At the American Society of Hematology meeting in December, the company reported that a Phase II study demonstrated higher rates of objective response and an improvement in event-free survival in AML patients who received volasertib in combination with chemotherapy compared to chemotherapy alone...The volasertib clinical development program is the company's most advanced in cell cycle inhibition

Secondary endpoints include progression-free survival, safety, overall response and immune response...BioAlliance Pharma SA, of Paris, said the FDA approved a U.S

Acceleron Pharma Inc., of Cambridge, Mass., said it started a Phase II study testing dalantercept (ACE-041), an angiogenesis inhibitor designed to target the activin receptor-like kinase pathway, in combination with Inlyta (axitinib, Pfizer Inc.), a vascular endothelial growth factor receptor tyrosine kinase inhibitor, in patients with metastatic renal cell carcinoma...The open-label, single-arm study will enroll about 37 patients after failure of second-line therapy, with a primary endpoint of

Cerulean Pharma Inc., of Cambridge, Mass., said the first patient was dosed in a Phase II study of CRLX101, a nanopharmaceutical designed to inhibit both topoisomerase 1 and hypoxia-inducible factor-1 alpha, in extensive-stage small-cell lung cancer sensitive to first-line platinum-based chemotherapy...The primary objectives of the trial are objective response rate and progression-free survival

Tivozanib – an oral, once-daily, VEGF receptor tyrosine kinase inhibitor, partnered by AVEO with Astellas Pharma Inc., of Tokyo – turned up pleasing results in the Phase III trial that compared progression-free survival rates with Nexavar (sorafenib, Onyx Pharmaceuticals Inc.) in kidney cancer, but overall survival (OS) rates caused some eyebrows to rise...Clinical Cancer Research included a paper that suggested the compound, ENMD-2076, acts potently against breast cancer cell lines that lack

Cerulean Pharma Inc., of Cambridge, Mass., said CRLX101 achieved the predefined gating criterion for advancement into the second stage of a Phase II trial in advanced ovarian cancer...That allows Lorus to initiate a biomarker clinical investigation to further explore the effects of the drug at relevant doses determined in the trial...The complete clinical study report for the interim analysis would be supplied to the FDA during the review within 60 days of the resubmission

Alnylam Pharmaceuticals Inc., of Cambridge, Mass., filed a clinical trial application with the U.K. Medicines and Healthcare Products Regulatory Agency to initiate a Phase I study of ALN-TTRsc, an RNAi therapeutic targeting transthyretin (TTR), in TTR-mediated amyloidosis...ALN-TTRsc is the first GalNAc-siRNA to enter clinical development...Cerulean Pharma Inc., of Cambridge, Mass., said it dosed the first patient in a Phase II study of lead candidate CRLX101 in advanced gastric cancer

We were losing a lot of patients to these clinical trials...Johnson & Johnson reported in June that Zytiga plus prednisone demonstrated a radiographic progression-free survival benefit and overall survival trend in patients who had not yet received chemotherapy, and the pharma submitted a supplemental new drug appliation to the FDA for that indication, receiving priority review...The FDA granted Xtandi (enzalutamide, Astellas Pharma Inc. and Medivation Inc.) approval in September for metastatic

The clinical relevance of neratinib as a 'pan-HER' family inhibitor and it being irreversible is yet to be proven," the paper said...Funds will be used to support the clinical development of cancer drugs aldoxorubicin and tamibarotene and for general corporate purposes, which could include working capital, capital expenditures, R&D and commercial activities.

The primary endpoint in the second stage will be a comparison of progression-free survival, and secondary endpoints will assess response rate and overall survival...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, reported data at the European Association for the Study of Diabetes meeting in Berlin supporting the use of once-daily glucagon-like peptide-1 receptor agonist lixisenatide in combination with basal insulin in Type II diabetes

The study is designed to assess the clinical impact of the absorption profile of BIOD-123 relative to currently marketed mealtime insulin analogues...Glenmark's partner, Paris-based Sanofi SA, has licensed all rights to the drug and is carrying out clinical development...Zealand Pharma A/S, of Copenhagen, Denmark, said it dosed the first patient in a Phase I study of ZP2929, a dual-acting glucagon/GLP-1 peptide agonist, in development for treating patients with Type II diabetes and/or patients with

Agenus Inc., of Lexington, Mass., said clinical data from a Phase I trial of a Prophage Series vaccine (HSPPC-96, vitespen) to treat patients with recurrent glioblastoma multiforme (GBM) were published online by Clinical Cancer Research...Clavis Pharma ASA, of Oslo, Norway, said its partner Clovis Oncology Inc., of Boulder, Colo., initiated a Phase I study of CP-4126 (CO-101) in combination with cisplatin in non-small-cell lung cancer (NSCLC

BHR Pharma LLC, of Phoenix, said it reached its SyNAPSe clinical trial enrollment midpoint of 590 patients...ICT-121 is the second dendritic-cell-based vaccine to enter clinical trials

Cerulean Pharma Inc., of Cambridge, Mass., completed enrollment in a Phase II trial of CRLX101, in non-small-cell lung cancer (NSCLC) and dosed its first patient in a Phase Ib/IIa trial of the same product in combination with Avastin (bevacizumab, Roche AG) in metastatic renal cell carcinoma (mRCC...Secondary endpoints include progression-free survival, tumor response and pharmacokinetics

Isotechnika Pharma Inc., of Edmonton, Alberta, said 3SBio Inc., of Shenyang, China, received approval in China to begin a Phase III trial of voclosporin...The study, dubbed TOURMALINE-MMI, is a randomized trial comparing MLN9708 plus Revlimid (lenalidomide, Celgene Corp.) and dexamethasone to placebo plus lenalidomide and dexamethasone, with progression-free survival as the primary endpoint

e-Therapeutics, of Oxford, UK, said that it has started a first clinical trial evaluating its ETS2101 compound as a treatment for cancer...Noxxon Pharma AG, of Berlin, has treated the first patient in a Phase IIa trial of its anti-CCL2/MCP-1 Spiegelmer NOX-E36 in patients with diabetic nephropathy...The subject was treated at the clinical site and has fully recovered, the company said

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...In an MET-high cohort, there also were statistically significant improvements in TTP, progression-free survival and overall survival

Secondary endpoints include progression-free survival and safety...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

The randomized, double-blind, placebo-controlled trial will evaluate safety and efficacy of single-agent MORAb-004 with supportive care for progression-free survival in patients with chemo-refractory metastatic colorectal cancer...It will enroll up to 160 patients at clinical centers in the U.S