Updates on Phase III Studies With Ofatumumab, Zalutumumab and Zanolimumab
COPENHAGEN, Denmark, May 29 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) reports today that the last patient to be included in the planned interim analysis (N=132 patients) in the pivotal Phase III clinical trial of ofatumumab (HuMax-CD20(R)) in refractory chronic lymphocytic leukemia (CLL) has now received the last scheduled treatment.
In order to complete the database and allow for assessment of the responses by an independent committee, the final data will now be collected and analysed with the results expected in early August 2008. Pending a positive outcome, a Biologics License application in this indication is expected to be filed before the end of 2008.
Ofatumumab is an investigational drug being developed to treat CLL, follicular non-Hodgkin's lymphoma, diffuse large B-cell lymphoma and rheumatoid arthritis under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.
Genmab also reported that to date, 132 patients have been dosed in the pivotal Phase III study of zalutumumab (HuMax-EGFr(TM)) to treat head and neck cancer patients considered incurable with standard therapy. As survival is the primary endpoint of this study, a planned interim analysis will take place based on the survival data for patients participating in the study. At present, the Company expects this analysis to occur in 2008, but the exact timing cannot be predicted.
In addition, Genmab announced that based on current recruitment rates, despite broadening the inclusion criteria, the Company does not expect the data to be available this year from the ongoing pivotal Phase III study with zanolimumab (HuMax-CD4(R)) in refractory cutaneous T-cell lymphoma patients.
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. 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); HuMax-CD32b(TM) and UniBody(R) are all trademarks of Genmab A/S.
Contact: Helle Husted, Sr. Director, Investor Relations, T: +45-33-44-77-30, M: +45-25-27-47-13, E: firstname.lastname@example.org
|SOURCE Genmab A/S|
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