On the heels of the

drug approval decision calendar

, I've compiled a new list of clinical trial results expected before the end of the year.

This clinical trials list covers experimental drugs currently undergoing testing in phase II and phase III studies by drug and biotech companies. Unlike

U.S. Food and Drug Administration

drug approvals, which are more precisely timed, the release dates for data from clinical trials is bit fuzzier, so the timelines here are culled from company guidance when possible.

The working list of clinical trials expected to be completed in 2009 is fairly long, so consider the calendar below just the first installment. Expect more information on clinical trials to watch in the coming weeks.

Note: I put this calendar together using company reports, sell-side research and the


service from

Sagient Research

-- a subscription-based tool for keeping track of biotech and drug catalysts.


Ariad Pharmaceuticals


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.


ARYx Therapeutics


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.



(INSM) - Get Insmed Incorporated Report

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.





Transition Therapeutics


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.


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Human Genome Sciences


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.


Rigel Pharmaceuticals

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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.


Acadia Pharmaceuticals

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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.


Arena Pharmaceuticals

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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.


Array Biopharma

(ARRY) - Get Array Technologies Report

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.


Chelsea Therapeutics


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.

Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;

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