Business Wire

Results from Phase 2 Studies of Oral Ozanimod in Crohn’s Disease and Ulcerative Colitis to Be Presented at World Congress of Gastroenterology at ACG2017

Del

Celgene Corporation (NASDAQ:CELG) today announced that phase 2 data of investigational compound ozanimod in Crohn’s disease and ulcerative colitis will be presented at the World Congress of Gastroenterology at ACG2017 (WCOG at ACG2017) in Orlando. The studies include new data from the STEPSTONE study in patients with moderately to severely active Crohn’s disease (CD) and long-term data from the open-label extension of the TOUCHSTONE study in patients with moderately to severely active ulcerative colitis (UC). Ozanimod is an investigational, selective sphingosine 1-phosphate (S1P) 1 and 5 receptor modulator.

“The new STEPSTONE findings further validate our hypothesis of ozanimod in Crohn’s disease and the latest data from the TOUCHSTONE study continue to support the potential of ozanimod to provide continued efficacy in ulcerative colitis at 92 weeks,” said Terrie Curran, President, Celgene Inflammation and Immunology. “The results in both studies are highly encouraging as we execute pivotal studies of ozanimod in Crohn’s disease and ulcerative colitis in hopes of advancing oral treatment options for these patients.”

The STEPSTONE data presented at WCOG at ACG2017 will include the first 12-week data from the phase 2, open-label study. STEPSTONE evaluated endoscopic improvement and clinical outcomes following treatment with ozanimod 1.0 mg daily for 12 weeks in 69 patients with a mean age of 37.7 years with moderately to severely active CD. Patients with available data at baseline and week 12 were included in the analyses of the simple endoscopic score for Crohn’s disease (SES-CD) matched intestinal segments (n=60) and the analysis of Crohn’s disease activity index (CDAI) (n=59).

SES-CD score reductions from baseline of at least 50 percent and 25 percent were seen in 27 percent and 43 percent of patients, respectively. Patients who had shorter disease duration (disease duration ≤5 years) had a greater endoscopic response: 50 percent and 25 percent reductions were seen in 36 percent and 50 percent of patients, respectively. Patients who had lower baseline endoscopic disease activity (SES-CD ≤12) also had a greater endoscopic response: 50 percent and 25 percent reductions were seen in 30 percent and 49 percent of patients, respectively.

Reductions in mean CDAI scores from baseline were seen at week 4 (first post-baseline assessment), with further reductions through week 12. At week 12, a CDAI response (CDAI decrease ≥100) was observed in 66 percent of patients, and CDAI remission (CDAI <150) was observed in 46 percent of patients. The mean CDAI reduction at week 12 was 130 points.

The most frequently reported adverse events (AEs) and serious AEs in patients appeared to be related to underlying CD. The most common AEs (≥5 percent) were CD flare, abdominal pain, nausea, lymphopenia, arthralgia, vomiting, increased gamma-glutamyl transpeptidase (GGT), urinary tract infection, paresthesia, anal abscess and increased alanine aminotransferase (ALT). The most common SAEs in two or more patients were CD flare, fistulizing disease, intestinal obstruction and abdominal abscess.

“Improvements in endoscopy are thought to correlate with long-term benefits for patients with Crohn’s disease, a chronic condition in which patients are regularly seeking out additional options to manage their disease,” said Brian G. Feagan, M.D., Robarts Clinical Trials and the University of Western Ontario in Canada. “The endoscopic, clinical improvement and the safety profile of ozanimod reported in the STEPSTONE study are encouraging and support its further development as a potential oral option for patients with Crohn’s disease.”

A separate presentation at WCOG at ACG2017 will report 92-week data on subjects who participated in the TOUCHSTONE open-label extension. TOUCHSTONE evaluated the efficacy and safety of 0.5 mg and 1.0 mg doses of ozanimod compared with placebo after eight weeks of treatment (induction phase) in 197 patients with moderate to severe UC. The primary endpoint was the proportion of patients in remission at week 8. Patients who achieved a clinical response at week 8 continued with their original treatment through week 32 in a maintenance phase. Previously reported results from TOUCHSTONE demonstrated statistically significant improvements in both the primary and secondary endpoints in patients who received 1.0 mg dose of ozanimod versus placebo.

TOUCHSTONE participants in all three treatment arms entered the ongoing open-label extension if they did not respond to treatment after the induction phase, relapsed during the maintenance phase or completed the maintenance phase (170 of the 197 patients). The objective of the extension phase was to evaluate the long-term efficacy and safety of daily ozanimod 1.0 mg. Efficacy data are reported as observed through week 92 and safety data includes all events through the data cut-off of March 2017.

