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"Platinum based chemotherapy is currently considered to be the bestavailable standard treatment for advanced head and neck cancer. We hopezalutumumab may some day provide a treatment option for patients who are inneed of less toxic therapies," said Lisa N. Drakeman, Ph.D., Chief ExecutiveOfficer of Genmab.
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About the trial
In the dose-escalation part of the study, 6 to 24 patients will beenrolled in cohorts of 3 patients per dose level of zalutumumab. The doselevel for each successive cohort will be determined by the aggregate safetydata observed in the prior cohorts. When the maximum tolerated dose ofzalutumumab is established, an additional cohort of 12 patients will beenrolled and treated at this level.
Patients in the study will receive 8 weekly infusions of zalutumumab withthe first cohort receiving an initial dose of 12 mg/kg of zalutumumabfollowed by 7 maintenance doses of 8 mg/kg of zalutumumab in addition toradiotherapy. Patients will be evaluated at 4 weeks following the last doseof zalutumumab and will be followed for a total of 2 years.
The objective of the study is to evaluate the safety of repeat dosing andestablish the maximum tolerated dose of zalutumumab in combination withradiotherapy in patients with advanced head and neck cancer who areineligible for platinum based chemotherapy. The primary endpoint of the studyis adverse events.
About Genmab A/S
Genmab is a leading international biotechnology company focused ondeveloping fully human antibody therapeutics for unmet medical needs. Usingcutting-edge antibody technology, Genmab's world class discovery, developmentand manufacturing teams have created and developed an extensive pipeline ofproducts for potential treatment of a variety of diseases including cancerand autoimmune disorders. As Genmab advances towards a commercial future, weremain committed to our primary goal of improving the lives of patients whoare in urgent need of new treatment options. For more information on Genmab'sproducts and technology, visit http://www.genmab.com.
This press release contains forward looking statements. The words"believe", "expect", "anticipate", "intend" and "plan" and similarexpressions identify forward looking statements. Actual results orperformance may differ materially from any future results or performanceexpressed or implied by such statements. The important factors that couldcause our actual results or performance to differ materially include, amongothers, risks associated with product discovery and development,uncertainties related to the outcome and conduct of clinical trials includingunforeseen safety issues, uncertainties related to product manufacturing, thelack of market acceptance of our products, our inability to manage growth,the competitive environment in relation to our business area and markets, ourinability to attract and retain suitably qualified personnel, theunenforceability or lack of protection of our patents and proprietary rights,our relationships with affiliated entities, changes and developments intechnology which may render our products obsolete, and other factors. Genmabis not under an obligation to up-date statements regarding the futurefollowing the publication of this release; nor to confirm such statements inrelation to actual results, unless this is required by law.
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