Genomic Health Inc., of Redwood City, Calif., has initiated an independent clinical validation study for its 18-gene Oncotype DX colon cancer assay...The study will use prospectively defined endpoints to assess the clinical utility of the Oncotype DX colon cancer assay to predict likelihood of recurrence for stage II colon cancer patients treated with surgery alone and the magnitude of treatment benefit with chemotherapy following surgery...Medicure Inc., of Winnipeg, Manitoba, said it started a
Ortho-McNeil's planned clinical studies also will include the evaluation of patients with Type II diabetes...The results are the subject of several abstracts for the American Society of Clinical Oncology annual meeting in May and the American Association of Cancer Research annual meeting in April...Pluristem plans to initiate the dose-ranging clinical trial during the second quarter 2009 at two sites in Berlin
All of the dose levels were well tolerated, and no serious adverse events were observed in any study cohorts...Data also showed that in most of the patients treated continuously with Cimzia, fistulas stayed closed with a majority of patients achieving clinical remission
The company's lead product, CPI-003, is an autologous adult stem cell product for myocardial infarction and is set to start clinical testing next year...CytRx Corp., of Los Angeles, said its orally available dual Bcr-Abl and Lyn-kinase inhibitor INNO-406 demonstrated clinical responses in patients with chronic myeloid leukemia...New studies will focus on finding the lowest dose of Oxycyte that reduces the platelet reduction (thrombocytopenia) and still provides clinical benefit in traumatic brain
continued to show improvements in the resolution of their signs and symptoms of treatment-failure gout with continuing pegloticase treatment, extending the positive clinical results seen in Phase III...The two clinical efficacy endpoints of most interest, gout flares and gout tophi, showed an increasing proportion of patients with favorable response over time...Incyte Corp., of Wilmington, Del., reported results from a 28-day Phase IIa trial showing that its orally available janus kinase (JAK
By Anette Breindl | Bio Perspectives | Tuesday, October 28, 2008
The company's take on the data was positive: In a press release, Savient described the results as showing that "a substantial subset of patients who completed the Phase III clinical trials and enrolled in the...continued to show improvements in the resolution of their signs and symptoms of treatment-failure gout with continuing pegloticase treatment, extending the positive clinical results seen in Phase III...The two clinical efficacy endpoints of most interest, gout flares and gout tophi, showed an
By Anette Breindl | BioWorld Today | Tuesday, October 28, 2008
Tumor stasis was seen at dose levels of 100 mg/kg/day, and tumor regression was observed at doses of 200 mg/kg/day...The company is testing its Reolysin in combination with carboplatin and paclitaxel in an ongoing clinical trial in advanced cancer patients
Also, SCD patients with abnormal scores of less than or equal to 1.67 at baseline demonstrated greater improvement at all dose levels (2.5, 5, 10 and 20 mg/kg...Those effects were accompanied by significant changes in clinical chemistry parameters indicative of a shift from the catabolic to the anabolic state...TZP-101 already is in clinical trials for the management of postoperative ileus and gastroparesis
The data come from cohorts 1 through 3 and four additional patients from cohort 4 in an ongoing clinical trial evaluating CK-1827452 in stable heart failure patients...In order to pursue clinical development of the product, Kamada will approach the regulatory authorities for guidance...Neurobiological Technologies Inc., of Emeryville, Calif., said that after a meeting with the FDA about the Viprinex (ancrod) clinical program for acute ischemic stroke it will consolidate and analyze data from its two
Evidence gathered from nonclinical and clinical studies indicated the primary action of Aerovant is local to the lung, while the PK data confirmed that the dry-powder inhaler achieved the targeted lung dose...Apogenix GmbH, of Heidelberg, Germany, has started the clinical Phase I trial in healthy volunteers with its lead compound AGP101...The first arm of the Phase Ib/IIa study is designed to assess the safety and efficacy of various dose levels of Imprime PGG in combination with Erbitux and
InterMune Inc., of Brisbane, Calif., said four abstracts from clinical and in vitro studies of ITMN-191 (R7227) accepted for poster presentation at the 59th Annual Meeting of the American Association for the Study of Liver Diseases...Patients in the study are treated once daily with one of three dose levels of VIA-2291, a small-molecule drug that targets inflammation in the blood vessel wall, or placebo
Acacia Pharma Ltd., of Cambridge, UK, initiated its first clinical trial, a Phase I study of its lead product candidate APD 405, being developed for the prevention and treatment of nausea and vomiting after surgery and after treatment with chemotherapy...Helix BioPharma Corp., of Aurora, Ontario, said it received the necessary regulatory approvals to open clinical sites in Germany to expand upon its clinical trial with topical Interferon Alpha-2b in patients with ano-genital warts, which is
Data were presented at the American Society of Clinical Oncology Breast Cancer Symposium in Washington...Data were presented at the American Society of Clinical Oncology Breast Cancer Symposium, in Washington...A single dose of XOMA 052 reduced median HbA1c in four of five drug dose levels compared to placebo
The trial is designed to investigate the drug in combination with two marketed cancer agents, carboplatin and etoposide, in about 30 patients at clinical sites in Australia and overseas...The study is designed to test the safety and pharmacokinetics of a single intravenous dose of GMI-1070 at a range of dose levels
The company received FDA and Health Canada approval for the clinical trial earlier this year...Data from the 23-patient study showed that, at both dose levels given, PTC124 was associated with statistically significant improvements in CFTR-mediated chloride transport with more than half of the patients entering the normal range during at least one treatment course
All dose levels of the drug were well tolerated, and no dose limiting toxicities were observed...The first study likely will start in the UK, under a separate clinical trial application, and will enroll up to 30 healthy volunteers to demonstrate the bioequivalence of safflower-produced insulin to comparator insulin products
Genaera Corp., of Plymouth Meeting, Pa., reported interim Phase I data showing that trodusquemine (MSI-1436), a PTP1B inhibitor, was well tolerated by overweight and obese volunteers with Type II diabetes at anticipated therapeutic dose levels with a very low level of adverse events and no evidence of serious adverse events...The primary endpoint will evaluate clinical and microbiologic response
The trial is designed to enroll about 300 patients diagnosed with bipolar I disorder and acute agitation who will be randomized to receive either one of two dose levels, 5 mg or 10 mg, of AZ-004 or placebo...While none of the 37 patients reached all criteria of the composite primary endpoint (complete cure), 15 of 37 patients (41 percent) demonstrated significant (greater than or equal to 25 percent) clinical improvement
While that permits the clinical program to proceed, Adolor said it still is not certain if its partner GlaxoSmithKline, of London, will continue its involvement...It is the third of several clinical efficacy studies being carried out in preparation for regulatory filing and completes the original core clinical trial program
Among the data emerging at this year's American Society of Clinical Oncology meeting in Chicago were results showing that a combination treatment regimen of Celgene Corp.'s Revlimid (lenalidomide) and Millennium Pharmaceuticals' Velcade (bortezomib), along with dexamethasone, yielded a complete response rate of 35 percent and an overall response rate of 100 percent in newly diagnosed myeloma patients...Six patients showed complete clinical responses, five of which are ongoing at four to 27 months
By Staff Reports | BioWorld Today | Tuesday, June 3, 2008
Genomic Health Inc., of Redwood City, Calif., has initiated an independent clinical validation study for its 18-gene Oncotype DX colon cancer assay...The study will use prospectively defined endpoints to assess the clinical utility of the Oncotype DX colon cancer assay to predict likelihood of recurrence for stage II colon cancer patients treated with surgery alone and the magnitude of treatment benefit with chemotherapy following surgery...Medicure Inc., of Winnipeg, Manitoba, said it started a