Navigation Links
Genmab Amends HuMax-CD4 Pivotal Study in CTCL
Date:10/11/2007

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 focu
'/>"/>

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

Page: 1 2 3

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:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... GEA Niro Soavi the leader in ... the PandaPLUS 2000, which is ideal for new applications ... cell disruption . This compact laboratory homogenizer is the ... food, food additives and ingredients as well as for ...
(Date:1/22/2015)... OH (PRWEB) January 22, 2015 Crystal Diagnostics ... today that it has received AOAC-PTM Certifications for the six ... O121, and O145; collectively referred to as STEC or the ... 1 colony forming unit (cfu) per 325 g of raw ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 Selexis SA, ... mammalian Research Cell Banks (RCBs) used for drug discovery ... Cell Banks will include Next-Generation Sequencing (NGS) ... architecture de-risks biologic manufacturing by ensuring the integrity of ...
(Date:1/22/2015)... CAMBRIDGE, Mass. , Jan. 22, 2015   GenoSpace , ... suite of tools to enable the broad use of genomic, ... today announced the appointment of Michelle Munson , CEO ... independent director. Logo - http://photos.prnewswire.com/prnh/20150122/170713 ...
Breaking Biology Technology:GEA Niro Soavi Announces the PandaPLUS 2000 Homogenizer for Processing New Applications for Nanoemulsions and Cell Disruption 2Crystal Diagnostics Awarded AOAC-PTM Accreditation for the Rapid Detection of “Big 6” E.coli Food Pathogens 2Selexis Generated Research Cell Banks Now Fully Sequenced Using Next-Generation Sequencing 2GenoSpace Expands Board with Appointment of Michelle Munson 2
... NV,(Euronext Brussels: THR), a biotechnology company focused on ... is today issuing a,business update for the nine ... De Haes, CEO of ThromboGenics, commenting on today,s,announcement, ... anticipated. We are now working hard to prepare ...
... 6 AmeriCares has,awarded its annual "Power ... global biotechnology, medical device and specialty pharmaceutical,company. ... Distribution,Management Association,s (HDMA) Annual Leadership Forum in ... award was created by AmeriCares and HDMA ...
... Calif., Nov. 6 ( http://www.amdl.com ),AMDL, Inc. ... with major operations in China and the U.S., ... Douglas MacLellan will present at,Rodman & Renshaw,s Annual ... 2008 at the New York Palace Hotel in ...
Cached Biology Technology:ThromboGenics N.V.: Business Update 2ThromboGenics N.V.: Business Update 3ThromboGenics N.V.: Business Update 4ThromboGenics N.V.: Business Update 5ThromboGenics N.V.: Business Update 6ThromboGenics N.V.: Business Update 7ThromboGenics N.V.: Business Update 8AmeriCares Presents 'Power of Partnership' Award to Baxter 2AmeriCares Presents 'Power of Partnership' Award to Baxter 3AMDL, Inc. New President & CEO Douglas MacLellan to Present at Rodman & Renshaw Annual Global Investment Conference November 12, 2008 2
(Date:12/17/2014)... The Defense Logistics Agency is insourcing its efforts ... microcircuits from entering into its supply chain. ... initiative dubbed DNA marking. The capability will validate the ... the supply chain. The new quality control measures will ...
(Date:12/17/2014)... RALEIGH, N.C. , Dec. 16, 2014 Valencell, ... licensed its PerformTek biometric technology to industry leaders such ... highly accurate, clinically validated, biometric wearable products. These products ... 6-9 in Las Vegas . ...
(Date:12/17/2014)... , Dec. 16, 2014  Automation is fundamentally transforming ... than at international borders. Over the past decade, ePassports, ... travelers to self process through border control via eGates ... number of airports, seaports, and land borders across the ...
Breaking Biology News(10 mins):Defense Logistics Agency Launches DNA Marking Capability to Strengthen Microcircuit Supply Chain 2Defense Logistics Agency Launches DNA Marking Capability to Strengthen Microcircuit Supply Chain 3Valencell PerformTek Biometrics Power the Most Accurate Wearables at CES 2015 2Automated Border Control (ABC) Transforms the Global Travel Experience With More Than 2500 ABC eGates and APC Kiosks Deployed In Airports, Seaports, and Land Borders Worldwide 2
... Panel of the American Association of Feline Practitioners ... feline patients based on risk assessment., From ... (2013) The American Association of Feline Practitioners, ... released updated guidelines on appropriate feline vaccination schedules ...
... process. Identification of important areas and species with ... objectives. China is one of mega-biodiversity countries of ... environmental degeneration, native and endemic species of China ... decades. It is an urgent agenda to set ...
... JPMorgan Chase & Co. (NYSE: JPM) and the Bill ... allow individual and institutional investors the opportunity to finance ... save millions of lives in low-income countries. ... investors including anchor support from Grand Challenges Canada ...
Cached Biology News:Appropriate vaccinations schedules for feline patients outlined 2Richness mapping and prediction of amphibians in Southern and Central China 2New investment fund will advance late-stage vaccines, other global health technologies 2New investment fund will advance late-stage vaccines, other global health technologies 3New investment fund will advance late-stage vaccines, other global health technologies 4
... The new Finnigan Pocket Surveyor software ... and existing Finnigan Surveyor HPLC Systems. ... computer running the popular Windows Pocket ... the ability to connect directly to ...
... separation and fractionation of nucleic-acid ... nuclei from cytosolic proteins A ... greatly facilitating study of low-abundance ... acid binding proteins (e.g., transcription ...
... solution is an isotonic, balanced salt solution. It ... permits the storage of whole blood at refrigerator ... equal volume of blood is collected into a ... mixed. The solution is placed in a refrigerator ...
... Hollandes is a fixative useful for ... fixation. It is stable and will decalcify ... with Hollande's can be stained successfully with ... the solution stabilizes red blood cell membranes ...
Biology Products: