Navigation Links
Genmab Initiates Ofatumumab Phase II Study in Diffuse Large B-Cell Lymphoma
Date:12/13/2007

Summary: Genmab has Initiated a Phase II Study of Ofatumumab in Relapsed

Diffuse Large B-Cell Lymphoma

COPENHAGEN, Denmark, December 13 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today that study centers have been initiated and are ready to enroll patients in a Phase II study of ofatumumab (HuMax-CD20(R)) to evaluate treatment of relapsed Diffuse Large B-Cell Lymphoma (DLBCL) in patients ineligible for or relapsed following a stem cell transplant. Approximately 75 patients will be enrolled in the study which is being conducted under Genmab's collaboration with GlaxoSmithKline (GSK). Genmab will receive a milestone payment of approximately DKK 87.2 million from GSK upon treatment of the first patient in the study, expected in the near future.

Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of B-cells. Other anti-CD20 antibodies currently available or in development bind to a different epitope on the CD20 receptor. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.

"We have now expanded the ofatumumab clinical development program into a fourth disease area," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We hope ofatumumab will offer a new and effective treatment option for patients suffering from DLBCL."

About the trial

In this open label trial, each patient will receive 8 weekly infusions of ofatumumab. The first infusion will be 300 mg and the 7 subsequent infusions will be 1000 mg of ofatumumab. Disease status will be assessed 4 weeks after the last infusion and then every 3 months for a total of 24 months after treatment start according to the "Revised response criteria for malignant lymphoma." After 24 months, patients will be followed until initiation of alternative DLBCL treatment or month 60. The objective of the study is to determine the efficacy of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after transplant. The primary endpoint of the study is objective response over a 6 month period from start of treatment.

About Diffuse Large B-Cell Lymphoma

Diffuse Large B-Cell Lymphoma is a cancer of the B-lymphocytes and represents 30% of non-Hodgkin's lymphomas in adults and is the most common lymphoid malignancy in the western world. There are an estimated 63,000 new cases of DLBCL diagnosed in the US per year. The median age at diagnosis is about 65 years.

About Genmab A/S

Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for unmet medical needs. Using unique, cutting-edge antibody technology, Genmab's world class discovery and development teams have created and developed an extensive pipeline of products for potential treatment of a variety of diseases including cancer and autoimmune disorders. As Genmab advances towards a commercial future, we remain committed to our primary goal of improving the lives of patients who are in urgent need of new treatment options. For more information on Genmab's products and technology, visit http://www.genmab.com.

This press release contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. Genmab is not under an obligation to up-date statements regarding the future following the publication of this release; nor to confirm such statements in relation to actual results, unless this is required by law.

Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD4(R); HuMax-CD20(R); HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); and UniBody(R) are all trademarks of Genmab A/S.


'/>"/>
SOURCE Genmab A/S
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Genmab and GlaxoSmithKline Initiate Ofatumumab Rheumatoid Arthritis Phase III Program
2. Tyco International Increases Quarterly Dividend 36 Percent to 15 Cents per Share; Initiates New $1 Billion Share Repurchase Program
3. Chemical Diversity Initiates International Prostrate Cancer Discovery Partnership
4. Vista Partners Initiates Coverage on Raptor Pharmaceuticals Corp.
5. Arete Therapeutics Initiates Phase 1 Clinical Trial For AR9281 as a First-in-Class Antihypertensive Agent
6. GenPrime Initiates External Clinical Trials of its Bacterial Contamination Test for Rapid Detection of Bacteria in Platelets
7. U.S. Oncology Initiates Complete Phase Ib Trial of Brostallicin Combination Therapy in Advanced Solid Tumors
8. Harbinger Research Initiates Coverage on HearAtLast
9. Wyeth Consumer Healthcare Initiates Voluntary Recall and Replacement Program for Several Robitussin Products and Childrens Dimetapp Cold & Chest Congestion
10. MAP Pharmaceuticals Initiates Phase 2a Clinical Trial of Combination Therapy in Adult Patients with Asthma
11. Amira Pharmaceuticals Announces Favorable Phase 1 Clinical Trial Results for Lead Product Candidate AM103 and Initiates Clinical Studies for the 2nd Entry Molecule for the Treatment of Respiratory and Cardiovascular Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... York, NY (PRWEB) , ... October 13, 2017 , ... ... influential people in business to advocate for action towards gender equality at their inaugural ... views from around the globe, and reached a social audience of over 3 million. ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader in agile ... a contract by the Center for Medicare and Medicaid Services (CMS). The Enterprise ... use of Agile methodologies in a consistent and high value manner across CMS ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 million ... by frequent cessation in breathing. Oral appliances can offer significant relief to about ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical Informatics ... PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s ... of Morris F. Collen, a pioneer in the field of medical informatics, this prestigious ...
(Date:10/12/2017)... ... 12, 2017 , ... HMP , a leader in healthcare events and ... Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during the Eddie ... annual award competition recognizes editorial and design excellence across a range of sectors. This ...
Breaking Medicine News(10 mins):
(Date:9/23/2017)... , Sept. 22, 2017 Janssen Biotech, Inc. ... response letter from the U.S. Food and Drug Administration ... of sirukumab for the treatment of moderately to severely ... additional clinical data are needed to further evaluate the ... severely active RA. ...
(Date:9/22/2017)... -- AVACEN Medical (AVACEN) announced that its CE-Marked AVACEN ... with the widespread pain associated with fibromyalgia in the ... Essex, England commented, "I had difficulty ... sleep at all, tremendous pain, with every movement sending ... AVACEN 100] enough, how this has and is helping ...
(Date:9/19/2017)... LOUISVILLE, Ky. , Sept. 19, 2017   ZirMed ... and predictive analytics, today announced that it has been ranked ... the Black Book™ Rankings 2017 User Survey. ZirMed ... software solution for large hospitals and medical centers over 200 ... in Black Book,s healthcare technology user survey history. ...
Breaking Medicine Technology: