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 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.
Helle Husted, Sr. Director, Investor Relations
|SOURCE Genmab A/S|
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