Paris, April 7, 2010 -- Neovacs, a biotechnology company developing proprietary immunotherapies for autoimmune and chronic diseases, today announced that it has initiated a Phase I/II study of its Interferon alpha (IFNa) Kinoid in lupus patients. Regulatory and ethics committee approvals for the trial have been received in France and Belgium, and further approvals are being sought in a number of other European countries. The IFNa-K is the second product candidate based on Neovacs’ novel Kinoid immunotherapy platform to enter clinical testing.
“There remains an urgent need for new therapies for lupus, and targeting interferon alpha is one of the most promising strategies being explored,” commented Professor Frédéric Houssiau, a leading lupus expert and head of the Department of Rheumatology at St. Luc University Hospital in Brussels and the Principal Investigator of the study. “We therefore welcome the opportunity to test Neovacs’ novel immunotherapy to IFNa in lupus patients.”
The Phase I/II study will employ a double-blinded ascending dose design, with a placebo group within each dose cohort. Subject participants must have moderate levels of disease. The primary objective of the study is to collect safety information. Secondary objectives are the immune response to the Kinoid, and measures of disease, including disease activity indices and markers for IFNa activity. Subject to recruitment of participants, first unblinded data from the study should be available early in 2011.
“We are very excited to have our second product entering clinical evaluation,” said Pierre Vandepapelière, Chief Medical Officer of Neovacs. “We believe that our novel approach may offer lupus patients key advantages, including the potential to be effective against all 13 sub-types of interferon alpha and the compliance advantages of an infrequent dosing regime.”
About lupus
Lupus is a chronic, life-threatening autoimmune disease, in which the body generates auto antibodies, especially against the cell nucleus. Prevalence estimates for the disease vary widely, one study cited on the CDC website estimating those with definite or probable SLE at 322,000 in the US, whereas the Lupus Foundation of America estimates US prevalence at 1.5 million, and 5 million worldwide. Lupus can occur at any age, but appears mostly in young people ages 15 to 45. About 90 percent of those diagnosed with lupus are women. Symptoms may include extreme fatigue, painful and swollen joints, fever, rash and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders. No new therapies have been approved for lupus for several decades. The over- production of interferon alpha, a cytokine that plays a key role in immune system regulation, has been identified by lupus researchers as strongly implicated in the disease.
About Neovacs
Neovacs is a biotechnology company focused on an active immunotherapy technology platform with applications in autoimmune diseases and other chronic conditions. It was founded as a spin-off from Pierre & Marie Curie University in Paris by Professor Daniel Zagury, MD, one of the world’s leading immunologists. The key investors are Truffle Capital, Novartis Venture Fund and OTC Asset Management.
Neovacs’ portfolio currently consists of drug 3 candidates: TNFa-K, IFNa-K and VEGF-K. The company’s lead immunotherapy program, TNFa-K targets TNFa-mediated autoimmune diseases. It is in a Phase I/II clinical trial in Crohn’s Disease patients, and a Phase II trial in rheumatoid arthritis patients. This clinical study is also the focus of a collaboration with the diagnostics company BMD, with the goal of developing theranostic tools for personalized care. At the end of 2008, TNF-K was selected by Thomson Reuters as the most promising drug to be entering Phase II clinical trials. The company second product candidate, IFNa K, an immunotherapy targeting interferon alpha (IFNa), in lupus patients is entering Phase I/II for lupus. The company’s R&D has generated a broad patent estate.
For more information, visit the Neovacs web site at www.neovacs.com.
