COPENHAGEN, Denmark, Dec. 5 /PRNewswire-FirstCall/ -- 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 http://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 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/SCONTACT: Helle Husted, Director, Investor Relations, Genmab A/S, T: +45 3344 77 30, M: +45 25 27 47 13, or E: hth@genmab.com
Web site: http://www.genmab.com/
