Healthcare Industry News: Zalutumumab
News Release - September 14, 2006
Genmab Initiates HuMax-EGFr Pivotal Study In Refractory Head and Neck CancerCOPENHAGEN, Denmark, Sept. 14 (HSMN NewsFeed) -- Genmab A/S (CSE: GEN ) announced today it has initiated a Phase III pivotal study with HuMax- EGFr(TM) (Zalutumumab) to treat patients with head and neck cancer that is considered incurable with standard treatment.
The pivotal study will include a maximum of 273 patients with squamous cell carcinoma of the head and neck (SCCHN) who are refractory to or intolerant of standard platinum-based chemotherapy.
"We are eager to begin the HuMax-EGFr pivotal study and are looking forward to starting treatment of these very sick head and neck cancer patients with the aim of increasing their life expectancy," said Lisa N. Drakeman, Ph.D., Chief Executive Officer.
About the trial
Patients in the study will be randomized into two treatment groups: HuMax-EGFr in combination with best supportive care or best supportive care alone. Patients treated with HuMax-EGFr in combination with best supportive care will receive an initial dose of 8mg/kg of HuMax-EGFr, followed by weekly infusions of a maintenance dose until disease progression. The maintenance dose will be adjusted as necessary until the patient develops a dose limiting skin rash, up to a maximum dose of 16 mg/kg of HuMax-EGFr. Disease status will be assessed every 8 weeks by CT scan or MRI according to RECIST criteria until disease progression and patients will be followed for survival.
The objective of the study is to evaluate the efficacy of HuMax-EGFr in combination with best supportive care as compared to best supportive care alone in terms of overall survival. The primary endpoint in the study is overall survival from randomization until death.
Genmab will hold a conference call to discuss the news today, Thursday, September 14 at:
The dial in numbers are as follows:
+1 800 274 0873 (in the US) and ask for the Genmab conference call
+1 719 457 2684 (outside the US) and ask for the Genmab conference call
To listen to a live webcast of the call please visit: https://cis.premconf.com/sc/scw.dll/usr?cid=vlllrznldxlvdncdl
The conference call will be held in English.
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® platform for the rapid creation and development of human antibodies to virtually any disease target. 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 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®; the Y-shaped Genmab logo®; HuMax®; HuMax-CD4®; HuMax- EGFr(TM); HuMax-Inflam(TM); HuMax-CD20(TM); HuMax-TAC(TM); HuMax-HepC(TM) and HuMax-CD38(TM) are all trademarks of Genmab A/S. UltiMAb® is a trademark of Medarex, Inc.
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