Finox Biotech AG, of Burgdorf, Switzerland, said its pivotal Phase III study of Afolia, a biosimilar recombinant follicle-stimulating hormone (r-FSH) in patients undergoing assisted reproduction technology met its primary endpoint, demonstrating clinical and statistical equivalence to reference product Gonal-f...Data also showed NeoCart provided significantly greater improvements in a greater number of patients, compared to microfracture, and it is associated with greater clinical efficacy two

Antisense Pharma GmbH, of Regensburg, Germany presented complete data from its Phase I/II study of trabedersen, an antisense compound that specifically inhibits expression of transforming growth factor beta 2 (TGF-β2) – a protein which is overexpressed in advanced tumors – in patients with advanced pancreatic cancer, malignant melanoma or colorectal cancer...CytRx Corp., of Los Angeles, reported Phase Ib/II data showing that tumor-targeting doxorubicin conjugate INNO-206 produced a clinical benefit

ImmunoCellular Therapeutics Ltd., of Woodland Hills, Calif., will present new data from its previously completed Phase I trial of ICT-107 in glioblastomoa multiforme at the American Society of Clinical Oncology meeting in Chicago...Veloxis Pharmaceuticals A/S, of Horsholm, Denmark, said a subgroup analysis of Study 3001, a Phase III noninferiority study of LCP-Tacro, showed that African-American stable kidney transplant patients may be safely converted from twice-daily Prograf (tacrolimus, Astellas

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...Preliminary data from the study will be presented at the upcoming American Society of Clinical Oncology meeting in Chicago...Tranzyme Pharma Inc., of Research Triangle Park, N.C., and Norgine BV, of Amsterdam, the Netherlands, said top

The data were presented at the American Association of Clinical Endocrinologists 21st annual Scientific and Clinical Congress

1 percent of patients with moderately to severely active ulcerative colitis who received gut-selective monoclonal antibody vedolizumab experienced clinical response vs. 25.5 percent in the placebo group (p < 0.0001...In the four-week and eight-week maintenance dosing arms, among patients who had responded at week six, 44.8 percent and 41.8 percent, respectively, experienced clinical remission at week 52, compared with 15.9 percent for placebo

Janssen Research & Development, of Raritan, N.J., a unit of Johnson & Johnson, reported findings showing that subcutaneous induction regimens of anti-TNF-alpha therapy Simponi (golimumab) induced clinical response in a majority of patients with moderately to severely active ulcerative colitis who had previously failed or were intolerant to conventional agents...More than 50 percent of patients in each of the two Simponi dosing groups achieved clinical response at week six, the primary endpoint of

The Phase II study design is based on the successful completion of a Phase I study of EP-100 in advanced solid tumors that will be presented at the American Society of Clinical Oncology annual meeting...Sigmoid Pharma Ltd., of Dublin, Ireland, said it completed a multicenter, placebo-controlled, randomized Phase II trial of CyCol, its lead candidate, in ulcerative colitis

The study is expected to enroll 100 patients and will assess the safety and efficacy of ALD-401 to improve clinical outcomes in patients with unilateral, cerebral ischemic stroke with an NIH stroke scale score of between 7 and 22, when administered between 13 days and 19 days post-ischemic event...EP-101 is delivered via the eFlow nebulizer device licensed from PARI Pharma GmbH, of Grafelfing, Germany

In both phases of the trial, induction and maintenance, vedolizumab demonstrated statistically significant improvement in the primary endpoint of clinical remission compared to placebo

Bionor Pharma ASA, of Oslo, Norway, Eurocine Vaccines AB, of Solna, Sweden, and Oslo University Hospital reported that a trial of Bionor Pharma's Vacc-4x and Eurocine Vaccines adjuvant Endocine produced vaccine-related immune responses in a nasal immunization study in human patients...Clinical activity observed included favorable bone marrow responses in high-risk patients who were refractory to hypomethylating agents, a reduction in need for red blood cell (RBC) transfusions in transfusion

The study's primary endpoint was time to treatment failure (defined as discontinuation due to insufficient clinical response or an adverse event, including exacerbation of underlying disease

But when a single patient in the trial developed autoimmune vasculitis, the FDA smacked a clinical hold on the program...But even with a superior product profile, Dynavax will no doubt face an uphill marketing battle against its entrenched big pharma competition...The company had previously hoped to sell 5.77 million shares priced between $12 and $14 apiece. (See BioWorld Today, Nov. 29, 2011.)

Syndax Pharmaceuticals Inc., of Waltham, Mass., said Phase II data published in the Journal of Clinical Oncology confirmed preclinical findings and demonstrated an improved overall survival in a subset of non-small-cell lung cancer (NSCLC) patients with tumors expressing elevated levels of E-cadherin treated with the company's HDAC inhibitor entinostat in combination with EGFR inhibitor Tarceva (erlotinib, Astellas Pharma Inc. and Roche AG

Noting that the billion-dollar fines big pharma is paying to settle Department of Justice investigations isn't curbing illegal practices, Sen...An amendment forcing the FDA to consider clinical trial data generated outside the U.S...The bill does include a provision to optimize global clinical trials

In a separate presentation, Novartis reported data from the Phase III FREEDOMS extension trial showing that Gilenya (fingolimod), an oral multiple sclerosis (MS) therapy, had significant improvements in clinical and MRI measures in patients who switched from placebo to Gilenya...The big pharma also presented results from a Phase II dose-finding study of BAF312 (siponimod), a selective modulator of the S1P receptor subtypes 1 and 5, in relapsing-remitting MS

Coronado Biosciences Inc., of Burlington, Mass., said development partner Dr. Falk Pharma GmbH, of Freiburg, Germany, disclosed the independent data monitoring committee's recommendation to continue Falk's Phase II trial in Europe evaluating Trichuris suis ova (TSO) in Crohn's disease following an interim analysis of clinical data, blinded to Falk, of the initial 120 patients

Novartis AG, of Basel, Switzerland, said the FDA has placed a full clinical hold on the development program of DEB025 (alisporivir), a first-in-class cyclophilin inhibitor being tested in hepatitis C, following the death of a patient and a number of reported cases of pancreatitis

Three smashing clinical successes by Gilead Sciences Inc.'s nuc drug GS-7977 for hepatitis C virus (HCV) have lit up the 2012 International Liver Congress of the European Association for the Study of the Liver, sending the company's stock up 12 percent Thursday...Novartis AG put its antiviral DEB025 on clinical hold following reports of pancreatitis