Genmab Initiates Ofatumumab Phase II Study in Diffuse Large B-Cell Lymphoma

Summary: Genmab has Initiated a Phase II Study of Ofatumumab in Relapsed

Diffuse Large B-Cell Lymphoma

    COPENHAGEN, Denmark, December 13 /PRNewswire-FirstCall/ -- Genmab A/S
 (OMX: GEN) announced today that study centers have been initiated and are
 ready to enroll patients in a Phase II study of ofatumumab (HuMax-CD20(R))
 to evaluate treatment of relapsed Diffuse Large B-Cell Lymphoma (DLBCL) in
 patients ineligible for or relapsed following a stem cell transplant.
 Approximately 75 patients will be enrolled in the study which is being
 conducted under Genmab's collaboration with GlaxoSmithKline (GSK). Genmab
 will receive a milestone payment of approximately DKK 87.2 million from GSK
 upon treatment of the first patient in the study, expected in the near
 future.
 
     Ofatumumab is an investigational, fully human, next generation
 monoclonal antibody that targets a unique epitope of the CD20 receptor on
 the surface of B-cells. Other anti-CD20 antibodies currently available or
 in development bind to a different epitope on the CD20 receptor. Ofatumumab
 is being developed under a co-development and commercialization agreement
 between Genmab and GlaxoSmithKline.
 
     "We have now expanded the ofatumumab clinical development program into
 a fourth disease area," said Lisa N. Drakeman, Ph.D., Chief Executive
 Officer of Genmab. "We hope ofatumumab will offer a new and effective
 treatment option for patients suffering from DLBCL."
 
     About the trial
 
     In this open label trial, each patient will receive 8 weekly infusions
 of ofatumumab. The first infusion will be 300 mg and the 7 subsequent
 infusions will be 1000 mg of ofatumumab. Disease status will be assessed 4
 weeks after the last infusion and then every 3 months for a total of 24
 months after treatment start according to the "Revised response criteria
 for malignant lymphoma." After 24 months, patients will be followed until
 initiation of alternative DLBCL treatment or month 60. The objective of the
 study is to determine the efficacy of ofatumumab in patients with relapsed
 DLBCL ineligible for transplant or relapsed after transplant. The primary
 endpoint of the study is objective response over a 6 month period from
 start of treatment.
 
     About Diffuse Large B-Cell Lymphoma
 
     Diffuse Large B-Cell Lymphoma is a cancer of the B-lymphocytes and
 represents 30% of non-Hodgkin's lymphomas in adults and is the most common
 lymphoid malignancy in the western world. There are an estimated 63,000 new
 cases of DLBCL diagnosed in the US per year. The median age at diagnosis is
 about 65 years.
 
     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 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); and UniBody(R) are all trademarks of Genmab
 A/S.
 
 
 

SOURCE Genmab A/S