Acacia Pharma Ltd., of Cambridge, UK, reported results from its Phase IIa study of APD403 for the prevention of acute nausea and vomiting in cancer patients receiving cisplatin, with initial exploratory cohorts showing that single-agent APD403 had encouraging benefit, especially in controlling nausea. When the drug was combined with a standard dose of 5-HT3 antagonist ondansetron, a complete response in 19 of 23 patients (83 percent) was achieved, higher than the 50 percent response rate that

Dendreon Corp., of Seattle, started enrolling patients in an open-label European study with Provenge (sipuleucel-T). The study is being conducted in European men with metastatic castrate-resistant prostate cancer to describe product-release parameters and report on safety in a European population. The study may enroll up to 45 patients in four sites across the EU. Provenge was approved in the U.S. in 2010. (See BioWorld Today, April 30, 2010.) MicroDose Therapeutx Inc., of Monmouth Junction

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, reported new patient-reported health-related outcomes for its investigational oncology compound afatinib, including lung cancer-related symptoms and quality of life. The data are secondary endpoints of LUX-Lung 3, a Phase III trial of afatinib (n = 230) compared to chemotherapy (pemetrexed/cisplatin) (n = 115) in patients with epidermal growth factor receptor mutation-positive advanced non-small

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it completed enrollment in two Phase III trials testing nintedanib (BIBF 1120) in patients with idiopathic pulmonary fibrosis. The identical studies will enroll a total of 970 patients to receive treatment or placebo over a 52-week period. The primary endpoint is the annual rate of decline in forced vital capacity, while secondary endpoints include health-related quality of life, exacerbations, respiratory mortality, overall survival and on

Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., said it was advised by the Department of Veterans Affairs Cooperative Studies Program (VACSP) that the availability of top-line results from its CPP-109 (vigabatrin) Phase IIb trial for cocaine addiction will be delayed, with top-line results now expected during the first half of November. Previously VACSP said top-line data would be provided around the end of September. The 207-patient study is designed to demonstrate that the rate

Clarus Therapeutics Inc., of Northbrook, Ill., said top-line data from the 90-day treatment phase of its ongoing Phase III study of CLR-610, an oral testosterone replacement product, demonstrated that 87 percent of the 141 men treated with CLR-610 achieved average serum T levels in the normal range (between 300 ng/dL and 1,000 ng/dL), the study's primary endpoint. The average serum T level in the CLR-610 group was 624 ng/dL. That compared to 80 percent of the 146 men in the T-gel comparison arm

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said recruitment was completed for two randomized Phase III trials assessing the efficacy and safety of nintedanib (formerly BIBF 1120) 150 mg twice daily in idiopathic pulmonary fibrosis (IPF). Approximately 1,000 patients are enrolled in the pivotal INPULSIS Phase III trials at sites in 23 countries, with a primary endpoint of the annual rate of decline in forced vital capacity over 52 weeks. Secondary endpoints include change from baseline in

Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., said researchers at Mount Sinai School of Medicine in New York initiated a an open-label safety and tolerability study of CPP-109 (vigabatrin) in young adults with treatment refractory Tourette's disorder (TD). The proof-of-concept study will explore whether CPP-109 may reduce severity of tics and will obtain systematic data regarding dosing, safety and tolerability of CPP-109 in young adults with treatment refractory TD. Recruitment

Amgen Inc., of Thousand Oaks, Calif., said treatment with RANK ligand inhibitor denosumab decreased the number of tumor giant cells in patients with giant-cell tumor of the bone, and increased new bone formation, according to results of a Phase II study published in Clinical Cancer Research. Data from the 20-patient study showed that all patients had a decrease in giant cells of 90 percent or greater, an indication of a reduction of tumor burden. About 65 percent of patients also had new bone

Advanced Accelerator Applications SA, of Saint Genis Pouilly, France, said it started a Phase III trial testing the effect of theranostic drug Lutathera in patients with inoperable progressive midgut carcinoid. The NETTER-1 study will compare Lutathera to Sandostatin LAR (octreotide, Novartis AG) in patients and will measure progression-free survival as the primary endpoint. Secondary endpoints include safety, objective response rate, time to tumor progression, overall survival and quality of

