Genmab says data expected from pivotal Hu-Max-CD20 study in 2007

By Jennifer Lanning Drey

Eugene, Ore., May 24 - Genmab A/S expects to have data in 2007 from its pivotal phase 3 study to evaluate the efficacy and safety of HuMax-CD20 (ofatumumab) in the treatment of refractory B-cell chronic lymphocytic leukemia, said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab, in a conference call on Wednesday.

The company announced on Tuesday that the phase 3 study would assess disease status at four-week intervals until week 28 and then every three months until disease progression or month 24. However, because the primary endpoint in the study is objective responses, Genmab will be able to close the database for the purposes of regulatory filings once the last patient has completed their week 24 visit, said Claus Juan Moller-San Pedro, M.D., Ph.D. chief operating officer for Genmab, during the conference call.

The company is also likely to begin other studies in the coming year that will enlarge the safety database for treatment of chronic lymphocytic leukemia, Moller said.

"At the time point where we are ready to file for approval, we will have the pivotal study completed, and we will have safety data from numerous additional patients in some of the additional studies," he said during the conference call.

Genmab received a fast-track designation from the Food and Drug Administration for HuMax-CD20 for the same indication in December 2004.

Because HuMax-CD20 is an un-partnered, phase 3 cancer product, which Drakeman said is rare in the biotech industry, Genmab has been active in partnering discussions. But she said the company is not able to provide details on when a partnership may occur.

Drakeman also said Wednesday that the company had not yet had any pricing discussions on HuMax-CD20, but when it does, it will take the fact that treatment could be costly since it involves high doses of the drug into account.

"Our first goal is to make this available. Our next goal will be to do everything we can so the patients who need the drug can get access to it," she said during the call.

Genmab is a biotechnology company that creates and develops human antibodies for the treatment of life-threatening and debilitating diseases. The company is located in Copenhagen, Denmark.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.