Date: 2015-07-09
Type of
information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Seattle Genetics (USA - WA)
Product: Adcetris® (brentuximab vedotin)
Action
mechanism:
- monoclonal antibody/antibody drug conjugate (ADC). Adcetris® (brentuximab vedotin) is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE). The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalisation into CD30-expressing tumor cells. The CD30 antibody part of the product acts as a carrier for the cytotoxic substance. When the antibody attached by the linker to the cytotoxin attaches to the CTCL cells, it is taken up by the cells. Once inside the cancer cells, the linker is cut and the cytotoxic molecule, monomethyl auristatin E, gets released and stops cell division. The cancer cells are then expected to undergo programmed cell death.
The anti-tumour activity of brentuximab-vedotin has been established in the HL and sALCL study populations as well as in the relapsed or refractory HL patients ineligible for ASCT/multidrug chemotherapy. The different clinical endpoints demonstrated clinical benefit in terms of disease control, resolution of B-symptoms and in terms of enabling further potentially curative treatment options.
Disease: systemic lupus erythematosus (SLE)
Therapeutic
area: Autoimmune diseases
Country: USA
Trial
details:
Latest
news:
- • On July 9, 2015, Seattle Genetics announced the initiation of a phase 2 clinical trial evaluating Adcetris® (brentuximab vedotin) in systemic lupus erythematosus. The trial is designed to assess the safety and activity of Adcetris® in adult patients with lupus. “Lupus is a debilitating autoimmune disorder that can affect many of the body’s organ systems, causing a number of serious symptoms. Treatment options are limited, with few FDA-approved disease-modifying therapeutics available,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Based on a retrospective review of information collected from patients being treated with Adcetris® in the U.S. for lymphoma, we noted some patients reported clinical improvement of concomitant autoimmune diseases, including lupus. Since elevated CD30 expression has been previously reported in lupus patients, we are enthusiastic to evaluate Adcetris® as a potential treatment option for this disease.”
- The study is a phase 2 randomized, double-blind, placebo-controlled dose-escalation clinical trial. The primary objective is evaluation of the safety of Adcetris® in adults with active lupus. In addition, the trial will evaluate the activity and pharmacokinetics of Adcetris® in lupus. Adcetris® will be administered every three weeks and approximately 40 patients will be enrolled at multiple centers in the United States.
Is
general: Yes
