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MINNEAPOLIS--The investigational antisclerostin antibody AMG 785 increased bone mineral density up to 50%-60% more than did standard drugs used to treat low bone mineral density in postmenopausal women, judging from the findings of a phase II trial.
The phase II trial randomly assigned 419 postmenopausal women with low bone mineral density to one of five doses of subcutaneous AMG 785 (70 mg monthly, 140 mg monthly, 210 mg monthly, 140 mg every 3 months, or 210 mg every 3 months) or placebo, and one of two open-label active comparators: 70 mg weekly oral alendronate or 20 mcg daily subcutaneous teriparatide.
In a news release, the company described one of the phase II trials as "failed or inconclusive." In this trial, doses of 20 mg, 40 mg, and 80 mg of lurasidone daily were compared with 10 mg of haloperidol daily and placebo.
A phase II trial of erlotinib in combination with bevacizumab in patients with metastatic breast cancer.
-- Initiated head-to-head Phase II trial comparing CH-4051 to methotrexate (MTX) in rheumatoid arthritis patients who are experiencing an inadequate response to MTX treatment;
In this ongoing exploratory Phase II trial the safety and efficacy of a second dose of ATIR101 is being tested in patients to investigate product flexibility in administering a further dose of ATIR101 should it be needed by physicians.
The Phase II trial is are structured as a multicentred, randomised, double-blinded, placebo-controlled and dose-finding study.
The phase II trial is an active (enoxaparin)-controlled, dose-escalating, multicentre, prospective, randomised, open label trial evaluating TB-402 for the prophylaxis of DVT after knee replacement surgery.
This new data in the two pediatric HSCT-TMA patients follows prior positive preclinical and ex-vivo studies in two other TMAs, Antiphospholipid syndrome and atypical hemolytic-uremic syndrome; Coversin is currently being investigated by Akari in a Phase II trial in patients with aHUS.
A phase II trial for colorectal cancer is on going, and CureTech intends to start a third phase II trial in metastatic melanoma in the near future.
NORDIC BUSINESS REPORT-6 January 2010-TopoTarget says belinostat enters phase II trial in USA(C)1994-2010 M2 COMMUNICATIONS http://www.m2.com
Known as MONOCLE, the Phase II trial is set to examine the efficacy of the drug tefinostat, in addition to investigating any myelomonocytic side effects that may arise in patients with chronic leukaemia (CMML).