All doses showed statistically significant separation from placebo starting at week two and at each subsequent time point, with the highest dose showing separation as early as week one of treatment
In the highest dose group, that increase continued throughout the three-month follow-up period, and no ITP rescue treatment was necessary in those patients
PG-free Melphalan, administered as half of a high-dose conditioning regimen, resulted in successful myeloablation (100 percent of patients) and subsequent engraftment (100 percent of patients) with no additional toxicity
Spectrum Pharmaceuticals Inc., of Henderson, Nev., said a randomized study, published online in Cancer, concluded that standard-dose Zevalin (ibritumomab tiuxetan) injection combined with beam high-dose chemotherapy is safe and possibly more effective than beam alone as a conditioning regimen for autologous stem-cell transplantation (ASCT
Thallion Pharmaceuticals Inc., of Montreal, and LFB Biotechnologies, of Les Ulis, France, have completed patient enrollment for the high-dose cohort (3 mg/kg) of a Phase II SHIGATEC trial, evaluating Shigamabs to treat Shiga toxin-producing E
AVI BioPharma Inc., of Bothell, Wash., said an independent data safety monitoring board determined that the Phase IIb study of eteplirsen in Duchenne's muscular dystrophy (DMD) was safe to proceed as planned following a review of the 12-week biopsy data from the highest dose cohort (50 mg/kg...The drug showed no dose-limiting toxicities up to and including the highest dose of 6 mg and, after three months of follow-up, patients treated by a single dose of QPI-1007 exhibited no further loss of visual
Chelsea Therapeutics International Ltd., of Charlotte, N.C., said a Phase II trial showed the highest dose tested of droxidopa, 600 mg TID, resulted in a 6.2-point improvement from a baseline and a 3.2-point pain improvement over placebo in a questionnaire for fibromyaligia
Repros Therapeutics Inc., of The Woodlands, Texas, reported top-line Phase II data showing Androxal significantly increased testosterone levels at both the low and high doses vs...There was a trend toward improved glycemic control in the men on the higher dose
Metabolex Inc., of Hayward, Calif., said an open-label clinical pharmacology study showed that the higher dose of arhalofenate plus Osaka, Japan-based Takeda Pharmaceutical Co
the high dose of atorvastatin alone in patients with primary hypercholesterolemia with elevated cholesterol who were on a stable low dose (10 mg) of atorvastatin
Inc., of Whitehouse Station, N.J., recently completed an additional multiple rising-dose Phase I study to explore higher doses of oral vernakalant, and data showed the drug was well tolerated
The Captisol-enabled product is designed to allow for longer administration and slower infusion rates, potentially allowing clinicians to safely achieve a higher dose intensity of pre-transplant chemotherapy
The double-blind trial will enroll 160 subjects with incomplete responses to a VEGF inhibitor to receive a VEGF inhibitor alone, VEGF inhibitor plus low-dose iSONEP, VEGF inhibitor plus high-dose iSONEP, and iSONEP alone
Pevion Biotech AG, of Bern, Switzerland, reported the latest results from its ongoing clinical study of volunteers vaccinated with the intramuscular high dose of Candida vaccine PEV7, showing high levels of specific antibodies and a 100 percent mucosal immune response rate
Bionomics Ltd., of Adelaide, Australia, said the higher dose level of 16 mg/m2 was cleared for BNC105, a vascular-disrupting agent that is being tested in a clinical trial in combination with mTOR inhibitor Afinitor (everolimus, Novartis AG) in patients with metastatic renal cell cancer
The company also initiated an additional Phase Ib trial of INX-189 designed to evaluate higher doses of the drug as a monotherapy or in combination with ribavirin for seven days
ReNeuron Ltd., of Guildford, UK, received clearance from an independent data safety monitoring board to advance to a higher dose of stem cell treatment ReN001 in its Phase I trial for stroke
All doses showed statistically significant separation from placebo starting at week two and at each subsequent time point, with the highest dose showing separation as early as week one of treatment