Isis has 28 candidates in preclinical and clinical development across a wide variety of indications, with nine scheduled to report data in the next 12 months...Dendreon also is continuing to evaluate partnering strategies for European expansion and to enroll patients in an open-label sipuleucel-T

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 open-label study will test the safety and efficacy of intra-articular injections of the autologous treatment in order to reduce inflammation and regenerate damaged joint tissue...Erytech Pharma SA, of Lyon, France, said it received clearance of its investigational new drug application for a Phase I trial of Eryasp (L-asparagainase-loaded erythrocytes) in patients 40 years and older with newly diagnosed acute lymphoblastic leukemia

Acasti Pharma Inc., of Laval, Quebec, a subsidiary of Neptune Technologies & Bioressources Inc., reported preliminary data from a randomized, open-label, dose-ranging, multicenter trial assessing the safety and efficacy of NKPL66, or CaPre, in mild-to-high hypertriglyceridemia

Secondary objectives of the trial include clinical activity by serum TTR levels...For the Uceris 9-mg group, 17.4 percent of patients achieved clinical and endoscopic remission, compared to 4.5 percent of the placebo group (p = 0.0047...Virobay Inc., of Menlo Park, Calif., and Leo Pharma A/S, of Ballerup, Denmark, achieved a milestone in their collaboration on development of an oral therapy for psoriasis upon initiation of a Phase I trial of VBY-891 by Virobay

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

Oculus Innovative Sciences pulled off positive results in an open-label pilot study of Atrapro Antipruritic Hydrogel in combination with Neosalus Cream, demonstrating statistically significant 50 percent reduction in body surface area of atopic dermatitis from baseline to week four...The company is planning to begin clinical studies in the first half of 2014

The open-label study followed 21 patients with unfavorable risk mRCC, with an expected survival of approximately 15 months...The company is currently enrolling patients in an ADAPT Phase III study for AGS-003 – a randomized, multicenter, open-label clinical trial that is expected to enroll 450 patients in approximately 120 global sites, mostly in North America...The open-label, dose-escalation trial was conducted in 52 men with hormone-refractory prostate cancer that had progressed despite prior

Two posters feature clinical data of PROSTVAC evaluated as monotherapy or in combination with a radiopharmaceutical...BHR Pharma LLC, of Herndon, Va., said the European Medicines Agency (EMA) granted an orphan medicinal product designation for treating moderate and severe traumatic brain injury (TBI) to its intravenous progesterone infusion agent, BHR-100...A randomized Phase II, open-label study of Provenge with concurrent or sequential abiraterone acetate (AA) plus prednisone (P) in metastatic

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

The study is an open-label trial of monthly Opaxio or Taxol for up to 12 consecutive months compared to surveillance in women with advanced ovarian cancer with no evidence of disease following platinum-taxane therapy...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

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

Acasti Pharma Inc., of Laval, Quebec, said it achieved significant progress in two ongoing clinical studies with CaPre for lipid management...The second Phase II open-label study should be completed by the end of the first quarter of 2013

Clavis Pharma ASA, of Oslo, Norway, said it reached the enrollment target for its Phase III CLAVELA study investigating elacytarabine in patients with relapsed or refractory acute myeloid leukemia (AML...The open-label trial enrolled kidney transplant patients who were stable on twice-daily tacrolimus, but suffering from tremor, and switched them to once-daily LCP-Tacro

Noxxon Pharma AG, of Berlin, said it treated the first patients in a Phase IIa trial of its anti-hepcidin Spiegelmer NOX-H94 to treat anemia associated with chronic disease...An open-label pilot phase will be followed by a three-arm, randomized, double-blind, placebo-controlled main phase comparing two different dose regimens of NOX-H94 with placebo

Tiltan Pharma Ltd., of Jerusalem, said it enrolled the first U.S...ViroPharma Inc., of Exton, Pa., said data from an open-label study testing escalating doses of C1 INH-nf in patients with hereditary angioedema (HAE) who are not adequately controlled with 1,000 U every three or four days provide evidence of the safety profile of Cinryze (C1 esterase inhibitor [human]) at doses of up to 2,500 units in HAE patients

Inc., of Whitehouse Station, N.J., presented early interim results from a single-arm, open-label Phase Ib study of MK-3475, its investigational immune-modulating therapy, in advanced melanoma...The data were presented during a late-breaking clinical trials session at the 9th International Congress of the Society for Melanoma Research in Hollywood, Calif

The paper cites data from an open-label, Phase II trial of single-agent neratinib in advanced HER2-positive breast cancer, which enrolled both trastuzumab-refractory (n=66) and trastuzumab-naive (n=70) patients, and demonstrated modest clinical activity in both cohorts...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

Alexion Pharmaceuticals Inc., of Cheshire, Conn., said researchers presented data from an open-label Phase II study in 14 patients with severe, relapsing neuromyelitis optica (NMO), showing that Soliris (eculizumab) met its primary endpoint with high degrees of clinical and statistical significance...AlphaCore Pharma Inc., of Ann Arbor, Mich., said its Phase I trial met the primary endpoint by demonstrating the safety and tolerability of ACP-501 (recombinant human LCAT...The positive clinical effects