Business Wire

Phase 2 Maintenance Data from Oral Ozanimod TOUCHSTONE Study in Ulcerative Colitis Presented at ACG Plenary Session

Del

Celgene Corporation (NASDAQ: CELG) today announced detailed results from the maintenance phase of the TOUCHSTONE phase 2 clinical trial of Ozanimod, an investigational compound, in patients with moderate to severe ulcerative colitis at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Honolulu. In the trial, a significantly greater proportion of patients on Ozanimod achieved or maintained clinical remission at 32 weeks compared with those on placebo.

“Along with the previously reported results from the induction phase of this trial, data from the maintenance phase suggest that orally administered Ozanimod has the potential to help patients with moderate to severe ulcerative colitis,” said Dr. Stephen Hanauer, Medical Director, Northwestern Medicine Digestive Health Center, and Professor of Medicine-Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine.

The TOUCHSTONE trial evaluated the efficacy and safety of 0.5 mg and 1 mg doses of Ozanimod compared with placebo after eight weeks of treatment (induction phase) in 197 patients with moderate to severe ulcerative colitis. The primary endpoint was the proportion of patients in remission at week 8. Secondary endpoints were: the proportion of patients achieving a clinical response, the proportion of patients with mucosal improvement and the change from baseline in Mayo score. Previously reported results showed TOUCHSTONE met its primary endpoint and secondary endpoints with statistical significance for patients on the 1 mg dose of Ozanimod versus placebo in the 8-week induction phase.

For the maintenance phase, 103 patients who achieved a clinical response at week 8 (reduction in Mayo score of ≥3 and ≥30 percent with a decrease in rectal bleeding score of ≥1 or a rectal bleeding score ≤1) continued with their original treatment for an additional 24 weeks; of these, 91 patients completed 32 weeks of treatment.

Twenty one percent (14/67) of patients on Ozanimod 1 mg achieved or maintained clinical remission at week 32 [compared with 6 percent (4/65) on placebo (p=0.0108) and clinical response at week 32 was achieved or maintained by 51 percent (34/67) and 20 percent (13/65) of patients, respectively (p=0.0002)].

Mucosal improvement was also significantly more likely with Ozanimod 1 mg than with placebo at week 32 [22/67 (32.8 percent) vs. 8/65 (12.3 percent); p=0.0046)].

Adverse events (AEs) occurred in 11/42 (26.2 percent) patients in the Ozanimod 1 mg arm, 4/36 (11.1 percent) in the Ozanimod 0.5 mg arm and 8/25 (32.0 percent) in the placebo arm. The most common AEs were worsening of ulcerative colitis (1, 0 and 2 patients, respectively) and urinary tract infection (0, 1 and 1). No AEs of special interest (cardiac, pulmonary, ophthalmologic, hepatic, malignancy or serious infection) were reported during the maintenance phase.

“Ozanimod has the potential to offer a novel oral therapeutic approach for patients with ulcerative colitis, who need new therapies,” said Scott Smith, President, Celgene Inflammation & Immunology. “We are pleased with these safety and efficacy results, which give us confidence as we move forward with our phase 3 clinical trial.”

About the Trial

TOUCHSTONE is a phase 2, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Ozanimod (also known as RPC1063) with placebo in patients with moderate to severe active ulcerative colitis. A total of 197 patients were randomized and treated once daily with 1 mg Ozanimod (n=67), 0.5 mg Ozanimod (n=65) or placebo (n=65) for 8 weeks (the induction phase). The primary endpoint was the proportion of patients in remission (Mayo score ≤2, no subscore >1) at week 8. Secondary endpoints were the proportion of patients achieving clinical response (reduction in Mayo score of ≥3 and ≥30% with a decrease in the rectal bleeding score of ≥1 or a rectal bleeding score ≤1), proportion of patients with mucosal improvement (endoscopy score ≤1, and the change in Mayo score. Safety assessments included ECG, Holter monitoring, pulmonary function testing, optical coherence tomography and AEs.

For the maintenance phase, patients who achieved a clinical response at week 8 continued with their original treatment through week 32.

About Ozanimod

Ozanimod is a small molecule sphingosine 1-phosphate 1 and 5 receptor modulator in development for immune-inflammatory indications including relapsing multiple sclerosis and inflammatory bowel disease. Treatment with S1P receptor modulators is believed to work by interfering with S1P signaling and blocks the response of lymphocytes (a type of white blood cell) to exit signals from the lymph nodes, sequestering them within the nodes. The result is thought to be a downward modulation of circulating lymphocytes and anti-inflammatory activity by inhibiting cell migration to sites of inflammation.

Ozanimod is an investigational compound that is not approved for any use in any country.

About Ulcerative Colitis

Ulcerative colitis is a chronic, relapsing condition triggered by an abnormal, prolonged immune response that creates long-lasting inflammation and ulcers (sores) in the mucosa (lining) of the large intestine (colon). Symptoms usually develop over time, rather than suddenly. The disease can be debilitating and can sometimes lead to life-threatening complications. Ulcerative colitis is the most common form of inflammatory bowel disease worldwide. About one in every 198 people in Europe and one in every 402 people in North America have ulcerative colitis. In 2004, 2.1 million prescriptions were written to treat ulcerative colitis, and 716,000 ambulatory care visits were related to the disease. In 2010, there were 107,000 hospitalizations due to ulcerative colitis.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn and YouTube.

