Navigation Links
Recruitment Completed in Ofatumumab NHL Pivotal Study
Date:9/23/2008

Summary: Genmab has Completed Recruitment of Patients in the Phase III

Study of Ofatumumab in Rituximab Refractory Follicular NHL

COPENHAGEN, September 23 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today it has completed recruitment of patients in the pivotal Phase III study of ofatumumab (HuMax-CD20(R)) in rituximab refractory follicular non-Hodgkin's lymphoma (NHL). Eighty-one patients receiving treatment at the 1000 mg dose level of ofatumumab have been recruited in the study. Data from these patients will be included in the primary efficacy analysis. An additional 31 patients were recruited at a 500 mg dose level prior to amending the study design to include only one dose. Data from these patients will be evaluated for safety and supportive efficacy analysis.

"We have now recruited the last patient into the study and keenly await the results which we hope will show a benefit for follicular NHL patients who need a new treatment option," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

Ofatumumab is an investigational, new generation, human monoclonal antibody that targets a distinct membrane proximal, small loop epitope (specific binding site)of the CD20 molecule on the surface of B-cells. Ofatumumab is being developed to treat CLL, follicular non-Hodgkin's lymphoma, diffuse large B-cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved for sale in any country.

About the trial

Patients in this study will receive one infusion of 300 mg of ofatumumab followed by 7 weekly infusions of 1000 mg of ofatumumab. Disease status will be assessed every 3 months until month 24.

The objective of the study is to determine the efficacy and safety of ofatumumab in rituximab refractory follicular NHL. The primary endpoint of the study is objective response as measured over a 6 month period from start of treatment assessed by an Independent endpoints Review Committee (IRC) according to the standardized criteria for NHL.

About Genmab A/S

Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for unmet medical needs. Using cutting-edge antibody technology, Genmab's world class discovery, development and manufacturing 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. For a further discussion of these risks, please refer to the section "Risk Management"in Genmab's Annual Report, which is available on http://www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this press release nor to confirm such statements in relation to actual results, unless 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); HuMax-CD32b(TM) and UniBody(R) are all trademarks of Genmab A/S.

Stock Exchange Release no. 43/2008


'/>"/>
SOURCE Genmab A/S
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
2. TARGETED GENE DELIVERY SIGNALS CANCER VACCINATION IN VIVO: Intravenous Infusions of Rexin-G Followed by Reximmune-C Induce Tumor Necrosis and Recruitment of Tumor Infiltrating Lymphocytes in Cancerous Lesions (ASCO 2008)
3. Genmab A/S - Company Announcement: Recruitment Completed In Ofatumumab CLL Front Line Study
4. Emisphere Announces Recruitment of Novartis Phase III Study for Oral Osteoporosis Treatment
5. Bronchitol Phase 3 Cystic Fibrosis Trial Completes Recruitment
6. Argonauta Assist(TM)ance: Argonauta Communications Strives to Enhance Site-Based Recruitment Efforts
7. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
8. First Clinical Volumetric Modulated Arc Therapy Treatment Completed With Elekta Synergy(R) S at General Hospital Vienna
9. Jazz Pharmaceuticals, Inc. Announces Final Patient Has Completed Phase III Clinical Trial of Sodium Oxybate to Treat Fibromyalgia
10. Genmab A/S - Company Announcement Ofatumumab in Subcutaneous Study in Rheumatoid Arthritis Summary: Subcutaneous Administration of Ofatumumab Investigated in Phase I/II Study
11. Genmab Reaches Milestone in Ofatumumab Collaboration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... , Dec. 8, 2016  Pennsylvania Physician ... of Drug and Alcohol Programs Gary Tennis ... insomnia medications, known as benzodiazepines, developed with the ... "Benzodiazepines are medications that are frequently prescribed for ... they are used with opioid pain medications, benzodiazepines ...
(Date:12/8/2016)... 2016  A new study by a pair of ... opioid therapy to treat chronic pain is not only ... harmful consequences, including death. Palliative care physicians ... Mehta , M.D., authored the study which provides a ... The study was published in the December 2016 edition ...
(Date:12/8/2016)... , Dec. 8, 2016  EIP Pharma, LLC ... obtained proof-of-mechanism for neflamapimod (previously code named VX-745), ... 2a clinical trials that demonstrated significant Alzheimer,s disease ... (12-week treatment) and Study 303 (6-week treatment) are ... in Alzheimer,s Disease (CTAD) scientific conference in ...
Breaking Medicine Technology:
(Date:12/9/2016)... ... 2016 , ... The Pennsylvania Athletic Trainers’ Society (PATS) aired ... of 2016. The program was made possible by a Pennsylvania Department of Health ... and Human Services Administration. The broadcast, Use Your Head: Properly Managing Sport ...
(Date:12/8/2016)... ... 2016 , ... The Florida Hospital Tampa Wound Healing Institute ... (UHMS), the leading authority in hyperbaric medicine. This accreditation identifies the Institute as ... facilities have earned this distinction. This is the second time the Florida Hospital ...
(Date:12/8/2016)... (PRWEB) , ... December 08, 2016 , ... ... Donuts Franchising Company LLC, announced the first national #QuackGivesBack campaign which supported ... , “This was our first franchise-wide Quack Gives Back initiative, and ...
(Date:12/8/2016)... and JENNERSVILLE, Pa. (PRWEB) , ... December 08, ... ... that Penn Medicine Southern Chester County, a Property owned by an affiliate of ... million, 72,000 square foot Penn Medicine Southern Chester County ambulatory care center (ACC) ...
(Date:12/8/2016)... ... ... CURE Media Group, the nation’s leading digital and print media enterprise focused ... in efforts to combat lung cancer, announced CURE Media Group President Michael J. Hennessy, ... is honored to team up with Upstage Lung Cancer in order to make major ...
Breaking Medicine News(10 mins):