Neovacs (Paris: ALNEV)(Alternext Paris: ALNEV), a biotech company focused on an active immunotherapy technology platform (KinoidsTM) with applications in the treatment of autoimmune diseases, inflammatory diseases and cancer has received DSMB authorization to proceed to a higher dosage in its ongoing phase I/II trial in lupus.
Administration of the third dose level in patients recruited since September was completed as expected. Having reviewed the data related to these patients on November 5, the Data and Safety Monitoring Board, an independent committee which is responsible for overseeing the conduct of the study and in particular for patient safety, authorized Neovacs to proceed to the next higher and final dose of INF?-Kinoid. Neovacs is now able to finalize recruitment of patients for this phase I/II trial, as planned.
the DSMB’s’ decision confirms the good tolerability of IFN?-Kinoid to date, which has now been administered to patients at three dose levels. Rapid progress has been made so far in this Phase I/II trial and the company is confident in achieving its objective of releasing preliminary results by the end of the first half 2011.
the study is placebo-controlled, double-blind with dose-escalation and randomisation at each dose level. Patients must present symptoms of moderate disease and the primary objective of the ongoing study is to gather data on the tolerability and safety of IFN?-Kinoid. Secondary objectives include analysis of the immune response and measurements of disease activity and IFN? markers.
About lupus
Systemic Lupus Erythematosus (SLE) is an autoimmune disease in which the immune system produces antibodies to cells within the body leading to widespread inflammation and tissue damage. Prevalence estimates vary widely, and range as high as 1.5 million in North America (the Lupus Foundation of America) and 5 million worldwide. the Centers for Disease Control estimates a 2005 prevalence of 322,000 with definite or probable SLE in the US. Lupus disease may first occur at any age, though peak diagnosis is between the ages of 15 and 40. it is far more common in women than men. People with SLE may experience fatigue, pain or swelling in joints, skin rashes, and fevers. it can also affect the lungs, kidneys, and blood vessels. there has been no new treatment approved for lupus for over fifty years. Scientists have highlighted the overproduction of the interferon alpha cytokine?as a key factor in the causation and development of the disease.
About Neovacs
Neovacs is a biotechnology company focused on an active immunotherapy technology platform (Kinoids?) with applications in autoimmune diseases and other chronic conditions. Neovacs’ current portfolio consists of 3 drug candidates: TNF-Kinoid, IFN?-Kinoid and VEGF-Kinoid. the company’s lead immunotherapy program (TNF-Kinoid) targets TNF-mediated chronic inflammatory diseases. For TNF-Kinoid, a Phase I/II clinical trial in Crohn’s disease and a Phase II trial in rheumatoid arthritis (RA) are ongoing. the latter clinical study is also the focus of collaboration with the French diagnostics company BMD, with the goal of developing theranostic tools for personalized care in RA. Patient recruitment is ongoing in a Phase I/II trial of Neovacs’ second product candidate (IFN? -Kinoid, an immunotherapy targeting interferon alpha) in the treatment of lupus. Neovacs’ R&D has generated a broad patent estate.
For more information, visit the Neovacs web site at neovacs.com
Presse – Alize RPCaroline Carmagnol+33 (0) 6 64 18 99 NeovacsFlorence Hocd?e – Leroy+33 (0) 1 53 10 93 Investors ? ActifinNicolas Meunier+ 33 (0) 1 56 88 11