About Receptos

Receptos Inc., located in San Diego, CA, is a wholly-owned subsidiary and research division of Celgene Corporation.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. Celgene Corporation undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond Celgene’s control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene’s Annual Report on Form 10-K and other reports filed with the U.S. Securities and Exchange Commission.

Contact information

Investors:
Patrick E. Flanigan III
Vice President, Investor Relations
908-673-9969
or
Media:
Catherine Cantone
Director, Corporate Communications
732-564-3592

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

AstraZeneca and Chi-Med’s Savolitinib Shows Encouraging Clinical Activity in 2nd-Line EGFR Mutation-positive Lung Cancer with MET-amplification16.10.2017 22:00Pressemelding

AstraZeneca and its partner Chi-Med today presented preliminary safety and clinical activity of savolitinib when given in combination with either Tagrisso (osimertinib) or Iressa (gefitinib) in two Phase Ib trials conducted in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET-amplification who had progressed following 1st-line treatment with an EGFR inhibitor.1,2 In both trials, the addition of savolitinib (600mg, once daily), an investigational selective inhibitor of c-MET (mesenchymal epithelial transition factor) receptor tyrosine kinase, to osimertinib (80mg, once daily) or gefitinib (250mg, once daily) demonstrated preliminary anti-tumour activity. The data were shared in two oral presentations at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan, 15-18 Oc

Orlando Melbourne Int’l (MLB) Lands Largest FAA Grant in Its History16.10.2017 21:34Pressemelding

When Air Force One landed at Orlando Melbourne International Airport (MLB) in February, Airport Executive Director Greg Donovan took advantage of the opportunity and advised the president of the United States that his 747-200 just landed on a commercial runway officially rated ‘poor’ in aviation terms. That’s going to change, thanks to an $18,132,588 FAA grant announced by U.S. Secretary of Transportation Elaine Chao today. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171016006292/en/ Greg Donovan, A.A.E. (Photo: Business Wire) “We asked for, and received, tremendous support from the Florida congressional delegation,” said Jack L. Ryals, chairman of the Melbourne Airport Authority. “We are deeply grateful to Congressman Posey, Senator Nelson and Senator Rubio for their advocacy on this critic

Colombia Selects IDEMIA to Upgrade Its Identification and Civil Registry Platform16.10.2017 14:34Pressemelding

IDEMIA, the global leader in trusted identities for an increasingly digital world, has been selected by the National Civil Registry of Colombia (Registraduría Nacional del Estado Civil de Colombia – RNEC 1 ) to update the identification and civil registry platform. This platform is the trusted repository of citizens’ biometric and alphanumeric data and ensures the uniqueness of identities. IDEMIA (formerly known as OT-Morpho) has worked with the RNEC since the beginning of this project and has constantly supported the successive improvements of the solution. In 2017, when in need to strengthen the platform in order to offer new services to the government and to the population while maintaining a high level of security and satisfaction of the users, RNEC decided to pursue its partnership with IDEMIA. Through this new contract, IDEMIA will e

ATB Financial Goes-Live on Murex’s SaaS Solution16.10.2017 14:00Pressemelding

Sibos - Murex, a global leader in trading, risk management and processing solutions, is pleased to announce the successful launch of the MX.3 SaaS solution at ATB Financial. MUREX SaaS is a managed services offering for the MX.3 platform, encompassing infrastructure and application management. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171016005092/en/ ATB pursued this initiative in order to create a simple yet comprehensive foreign exchange experience for their customers. In addition to the customer benefit, ATB was also able to rationalize their IT landscape, broaden the scope of financial instruments they provide on their digital platform, and prepare for a large volume increase in their trading activities. Due to the strength of the solution’s risk management capabilities, extensive asset class coverage, and the ra

Leave a review on print24.com and win a VW up!16.10.2017 13:59Pressemelding

The online print shop UNITEDPRINT SE, owner of renowned brands including print24.com, is asking its customers for their opinions on the company’s products and services. In return for their views, customers will receive vouchers and be entered into a prize draw. The online print shop is offering one voucher for every review submitted across various portals. The vouchers – worth up to €25.00 and valid until 31 March 2018 – will be subject to a minimum order amount (product price inc. VAT, not including delivery) of €250.00 per voucher. All reviews received up to 31 December 2017 will be eligible, regardless of length and content. You can learn more about the review campaign at https://print24.com/rate/ But not only that, print24.com is also giving every reviewer the chance to win a brand-new VW up! Ali Jason Bazooband, Managing Director for Innovation/Marketing at print24.com,

Bentley Systems Announces Winners of 2017 Be Inspired Awards16.10.2017 13:52Pressemelding

The Year in Infrastructure 2017 Conference – Bentley Systems, Incorporated, a leading global provider of comprehensive software solutions for advancing infrastructure, has announced the winners of the 2017 Be Inspired Awards. The annual awards program honors the extraordinary work of Bentley users advancing the world’s infrastructure. At a ceremony and gala at their Year in Infrastructure 2017 Conference, Bentley acknowledged 17 Be Inspired Awards winners and six Special Recognition Awards winners. The Year in Infrastructure Conference is Bentley’s annual global gathering of leading professionals in the world of infrastructure design, construction, and operations. In addition to thought-provoking keynotes, technology demonstrations, industry forums, and panel discussions, the agenda included presentations by finalists in the Be Inspired Awards program, culminating in the selection of t

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom