Argos Therapeutics Inc., of Durham, N.C., said it validated the durability of the immune response for metastatic renal cell carcinoma patients treated with AGS-003. The company also said it confirmed the correlation between specific immune markers and overall survival in those patients is statistically significant. Data from the studies will be presented during two poster sessions at Keystone Symposia's Understanding Dendritic Cell Biology to Advanced Diseases Therapies Conference this week in

Anacor Pharmaceuticals Inc., of Palo Alto, Calif., reported positive preliminary results from the second of two Phase III trials of tavaborole (known as Study 302). Tavaborole is a topical anti-fungal for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the U.S. Results from the first Phase III trial (known as Study 301) were announced in January. In both studies, tavaborole achieved statistically significant and

Alchemia Ltd., of Brisbane, Australia, said it completed enrollment in a pivotal Phase III trial evaluating HA-Irinotecan for the treatment of metastatic colorectal cancer, with 415 patients recruited, including 71 subjects enrolled in a substudy designed to provide additional pharmacokinetic and cardiotoxicity data. The primary endpoint of the study is progression-free survival, and results are expected in early 2014. CytRx Corp., of Los Angeles, said it completed enrollment of 140 patients

Boehringer Ingelheim GmbH, of Ingelheim, Germany, enrolled the first patient in its Phase III study (POLO-AML-2) investigating volasertib, a selective polo-like kinase inhibitor, in combination with chemotherapy in patients with acute myeloid leukemia (AML) who are ineligible for intensive therapy. The primary endpoint is objective response to the combination treatment compared to the chemotherapy alone, with overall survival as the main secondary endpoint. At the American Society of Hematology

Agenus Inc., of Lexington, Mass., said it completed patient screening for its Phase II study for HerpV, a recombinant, off-the-shelf therapeutic vaccine candidate for the treatment of genital herpes in herpes simplex virus-2-positive patients. HerpV contains Agenus' QS-21 Stimulon adjuvant. The study is testing the biological efficacy of the vaccine as measured by the effect on genital viral shedding after three injections. A booster of HerpV will be given at six months after treatment to

Antisense Pharma GmbH, of Regensburg, Germany, revised its business objectives related to the advancement of its next-generation TGF-beta inhibitor oligonucleotide program. The company is analyzing data from SAPPHIRE (G005), the Phase III study of lead compound trabedersen (AP12009) in glioma that was terminated early, with final results expected in the third quarter. However, preliminary safety data analyses suggested the benefit/risk ratio might not favor the trabedersen treatment arm due to

Adynxx Inc., of San Francisco, said the first patient was dosed in a Phase II study of AYX1 , its lead candidate to prevent post-surgical pain. The 90-patient, placebo-controlled study will evaluate the safety and efficacy of a single administration of AYX1 given prior to unilateral total knee arthroplasty to reduce acute pain and prevent the transition to persistent pain. The study will follow patients for 42 days, with a primary endpoint of pain with walking. Secondary and exploratory

Synthetic Biologics Inc., of Rockville, Md., said its flupirtine sublicensee, Meda AB, of Goteborg, Sweden, received a green light from the FDA to conduct a Phase II proof-of-concept study for the treatment of fibromyalgia, as reported in Meda's 2012 year-end report. Meda has announced that the randomized, double-blind, placebo and active-controlled study of patients with fibromyalgia will be conducted at 25 clinics in the U.S. Flupirtine is described as a first-in-class type of central nervous

Sihuan Pharmaceutical Holdings Group Ltd., of Hong Kong, said pinoxacin hydrochloride received approval for clinical studies from the State Food and Drug Administration. Phase I studies are set to begin in the first half of this year. The compound is in the DPP-4 inhibitor class of oral hypoglycemic agents, a drug with a new structure for treating Type II diabetes.

