Genmab Initiates Study of Zalutumumab With Radiotherapy in Head and N... ( Summary: Genmab Initiates a Phase I/...)

Genmab Initiates Study of Zalutumumab With Radiotherapy in Head and Neck Cancer

Date:6/24/2008

Summary: Genmab Initiates a Phase I/II Study of Zalutumumab in Combination With Radiotherapy for the Treatment of Advanced Head and Neck Cancer.

COPENHAGEN, June 24 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today it has initiated a Phase I/II study of zalutumumab (HuMax-EGFr(TM)) in combination with radiotherapy for the treatment of advanced head and neck cancer. The study will include a maximum of 36 patients who are ineligible for platinum based chemotherapy.

"Platinum based chemotherapy is currently considered to be the best available standard treatment for advanced head and neck cancer. We hope zalutumumab may some day provide a treatment option for patients who are in need of less toxic therapies," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

About the trial

In the dose-escalation part of the study, 6 to 24 patients will be enrolled in cohorts of 3 patients per dose level of zalutumumab. The dose level for each successive cohort will be determined by the aggregate safety data observed in the prior cohorts. When the maximum tolerated dose of zalutumumab is established, an additional cohort of 12 patients will be enrolled and treated at this level.

Patients in the study will receive 8 weekly infusions of zalutumumab with the first cohort receiving an initial dose of 12 mg/kg of zalutumumab followed by 7 maintenance doses of 8 mg/kg of zalutumumab in addition to radiotherapy. Patients will be evaluated at 4 weeks following the last dose of zalutumumab and will be followed for a total of 2 years.

The objective of the study is to evaluate the safety of repeat dosing and establish the maximum tolerated dose of zalutumumab in combination with radiotherapy in patients with advanced head and neck cancer who are ineligible for platinum based chemotherapy. The primary endpoint of the study is adverse events.

About Genmab A/S

Genmab is a leading international biotechnology co
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