Dose escalation is ongoing, and the primary endpoint is to establish a maximum safe dose...Cytos Biotechnology AG, of Zurich, Switzerland, said results from its combined Phase I/II study of CYT009-GrQb, a therapeutic vaccine for obesity, failed to meet its primary endpoint of weight loss

MedImmune Inc., of Gaithersburg, Md., said preliminary Phase III results showed that Numax met its primary endpoint of non-inferiority by reducing the incidence of hospitalizations caused by respiratory syncytial virus (RSV) in infants at high risk for serious RSV disease by 26 percent compared to Synagis (palivizumab), its marketed drug in this indication (p<0.01...Poniard, which expects to enroll about 400 patients in its Phase III trial to test survival as its primary endpoint, plans to file a

It will enroll 40 patients who have not yet received prior chemotherapy, and its primary endpoint is efficacy based on prostate specific antigen response

The primary endpoint will be survival at six months, while tumor response rate and progression-free survival will be evaluated as secondary endpoints...The primary endpoint is a comparison of overall survival, and secondary endpoints include the percentage of complete remission, remission duration, safety and other assessments...The primary endpoint was improvement in pain and urgency at the end of the study, as monitored by the PORIS (Patient Overall Rating of Improvement of Symptoms) questionnaire

The studies' primary endpoint, patient response rate after a year, is a composite score that includes elements of the SELENA, SLEDAI and BILAG disease activity indices, as well as the Physician's Global Assessment index

The primary endpoint is a reduction of visceral adipose tissue, which is a risk factor for cardiovascular disease and Type II diabetes

Reduction in bone-ALP levels was the primary endpoint of the trial...The drug met its primary endpoint by demonstrating statistically significant improvement over placebo in latency to persistent sleep, a measure of sleep onset

NeurogesX Inc., of San Carlos, Calif., reported that a Phase III trial of Transacin (NGX-4010) met its primary endpoint of reducing pain after a single, one-hour treatment in patients with post-herpetic neuralgia (p=0.001

The study achieved its primary endpoint of superior serum phosphorus control vs

The study's primary endpoints are best overall antitumor response rate and the percentage of patients surviving at least two years

The study met its primary endpoint and was the first psoriasis study to feature a head-to-head comparison between a biologic and a standard systemic treatment...Primary endpoints are a reduction in the intensity of migraine pain without two hours after treatment and an absence of drug-related adverse events

The 144-patient study, conducted in collaboration with partner, Irvine, Calif.-based Spectrum Pharmaceuticals Inc., achieved its primary endpoint of improving clinical symptoms of BPH at week 12, as measured by significant changes in the International Prostate Symptom Score (I-PSS

Survival at six months from randomization will be the primary endpoint...The primary endpoint is based on the proportion of subjects achieving a score of "clear" or "almost clear" in the Static Physician's Global Assessment score at 12 weeks

Vivus Inc., of Mountain View, Calif., said Phase IIb results of Alista (topical alprostadil) failed to achieve statistical significance in its primary endpoint as a treatment of female sexual arousal disorder in women who have undergone a hysterectomy

If the primary endpoint is met, the drug could get a broader label, for treating acute coronary syndromes and secondary prevention...In addition, if treatment with Ranexa in this study is not associated with an adverse trend in death or arrhythmia compared to placebo, that safety database could support approval as a first-line chronic angina therapy, even if the primary endpoint is not met

Boston Life Sciences Inc., of Hopkinton, Mass., said results from the POET-1 (Parkinson's or Essential Tremor) demonstrated that scans with the Altropane molecular imaging agent showed statistically significant superiority over the diagnosis of PCPs on measures of both specificity and sensitivity, the study's primary endpoint

Primary endpoints will assess wake after sleep onset, as well as total sleep time, as determined by polysomnography, and secondary endpoints include additional measures such as latency to persistent sleep and number of awakenings...The drug's effect on survival will be the primary endpoint, and secondary objectives will compare overall survival between study arms, evaluate safety and explore the prognostic value of EGFR-related biomarkers

The study is expected to enroll up to 81 patients by mid-2007, and the primary endpoint for the trial will be hematologic response rate...Duration of postoperative ileus, as measured by time to first bowel movement, will be the primary endpoint

Overall, patients treated with NX-1207 showed a total pooled mean improvement of 9.35 points in the primary endpoint of AUA Symptom Score values, which reached statistical significance when compared to placebo