Array BioPharma Inc., of Boulder, Colo., reported clinical data at the International Myeloma Workshop in Kyoto, Japan, showing that ARRY-520, a selective KSP inhibitor, demonstrated single-agent activity in heavily pretreated patients with relapsed or refractory multiple myeloma, with 19 months median overall survival and a 16 percent overall response rate...Cerulean Pharma Inc., of Cambridge, Mass., will present Phase II data for investigational nanopharmaceutical product CRLX101 at the American

The study enrolled 87 patients with Stage III or Stage IV lung cancer or colorectal cancer who also are suffering severe weight loss and fatigue...Targeted Medical Pharma Inc., of Los Angeles, said results from an open-label study of oral amino acid-based erythrocyte stimulating system (ESS) for the treatment of chronic anemia showed that hemoglobin increased an average of 11.39 percent from baseline measurement to 45 days

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...Nektar Therapeutics Inc., of San Francisco, said it started a Phase II study of etirinotecan pegol in patients with metastatic and

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

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

Acasti Pharma Inc., of Laval, Quebec, said it achieved significant progress in two ongoing clinical studies with CaPre for lipid management...The registrational Phase II double-blind, placebo-controlled clinical study has completed the first of two interim analyses

Data also indicated rapid onset of activity, with clinical activity reported for 16 of 19 responders occurring within the first two cycles of treatment...OncoSec plans to use the proceeds to fund clinical trials and research and development and for other corporate purposes...The company plans to use the proceeds to fund research and development, clinical trials and for other corporate purposes.

Cellceutix Corp., of Beverly, Mass., said it has recruited the first patients with advanced solid tumors for clinical studies of cancer candidate Kevetrin...GTx Inc., of Memphis, Tenn., said an independent data safety monitoring board recommended that the firm continue development as planned with two pivotal Phase III studies testing enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with non-small-cell lung cancer, following a per-protocol interim safety review

Clinical trials now represent an aggregate expense of approximately $31.3 billion, or nearly 40 percent of the R&D budget of major drug developers – much of that due to systemic inefficiency, according to the report...The PCAST report is timely, given that industry concern about the cost and inefficiency of clinical trials prompted formation of the nonprofit TransCelerate BioPharma Inc., the pharma industry's initiative to accelerate drug commercialization that was officially launched last week

The company anticipates initially focusing on patients with non-small-cell lung cancer who have developed resistance to reversible tyrosine kinase inhibitors such as Tarceva (erlotinib, Roche AG and Astellas Pharma Inc.) and/or Iressa (gefitinib, AstraZeneca plc...The first clinical study, to be conducted in the U.S

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

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

One of those ALK inhibitors is TSR-011, which is in preclinical development with a plan to advance the product into clinical testing as a treatment for non-small-cell lung cancer and potentially other cancer indications...Gemmus Pharma Inc., of San Francisco, closed a Series A round to advance its host-targeted treatment for influenza

Bristol-Myers Squibb Co., of New York, formed a strategic partnership with Emory University in Atlanta to conduct clinical trials involving the pharma's investigational compounds...NovaRx Corp., of San Diego, said it completed enrollment in its Phase III trial testing Lucanix (belagenpumatucel-L), a whole tumor cell vaccine, in post-front-line maintenance in non-small-cell lung cancer

Celgene also reported that it has filed additional regulatory submissions in Japan, Australia and New Zealand for Abraxane in non-small-cell lung cancer (NSCLC...Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, completed enrollment of 1,680 patients in the Phase III PREVAIL study of enzalutamide for advanced prostate cancer

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...Axelar AB, of Stockholm, Sweden, reported Phase I data showing that IGF-1R inhibitor AXL1717 was well tolerated in patients with non-small

Cancer Research UK, of London, said its drug development office opened the first trial testing the combination of Caprelsa (vandetanib, AstraZeneca plc) and selumetinib, a small-molecule MEK inhibitor from Array BioPharma Inc., of Boulder, Colo., in patients with non-small-cell lung cancer...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

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

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...Novelos Therapeutics Inc., of Madison, Wis., said the University of Wisconsin Carbone Cancer Center completed dosing its