Dyax Corp., of Cambridge, Mass., said findings from its 77-patient EDEMA2 study of DX-88 (ecallantide) in hereditary angioedema demonstrated clinical response at or before four hours for all dose levels of the drug, with 92 percent response at 5 mg/m2 (I.V.), 85 percent response at 10 mg/m2 (I.V.), 87 percent response at 20 mg/m2 (I.V.) and 92 percent response at 30-mg flat dose subcutaneous...Immunomedics Inc., of Morris Plains, N.J., said its partner, UCB SA, of Brussels, Belgium, received an FDA
Data also showed that oral insulin had no statistical difference in hypoglycemic episodes, serious adverse events or insulin antibodies when compared to placebo...The study is designed to confirm and quantify the clinical observation that patients with pancreatic disease have reduced pancreatic fluid production in response to stimulation by secretin, which might be useful in early diagnosis of chronic pancreatitis
Though efficacy was designated only as a secondary outcome, the trial also yielded statistically significant clinical efficacy and neuro-imaging results, the company said...The study demonstrated that the dose-limiting toxicity of the drug occurs at 315mg/m2 dose in the form of fatigue, and no other serious adverse reactions were observed
It exhibited a favorable safety risk profile as both a monotherapy and in combination with ciprofloxacin, with no serious adverse events indicating that they can be safely administered together...Nitec Pharma AG, of Basel, Switzerland, said it saw positive results in a Phase III clinical trial with Lodotra, a new, modified-release tablet that has been developed to optimize the efficacy of orally administered low-dose prednisone in rheumatoid arthritis
There were no serious adverse events reported with the 120 volunteers...The study's primary endpoint is to demonstrate Oxycyte's ability to increase brain oxygen tension and favorably affect other brain chemistries that impact clinical outcome in head injury patients
Introgen Therapeutics Inc., of Austin, Texas, reported data showing that molecular and clinical biomarker data can predict Advexin therapeutic efficacy, with analyses of predictive biomarkers defining subset populations of head and neck cancer patients that might achieve the most benefit from Advexin...No serious adverse events were reported
Cytomedix Inc., of Rockville, Md., said clinical results showed that 68.4 percent of diabetic foot ulcer wounds treated with the AutoloGel System, and 42.9 percent of those treated with a control, healed...The multicenter, open-label study will be conducted in up to 15 clinical sites and is designed to enroll up to 34 patients with hereditary or sporadic papillary renal cell carcinoma...Talecris Biotherapeutics Inc., of Research Triangle Park, N.C., started clinical trials with an alpha-1 antitrypsin
Cytos Biotechnology AG, of Zurich, Switzerland, said a clinical trial of CYT003-QbG10, a vaccine to treat allergic diseases, showed that previous efficacy observed is conferred by the QbG10 component alone, and that addition of a specific allergen extract may not be required...Sangamo BioSciences Inc., of Richmond, Calif., said Phase Ib data of SB-509, a formulation of a zinc finger DNA-binding protein transcription factor, show clinical tolerability and improvements in pain and neurologic effects
Corautus Genetics Inc., of Atlanta, filed a response to the FDA's clinical hold on the GENASIS trial, which was imposed in April due to potential safety concerns with the delivery of its gene therapy product for angina...The results were statistically significant relative to the placebo control arm (p=0.0275), and no serious adverse events were observed in patients exposed to MLN1202
The treatment was tolerable with no serious adverse events or dose-limiting toxicities reported to date...GeoVax Inc., of Atlanta, has started clinical trials following FDA clearance of an investigational new drug application for an HIV/AIDS vaccine developed by researchers at GeoVax, the Yerkes National Primate Research Center at Emory University and the Emory Vaccine Center, along with colleagues at the National Institutes of Health and the Centers for Disease Control and Prevention
No serious adverse events were reported in the Phase I trial...Curis Inc., of Cambridge, Mass., said preliminary clinical data suggested that a topical Hedgehog antagonist studied in 34 patients with basal-cell carcinoma was generally well tolerated
Medivation Inc., of San Francisco, received a letter from the FDA expressing the need for additional rat toxicology data before human clinical trials can begin with the company's product Dimebon for Huntington's disease...NG2-73 was well tolerated at all doses and had no drug-related serious adverse events or drug-related premature subject withdrawals
market and halted ongoing clinical trials last year based on reports of PML...All subjects completed the 42-day trial, and no serious adverse events were found
CX717 was well tolerated, and there were no serious adverse events or other significant safety concerns, including rises in blood pressure or heart rate, with either dose...The initial clinical protocol was designed to evaluate a single intravesical administration of Chemophase along with the anticancer drug mitomycin in patients with superficial bladder cancer
Findings in a clinical poster showed evidence of satraplatin’s antitumor activity in a heavily pre-treated group of 17 patients that included seven with hormone-refractory prostate cancer...The drug also was well tolerated with no serious adverse events reported related to the drug
Metabasis and Sankyo recently decided to resume full development after they halted a Phase IIb trial in March when two serious adverse events involving lactic acidosis were reported in combination studies with metformin...The financing will help Tessera to prepare the technology for clinical trials and commercialization.
By Karen Pihl-Carey | BioWorld Today | Tuesday, October 4, 2005
In particular, it has been discussing new information on insertional oncogenesis, based on the analysis of available nonclinical and clinical data following two serious adverse events reported in a gene therapy trial in France for the treatment of children affected by X-linked severe combined immunodeficiency
By Peter O'Donnell | BioWorld International | Wednesday, June 4, 2003
Dyax Corp., of Cambridge, Mass., said findings from its 77-patient EDEMA2 study of DX-88 (ecallantide) in hereditary angioedema demonstrated clinical response at or before four hours for all dose levels of the drug, with 92 percent response at 5 mg/m2 (I.V.), 85 percent response at 10 mg/m2 (I.V.), 87 percent response at 20 mg/m2 (I.V.) and 92 percent response at 30-mg flat dose subcutaneous...Immunomedics Inc., of Morris Plains, N.J., said its partner, UCB SA, of Brussels, Belgium, received an FDA