and dont forget thi one for MEDX
Tuesday January 9, 07:20 AM
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GENMAB INITIATES SECOND PHASE II STUDY WITH HUMAX-CD4(TM)
This press release is transmitted on behalf of Genmab A/S Copenhagen, Denmark - Genmab A/S (CSE: GEN; Neuer Markt: GE9D) announced today that it has initiated a Phase II clinical trial with its fully human antibody HuMax(TM)-CD4 to treat patients with severe psoriasis.
This multi-center study will include four different dose levels plus a placebo arm and it is designed to provide safety and efficacy data, as well as dose finding information.
HuMax-CD4 Phase I/II results were presented at the American College of Rheumatology meeting in Philadelphia in November and showed that the fully human antibody was well tolerated and that patients' CD4 counts remained stable in response to the treatment.
In this single dose study, the four highest dose cohorts, 0.5, 1, 2 and 4 mg/kg, fifty percent of the treated patients achieved favorable responses to the antibody, as measured by objective criteria defined by the American College of Rheumatology and routinely used by companies seeking regulatory approval of arthritis products.
Eight of 16 achieved ACR 20, one of those achieved ACR 50, and two of the group achieved ACR 70.
"Genmab has achieved another development milestone with the initiation of this second Phase II study with HuMax-CD4," said Lisa.
N.
Drakeman, Ph.D., Chief Executive Officer.
"Current treatments can be extremely toxic to patients and new therapies are urgently needed for the millions of people who suffer from psoriasis." Genmab A/S is a biotechnology company that creates and develops fully human antibodies for the treatment of life-threatening and debilitating diseases.
Genmab has four products in development to treat cancer, rheumatoid arthritis and other inflammatory conditions, and intends to assemble a broad portfolio of new therapeutic products arising from research into the human genome.
At present, Genmab's commercial opportunities are based upon research conducted at leading international companies, such as Immunex Corporation, Gemini Genomics plc, Oxford GlycoSciences (LSE: OGS.L - news) Ltd., Eos Biotechnology Inc.
and Medarex, Inc.
as well as in its own laboratories.
A broad alliance provides Genmab with access to Medarex's array of proprietary technologies, including the HuMAb-Mouse(R), for the rapid creation and development of fully human antibodies to virtually any disease target.
For more information about Genmab, visit genmab.com.
Except for the historical information presented, certain matters discussed in this press release are forward-looking statements that are subject to a number of risks and uncertainties that could cause actual results to differ materially from results, performance or achievements expressed or implied by such statements such risks and uncertainties associated with product discovery and development including statements regarding the Company's clinical development programs and the expected timing of clinical trials and regulatory filings.
Such statements are based on management's current expectations, but actual results may differ materially.
HuMAb-Mouse is a registered trademark of Medarex, Inc. |