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said The New England Journal of Medicine published findings from the RE-MEDY and RE-SONATE trials investigating Pradaxa (dabigatran etexilate) in the long-term prevention of deep vein thrombosis or pulmonary embolism. The results demonstrate that Pradaxa 150 mg twice daily is an effective option with a favorable safety profile for the extended prevention of recurrence of venous blood clots (known as venous thromboembolism) after a first event

Aeterna Zentaris Inc., of Quebec City, said the first patient was treated in its Phase II trial of targeted doxorubicin peptide conjugate AEZS-108 in chemotherapy-refractory triple-negative luteinizing hormone-releasing hormone receptor-positive metastatic breast cancer. Up to 74 patients will be involved, and the primary endpoint is median time of progression-free survival. Secondary endpoints include overall response rate and overall survival. Onyx Pharmaceuticals Inc., of South San

Mundipharma International Corp., of Cambridge, UK, said results from the StiL NHL-1 study published in The Lancet showed that a first-line treatment regimen of bendamustine plus Rituxan (rituximab, Biogen Idec Inc. and Roche AG) doubled progression-free survival compared with CHOP plus rituximab in newly diagnosed patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma (69.5 months vs. 31.2 months; p < 0.0001).

Amicus Therapeutics Inc., of Cranbury, N.J., reported additional six-month (Stage 1) results from the first ongoing Phase III global registration study (Study 011) of investigational oral migalastat HCl monotherapy (150 mg, every-other-day) in males and females with Fabry disease who had genetic mutations identified as amenable to migalastat HCl. Stage 1 results were highlighted in an oral platform presentation at the Lysosomal Disease Network WORLD Symposium in Orlando, Fla. Study 011 consists

Ablynx NV, of Ghent, Belgium, reported efficacy and safety data for its anti-IL-6R nanobody, ALX-0061, at the 24-week final analysis of the Phase II part of a Phase I/II study in patients with moderately to severely active rheumatoid arthritis on a stable background of methotrexate. The Phase II data showed ACR20, ACR50 and ACR70 scores of up to 100 percent, 75 percent and 63 percent, respectively, for patients who were consistently dosed at 3mg/kg Q4W over 24 weeks. At all doses tested, ALX

Janssen Research & Development LLC, of Titusville, N.J., a unit of Johnson & Johnson, said updated Phase III results showed Zytiga (abiraterone acetate) plus prednisone continued to provide statistically significant improvements in disease progression compared to placebo plus prednisone, and longer overall survival in men with metastatic castration-resistant prostate cancer. The randomized, multicenter, placebo-controlled study also demonstrated statistically significant improvement compared to

Critical Pharmaceuticals Ltd., of Nottingham, UK, completed a second clinical study of CP024, a growth hormone nasal spray in development for growth disorders in children and adults. The results showed that CP024 was safe and well tolerated with highly reproducible pharmacokinetics. The drug strongly induced production of insulin-like growth factor, a principal mediator of growth hormone activity. Critical Pharmaceuticals said that the trial provided proof of concept for the product

Biogen Idec Inc., of Weston, Mass., and Swedish Orphan Biovitrum, of Stockholm, Sweden, reported data confirming that investigational recombinant factor VIII Fc (rFVIIIFc) fusion protein and factor IX Fc (rFVIXc) fusion protein gave long-lasting protection from bleeding with fewer injections than the standard of care for hemophilia. In A-LONG, patients with hemophilia A maintained low bleeding rates with once-to-twice weekly prophylactic injections of rFVIIIFc. In B-LONG, prophylactic

Pozen Inc., of Chapel Hill, N.C., reported results from two Phase III studies of PA32540 in ischemic stroke showing that compared to EC-ASA (aspirin), treatment with PA32540 significantly reduced the rate of endoscopic gastroduodenal ulcers (2.0 percent vs. 12.4 percent; p = 0.005). The rate of adjudicated major adverse cardiac events was similar in both groups. Adverse GI events commonly lead to discontinuation of aspirin therapy, which can increase the risk of adverse cardiovascular and

Vaximm AG, of Basel, Switzerland, said top-line data from its Phase I/II dose-escalation study of oral cancer vaccine VXM01 met key safety and tolerability endpoints. The study, VXM01-01-DE, enrolled 45 patients with inoperable pancreatic cancer at the Heidelberg (Germany) University Hospital. In addition to standard-of-care treatment, the patients received several doses of the therapeutic vaccine, which targets the tumor vasculature, or placebo. Results indicated the vaccine was safe and well