COPENHAGEN, Denmark, May 30 /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 irinotecan chemotherapy to treat colorectal cancer (CRC). The study will include a maximum of 97 patients who have failed standard chemotherapy and progressed during or within three months 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 both parts of the study, patients will receive weekly doses until disease progression. Part 1 will include 3 to 15 patients who will receive weekly doses of first 8mg/kg of zalutumumab in combination with bi-weekly irinotecan and if safe patients will subsequently receive 16 mg/kg zalutumumab in combination with irinotecan.
Part 2 will be an open label randomized parallel group enrolling 14 to 82 patients pending the number of treatment arms and early termination from part 1. Patients in part 2 will receive weekly doses of zalutumumab with or without bi-weekly irinotecan administration until disease progression. In total a maximum of 97 patients will be enrolled into the study.
Safety data from Part 1 of the trial will be evaluated by an independent data 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 of zalutumumab in combination with irinotecan. The primary endpoint of the study is adverse events.
About Colorectal Cancer
CRC is a public health problem in developed countries. Although potentially curable in early stages, a proportion of patients will present with or eventually develop metastatic, incurable disease.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for unmet medical needs. Using cutting-edge antibody technology, Genmab's world class discovery, development and manufacturing 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-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-CD32b(TM) and UniBody(R) are all trademarks of Genmab A/S.
SOURCE Genmab A/S
