Navigation Links
Positive Clinical Data on CC-10004 Confirms Potential as Novel Oral,Approach to Treating Inflammatory Diseases

Celgene to Advance Clinical and Regulatory Development of Oral Anti-Inflammatory Franchise

SUMMIT, N.J., May 22, 2007 /PRNewswire-FirstCall/ -- Celgene Corporation announced its plans to advance the development of leading oral anti-inflammatory candidates across a broad range of inflammatory diseases. CC-10004 (apremilast), an oral TNF antagonist and anti-inflammatory agent has demonstrated significant activity and an excellent side effect profile in a placebo controlled proof-of-mechanism trial in psoriasis.

The multicenter, randomized, double blind, placebo-controlled Phase II study achieved the primary endpoint after 12 weeks of treatment with 24% of patients receiving CC-10004 twice daily achieving a PASI-75 score compared to 10% of those receiving placebo. The Psoriasis Area and Severity Index (PASI) is a standard measurement of response utilized to assess improvement in patients with moderate to severe psoriasis. In addition, 57% of patients receiving CC-10004 twice daily achieved a PASI-50 compared to 23% of those receiving placebo. Most importantly, patients receiving CC-10004 continued to improve over time.

"The data from the Phase II study in patients with moderate-to-severe psoriasis are clinically and statistically significant compared with placebo. In addition, patients continued to improve throughout the 12 week treatment regimen with an oral therapy that has a good side effect profile addressing an unmet medical need," said Alice Gottlieb, M.D., Ph.D., Dermatologist in Chief and Chair, Department of Dermatology of Tufts-New England Medical Center. "The PASI-90 response of 14% for CC-10004 is comparable to Enbrel dosed at 25 mg twice weekly."

Based on these results, Celgene is accelerating clinical and regulatory strategies for CC-10004 in psoriasis, psoriatic arthritis, rheumatoid arthritis and other inflammatory diseases. The Company is also initiating development plans to a dvance CC-11050 and other compounds from this class of oral TNF alpha inhibitors, as potential novel oral therapies for chronic inflammatory diseases.

"CC-10004 is a unique oral therapy that demonstrates reasonable efficacy and favorable safety profile in a moderate to severe psoriasis setting. The drug is clearly working," said Kim Papp, M.D., Ph.D., Assistant Clinical Professor of Medicine at the University of Western Ontario, Canada and a principle investigator of the Phase II study.

Adverse side effects in patients receiving CC-10004 were mild and well tolerated. Overall, the percentage of patients who reported at least one adverse event in the CC-10004 twice daily arm (54%) was equivalent to that experienced with the placebo arm of the study (60%).

"These positive results validate the potential of our oral class of anti- inflammatory compounds," said Sol J. Barer, Ph.D., Chairman and Chief Executive Officer of Celgene Corporation. "We plan to evaluate multiple opportunities across a broad range of debilitating inflammatory diseases where there are limited effective oral treatment options for these devastating conditions."

About the Phase II Study

This Phase II study was a multicenter, randomized, double blind, placebo- controlled, parallel-group, dose comparison efficacy study in 260 patients with moderate-to-severe plaque-type psoriasis who were candidates for systemic therapy. Patients who participated in this study were required to have a minimum of a 6-month history of moderate-to-severe plaque-type psoriasis prior to enrollment.

About Chronic Inflammatory Diseases

Chronic inflammatory diseases are caused by persistent stimulus to tissues in the body over a prolonged period of time resulting in inflammation. This class of diseases includes immune-mediated conditions, such as rheumatoid arthritis and psoriasis, where a person's immune system attacks their own body tissues trying to heal and repair them, but ul timately causing inflammation. Chronic inflammatory diseases afflict millions of people worldwide and are a physical, social and economic burden to patients and their families. Despite the burden and prevalence of inflammatory diseases, there have been relatively few innovative breakthroughs in identifying their cause, treatment or cure.

