Patients treated with afatinib lived for almost a year before their tumor started to grow again (progression-free survival [PFS], the primary endpoint) as compared with just under six months for patients treated with gemcitabine/cisplatin...In the study, at Day 28 (primary endpoint, p = 0.26), 24 percent of treated patients achieved resolution compared to 12 percent in the sham injection arm

The primary endpoint of the HCL registration trial, sponsored by the National Cancer Institute (NCI), will be the rate of durable complete response in patients treated with a 40 mcg/kg intravenous infusion delivered over 30 minutes on days one, three and five of each 28-day cycle

The primary endpoint in Phase II will be progression-free survival

ARMOR2, the second study in Tokai's ARMOR (Androgen Receptor Modulation Optimized for Response) program, is testing a new oral formulation of galeterone in CRPC patients, including those with either metastatic or nonmetastatic disease and those whose disease has progressed while on currently approved prostate cancer drugs Zytiga (abiraterone acetate, Johnson & Johnson) or Xtandi (enzalutamide, Medivation Inc. and Astellas Pharma Inc.) Primary endpoints are measuring a reduction in prostate

The trial, which has enrolled 17, treated 12 with FANG plus standard treatment and five with only the standard treatment, which consists of surgery and chemotherapy, with an eye on the primary endpoint of time to recurrence

The trial has a complex primary endpoint, comprising mortality, morbidity, quality-of-life measures, performance on a six-minute walk test, as well as measures of cardiac function

Rifamycin SV already attained the primary endpoint of one Phase III trial, but a second trial has been delayed owing to recent restrictions placed by the Indian government on drug trials in the country, even though the study was to recruit tourists rather than inhabitants of India

Sosei and its partner Novartis reported that the drug met its primary endpoint in a fifth Phase III trial in more than 2,000 subjects, showing statistically significant reduction in moderate to severe exacerbations of COPD compared to patients treated with glycophyrronium 50 mg

The primary endpoint for the

Rifamycin SV already attained the primary endpoint of one Phase III trial, but a second trial has been delayed owing to recent restrictions placed by the Indian government on drug trials in the country, even though the study was to recruit tourists rather than inhabitants of India

The study's primary endpoint is complete response at 26 weeks (+/- 3 weeks) from the start of HD IL-2

The primary endpoint of the single-blind, single-arm patiromer treatment phase (Part A) is change in serum potassium from baseline to week four after treatment with patiromer

Company (Location) Product Description Indication Status Date AUTOIMMUNE Biogen Idec Inc. (Weston, Mass.) DAC HYP A daclizumab high-yield process Multiple sclerosis Phase IIb data showed it reduced the annualized relapsed rate by 54%, meeting the study's primary endpoint 4/5/13 Fibrocell Science Inc. (Exton, Pa.) LaViv Autologous fibroblast injection azficel-T Moderate-to-severe acne scars Phase II study demonstrated that azficel-T treatment was associated with clinically meaningful improvement

primary endpoints 4/17/13 Bayer HealthCare Pharmaceuticals Inc. (Wayne, N.J.) Riociguat Oral compound Chronic thromboembolic pulmonary hypertension FDA accepted for filing its NDA 4/9/13 BD Rx Inc. (Franklin Lakes, N.J.; subsidiary of Becton, Dickinson and Co.) Metoclo-pramide Part of BD Simplist line of prefilled generic injectables Nausea and vomiting FDA has approved it 4/24/13 Cipla Ltd. (Mumbai, India) Biosimilar etanercept Etanercept first gained approval as Enbrel Rheumatic disorders

the primary endpoint was met in arm C with a complete early viral response of 64%, compared to 30% in the control arm 4/30/13 Vertex Pharmaceuticals Inc. (Cambridge, Mass.) ALS-2200 VX-135 Hepatitis C virus genotypes 1, 3 or 4 Data from a viral kinetic study showed a reduction in HCV RNA after seven days of dosing 4/24/13 Notes: Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue

eflornithine/sulindac Colon adenomas Started a Phase III trial 4/19/13 Celsion Corp. (Lawrenceville, N.J.) ThermoDox Heat-activated liposomal encapsulation of doxorubicin Liver cancer Did not meet the Phase III HEAT study's primary endpoint 4/24/13 Celltrion Inc. (Korea) CT-P10 Rituximab biosimilar Advanced follicular lymphoma Halted a two-arm Phase III study, and plans a three-arm Phase III study to facilitate a filing in both the U.S

Amgen Inc., of Thousand Oaks, Calif., said the Phase III head-to-head ASPECCT ('763) trial evaluating its Vectibix (panitumumab) vs. Erbitux (cetuximab, Eli Lilly and Co.) as a single agent for the treatment of chemorefractory metastatic colorectal cancer in patients with wild-type KRAS tumors (n = 1 ,010) met its primary endpoint of noninferiority for overall survival

The goal of the study is to find a significant reduction in the cumulative number of total gadolinium-enhancing lesions as determined by magnetic resonance imaging, while the primary endpoint in the Phase III portion, according to a special protocol assessment with the FDA, will be annualized relapsed rate

The trial has a complex primary endpoint, comprising mortality, morbidity, quality of life measures, performance on a six-minute walk test, as well as measures of cardiac function