COPENHAGEN, Denmark, Oct. 24 /PRNewswire-FirstCall/ -- Genmab A/S (CSE: GEN) announced today it has initiated a Phase I/II study of HuMax- EGFr(TM) (zalutumumab) in combination with chemo-radiation as first line treatment of head and neck cancer. The study will include a total of 36 patients with advanced squamous cell carcinoma of the head and neck (SCCHN).
“We welcome the expansion of the HuMax-EGFr program, which we hope will benefit earlier stage patients,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
About the trial
The open label study consists of an initial dose-escalation part and a subsequent parallel group design. In the dose-escalation part of the study, three dose levels of HuMax-EGFr will be tested in combination with conventional fractionated radiotherapy and cisplatin. Patients in the first treatment group will receive one initial dose of 8 mg/kg of HuMax-EGFr followed by seven weekly maintenance doses of 4 mg/kg. The safety of this dose level will then be evaluated before dosing is continued at the next level. The planned dosing for the two other dose groups is an initial dose of 12 or 16 mg/kg followed by seven weekly maintenance doses of 8 or 12 mg/kg, respectively, but can be adjusted according to safety data from the first treatment group.
In the following parallel group design part of the study, HuMax-EGFr will be tested in combination with cisplatin and three different regimes of accelerated radiotherapy.
All patients in the study will be evaluated four weeks after administration of the last dose of HuMax-EGFr and will be followed for at least three years.
The objective of the study is to investigate the safety and efficacy of HuMax-EGFr in combination with chemo-radiation as first line treatment of patients with advanced SCCHN. The primary endpoint of the study is safety and patients will also be evaluated for efficacy.
About Genmab A/S
Genmab A/S is a biotechnology company that creates and develops human antibodies for the treatment of life-threatening and debilitating diseases. Genmab has numerous products in development to treat cancer, infectious disease, rheumatoid arthritis and other inflammatory conditions, and intends to continue assembling a broad portfolio of new therapeutic products. At present, Genmab has multiple partnerships to gain access to disease targets and develop novel human antibodies including agreements with Roche, Amgen and Serono. A broad alliance provides Genmab with access to Medarex, Inc.'s array of proprietary technologies, including the UltiMAb(R) platform for the rapid creation and development of human antibodies to virtually any disease target. Genmab, furthermore, develops antibody therapeutics based on its proprietary UniBody(TM) format. Genmab has operations in Copenhagen, Denmark, Utrecht, the Netherlands, Princeton, New Jersey, US and Hertfordshire in the United Kingdom. For more information about Genmab, 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- EGFr(TM); HuMax-Inflam(TM); HuMax-CD20(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); and UniBody(TM) are all trademarks of Genmab A/S. UltiMAb(R) is a trademark of Medarex, Inc.
Genmab A/S
CONTACT: Helle Husted, Director, Investor Relations for Genmab A/S,+45-33-44-77-30, M: +45-25-27-47-13, hth@genmab.com
Web site: http://www.genmab.com/
