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Clinical Trials

Date: 2011-11-01

Type of information:

phase: 1

Announcement: initiation

Company: Philogen (Italy)

Product: Dekavil

Action mechanism: Dekavil (F8-IL10) is an immunocytokine consisting of a vascular targeting antibody (human antibody F8, specific to the extra-domain A of fibronectin) fused to the anti-inflammatory cytokine interleukin-10 (IL10). Dekavil is believed to selectively modulate anti-inflammatory effects in the target area, sparing unwanted effects on other tissues and potentially restoring healthy immune function. Dekavil potently inhibited progression of established arthritis in the collagen-induced mouse model when tested alone and in combination with methotrexate.

Disease: rheumatoid arthritis

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases

Country: Italy

Trial details: This dose-finding, pharmacokinetic Phase I study aims to establish the maximum tolerated dose (MTD) and the recommended dose (RD) of Dekavil (F8IL10) when administered in combination with Methotrexate. The study will recruit a maximum of 33 patients.

Latest news:

Philogen has announced that Dekavil’s first clinical trial has started in november 2011 in Siena University Hospital ‘Policlinico Santa Maria alle Scotte’, at the UOC Rheumatology Team, coordinated by Professor Mauro Galeazzi.

Is general: Yes