the impact of the vaccine on ciprofloxacin as the primary objective

The open-label study, based on an investigational new drug application filed in 2010, will enroll up to eight patients with thoracic spinal cord injuries (T2-T12), who have an American Spinal Injury (AIS) Association A level of impairment, between one and two years after injury

The open-label trial will enroll about 30 patients for the dose-escalation phase, followed by 30 additional patients in the expansion phase

Achillion Pharmaceuticals Inc., of New Haven, Conn., said it completed enrollment in a pilot Phase IIa trial evaluating ACH-3102, a second-generation pan-genotypic NS5A inhibitor, in combination with ribavirin in patients with chronic genotype 1b hepatitis C virus (HCV) infection. The initial cohort enrolled eight patients to receive 12 weeks of combination treatment. To date, five patients have completed four weeks of treatment, and ACH-3102 has been well tolerated, with no serious adverse

The open-label, randomized trial will be carried out in North America and Europe, and will compare AEZS-108 with dosorubicin as second-line therapy in endometrial cancer

Celator Pharmaceuticals Inc., of Princeton, N.J., treated its first patient in a Phase III, randomized, open-label trial of CPX-351 (cytarabine/daunorubicin) liposome injection compared to conventional cytarabine and daunorubicin for first-line therapy of acute myeloid leukemia

The second Phase II open-label study should be completed by the end of the first quarter of 2013

The open-label study will enroll 50 patients randomized to either oral CEM-102 plus rifampin or current standard of care, which is intravenous antibiotic therapy with vancomycin, nafcillin or cefazolin

After completion of the study protocol, patients will have the option to continue to receive PRX-102 in an open-label extension trial...The open-label biomarker study is designed to provide proof of concept of the use of the angiotensin II Type II receptor antagonist in CIPN

Sarepta Therapeutics Inc., of Cambridge, Mass., said updated data from Study 202, its open-label, Phase IIb extension study of eteplirsen for the treatment of Duchenne's muscular dystrophy, showed that patients treated with eteplirsen for 62 weeks and evaluable on ambulatory measures (modified intent-to-treat population) maintained a statistically significant clinical benefit on the primary clinical outcome measure, the six-minute walk test, compared to patients who received placebo for 24 weeks

The study is a 380-patient Phase III open-label randomized, controlled trial comparing elacytarabine with the investigator's choice of treatment in patients with relapsed or refractory AML...The open-label trial enrolled kidney transplant patients who were stable on twice-daily tacrolimus, but suffering from tremor, and switched them to once-daily LCP-Tacro

UCB SA, of Brussels, Belgium, said a subgroup analysis of pooled data from three long-term open-label extension trials showed a consistent safety profile with epilepsy drug Vimpat (lacosamide), with the most commonly reported treatment-emergent adverse events being dizziness, headache and nasopharyngitis

An open-label pilot phase will be followed by a three-arm, randomized, double-blind, placebo-controlled main phase comparing two different dose regimens of NOX-H94 with placebo

Kythera Biopharmaceuticals Inc., of Los Angeles, said interim results from Study ATX-101-11-26, an open-label, long-term study designed to test ATX-101, a facial injectable for the reduction of submental fat, found the product to be well tolerated, with a consistent safety profile compared to findings from previous Phase II and European Phase III trials

Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said recruitment will begin for NX02-0022, an open-label study of NX-1207, the firm's Phase III-stage drug for benign prostatic hyperplasia...The three-part, open-label trial will include a total of 26 subjects

The single-arm, open-label extension study is designed to test the safety, bioactivity and antitumor effects of the infusion of those T cells, which were genetically altered to express cancer testis antigens NY-ESO-1 and LAGE-1

The open-label study will measure progression-free survival and objective tumor response

Savient Pharmaceuticals Inc., of Bridgewater, N.J., disclosed results from new post-hoc analyses of the Krystexxa (pegloticase) pivotal Phase III and open-label extension trials that reinforced the health-related quality-of-life benefits of Krystexxa treatment in adult patients with refractory chronic gout, including tophus reduction outcomes...ViroPharma Inc., of Exton, Pa., said data from an open-label study testing escalating doses of C1 INH-nf in patients with hereditary angioedema (HAE) who

Inc., of Whitehouse Station, N.J., presented early interim results from a single-arm, open-label Phase Ib study of MK-3475, its investigational immune-modulating therapy, in advanced melanoma