Genmab Initiates HuMax-CD20 Front Line CLL Study

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Blood / Hematology;  Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 24 Dec 2006 - 0:00 PDT

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Genmab A/S (CSE: GEN) announced today it has initiated a Phase II study of HuMax-CD20(TM) (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients. A total of 56 patients will be enrolled in the study.

"Disease progression in patients with advanced CLL is usually rapid and we hope using HuMax-CD20 in combination with FC as first line therapy will result in significant disease improvement for these patients," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

About the trial

Patients in this open label study will be randomized into two treatment groups of 28 patients each. Each patient will receive 6 monthly infusions of either 500 or 1000 mg of HuMax-CD20 in combination with FC. Disease status will be measured every 4 weeks until week 24 according to National Cancer Institute Working Group Guidelines and every 3 months thereafter until disease progression or 24 months. Patients not having progressed on their disease at 24 months, will be followed for disease progression at 6 month intervals until 48 months.

The objective in the study is to determine the efficacy of HuMax-CD20 in combination with FC in previously untreated CLL patients. The primary endpoint is complete remission measured at any time during the treatment period.

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 and Amgen. 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. In addition, Genmab has developed UniBody(TM), a new proprietary technology that creates a stable, smaller antibody format. Genmab has operations in Copenhagen, Denmark, Utrecht, the Netherlands, Princeton, New Jersey, US and Hertfordshire in the United Kingdom. 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); HuMax-CD38(TM); and UniBody(TM) are all trademarks of Genmab A/S.

UltiMAb(R) is a trademark of Medarex, Inc.

Genmab A/S
http://www.genmab.com