COPENHAGEN, Denmark, July 10 /PRNewswire-FirstCall/ -- Genmab A/S (CSE: GEN) announced today it has initiated a pivotal study to treat follicular non- Hodgkin’s lymphoma (NHL) patients who are refractory to rituximab.
The pivotal study will include approximately 162 NHL patients who are refractory to rituximab in combination with chemotherapy or to rituximab given as maintenance treatment.
“NHL is the second indication to enter a pivotal study for HuMax-CD20(TM),” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We now have two possible pathways to initial approval for HuMax-CD20 targeting two different disease indications.”
About the trial
Patients in the study will be randomized into two dose groups. Patients in each dose group will receive one infusion of 300 mg of HuMax-CD20 followed by 7 weekly infusions of either 500 or 1000 mg of HuMax-CD20. Disease status will be assessed every 3 months until month 24.
The objective of the study is to determine the efficacy and safety of two dose regimens of HuMax-CD20. 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 response criteria for non-Hodgkin’s lymphomas.
Conference Call
Genmab will hold a conference call to discuss the news today, Monday, July 10, 2006 at:
8.30 am CEST 7.30 am BST 2.30 am EDT To participate in the call by phone, please dial: +1 800 289 0496 (in the US) and ask for the Genmab conference call +1 913 981 5519 (outside the US) and ask for the Genmab conference call
To listen to a live webcast of the call please visit: https://cis.premconf.com/sc/scw.dll/usr?cid=vlllrzrwnlsvwxmlc
The conference call will be held in English.
About Genmab A/S
Genmab A/S is a biotechnology company that creates and develops human antibodies for the treatment of life-threatening and debilitating diseases. Genmab has numerous products in development to treat cancer, infectious disease, rheumatoid arthritis and other inflammatory conditions, and intends to continue assembling a broad portfolio of new therapeutic products. At present, Genmab has multiple partnerships to gain access to disease targets and develop novel human antibodies including agreements with Roche, Amgen and Serono. A broad alliance provides Genmab with access to Medarex, Inc.'s array of proprietary technologies, including the UltiMAb(R) platform for the rapid creation and development of human antibodies to virtually any disease target. Genmab has operations in Copenhagen, Denmark, Utrecht, the Netherlands, and Princeton, New Jersey in the US. For more information about Genmab, 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- EGFr(TM); HuMax-Inflam(TM); HuMax-CD20(TM); HuMax-TAC(TM); HuMax-HepC(TM) and HuMax-CD38(TM) are all trademarks of Genmab A/S.
UltiMAb(R) is a trademark of Medarex, Inc.
Genmab A/S
CONTACT: Helle Husted, Director, Investor Relations of Genmab A/S,+45-33-44-77-30, or Mobile: +45-25-27-47-13, hth@genmab.com
Web site: http://www.genmab.com/