At week 92, of the 100 patients who underwent efficacy evaluations, 91 percent had little or no active disease based on the physician global assessment (PGA 0 or 1), 97 percent had little or no blood in their stools (rectal bleeding subscore [RBS] 0 or 1) and 86 percent had no blood in the stools (RBS 0).

The safety profile at week 92 was similar to that reported in the placebo-controlled portion of the study. The most common AEs were UC flare, anemia, upper respiratory tract infection and back pain. The only SAEs in two or more patients were anemia and UC flare.

“People with ulcerative colitis need additional treatment options that can provide long-term benefit,” said William Sandborn, M.D., Professor of Medicine and Chief, Division of Gastroenterology and Director, University of California San Diego Inflammatory Bowel Disease Center. “These results further support the potential of longer-term treatment with ozanimod.”

About STEPSTONE

STEPSTONE is a phase 2, open-label study in patients with moderately to severely active Crohn’s disease (CD). Data from the first 12 weeks examined endoscopic and clinical outcomes following treatment with ozanimod 1.0 mg daily for 12 weeks. Active Crohn’s disease was defined as CDAI score 220-450 and total SES-CD of 6 or greater (or in isolated ileum disease SES-CD of 4 or greater). For the 69 enrolled patients, baseline mean age was 37.7 years, mean SES-CD was 13.3 and mean CDAI was 320. Mean CD duration was 10 years, with 54 percent of patients having had prior exposure to biologic therapy. All endoscopic assessments were read in a blinded manner by an imaging core lab. Daily electronic diary records were used to collect CD symptoms (including abdominal pain and soft/loose stool frequency). SES-CD was evaluated at baseline and week 12, and CDAI was assessed at baseline and weeks 4, 8 and 12.

About TOUCHSTONE

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 moderately to severely active ulcerative colitis. A total of 197 patients were randomized and treated once daily with 1.0 mg ozanimod (n=67), 0.5 mg ozanimod (n=65) or placebo (n=65) for eight 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 percent 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 testing, pulmonary function testing, optical coherence tomography and adverse events.

For the maintenance phase, patients who achieved a clinical response at week 8 continued with their original treatment through week 32. In the open-label extension phase, all patients (n=170) were treated with ozanimod 1.0 mg. The week 44 visit was completed by 131 patients.

About Ozanimod

Ozanimod is a novel, oral, selective, sphingosine 1-phosphate 1 and 5 receptor modulator in development for immune-inflammatory indications including relapsing multiple sclerosis, ulcerative colitis and Crohn's disease. Selective binding with S1PR1 receptors is believed to inhibit a specific subset of activated lymphocytes from migrating to sites of inflammation. The result is a reduction of circulating lymphocyte count that leads to anti-inflammatory activity. Importantly, immune surveillance is maintained.

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

About Crohn’s Disease

Crohn's disease is an immune-mediated, chronic inflammatory condition of the gastrointestinal tract. Estimated to affect as many as three out of every 1,000 people in Europe and North America, the disease is becoming more common for all ethnic groups. Symptoms of Crohn's disease — including abdominal pain, diarrhea, fatigue, fever, weight loss and malnutrition — most commonly begin to appear between the ages of 13 and 30, although the disease can strike at any age. The disease may affect any part of the GI tract, from the mouth to the anus, but most commonly affects the end of the small bowel (the ileum) and the beginning of the colon. The exact cause of Crohn's disease is unknown, and there is no cure. People with Crohn's disease have a slightly reduced life expectancy.

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 next‐generation solutions in protein homeostasis, immuno‐oncology, epigenetics, immunology and neuro‐inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

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. We undertake 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 our 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 our Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission.

Hyperlinks are provided as a convenience and for informational purposes only. Celgene bears no responsibility for the security or content of external websites.

Contact information

For inquiries, please contact:
Celgene Corporation
Investors:
Patrick E. Flanigan III, 908-673-9969
Corporate Vice President, Investor Relations
or
Media:
Catherine Cantone, 908-897-4256
Senior Director, Corporate Communications

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

Celltrion Receives Positive CHMP Opinion for Herzuma® for Trastuzumab Biosimilar15.12.2017 22:13Pressemelding

