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These study amendments have been agreed to by the FDA under the SpecialProtocol Assessment agreement already in place.
In addition, HuMax-CD4 has received an orphan drug designation for thetreatment of refractory CTCL in Australia and for the treatment of refractorynodal T-cell lymphoma in Europe. HuMax-CD4 previously received Fast TrackStatus from the FDA and orphan drug status in the US and Europe for thetreatment of refractory CTCL.
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"We believe expanding the HuMax-CD4 pivotal study to include a broadergroup of CTCL patients will allow us to speed up patient enrollment, test ata more effective dose level and potentially offer treatment for SezarySyndrome patients as well as MF patients," said Lisa N. Drakeman, Ph.D.,Chief Executive Officer of Genmab. "The potential of HuMax-CD4 in treatingT-cell lymphoma patients with unmet medical needs continues to be recognizedby the international regulatory authorities."
About Genmab A/S
Genmab is a leading international biotechnology company focused ondeveloping fully human antibody therapeutics for unmet medical needs. Usingunique, cutting-edge antibody technology, Genmab's world class discovery anddevelopment teams have created and developed an extensive pipeline ofproducts for potential treatment of a variety of diseases including cancerand autoimmune disorders. As Genmab advances towards a commercial future, weremain committed to our primary goal of improving the lives of patients whoare in urgent need of new treatment options. For more information on Genmab'sproducts and technology, visit http://www.genmab.com.
This press release contains forward looking statements. The words"believe", "expect", "anticipate", "intend" and "plan" and similarexpressions identify forward looking statements. Actual results orperformance may differ materially from any future results or performanceexpressed or implied by such statements. The important factors that couldcause our actual results or performance to differ materially include, amongothers, risks associated with product discovery and development,uncertainties related to the outcome and conduct of clinical trials includingunforeseen safety issues, uncertainties related to product manufacturing, thelack of market acceptance of our products, our inability to manage growth,the competitive environment in relation to our business area and markets, ourinability to attract and retain suitably qualified personnel, theunenforceability or lack of protection of our patents and proprietary rights,our relationships with affiliated entities, changes and developments intechnology which may render our products obsolete, and other factors. Genmabis not under an obligation to up-date statements regarding the futurefollowing the publication of this release; nor to confirm such statements inrelation 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-Inflam(TM); HuMax-TAC(TM);HuMax-HepC(TM); HuMax-CD38(TM); HuMax-ZP3(TM); and UniBody(TM) are alltrademarks of Genmab A/S.
Stock Exchange Release no. 48/2007
SOURCE Genmab A/S