Aprea AB, of Stockholm, Sweden, reported positive data from a Phase I/II study with investigational drug APR-246. In the trial, escalating doses of APR-246 were administered as a monotherapy to 22 patients with advanced blood or prostate cancer for up to four consecutive days. Dose-limiting toxicity was shown at plasma levels well above predicted therapeutic plasma levels. The study also demonstrated dose-proportional and time-independent pharmacokinetics for APR-246 over the dose range studied

Addex Therapeutics SA, of Geneva, said Janssen Pharmaceuticals Inc. unit Janssen Research & Development LLC, part of Johnson & Johnson, of New Brunswick, N.J., dosed the first patient in a multicenter, double-blind, Phase II study of ADX71149 in adults with major depressive disorder who also show anxiety symptoms. The positive allosteric modulator of metabotropic glutamate receptor 2, a Family C class of G protein coupled receptors, is being developed jointly by Addex and Janssen

Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported findings at the Asia Pacific Stroke Conference in Tokyo, confirming that, in Asian populations, Pradaxa (dabigatran etexilate) offered considerable benefits for the management of patients with atrial fibrillation. Subanalysis from the RE-LY trial demonstrated consistently superior efficacy of Pradaxa compared to warfarin for that particular patient group. Pradaxa also showed larger risk reductions in the rate of hemorrhagic stroke and

Sanofi Pasteur, of Lyon, France, the vaccines division of Sanofi SA, said clinical results published in The Lancet showed the ability of its vaccine candidate to protect against dengue fever caused by three dengue virus types. The full analysis showed vaccine efficacy to be 61.2 percent against dengue virus Type I, 81.9 percent against Type III and 90 percent against Type IV. One of the dengue virus types (serotype 2) eluded the vaccine. The study enrolled 4,002 children, ages 4 to 11, and

GE Healthcare, of Chalfont St Giles, UK, reported at the 16th Congress of the European Federation of Neurological Societies in Stockholm, Sweden, pooled results from a Phase III brain autopsy and biopsy studies on the investigational PET amyloid imaging agent, [(18)F]flutemetamol, which showed a strong concordance between the imaging agent images and Alzheimer's disease-associated beta-amyloid brain pathology. The imaging agent is being developed for the detection of beta amyloid deposits in

Astex Pharmaceuticals Inc., of Dublin, Calif., said it started a Phase I/II trial of Hsp90 inhibitor AT13387 in castration-resistant prostate cancer (CRPC) patients who are no longer responding to standard-of-care therapies Zytiga (abiraterone acetate, Johnson & Johnson) and steroids. The Phase I portion will enroll up to 52 patients who will continue to receive the same doses of abiraterone acetate and steroids received prior to entering the study and will be randomized to receive one of two

Actinium Pharmaceuticals Inc., of New York, said it is moving forward with enrollment and treatment of additional patients in a trial for acute myeloid leukemia (AML) in subjects older than 60. The firm will proceed with patient screening and enrollment for the second cohort, which will be injected with two times higher activity of its Actimab-A, which combines Actinium's PIT technology and consists of CD33-targeting monoclonal antibody Lintuzumab used to guide alpha-emitting radioisotope

Eli Lilly and Co., of Indianapolis, said the Phase III POINTBREAK trial did not meet its primary endpoint of improved overall survival for patients with nonsquamous non-small-cell lung cancer who were randomized to receive a combination of Alimta (pemetrexed) with Avastin (bevacizumab, Roche AG) and carboplatin induction followed by Alimta plus Avastin maintenance, compared to the combination of paclitaxel with Avastin and carboplatin followed by Avastin maintenance. The study did meet one of

Amicus Therapeutics Inc., of Cranbury, N.J., reported updated details at the Society for the Study of Inborn Errors of Metabolism Annual Symposium in Birmingham, UK, on patients screened for one of its global Phase III registration studies (Study 011) investigating the chaperone migalastat HCl in Fabry disease. Approximately 86 percent (n = 154) of the 180 Fabry patients screened for Study 011 had missense mutations, compared to a current estimate in the Fabry population of approximately 60