Navigation Links
Takeda Initiates Two Phase III Studies with Vedolizumab (MLN0002) in Patients with Inflammatory Bowel Disease
Date:1/21/2009

Simultaneous Studies to Investigate Novel Therapy for Ulcerative Colitis and Crohn's Disease

OSAKA, Japan, Jan. 22 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") announced today that its wholly-owned subsidiary, Millennium Pharmaceuticals, Inc., has initiated two Phase III clinical trials for vedolizumab (MLN0002), an investigational compound for inflammatory bowel disease (IBD). The trials, known as the GEMINI(TM) program, will study vedolizumab for the treatment of ulcerative colitis and Crohn's disease, the two main types of IBD. Developed by Millennium, vedolizumab is a novel alpha4 beta7 integrin antagonist, a highly selective humanized monoclonal antibody.

"Dosing of the first patient in the Phase III development program of vedolizumab is an exciting milestone," said Brian Feagan, M.D., professor of Medicine at the University of Western Ontario, London, Canada and principal investigator of the GEMINI(TM) studies. "This treatment has great potential to improve the lives of patients with Crohn's disease and ulcerative colitis."

Though current IBD treatments have been effective for many patients with mild to moderate disease, a significant unmet need exists for those patients with moderate to severe IBD. Failure of current medical therapy for ulcerative colitis and Crohn's disease frequently leads to surgical removal of the colon in the case of ulcerative colitis, and multiple bowel resections in the case of Crohn's disease.

If approved by the U.S. Food and Drug Administration (FDA), commercialization of vedolizumab will be the responsibility of Takeda Pharmaceuticals North America, Inc., a subsidiary of Takeda Pharmaceutical Company Limited. Takeda has been a leader in gastroenterological therapies, such as Prevacid(R), for more than 10 years and is committed to bringing new therapies to market that may benefit patients.

"We are excited to advance vedolizumab to pivotal Phase III clinical studies with the goal of registration in both ulcerative colitis and Crohn's disease," said Nancy Simonian, M.D., chief medical officer, Millennium. "Unlike existing IBD therapies, the unique gut-selective targeting of vedolizumab has the potential to benefit IBD patients without compromising systemic immune function."

Vedolizumab is being studied to induce and maintain clinical response and remission in moderately to severely active IBD patients who have failed at least one conventional therapy. In ulcerative colitis, vedolizumab is also being studied for its effect on inducing and maintaining mucosal healing. Studies have demonstrated that vedolizumab works by blocking a key inflammatory marker on white blood cells, thereby preventing the migration of these inflammatory cells into the intestinal wall.

The two randomized, placebo-controlled, blinded Phase III studies will enroll nearly 2,000 patients in more than 40 countries. Each trial consists of a six-week induction phase followed by 46 weeks of maintenance therapy. In addition, patients will be given the opportunity to continue treatment for up to 100 weeks as part of a follow-up study for safety and efficacy. Vedolizumab will be administered as an intravenous infusion. The GEMINI(TM) program was built upon the basis of favorable results of two randomized Phase II trials, one of which was published in the New England Journal of Medicine in 2005.

About Ulcerative Colitis and Crohn's Disease

Ulcerative colitis and Crohn's disease are chronic, relapsing-remitting conditions, caused by an overactive inflammatory response in the gastrointestinal tract. Common symptoms include diarrhea, rectal bleeding, incontinence, abdominal pain, fever, malaise and weight loss.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda (TSE: 4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, www.takeda.com.


'/>"/>
SOURCE Takeda Pharmaceutical Company Limited
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cancer
2. Takedas Investigational PPI TAK-390MR Demonstrated Higher Healing Rates Compared to Lansoprazole as the Severity of Erosive Esophagitis Grade Increased, a New Integrated Analysis Showed
3. Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes
4. Takeda Doses First Patient in a U.S. Phase 1 Study of Hematide(TM) to Treat Chemotherapy Induced Anemia
5. Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.
6. Alexza Initiates AZ-104 (Staccato(R) Loxapine) Phase 2b Clinical Trial in Patients With Migraine Headaches
7. Idenix Pharmaceuticals Initiates Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)
8. Cara Therapeutics Initiates Phase II Proof-Of-Concept Trial of Novel Analgesic in Acute Post-Operative Pain
9. Solace Pharmaceuticals Initiates Phase IIa Trial of Glial Cell Modulator SLC022 in Post-Herpetic Neuralgia
10. Osteotech Initiates Pivotal Clinical Trial for DuraTech(TM) BioRegeneration Matrix
11. Cylene Pharmaceuticals Initiates Phase I Trial With CX-4945 -Breakthrough First-in Class Inhibitor of CK2
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... FRANCISCO, Calif. , June 24, 2016 /PRNewswire/ ... ), a biopharmaceutical company developing novel therapeutics for ... unmet needs, today announced the closing of its ... of common stock, at the public offering price ... in the offering were offered by GBT. GBT ...
(Date:6/24/2016)... Dublin - ... " Global Markets for Spectroscopy Equipment" report ... This report focuses on the global market of ... applications in various applications. The report deals with spectroscopy ... industries: pharmaceutical and biotechnology, food and beverage, and environmental ...
(Date:6/24/2016)... ALEXANDRIA, Va. , June 24, 2016 ... a set of recommendations that would allow ... information (HCEI) with entities that make formulary and coverage ... determine the "value" of new medicines. The ... that does not appear on the drug label, a ...
Breaking Medicine Technology:
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... Austin residents ... the American College of Mohs Surgery and to Dr. Russell Peckham for medical and ... highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture ... said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package ... Final Cut Pro X . Simply select a ProHand generator and drag it ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar ... M.D from the David Geffen School of Medicine at UCLA. He trained in Internal ... complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary ... Work award to iHire in recognition of their exemplary accomplishments in worksite health promotion. ... Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire ...
(Date:6/24/2016)... ... 24, 2016 , ... A recent article published June 14 on ... article goes on to state that individuals are now more comfortable seeking to undergo ... such as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills ...
Breaking Medicine News(10 mins):