US FDA APPROVES GENMAB’S IND FOR HUMAX-CD4 TO TREAT LYMPHOMA
TWO PHASE II STUDIES INITIATED
Resume: The US Food and Drug Administration (FDA) has approved Genmab’s Investigational New Drug (IND) application to begin two Phase II clinical studies using HuMax-CD4 to treat T-cell lymphomas.
Copenhagen, Denmark; January 27, 2003 – Genmab A/S (CSE: GEN) announced today that the US FDA has approved the start of two Phase II open label studies using HuMax-CD4 to treat a form of cancer known as Cutaneous T-cell Lymphoma (CTCL).
About the studies
Genmab will run two studies concurrently, each with an initial 12 patients. One study will focus on refractory patients and the other will be for patients with persistent early stage disease. In both studies patients will receive a 280 mg dose of HuMax-CD4 once a week for 16 weeks. Patients will be followed for at least four weeks after the end of treatment or until disease progression. The objective of the studies is to determine the efficacy and safety of HuMax-CD4 in the treatment of CTCL.
“There is an unmet medical need for therapies to help patients who suffer from CTCL, a disease that is both debilitating and eventually life threatening,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “With these trials, we continue our work on products that may help patients who currently have a significant need for treatment alternatives.”
About T-cell lymphomas and CTCL
T-cell lymphomas positive for the CD4 receptor constitute around 5% of Non Hodgkin’s Lymphomas.
CTCL is one group of CD4+ lymphomas. This type of lymphoma expresses the CD4 receptor which can be targeted by Genmab’s HuMax-CD4 antibody. CTCL is a highly symptomatic disfiguring disease which is life threatening in the advanced stages and is incurable except at its very earliest stages.
CTCL patients tend to have a lifespan of 10 to 30 years and therefore could be treated several times during the disease progression. CTCL covers a range of diseases characterized by infiltration of the skin by malignant T-cells. This range of diseases includes Mycosis fungoides and the Sezary syndrome. Mycosis fungoides represents around 70% of all CTCLs. Most patients show symptoms even at the earliest stage of the disease with itching and susceptibility to recurrent skin infections, and the majority suffer moderate to severe cosmetic disfigurement. In several groups of CTCL patients, defective apoptosis (or programmed cell death) has been documented, which may contribute to the difficulty of killing these types of tumors. An anti-CD4 antibody that depletes CD4+ cells in vivo has the potential to induce a clinical response.
There are about 1,000 new cases of CTCL per year in the US and the prevalence of the disease is estimated at 16,000 to 20,000. |