Celltrion, Inc. (KOSDAQ: 068270) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending that Herzuma® (trastuzumab biosimilar) be granted marketing authorization in the European Union (EU) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. The CHMP’s opinion will now be sent to the European Commission (EC) for final review. Herzuma® is a biosimilar to Herceptin®i, a breast cancer and gastric cancer treatment antibody biologic drug developed by Genentech and marketed by Roche. Herceptin® is a blockbuster drug which had worldwide sales of CHF 6.8 billionii (US$6.8 billion) in 2016, of which CHF 2.1 billioniii (US$2.1 billion) was in

Takeda and TiGenix announce that Cx601 (darvadstrocel) has received a positive CHMP opinion to treat complex perianal fistulas in Crohn’s disease15.12.2017 12:34Pressemelding

Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) and TiGenix NV (Euronext Brussels and NASDAQ: TIG) (“TiGenix”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), has adopted a positive opinion recommending a marketing authorization (MA) for investigational compound Cx601 (darvadstrocel). Cx601 is expected to be indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.2 This recommendation marks the first allogeneic stem cell therapy to receive a positive CHMP opinion in Europe. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/201712

Bitcoin Romania and Twispay Announce Integration Partnership Providing Users with the Ability to Purchase Bitcoin with Bank Cards15.12.2017 12:21Pressemelding

Bitcoin Romania, leading Eastern European Bitcoin exchange & brokerage firm, and Twispay, Swiss-owned European payment processor and FinTech pioneer, today announced the availability of a payment integration that allows a global clientele to acquire Bitcoin and Ethereum cryptocurrencies using Visa and Mastercard bank cards. Unprecedented in Romania, this is one of the first East-Central European integration partnerships that allow consumers to use their cards to purchase cryptocurrency. Until recently, investors could only acquire cryptocurrencies through bank transfers and cash deposits, but the volatility of cryptocurrency markets dictates the need for additional operational flexibility. Investors require faster, safer, more reliable, and more comfortable ways to complete purchases. “One minute can make the difference between a million lost and a million earned. That is pr

Upon Conclusion of the Fourth Annual Forum for Promoting Peace in Muslim Societies, Scholars and Intellectuals Visit the Louvre Abu Dhabi Museum15.12.2017 11:38Pressemelding

A high-level delegation of dignitaries, scholars and intellectuals participating in the fourth annual Forum for Promoting Peace in Muslim Societies, visited the Louvre Abu Dhabi museum. The delegation was headed by H.E Mustafa Ceric, former Grand Mufti of Bosnia; alongside Sheikh Mohammad Mukhtar Ould Imbala, Head of Mauritania’s Fatwa & Grievances Supreme Council; H.E Amar Mirghani Hussein, Sudanese Minister of (religious) Guidance and Endowments; and H.E Salho Jay, Imam of the Juma Masjid in South Africa. The Forum was held in Abu Dhabi from 11-13 December 2017, with the participation of more than 700 scholars, intellectuals and religious dignitaries from around the world. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171215005255/en/ Group Photo of the Scholars and Intellectuals during their visit to the L

Kennedy Wilson Acquires 124-Unit Northbank Apartments in Dublin, Ireland for €45 Million15.12.2017 11:00Pressemelding

Global real estate investment company Kennedy Wilson (NYSE: KW) announces that it has acquired Northbank Apartments, a wholly-owned 124-unit apartment community in Dublin’s North Docks, for €45 million from Jarmar Properties Limited (In Receivership) acting through David Carson of Deloitte as Statutory Receiver, the lender being the National Asset Management Agency (“NAMA”). Situated in Dublin’s North Docks, Northbank is located just 50 meters from Kennedy Wilson’s existing 84-unit Liffey Trust apartments. The two buildings benefit from great transport links as the LUAS Red line is immediately adjacent connecting to Dublin’s city centre and main train stations in five minutes. “The successful acquisition of Northbank in such close proximity to our Liffey Trust asset allows us to leverage our existing presence and implement our value-add asset management strategy, including a

AML BitCoin Enters Phase II of ICO15.12.2017 09:00Pressemelding

NAC Foundation, LLC announces today that the initial coin offering for the AML BitCoin – the world’s only patent-pending compliant digital currency – has been extended for another month to accommodate a torrent of last minute, new coin purchasers and the demands of thousands of current owners of the coin, who have had difficulty navigating the process of establishing the specialized wallet required to hold the innovative digital currency. This second phase of the AML BitCoin initial coin offering will see an increase in the price of the coin, from US $1.00 to US $1.25. The company has already been contacted by prospective purchasers in the slightly higher priced Phase II, and anticipates a further price increase to US $1.50 within a week or two. HitBTC, one of the world’s largest and most active digital currency exchanges, was prepared to list the AML BitCoin for trading on

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

Besøk vårt presserom