Genmab Announces Partial Clinical Hold on Zalutumumab Studies |
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COPENHAGEN, Denmark, June 3, 2009 (GLOBE NEWSWIRE) -- Summary: Genmab announces that the FDA has placed a partial clinical hold on zalutumumab clinical trials. Genmab A/S (Copenhagen:GEN) announced today that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on zalutumumab clinical studies being conducted under the U.S. Investigational New Drug (IND) application, as well as requests for new studies. The affected studies are the Phase II study in patients with head and neck cancer considered incurable with standard treatment and the Phase I/II front line study of zalutumumab in combination with chemo-radiation. The partial clinical hold does not affect the two ongoing Phase III studies of zalutumumab in head and neck cancer or the Phase I/II study of zalutumumab in combination with radiotherapy as these are conducted outside the U.S. IND. Results from the pivotal Phase III study in refractory head and neck cancer, for which 264 patients have been recruited to date, are still expected by the end of 2009. A partial clinical hold is a delay or suspension of only part of the clinical work requested under an IND. Under the partial clinical hold on zalutumumab, patients already enrolled in the Phase II and Phase I/II studies who are not experiencing serious adverse events may continue to receive treatment, however, no additional patients may be enrolled. The FDA has requested an updated analysis of safety data since the company's most recent annual report which covered the period through July 29, 2008. Genmab is working to respond to the request and expects to make the required submission shortly. "Genmab is fully committed to working with the FDA to meet their requests for additional information and to resume enrollment in the affected zalutumumab clinical trials as quickly as possible," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. About zalutumumab Zalutumumab is a high-affinity human antibody that targets the Epidermal Growth Factor receptor (EGFr), a molecule found in abundance on the surface of many cancer cells, and is a well validated target. Zalutumumab is in development to treat head and neck cancer and has received a Fast Track designation from the FDA covering patients with head and neck cancer who have previously failed standard therapies. About Genmab A/S Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. Genmab's world class discovery, development and manufacturing teams are using cutting-edge technology to create and develop products to address unmet medical needs. Our primary goal is to improve the lives of patients who are in urgent need of new treatment options. For more information on Genmab's products and technology, visit www.genmab.com. This Stock Exchange 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. For a further discussion of these risks, please refer to the section "Risk Management" in Genmab's Annual Report, which is available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward-looking statements in this Stock Exchange Release nor to confirm such statements in relation to actual results, unless required by law. Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD20(R); HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-CD32b(TM); HuMax-TF(TM); HuMax-Her2(TM); HuMax-VEGF(TM) and UniBody(R) are all trademarks of Genmab A/S. Arzerra(TM) is a trademark of GlaxoSmithKline. |
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