Navigation Links
Genmab Amends HuMax-CD4 Pivotal Study in CTCL

Receives Orphan Drug Designation for Nodal T-Cell Lymphoma

Summary: Genmab Announced Today it has Amended the Ongoing HuMax-CD4 Pivotal Study to Treat Refractory CTCL and has Received an Orphan Drug

Designation for the Treatment of Nodal T-Cell Lymphoma

COPENHAGEN, Denmark, October 11 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today it has amended the design of the ongoing pivotal study of HuMax-CD4(R) (zanolimumab) to treat refractory cutaneous T-cell lymphoma (CTCL) patients. The study which previously only included patients with the Mycosis Fungoides (MF) form of CTCL has been expanded to include patients with Sezary Syndrome as well. Furthermore, due to higher response rates observed at the 14 mg/kg dose level during the first part of the pivotal study, the 8 mg/kg dose level will now be discontinued, with all patients to be treated with 14 mg/kg of HuMax-CD4 once a week for 12 weeks.

These study amendments have been agreed to by the FDA under the Special Protocol Assessment agreement already in place.

In addition, HuMax-CD4 has received an orphan drug designation for the treatment of refractory CTCL in Australia and for the treatment of refractory nodal T-cell lymphoma in Europe. HuMax-CD4 previously received Fast Track Status from the FDA and orphan drug status in the US and Europe for the treatment of refractory CTCL.

"We believe expanding the HuMax-CD4 pivotal study to include a broader group of CTCL patients will allow us to speed up patient enrollment, test at a more effective dose level and potentially offer treatment for Sezary Syndrome patients as well as MF patients," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "The potential of HuMax-CD4 in treating T-cell lymphoma patients with unmet medical needs continues to be recognized by the international regulatory authorities."

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

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-Inflam(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-ZP3(TM); and UniBody(TM) are all trademarks of Genmab A/S.

Stock Exchange Release no. 48/2007

Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Antibodies for Studying NMDA Receptor Protein Expression and Synapse-Specific Immunolabeling
2. Optimizing Transfection Conditions for Studying Signal Transduction Pathways
3. Enzyme Immunoassay for Studying Intracellular Levels of cAMP
4. RT-PCR Primers for the Study of Apoptosis
5. A Comparison Study of Lipid Tranfection Reagents in A549, NIH 3T3 and COS-7 Cell Lines
6. New Reporter Plasmids for Studying Interferon-Stimulated Signal Transduction Pathways
7. New Fusion Trans-Activator Plasmids for Studying Signal Transduction Pathways
8. Medical College receives $377K to study brain disease
9. Kauffman study shows consistent entrepreneurial growth
10. Study affirms information technology-productivity link
11. Deltanoid Pharmaceuticals begins phase II osteoporosis study
Post Your Comments:
(Date:6/23/2016)... ... June 23, 2016 , ... Charm ... Mold) microbial test has received AOAC Research Institute approval 061601. , “This is ... last year,” stated Bob Salter, Vice President of Regulatory and Industrial Affairs. “The ...
(Date:6/23/2016)... NEW YORK , June, 23, 2016  The ... students to envision new ways to harness living systems ... of Modern Art (MoMA) in New York ... more than 130 participating students, showcased projects at MoMA,s ... included Paola Antonelli , MoMA,s senior curator of ...
(Date:6/23/2016)... ... 23, 2016 , ... Supplyframe, the Industry Network for electronics ... Lab . Located in Pasadena, Calif., the Design Lab’s mission is to bring ... designed, built and brought to market. , The Design Lab is Supplyframe’s physical ...
(Date:6/23/2016)... ... June 23, 2016 , ... In a new case report ... detail how a patient who developed lymphedema after being treated for breast cancer benefitted ... change the paradigm for dealing with this debilitating, frequent side effect of cancer treatment. ...
Breaking Biology Technology:
(Date:6/3/2016)... June 3, 2016 ... Nepal hat ein ... hochsicherer geprägter Kennzeichen, einschließlich Personalisierung, Registrierung und ... der Produktion und Implementierung von Identitätsmanagementlösungen. Zahlreiche ... im Januar teilgenommen, aber Decatur wurde als ...
(Date:5/24/2016)... Calif. , May 24, 2016 Ampronix facilitates superior patient care by ... LMD3251MT  3D medical LCD display is the latest premium product recently added to the ... ... ... Sony 3d Imaging- LCD Medical Display- Ampronix News ...
(Date:5/3/2016)... VILNIUS, Lithuania , May 3, 2016 /PRNewswire/ ... today released the MegaMatcher Automated Biometric Identification ... deployment of large-scale multi-biometric projects. MegaMatcher ABIS can ... and accuracy using any combination of fingerprint, face ... of MegaMatcher SDK and MegaMatcher ...
Breaking Biology News(10 mins):