Data from lymphoma study to be presented at cancer congress

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The Fourth International Congress on Monoclonal Antibodies in Cancer is scheduled to take place in the Springs next month. As part of the meetings, Genmab A/S will present new HuMax-CD4 Phase II data about the duration of patients.

Genmab, which is headquartered in Copenhagen, Denmark, and has operations in Utrecht, The Netherlands, and Princeton, N.J., is a biotechnology company that creates and develops human antibodies for the treatment of life-threatening and debilitating diseases.

The company’s presentation, which is scheduled for 12:30 p.m. Sep. 3 and will be given by Dr. Jan van de Winkel, Genmab’s chief scientific officer, will include information about cutaneous T-cell lymphoma (CTCL) patients at all dose levels who achieved clinical responses in the two Phase II studies.

Thirty-eight CTCL patients with Mycosis Fungoides (MF) were treated as part of the studies and 42 percent achieved at least a partial response, 30 percent at the 280 mg dose, 50 percent at 560 mg and 75 percent at 980 mg as measured by Composite Assessment of Index Lesion Disease Activity score, according to Genmab. Safety and efficacy data for the 280 mg dose were presented at the 45th Annual Meeting of the American Society of Hematology in December. The higher dose data, along with an update on the 280 mg dose, were presented in April at the Society for Investigative Dermatology Conference.

HuMax-CD4 is a high affinity human antibody that targets the CD4 receptor on T-lymphocytes, the company says. Genmab has run two Phase II studies using HuMax-CD4 to treat CTCL, one in early stage patients and the other for patients with advanced disease, both of which achieved positive results.

Overall in the Phase II studies, 55 percent of MF patients (10/18) treated at higher doses achieved at least a partial response, the company says. Of fourteen early stage MF patients treated at the 560 mg dose level, seven achieved at least a partial response, including two who obtained a complete response. Three of four advanced stage MF patients treated at the 980 mg level obtained a partial response. There was also a statistically significant dose response correlation in 38 early and late stage mycosis fungoides patients, according to Genmab.

T-cell lymphomas positive for the CD4 receptor constitute about 5 percent of Non Hodgkin’s Lymphomas. The U.S. prevalence of the MF is estimated at 16,000 to 20,000. CTCL patients tend to have a lifespan of 10 to 30 years and therefore could be treated several times during the disease progression.

Non-cutaneous CD4 positive T-cell lymphomas originate predominantly in the lymph nodes. Their prevalence in the Unites States and Canada is approximately 8,000 to 10,000.