Bristol-Myers Squibb Co., of New York, and Abbvie Inc., of Chicago, announced updated efficacy and safety data from a small, randomized Phase II, open-label study in patients with previously treated multiple myeloma that evaluated two doses of the investigational monoclonal antibody elotuzumab (10 mg/kg and 20 mg/kg) in combination with lenalidomide and low-dose dexamethasone
The multicenter MM-003 study assessed the efficacy and safety of pomalidomide (POM) in combination with low-dose dexamethasone (POM+LoDex) and in comparison to high-dose Dex in MM patients with late-stage disease who previously failed lenalidomide (Revlimid) and bortezomib (Velcade, Millennium: The Takeda Oncology Co
The study, which is designed to enroll approximately 750 patients, includes a three- to five-week screening period followed by a 12-week treatment period during which patients receive either one of three doses of TC-5214 (0.5 mg, 1 mg or 2 mg) or placebo twice daily, randomized in a ratio of 2:1:1:1 (placebo, low dose, mid dose, high dose
Array BioPharma Inc., of Boulder, Colo., reviewed the abstracts released ahead of the American Society of Hematology meeting next month, showing that ARRY-520, a dual p38/Tie2 inhibitor, plus low-dose dexamethasone produced a 22 percent overall response rate in patients with triple-refractory multiple myeloma who have had a median number of 10 prior treatment regimens
Celgene Corp., of Summit, N.J., said its Celgene International Sarl subsidiary reported the data safety monitoring board (DSMB) determined that the Phase III study MM-003 testing pomalidomide plus low-dose dexamethasone compared to high-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma met the primary endpoint of improvement in progression-free survival (PFS) at the PFS final analysis
Actimab-A is being testing in a Phase I/II trial in combination with low-dose cytarabine in older AML patients...Immunovaccine Inc., of Halifax, Nova Scotia, reported interim results from its Phase I trial of DPX-Survivac, an ovarian cancer vaccine, showing that, to date, all nine patients receiving the vaccine in combination with low-dose oral cyclophosphamide produced a targeted immune response following only one or two vaccine administrations
Repros Therapeutics Inc., of The Woodlands, Texas, said the FDA agreed to a reclassification of the full clinical hold on further oral Proellex studies to a partial clinical hold to allow the firm to conduct a Phase II study of low-dose oral progesterone receptor blocker in endometriosis
Inc., reported data from two Phase III trials testing low-dose mesylate salt of paroxetine (LDMP) 7.5 mg/day in moderate to severe vasomotor symptoms (VMS) associated with menopause
The first part of the Phase II study included two cohorts, each with a placebo group and a treatment group – one receiving a low dose of MultiStem and the second receiving a higher dose
Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said the independent data monitoring committee for the Phase II study of NX-1207 in low-risk localized prostate cancer reported a positive interim analysis from the first group of patients to receive either a high- or low-dose of the drug
The 168-patient trial will test TO-2061, a low-dose formulation of 5-HT3 receptor antagonist odansetron, with a primary endpoint measuring the difference between active and placebo treatment arms in the change from baseline according to the Yale-Brown Obsessive-Compulsive Scale
Prior studies also showed that more than 90 percent of TC-5214 is eliminated unchanged through the bladder, supporting use of a low dose and creating the potential to minimize unwanted side effects. (See BioWorld Today, Nov. 9, 2011
Repros Therapeutics Inc., of The Woodlands, Texas, said the FDA provided guidance for a Phase II study of low-dose oral Proellex in the treatment of endometriosis
Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., reported that a further analysis of Phase II data showed six out of seven subjects with diabetic macular edema who received the optimal low dose of Optina (danazol) saw a clinically relevant change in retinal thickness after 12 weeks, the primary endpoint, compared with 29 percent of subjects in the placebo group
Bristol-Myers Squibb Co., of New York, and Abbvie Inc., of Chicago, announced updated efficacy and safety data from a small, randomized Phase II, open-label study in patients with previously treated multiple myeloma that evaluated two doses of the investigational monoclonal antibody elotuzumab (10 mg/kg and 20 mg/kg) in combination with lenalidomide and low-dose dexamethasone