COPENHAGEN, Denmark, Dec. 11 /PRNewswire-FirstCall/ -- Genmab A/S (CSE: GEN) announced today additional positive results in the HuMax-CD20(TM) (ofatumumab) Phase I/II study to treat patients with relapsed or refractory chronic lymphocytic leukemia (CLL). An objective response rate of 50% (13 of 26 evaluable patients) was observed in patients treated at the highest dose level (2000 mg). This included one nodular partial remission (nPR) confirmed by CT scan and one patient who qualified as nPR but had residual lymphadenopathy revealed by CT.
Responders include one additional patient compared to previously reported data.
The median time to disease progression in all patients treated at 2000 mg was approximately 16 weeks ranging from 15 to 23 weeks. In the patients responding to HuMax-CD20 treatment, the median time to disease progression was 23 weeks ranging from 20 - 31 weeks. The median time to next anti-CLL treatment was 52 weeks. These survival endpoints correlated statistically to the patients' total exposure to HuMax-CD20 over time and to the clearance of the antibody.
"The CLL patients in this study appear to have benefited from treatment with HuMax-CD20. These data strongly support further development of HuMax- CD20 in CLL," said Lisa N. Drakeman, Ph.D., Chief Executive Officer at Genmab.
These results are being presented at poster session #2842 on December 11 from 10:30AM to 7PM local time in Hall E1 West, board 71-III at the 48th Annual American Society of Hematology Annual Meeting and Exposition in Orlando, Florida.
About the study
The study is an open-label dose escalation trial that enrolled 33 patients who had failed previous therapy. The trial has three dose levels. Three patients at the first dose level received an initial dose of 100 mg followed by three weekly doses of 500 mg; at the second dose level three patients received a dose of 300 mg followed by three weekly doses of 1,000 mg; and at the third level, 27 patients received an initial dose of 500 mg followed by three weekly doses of 2,000 mg.
The total follow up period for this study is 12 months from treatment start and the primary endpoint of the trial is objective response over the period from screening to week 19. An objective response is one that lasts at least 8 weeks by the NCI working group guidelines for CLL.
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, +45 33 44 77 30, ormobile, +45 25 27 47 13, hth@genmab.com
Web site: http://www.genmab.com/
