COPENHAGEN, Denmark, May 30 Genmab A/S (OMX:GEN) announced today it has initiated a Phase I/II study of zalutumumab(HuMax-EGFr(TM)) in combination with irinotecan chemotherapy to treatcolorectal cancer (CRC). The study will include a maximum of 97 patients whohave failed standard chemotherapy and progressed during or within threemonths of stopping cetuximab-based therapy.
"We are glad to expand the zalutumumab program with this new indication,"said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
About the trial This open label study consists of two parts. In bothparts of the study, patients will receive weekly doses until diseaseprogression. Part 1 will include 3 to 15 patients who will receive weeklydoses of first 8mg/kg of zalutumumab in combination with bi-weekly irinotecanand if safe patients will subsequently receive 16 mg/kg zalutumumab incombination with irinotecan.
Part 2 will be an open label randomized parallel group enrolling 14 to 82patients pending the number of treatment arms and early termination from part1. Patients in part 2 will receive weekly doses of zalutumumab with orwithout bi-weekly irinotecan administration until disease progression. Intotal a maximum of 97 patients will be enrolled into the study.
Safety data from Part 1 of the trial will be evaluated by an independentdata monitoring committee who will determine if it is safe to begin Part 2.The objective of the study is to evaluate the safety and efficacy ofzalutumumab in combination with irinotecan. The primary endpoint of the studyis adverse events.
About Colorectal Cancer
CRC is a public health problem in developed countries. Althoughpotentially curable in early stages, a proportion of patients will presentwith or eventually develop metastatic, incurable disease.
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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