Drug/indication: deforolimus for sarcoma
Clinical trial event: phase III "Succeed" first interim analysis
Timing: second quarter The first interim analysis from this pivotal study of deforolimus, also known as AP23573, in patients with metastatic soft-tissue and bone sarcoma is driven by the number of progression events -- when a cancer starts growing or a patient dies -- that take place in the trial, but the company expects the analysis (at one-third of events) to take place later in the second quarter. This first interim analysis is likely to be just a "go/no go" decision for the rest of the trial. A more important second interim analysis will be run after two-thirds of the total progression events in the trial have occurred.
Drug/indicaton: tecarfarin for anticoagulation
Clinical trial event: phase II/III "EmbraceAC" top-line results
Timing: end of second quarter Tecarfarin is a re-engineered and safer version of the widely used oral anticoagulant warfarin. ARYx is conducting a phase II/III study of tecarfarin vs. warfarin, aiming to demonstrate that patients treated with tecarfarin have more stable control over blood clotting. Results from this study -- one of two required to seek FDA approval -- are expected in June. If the data are positive, ARYx wants to license tecarfarin to a larger drug company partner. Company: Insmed ( INSM)
Drug/indication: iPlex for muscular dystrophy
Clinical trial event: phase II top-line results
Timing: second quarter The study enrolled 60 adult patients with muscular dystrophy to determine whether 24 weeks of treatment with iPlex improves walking ability compared to placebo. Company: Elan ( ELN) and Transition Therapeutics ( TTHI)
Drug/indicaton: ELND-005 for Alzheimer's disease
Clinical trial event: phase II
Timing: July 11-16, 2009 Elan and Transition will have a series of research abstracts on ELND-005 presented at the 2009 International Conference on Alzheimer's Disease (ICAD) in July. Completion of the phase II study, which is enrolling 340 patients with mild to moderate Alzheimer's and treating them with ELND-005 or placebo for 18 months, is expected in early 2010, with results probably ready by mid-2010. Company: Human Genome Sciences ( HGSI)
Drug/indication: lymphostat-B for systemic lupus erythematosus (SLE)
Clinical trial event: phase III "Bliss-52" top-line results
Timing: July The first of two pivotal phase III studies testing lymphostat-B in lupus patients will be released in July. Results from the second study are expected in November. The study compares lymphostate-B plus standard therapy against standard therapy alone in more than 800 patients with active lupus. The primary endpoint of the study is patient response rate after 52 weeks of treatment.
Drug/indication: R788 for rheumatoid arthritis
Clinical trial event: phase II "TASKI-2" and "TASKI-3" top-line data
Timing: July and August The TASKi2 study enrolls patients with rheumatoid arthritis who have previously failed to respond to methotrexate and treats them with up to six months of R788 or placebo. The TASKi3 study is similar except that patients enrolled have failed to respond to at least one marketed biologic therapy for rheumatoid arthritis. Company: Acadia Pharmaceuticals ( ACAD)
Drug/indication: pimavanserin for Parkinson's disease pychosis (PDP)
Clinical trial event: Phase III "ACP-103-012" top-line results
Timing: third quarter The Phase III trial is designed to evaluate the safety and efficacy of pimavanserin in patients with PDP. A total of 298 patients were enrolled in the trial and randomized to two different doses of pimavanserin or placebo. All patients also receive standard therapy for Parkinson's disease. The study will determine whether pimavanserin can have a significant antipsychotic effect compared to placebo. Company: Arena Pharmaceuticals ( ARNA)
Drug/indication: lorcaserin for obesity
Clinical trial event: phase III "Blossom" top-line results
Timing: September 2009 After posting mixed results from the first phase III study of lorcaserin, Arena will have another shot with the Blossom study, which is evaluating two doses of loracaserin vs. a placebo over one year in obese patients.
Drug/indication: ARRY-162 for rheumatoid arthritis
Clinical trial event: phase II top-line results
Timing: summer ARRY-162 is an oral pill being studied in a 12-week, placebo-controlled study in patients with active rheumatoid arthritis who are not responding well to methotrexate. Company: Chelsea Therapeutics ( CHTP)
Drug/indication: droxidopa for orthostatic hypotension
Clinical trial event: phase III top-line results
Timing: third quarter Chelsea is conducting two pivotal studies of droxidopa in patients with orthostatic hypotension, a condition in which blood pressure drops when a patient stands up, causing dizziness and other symptoms.