DAHANCA Initiates Head And Neck Cancer Study With Genmab's HuMax-EGFr

Main Category: Cancer / Oncology
Also Included In: Ear, Nose and Throat;  Clinical Trials / Drug Trials
Article Date: 14 Sep 2007 - 0:00 PDT

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Genmab A/S (OMX: GEN) announced the initiation of a Phase III study of HuMax- EGFr(TM) (zalutumumab) to treat head and neck cancer in cooperation with the Danish Head and Neck Cancer Group (DAHANCA). The study will include approximately 600 previously untreated head and neck cancer patients to assess whether concomitant therapy with HuMax-EGFr can improve the efficacy of primary curative radiotherapy.

"We are excited for DAHANCA to begin the largest HuMax-EGFr trial to date," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We hope that HuMax-EGFr provides additional benefit to head and neck cancer patients receiving radiotherapy."

About the trial

Patients in the study will be randomized to treatment with radiotherapy or HuMax-EGFr plus radiotherapy. All patients will receive treatment with accelerated radiotherapy plus nimorazole and may also receive cisplatin chemotherapy. Patients receiving HuMax-EGFr will receive six weekly doses of 8 mg/kg of HuMax-EGFr. Patients will be followed for at least 5 years and will be clinically evaluated at months 2, 5, 8 and 12 after completion of treatment. Evaluations will continue every 4 months in the second year and every 6 months the third and fourth year and once a year thereafter.

The objective of the study is to determine the efficacy of HuMax-EGFr in combination with radiotherapy in treating patients with squamous cell carcinoma of the head and neck. The primary endpoint is loco-regional control and secondary endpoints are overall survival, disease free survival and acute and late side effects.

About cancers of the head and neck

Head and neck cancers may affect the mouth, nasal cavities, sinuses, larynx and pharynx. Most are squamous carcinomas but others include lymphoepithelioma and lymphoma. Head and neck cancers account for 3 % of all cancers in the U.S., with 40,000-60,000 cases diagnosed and 12,000 deaths annually. Worldwide incidence is about half a million with nearly 250,000 deaths.

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-Inflam(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-ZP3(TM); and UniBody(TM) are all trademarks of Genmab A/S.

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

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