суббота, 28 мая 2011 г.

Genmab Announces Positive Interim Data For The HuMax-CD20 Phase II RA Study

Genmab A/S (CSE:
GEN) announced today positive results from an interim analysis of the first
100 patients in the ongoing Phase II rheumatoid arthritis (RA) study. A
statistically significant proportion of patients on active treatment
obtained a 20% improvement of the American College of Rheumatology (ACR)
response compared to patients treated with placebo. Correspondingly, in all
groups treated with HuMax-CD20, a greater proportion of patients benefited
from moderate or good EULAR responses compared to placebo.



Rates of overall adverse events were comparable between the 3 groups of
patients receiving HuMax-CD20 these were primarily infusion related and do
not limit plans for continued development. Serious infections among treated
patients were confined to one event of bronchopneumonia in the 300 mg dose
group.



With this data in hand, Genmab will start planning Phase III studies.
These studies are expected to begin in 2007.



"The interim data are comparable to the Phase I/II RA data trial
released earlier this year and support our plan to move into Phase III with
HuMax-CD20 in RA," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of
Genmab. "Our fully human antibody should be suitable for treating
chronically ill patients and we look forward to continued development of
this potential alternative to available treatments."



There are 226 patients enrolled in the Phase II study which completed
accrual in September. Genmab expects to present results for the full Phase
II study during the first half of 2007. This analysis was carried out to
assist in decision making and planning for the expected Phase III studies
in RA.



About the study



The study is a double-blind, randomized, placebo controlled,
multicenter Phase II trial for patients with active RA who have previously
failed one or more DMARDs. Patients were randomized to one of 4 treatment
groups (300 mg, 700 mg or 1000 mg of HuMax-CD20 or placebo). Patients were
permitted to continue therapy with stable doses of methotrexate and low
dose prednisolone was also allowed. ACR and EULAR responses were assessed
in the primary intention-to-treat efficacy population at 24 weeks.



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 and Amgen. 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. In addition, Genmab has developed
UniBody(TM), a new proprietary technology that creates a stable, smaller
antibody 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 genmab.
















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 update 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

genmab

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