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Seattle Genetics begins Phase II trial of Adcetris to treat lupus

US-based biotechnology firm Seattle Genetics has started a Phase II clinical trial of its antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin) to treat patients with systemic lupus erythematosus (SLE or lupus), a chronic autoimmune disease.

In lupus, the body’s own immune system overreacts and attacks healthy organs, causing inflammation, pain, permanent organ damage or death.

Adcetris is directed to CD30, which is expressed on activated lymphocytes that are thought to play a major role in the development of autoimmune diseases, including lupus.

The Phase II trial is designed to evaluate the safety and activity of Adcetris in adult patients with lupus. Currently, Adcetris is not approved for the treatment of lupus.

Seattle Genetics president and chief executive officer Clay Siegall said: "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.

"Based on a retrospective review of information collected from patients being treated with Adcetris in the US 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."

Primary objective of the randomized, double-blind, placebo-controlled dose-escalation Phase II clinical trial is evaluation of the safety of Adcetris in adults with active lupus.

Additionally, the Phase II trial will evaluate the activity and pharmacokinetics of Adcetris in lupus. Around 40 patients will be enrolled at multiple centers in the US and they will be administered Adcetris every three weeks.