As with the previous dose level, no drug-related serious adverse events or dose-limiting toxicities were noted...Over cohorts 1 and 2, at the two lowest dose levels, stabilization of serum monoclonal protein levels has been observed in three of the five evaluable multiple myeloma patients and in three of nine patients overall
The study, which includes cohorts of patients with different types of cancer such as pancreatic, colon, liver and melanoma, will test various dose levels in the Phase I stage, with the Phase II stage designed to test the efficacy of the DCVax-Direct treatment
Helix BioPharma Corp., of Aurora, Ontario, initiated enrollment of the fourth dose level cohort of 0.46 mcg/kg of L-DOS47 in its ongoing Phase I/II open-label safety, tolerability and preliminary efficacy study of L-DOS47, which is being conducted at four sites in Poland
Senesco Technologies Inc., of Bridgewater, N.J., said the Data Review Committee (DRC) for its SNS01-T trial in multiple myeloma and non-Hodgkin's B-cell lymphoma approved initiating cohort 3 and escalating the SNS01-T dose level fourfold to 0.2 mg/Kg
The study tested two dose levels of the RSV F protein nanoparticle vaccine candidate with and without aluminum phosphate as an adjuvant and enrolled 330 women to receive either one or two intramuscular injections of a single-dose of vaccine or placebo, at study day 0 and day 28
The 350-patient study will assess the dose-response of the drug at four dose levels compared to placebo after 24 weeks, using the change in glycosylated hemoglobin as the primary endpoint
The Phase I proof-of-concept trial ARMOR1 , part of the ARMOR (Androgen Receptor Modulation Optimized for Response), enrolled 49 patients and was a dose-finding study to evaluate escalating dose levels of galeterone
The protocol has been expanded to enroll up to 25 additional patients at the 900-mg dose level in the Phase I/II trial evaluating the safety, tolerability and efficacy of ublituximab, the company's third-generation anti-CD20 monoclonal antibody, for patients with rituximab (Rituxan, Biogen Idec Inc. and Roche AG) relapsed or refractory B-cell non-Hodgkin's lymphoma
The study will test the safety and immunogenicity of the vaccine for post-exposure prophylaxis of anthrax infection using two-and three-dose immunization schedules and two dose levels
Lorus Therapeutics Inc., of Toronto, said its Phase I study of LOR-253, a drug designed to target KLF4, successfully escalated to the target dose level based on predicted and observed clinical effects without limitation by toxicity
The 30-patient dose escalation trial evaluated the detailed pharmacokinetics of mibefradil administered four times a day and confirmed its safe dose levels for use in a Phase Ib trial
Results showed evidence of increasing efficacy at increasing dose levels, with the 3-mg dose demonstrating a 19 percent (p = 0.009) overall responder rate
Idera Pharmaceuticals Inc., of Cambridge, Mass., said 48 percent of patients with moderate to severe plaque psoriasis (12 of 15) treated with IMO-3100, a selective antagonist of Toll-like receptors 7 and 9, demonstrated improvements in Psoriasis Area Severity Index (PASI) scores of 35 percent to 90 percent from baseline at the completion of a 44-patient Phase IIa study testing two dose levels of the drug administered for four weeks, with a four-week follow-up period...Treatment at both dose levels
BCI-838 showed a favorable safety profile, with no treatment-related trends in clinical laboratory results, vital sign measurements, 12 lead ECG results or physical examination findings, and the drug was well tolerated up to the dose levels predicted for efficacy...The agency agreed with the company's proposed randomization trial design comparing two dose levels of Cotara in up to 300 patients, with multiple interim analyses that have the potential to stop patient accrual early based on predicted
Oxford BioMedica plc, of Oxford, UK, and partner Sanofi SA, of Paris, disclosed a positive interim review of the ongoing UshStat Phase I/IIa study by the data safety monitoring board (DSMB), with no serious adverse events in the three patients treated at dose level one related to the product
As with the previous dose level, no drug-related serious adverse events or dose-limiting toxicities were noted...Over cohorts 1 and 2, at the two lowest dose levels, stabilization of serum monoclonal protein levels has been observed in three of the five evaluable multiple myeloma patients and in three of nine patients overall