BioWorld International Correspondent

For Lisa Drakeman, CEO of Genmab A/S, the news that HuMax-CD4 failed to demonstrate efficacy in a Phase IIb trial involving 118 psoriasis patients was "not particularly" disappointing.

"We had a very small investment in this trial," she told BioWorld International Friday, when the company said it would discontinue the program. "The big news for HuMax-CD4 is the cancer data."

Earlier last week, Copenhagen, Denmark-based Genmab unveiled promising interim results from two Phase II trials of the same antibody in cutaneous T-cell lymphoma.

Based on an evaluation using the Physician's Global Assessment (PGA), 55 percent of 11 early stage patients and 38 percent of 13 advanced-stage patients achieved at least a partial response, measured as a minimum improvement of 50 percent in disease status. The two studies also yielded positive data on secondary measures, including pruritus (severe itching).

Genmab initially was limited to administering a maximum dose of 280 mg per week over 16 weeks, which it already had employed in its psoriasis studies. It is seeking improved responses by adding additional subjects to the ongoing Phase II studies. Seven late-stage patients are now receiving 980 mg/week, while 10 early stage patients are receiving 560 mg/week.

Analysts had previously questioned the potential of HuMax-CD4 in psoriasis, following its high-profile failure in a Phase II trial in rheumatoid arthritis, which was a major setback for Genmab. (See BioWorld International, Oct. 2, 2002.)

"The two indications are basically related inflammatory indications, where we try to balance the immune system," Drakeman said. The strategy in lymphoma is different, she said, in which "the goal is just to deplete the CD4-positive cells."

Cutaneous T-cell lymphomas are characterized by an infiltration of the skin by malignant T cells. In the U.S., they arise at a frequency of about 1,000 new cases per year, but because of the long survival time of patients - about 10 to 30 years - the prevalence at any given time is about 16,000 to 20,000 cases. Genmab aims to position HuMax-CD4 as a treatment for non-cutaneous T-cell lymphomas that express the CD4 receptor as well, and it already has seen a positive response from one such patient receiving the drug on a compassionate-use basis.

Genmab's stock dropped 15 percent to DKK45 (US$7.45) from its opening position of DKK53 on the Copenhagen Stock Exchange Friday, but recovered to close at DKK50.50 as investors digested the news. It edged back to DKK52.50 by Monday's close. Astrid Samuelsson, an analyst at Stockholm, Sweden-based Handelsbanken Securities, said her forecasts for the psoriasis program were very cautious.

"I had not really taken that project into huge account," she said, adding that the initial cancer data were impressive, given the low doses involved.

"I thought it looked really interesting, actually," she said.