COPENHAGEN, November 9 /PRNewswire/ --
- Summary: Genmab Will Present Phase II Non-Cutaneous T-cell Lymphoma Zanolimumab Data and Pre-Clinical Ofatumumab Data on at the 2007 Annual Meeting of the American Society of Hematology in December.
Genmab A/S (OMX: GEN) announced today it will present clinical data from the zanolimumab (HuMax-CD4(R)) Phase II study in non-cutaneous T-cell lymphoma (NCTCL) and pre-clinical data on ofatumumab's (HuMax-CD20(R)) mechanisms of action in poster sessions at the 2007 Annual Meeting of the American Society of Hematology December 8-11 in Atlanta, Georgia, USA.
Additional positive results have been obtained in the Phase II study to treat patients with relapsed or refractory NCTCL. A total of 21 patients were enrolled in the study and received 980 mg of zanolimumab once weekly for 12 weeks. Objective tumor response was obtained in 5 of 21 patients (24%). Three patients obtained partial responses lasting 43 and 51 days with one patient not relapsing at 182 days. Two patients obtained a complete response unconfirmed, one lasting 46 days and one showing no relapse after 252 days. During the study period, a total of 6 serious adverse events were assessed as related to zanolimumab treatment and included 4 infusion related events. The patients with related serious adverse events completely recovered.
In a pre-clinical study, ofatumumab appeared to be more effective than rituximab in treating chemotherapy refractory diffuse large B-cell lymphoma (DLBCL). Ofatumumab was significantly more effective in inducing the immune system killing mechanism complement dependent cytotoxicity (CDC) in 9 of 10 DLBCL tumor samples when compared to rituximab. In addition, the dose of ofatumumab required to kill the patients' tumor cells was lower than that required for rituximab.
In an additional pre-clinical study, B-cells incubated with cholesterol depleting agents called statins were found to be killed less effectively by CD20 monoclonal antibodies. Importantly, cell lysis of statin-treated B-cells was consistently higher when using ofatumumab in comparison to rituximab. Statin incubation was shown to induce conformational changes in the CD20 target and impaired the binding of ofatumumab and rituximab to the CD20 molecule.
Previously reported data illustrating that ofatumumab appears to induce CDC of target cells far more rapidly and effectively than rituximab will also be presented at the ASH conference.
Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of B-cells. This epitope is different to the other anti-CD20 antibodies currently available or in development. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.
"We are pleased to present this new information on zanolimumab and ofatumumab at the ASH conference," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "The response rate in the zanolimumab trial for NCTCL is encouraging and we look forward to investigating zanolimumab in combination with other therapies for NCTCL."
ASH Poster Sessions Poster 628 - Zanolimumab (HuMax-CD4), a Fully Human Monoclonal Antibody: Efficacy and Safety in Patients with Relapsed or Treatment-Refractory Non-Cutaneous CD4+ T-cell Lymphoma
Poster 536 - Chemotherapy-Refractory Diffuse Large B-Cell Lymphomas (DLBCL) Are Effectively Killed by Ofatumumab-Induced Complement-Mediated Cytoxicity
Poster 531 - Statins Impair Antitumor Effects of CD20 mAb by Inducing Conformational Changes of CD20
Poster 1499 - Spinning Disk Confocal Fluorescent Microscopy (SDCFM) Analyses of Complement Activation Promoted by Anti-CD20 Monoclonal Antibodies (mAbs) Rituximab and Ofatumumab
Poster 1506 - Complement Activation and Complement-Mediated Killing of B Cells Promoted by Anti-CD20 Monoclonal Antibodies (mAb) Rituximab and Ofatumumab Are Rapid, and Ofatumumab Kills Cells More Rapidly and with Greater Efficacy
A/S Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for unmet medical needs. Using unique, cutting-edge antibody technology, Genmab's world class discovery and development teams have created and developed an extensive pipeline of products for potential treatment of a variety of diseases including cancer and autoimmune disorders. As Genmab advances towards a commercial future, we remain committed to our primary goal of improving the lives of patients who are in urgent need of new treatment options. For more information on Genmab's products and technology, 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 up-date 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.
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