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
Advanced Cell Technology Inc. (ACT), of Marlborough, Mass., said its clinical partner, the University of California, Los Angeles (UCLA), received FDA approval for its investigational new drug application. Steven Schwartz, professor of ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute, plans to lead a Phase I/II study using ACT's retinal pigment epithelial (RPE) cells, derived from human embryonic stem cells (hESC), to
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
Eli Lilly and Co., of Indianapolis, halted its Phase III rheumatoid arthritis (RA) program for tabalumab, an anti-B cell activating factor monoclonal antibody, for lack of efficacy. The company said the tabalumab Phase III ILLUMINATE program in systemic lupus erythematosus is continuing. In December 2012, Lilly discontinued the Phase III RA registration study FLEX-M for lack of efficacy. FLEX-M was investigating tabalumab in patients with moderate to severe RA who had an inadequate response to
Genelux Corp., of San Diego, said researchers at Memorial Sloan Kettering Cancer Center in New York treated the first patient in a Phase I trial of GL-ONC1 in malignant pleural effusion, a complication that occurs in about 30 percent of lung cancers. The safety and dose-escalation trial will test GL-ONC1 as administered intrapleurally as a single-agent therapy. The primary goal will be to establish a recommended dose, while secondary objectives include the feasibility, safety and tolerability
Teva Pharmaceutical Industries Ltd., of Jerusalem, said it enrolled the first patient in the Phase IV MODERATO study to test Azilect (rasagiline tablets) on cognitive function in adults with mild cognitive impairment in Parkinson's disease. The study will measure cognitive function using the Scales for Outcomes of Parkinson's Disease-Cognition after 24 weeks of treatment and will enroll about 170 patients.
Amarantus BioScience Inc., of Sunnyvale, Calif., said additional analysis of preclinical data reported last month on its mesencephalic astrocyte-derived neurotrophic factor (MANF) in Parkinson's disease showed statistical significance in increasing dopaminergic nerve terminal reinnervation and increasing dopamine concentrations in the striatum. The company retained a Swiss neuroscience-focused consulting firm to conduct a full audit of data from the preclinical experiments and to assist
Tekmira Pharmaceuticals Corp., of Vancouver, British Columbia, said that complete results from a Phase I trial of its RNAi therapeutic, ALN-VSP have been published. The company said that the results validate longer-term safety and tolerability of its LNP delivery platform. Alnylam Inc., of Cambridge, Mass., licensed the LNP technology from Tekmira, and is developing several products under that license. Tekmira is due a $5 million payment related to initiation of clinical trials for ALN-VSP in
ArQule Inc., of Woburn, Mass., and Daiichi Sankyo Co. Ltd., of Tokyo, enrolled their first patient in a pivotal Phase III trial (METIV-HCC) of tivantinib (ARQ197) in hepatocellular carcinoma (HCC). The randomized, double-blind, placebo-controlled trial will enroll about 300 previously treated patients with MET-high inoperable HCC to receive tivantinib or placebo, with a primary endpoint of overall survival and a secondary endpoint of progression-free survival. (See BioWorld Today, Oct. 3, 2012
Seattle Genetics Inc., of Bothell, Wash., said interim results from a Phase I trial of ASG-5ME in metastatic pancreatic ductal adenocarcinoma identified the maximum-tolerated dose for weekly administration, demonstrated tolerability and provided preliminary evidence for antitumor activity. The best response for 18 patients treated at 1.2 mg/kg weekly included one patient (6 percent) who achieved a partial response, six patients (33 percent) with stable disease and four (22 percent) with
Teva Pharmaceutical Industries Ltd., of Jerusalem, said top-line results of its Phase III program testing narcolepsy drug Nuvigil (armodafinil) as adjunct therapy in adults with major depression associated with bipolar I disorder showed that the drug produced a numerical improvement but did not reach statistical significance in meeting its primary endpoint – determining whether armodafinil treatment, at a dosage of 150 mg per day, is more effective than placebo as adjunct therapy to mood
CSL Behring, of King of Prussia, Pa., said it enrolled the first patient in the pivotal pediatric Phase III trial to test efficacy and pharmacokinetics of recombinant fusion protein linking coagulation Factor IX with recombinant albumin in previously treated children (up to age 11).
Actinium Pharmaceuticals Inc., of New York, said Johns Hopkins University School of Medicine in Baltimore joined an ongoing Phase I/II trial of Actimab-A in about 50 elderly patients newly diagnosed with acute myeloid leukemia. The goal of the trial is to establish the drug's safety and efficacy. Actinium is planning to complete the study by the end of 2013. Amgen Inc., of Thousand Oaks, Calif., reported top-line Phase III results for Aranesp (darbepoetin alfa) showing that the trial did not
Neuralstem Inc., of Rockville, Md., said it has received FDA approval to start a Phase I trial of lead cell therapy candidate NSI-566 in chronic spinal cord injury patients. The open-label study, based on an investigational new drug application filed in 2010, will enroll up to eight patients with thoracic spinal cord injuries (T2-T12), who have an American Spinal Injury (AIS) Association A level of impairment, between one and two years after injury. The primary objective is to determine the
Novartis AG, of Basel, Switzerland, said data published in The Lancet showed that patients on mTOR inhibitor Afinitor (everolimus) tablets with noncancerous kidney tumors known as renal angiomyolipomas associated with tuberous sclerosis complex experienced a significant reduction in tumor size and the absence of tumor progression. In the study, 42 percent of patients on everolimus experienced an angiomyolipoma response vs. 0 percent on placebo.
BioTime Inc., of Alameda, Calif., said it submitted a clinical investigation protocol to European regulatory authorities for approval to initiate studies for its Renevia stem cell delivery platform. Renevia, a member of the firm's HyStem family of hydrogels, is a formulation designed to mimic human extracellular matrix. Studies are expected to start in the second quarter. GeoVax Labs Inc., of Atlanta, said it completed enrollment in a nine-patient Phase I/II trial testing its DNA/MVA vaccine
TapImmune Inc., of Seattle, said an interim safety analysis of the first five breast cancer patients treated with HER2/neu Class II antigens did not show any serious adverse events, so treatment of the remaining 17 patients in the Phase I study at the Mayo Clinic will progress
Advanced Cell Technology Inc., of Marlborough, Mass., reported evidence of engraftment of transplanted human embryonic stem cell-derived retinal pigment epithelial cells and visual acuity gain in a Phase I/II trial in Stargardt's macular dystrophy (SMD) and dry age-related macular degeneration (AMD). Patients were treated over 18 months, and no safety issues were raised. The company also observed persisting engraftment in more recent SMD and AMD patients, as well. Intercept Pharmaceuticals Inc
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