Business Wire

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

19.10.2015 12:00 | Business Wire

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

Out-of-this-World Science Project to be Featured as Keynote at SC17’s High Performance Computing Conference in Denver16.8.2017 13:00Pressemelding

Professor Philip Diamond, Director General of the international Square Kilometer Array (SKA) project, will be the keynote speaker at SC17, the International Conference for High Performance Computing, Networking, Storage and Analysis in Denver, Nov. 12-17. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170816005129/en/ SC17 Keynote Speaker Philip Diamond (Photo: Business Wire) SKA is an international collaboration to build the world’s largest radio telescope that will change our understanding of space as we know it. Professor Diamond, accompanied by Dr. Rosie Bolton, SKA Regional Centre Project Scientist, will take SC17 attendees around the globe and out into the deepest reaches of the observable universe as they describe the SKA’s international partnership that will map and study the e

Maxion Wheels to Feature Market Leading Commercial Vehicle Steel Wheels at COMTRANS 201716.8.2017 13:00Pressemelding

Maxion Wheels, the world’s largest wheel manufacturer, announced today its participation in the biennial COMTRANS / 17 International Commercial Vehicle Show held in Moscow, Russia from September 4 – 9, 2017, in Hall 15/ Stand 15-432. Customers and visitors to the Maxion Wheels exhibit will have the opportunity to learn more about the state-of-the-art commercial vehicle steel wheels that have supported the success of global original equipment manufacturers for almost 100 years. One of the key products on display will be the new 8.5” x 24” wheel for tubeless tire applications in Russia, the Middle East and Africa. The wheel boasts 15 percent less weight than the prior generation wheel, enhancing tire life and improving fuel efficiency. ABOUT MAXION WHEELS Maxion Wheels, a division of IOCHPE-MAXION S.A., is a leading wheel manufacturer for passenger cars,

Scientist.com Ranks No. 155 on the 2017 Inc. 5000 List of Fastest-Growing Companies16.8.2017 12:06Pressemelding

Scientist.com, the leading marketplace for outsourced scientific services, today announced that it ranked no. 155 on Inc. magazine’s 2017 List of the 5000 Fastest-Growing privately-owned companies in America, and it ranked no. 11 in the country in the Health category. The San Diego-based company builds private marketplaces that connect many of the world’s largest life science research organizations with a global network of thousands of research suppliers. “Using Scientist.com, research organizations of pharmaceutical companies, biotech start-ups and academic and research institutes can get near instant access to thousands of the latest research technologies and services,” stated Paul A. Stone, JD, Partner at 5AM Ventures, a Scientist.com investor. “The marketplace saves researchers time, reduces costs, promotes access to innovation and ensures regulatory compliance. Scientist.com is im

CMB Successfully Goes-Live on Murex’s MX.3 Platform16.8.2017 08:00Pressemelding

Murex, a global leader in trading, risk management and processing solutions, is pleased to announce the successful launch of the MX.3 platform at China Merchants Bank (CMB). As one of China’s largest commercial banks, CMB financial market department currently averages 8,000 trades per day with a portfolio of 320,000 live trades on MX.3. CMB decided to launch the project to implement an enterprise-wide solution for their capital markets teams based in Shenzhen and Shanghai. This was done in order to improve control over their end-to-end trading cycle from front-to-back through risk, streamline and automate their operations, and enable new business. Murex’s MX.3 platform was selected as it provided the functional, geographical and product coverage that was required by the bank. Covering Front Office, Processing, Finance, and Risk Management, MX.3 also provides VaR analytics across all asset

euNetworks Adds New High Density Fibre Network in Manchester16.8.2017 08:00Pressemelding

euNetworks, a provider of bandwidth services in Europe, today announced it has made further investment in Manchester in the United Kingdom, having built out a new high density fibre network covering over 40 route kilometres in the city. This follows initial expansion into Manchester’s MediaCityUK in May 2016, which supported euNetworks’ Media customer’s bandwidth needs, as well as enabling a seamless network experience from London through to Manchester and Dublin and onwards to Europe. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170816005067/en/ euNetworks Fibre in Manchester (Photo: Business Wire) This new network in Manchester city was designed for resilience, with fully diverse nodes. euNetworks undertook a combination of new construction and duct acquisition to complete this network

The Peninsula Classics Best of the Best Award for 2016 Awarded to 1954 Maserati A6GCS/53 Berlinetta by Pinin Farina16.8.2017 07:28Pressemelding

At a highly-anticipated private gathering during the famed Monterey Car Week, a 1954 Maserati A6GCS/53 Berlinetta by Pinin Farina, from the Monaco-based Destriero Collection, was named winner of the prestigious second-annual The Peninsula Classics Best of the Best Award . This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170816005384/en/ 1954 Maserati A6GCS/53 Berlinetta by Pinin Farina was named winner of the prestigious The Peninsula Classics Best of the Best Award. Photo Credit: Adam Swords Only four Berlinetta-bodied sports cars from Pinin Farina were ever produced, and this exquisite model is considered to be the best preserved, as it is the only one that retains its original chassis and body. Custom ordered by the Roman dealer of the marque, the sports car is

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

Besøk vårt presserom