Robert J. Hugin, President and CEO, maintained guidance for the enrollment completion of the Apremilast phase III programs. He stated, "Our immunology and inflammation franchise is making significant progress with full enrollment of the 6 phase III Apremilast studies expected by year end."
Source: Q2 2011, earnings conference call, 7/28/11.
Robert J. Hugin, President and CEO, gave an update on the progress being made with enrollment in the Apremilast programs. He stated, "We are making excellent progress with our Apremilast program, 6 phase III trials are studying the efficacy and safety of Apremilast in psoriasis and psoriatic arthritis and are accruing ahead of schedule. We also expect phase II data in at least one additional indication to be available later this year."
Source: Q1 2011, earnings conference call, 4/28/11.
Robert J. Hugin, President and CEO, gave guidance for data from the Apremilast for psoriasis programs. He stated, "During the last two quarters, we have initiated four out of our six pivotal studies in psoriasis and psoriatic arthritis with Apremilast. Our phase III program encompasses approximately 3,500 patients at 450 sites worldwide. Our ambitious but obtainable corporate objective is to have all patients in our pivotal studies enroll by the end of 2011, with data available as early as mid 2012."
Source: Q3 2010, earnings conference call, 10/28/10.
Robert J. Hugin, President and CEO, gave an overview of the time-line for the Apremilast phase III development programs. He stated, "Our most advanced program is Apremilast. In just the past few weeks, we have dosed our first patients in PSA-002, the first of our pivotal trials. We have an extensive development program for Apremilast in psoriatic arthritis, moderate-to-severe psoriasis, rheumatoid arthritis and other serious immune/inflammatory diseases. All of our pivotal trials in psoriatic arthritis and psoriasis are targeted to be initiated before the end of this year."
Source: Q2 2010 earnings conference call, 7/29/10.
PALACE-1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Two Doses Of Apremilast (CC-10004) In Subjects With Active Psoriatic Arthritis
Estimated Enrollment: 495
Study Start Date: June 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01172938?term=apremilast&phase=2&r...
|Apremilast (CC-10004) Psoriatic arthritis||Rheumatology||Psoriatic arthritis||Anti-inflammatory||Immune system|
Mechanism of action: CC-10004 (apremilast), a SM-inhibitor, down regulates inflammatory reactions via an orally available small molecules that inhibit the production of multiple pro inflammatory mediators including: interleukin-2 (IL-2), IL-12, interferon-gamma, TNF-alpha, leukotrienes, and nitric oxide synthase.
Phase of Development: III
Event Type: Data: Phase III trial results
Dates: 2012-03-01 - 2012-05-31
Oral Apremilast Achieves Statistical Significance for the Primary Endpoint of ACR20 in the First Phase III Study (PALACE-1) in Patients with Psoriatic Arthritis
Apremilast significantly improves signs and symptoms of PsA in DMARDs-failure patients, including biologic-treatment-failure patients
Apremilast monotherapy demonstrates robust improvement across primary and secondary endpoints
Highest response demonstrated in biologic-naïve patient population
No significant safety signals were observed and tolerability improved over phase II program
BOUDRY, Switzerland--(BUSINESS WIRE)--Nov. 13, 2012-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today presented the results from PALACE-1, the Company’s first Phase III study in psoriatic arthritis, at the American College of Rheumatology annual meeting in Washington, D.C.
The company previously announced statistical significance for the primary endpoint of ACR20 for patients receiving apremilast in the PALACE-1 study, the first of three pivotal phase III, randomized, placebo-controlled studies evaluating the Company’s novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with psoriatic arthritis who had received oral disease-modifying antirheumatic drugs (DMARD) and/or biologic therapy and/or had failed on an anti-tumor necrosis factor (TNF) agent. Apremilast treatment in this study was used alone or in combination with oral DMARDs. PALACE-1 is the first phase III study demonstrating statistical significance in a psoriatic arthritis patient population that included both prior biologic exposure (23.6%) and biologic failures (9.3%).
Source: press release, 11/13/12. http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&ID=17582...
Apremilast Achieves Statistical Significance for the Primary Endpoint of the First Phase III Study (PALACE-1) in Patients with Psoriatic Arthritis
Apremilast achieves clinically meaningful and statistically significant improvement in measures of both signs and symptoms and physical function
Safety is consistent with previous studies and tolerability improved over phase II program
Celgene targets first apremilast NDA filing in the first half of 2013
Update on comprehensive global apremilast clinical program
BOUDRY, Switzerland--(BUSINESS WIRE)--Jul. 12, 2012-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced top-line results from the PALACE-1 study, the first of three pivotal phase III, randomized, placebo-controlled studies evaluating the Company’s novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with psoriatic arthritis who had received an oral disease-modifying antirheumatic drug (DMARD), biologic therapy or had failed on an anti-tumor necrosis factor (TNF) agent. Apremilast treatment in this study was used alone or in combination with an oral DMARD.
Source: press release, 7/12/12. http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&ID=17141...