ARMOR2, the second study in Tokai's ARMOR (Androgen Receptor Modulation Optimized for Response) program, is testing a new oral formulation of galeterone in CRPC patients, including those with either metastatic or nonmetastatic disease and those whose disease has progressed while on currently approved prostate cancer drugs Zytiga (abiraterone acetate, Johnson & Johnson) or Xtandi (enzalutamide, Medivation Inc. and Astellas Pharma Inc.) Primary endpoints are measuring a reduction in prostate

Astellas Pharma Inc., of Tokyo, and Drais Pharmaceuticals Inc., of Bridgewater, N.J., will repeat for the third time a spinout maneuver that has been successful with two other programs in the past

Cerulean Pharma Inc., of Cambridge, Mass., will present Phase II data for investigational nanopharmaceutical product CRLX101 at the American Association for Cancer Research Annual Meeting...The cohort evaluated MM-121 in combination with Tarceva (erlotinib, Astellas Pharma Inc.) to treat patients with NSCLC whose disease progressed on an anti-EGFR tyrosine kinase inhibitor (EGFR-TKI

The current standard of care for atopic dermatitis includes corticosteroids and calcineurin inhibitors such as Prograf (tacrolimus, Astellas Pharma Inc...The company is planning to begin clinical studies in the first half of 2014

ASG-5ME is an antibody-drug conjugate targeting the SLC44A4 antigen and is being co-development with Agensys Inc., an affiliate of Tokyo-based Astellas Pharma Inc...Data were presented at the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium in San Francisco

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 it dosed the first patient in a Phase II study of lead candidate CRLX101 in advanced gastric cancer...Data showed that LCP-Tacro dosed once daily was not inferior to leading transplant drug Prograf (tacrolimus, Astellas Pharma Inc.) dosed twice daily

At least a year shy of the next milestone payment from partner Astellas Pharma Inc., Ambit Biosciences Inc...The net proceeds will be used for working capital and general corporate purposes, including the continued conduct of the Abili-T clinical study, Opexa's recently initiated Phase IIb trial of personalized T-cell therapy Tcelna in patients with secondary progressive multiple sclerosis.

The FDA granted Xtandi (enzalutamide, Astellas Pharma Inc. and Medivation Inc.) approval in September for metastatic castration-resistant prostate cancer patients who have previously received docetaxel. (See BioWorld Today, Sept. 4, 2012.) Dendreon said it is looking for a European marketing partner, rather than just a manufacturing partner

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

Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, published Phase III results from the AFFIRM trial of enzalutamide (MDV3100) in metastatic castration-resistant prostate cancer patients previously treated with docetaxel-based chemotherapy in the New England Journal of Medicine

Berg Pharma LLC, of Boston, began a Phase I trial of compound 31543 for chemotherapy-induced alopecia...Onyx Pharmaceuticals Inc., of South San Francisco, Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., and Astellas Pharma Inc., of Tokyo, said a Phase III trial of Tarceva (erlotinib) with Nexavar (sorafenib) failed to improve overall survival for patients with unresectable hepatocellular carcinoma, compared to Nexavar alone

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

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

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

In Phase I/II studies, both candidates demonstrated clinical activity, including durable complete responses and an overall survival (OS) benefit...The cancer stem cell space is increasingly busy, with efforts from biotechs and big pharmas, including Astellas Pharma Inc., Sanofi SA, GlaxoSmithKline plc, Boehringer Ingelheim GmbH, Pfizer Inc., OncoMed Pharmaceuticals Inc., Verastem and others

The Phase I/II study will involve a dose-escalation portion, followed by an expansion cohort testing the drug in NSCLC patients who have failed EGFR-directed therapies such as Tarceva (erlotinib, Astellas Pharma Inc. and Roche AG) and Iressa (gefitinib, AstraZeneca plc) and have developed the T790M mutation...The findings, reported online in Stem Cells, indicated one patient showed improved clinical status, although the study was not designed to show efficacy

Vical's partner, Astellas Pharma Inc., of Tokyo, is preparing to move TransVax into a multinational Phase III trial to control cytomegalovirus reactivation in hematopoietic stem cell transplant recipients, plus a Phase II trial in solid organ transplant recipients. (See BioWorld Today, July 18, 2011, and Jan. 9, 2012

Vical also has completed a Phase I trial of a DNA vaccine for H1N1 pandemic influenza, and its partner, Astellas Pharma Inc., of Tokyo, is preparing to move TransVax into a multinational Phase III trial to control cytomegalovirus reactivation in hematopoietic stem cell transplant recipients, plus a Phase II trial in solid organ transplant recipients...Funds are expected to be used for general corporate purposes, which might include R&D expenses, clinical trial expenditures, manufacture and supply