About CC-10004

CC-10004 is a member of a proprietary pipeline of novel small molecules with anti-inflammatory activities that inhibit the production of multiple proinflammatory mediators including, PDE-4, TNF-alpha, interleukin-2 (IL-2), interferon-gamma, leukotrienes, and nitric oxide synthase. CC-10004 is our lead investigational drug in this class of anti-inflammatory compounds. Based on promising results from proof-of-mechanism studies, Celgene is accelerating the evaluation of clinical and regulatory strategies around the development of CC-10004 and other anti-inflammatory agents into clinical trials designed to determine their potential across a broad range of debilitating inflammatory diseases.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.com.

This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports.

CONTACT: David Gryska, Sr. Vice President and Chief Financial Officer,+1-908-673-9059, or Brian P. Gill, Vice President, CorporateCommunications, +1-908-673-9530, both of Celgene Corporation

Web site: http://www.celgene.com//

Ticker Symbol: (NASDAQ-NMS:CELG)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
2. Positive Aggrastat Results Featured in the Journal of the American College of Cardiology
3. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Protox Announces Positive Clinical Data from Prostate Cancer Study
5. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
6. Cougar Biotechnology Announces Presentation of Positive CB7630 Clinical Data at ESMO Conference
7. TransPharma Medical Announces Positive Results of Phase I Clinical Trials for Transdermal Delivery of hPTH (1-34) for Osteoporosis Treatment
8. Positive ZIO-201 Interim Phase II Sarcoma Data Presented at European Society for Medical Oncology
9. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
10. Portola Pharmaceuticals Announces Positive Phase II EXPERT Results and Additional Oral and Poster Presentations at the XXI Congress of the International Society on Thrombosis and Haemostasis (ISTH)
11. Chi-Med Announces Positive Phase II Proof-of-Concept Data for HMPL-004 in Ulcerative Colitis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/6/2016)... , Dec. 6, 2016 Diabetes & ... The diabetes and obesity disease cluster is currently dominated ... and type 2 diabetes mellitus (T2DM), and the majority ... quality of products, is attributable to these indications. While ... large market presence, there are a large number of ...
(Date:12/6/2016)... 6, 2016 Human Vaccines Market: Scope ... wise and country wise analysis of the human ... of human vaccines products, raw material suppliers, vaccine ... the market. The report provides qualitative and ... Qualitative analysis comprises market dynamics, trends, product overview, ...
(Date:12/6/2016)... -- BTL Aesthetics today announced the release of a ... device was effectively redesigned for more efficient, predictable ... The result: Significantly better outcomes in abdominal fat ... versus BTL Vanquish. "We are committed ... with the most highly-advanced devices on the market," ...
Breaking Medicine Technology:
(Date:12/7/2016)... ... December 07, 2016 , ... Gensuite ... Brilliance Awards under the Best New Product Launch category. Gensuite’s entry on their ... experience. , BOC Global Events & Training Group is a professional event and ...
(Date:12/7/2016)... ... December 07, 2016 , ... “The Road To Restoration”: an ... not a one hour a week showing of hands. “The Road To Restoration” is ... “Perhaps you are familiar with the brass ring that you could reach out for, ...
(Date:12/7/2016)... , ... December 07, 2016 , ... “Fred Rides a ... Christmas Day that follows. , “Fred Rides a Train” is the creation of ... short stories since her teen years in Michigan. The "Fred, the Dog" series is ...
(Date:12/7/2016)... ... 2016 , ... Dr. Greg Leyer, the Chief Scientific Officer ... DC workshop on November 2nd. The conference was an opportunity for both probiotic ... regulations. , Dr. Leyer spoke about two main topics at the IPA ...
(Date:12/6/2016)... ... 06, 2016 , ... People with Parkinson’s disease and cognitive ... type of MRI, according to a study appearing online in the journal Radiology. ... characterized by tremors or trembling and stiffness in the limbs, impaired balance and ...
Breaking Medicine News(10 mins):