Date: 2016-11-07
Type of
information: update on patient enrollment
phase: 2b
Announcement: update on patient enrollment
Company: Neovacs (France)
Product: IFN alpha-Kinoid
Action
mechanism: kinoid/immunotherapy product. A Kinoid is obtained by chemically linking the cytokine of interest to a foreign carrier protein, KLH ( Keyhole Limpet Hemocyanin), and then treating the resultant compound to inactivate the cytokine. These active immunotherapies have been designed to induce an antibody response by the patient’s immune system that targets a particular over-expressed cytokine responsible for the pathogenesis and development of a given disease. The Kinoid technology can be applied in principle to any cytokine target. Three targets (Tumor Necrosis Factor (TNF), Interferon alpha (IFNalpha) and Vascular Endothelial Growth Factor (VEGF) are considered as playing a key role in the pathogenesis of certain diseases.
Disease: systemic lupus erythematosus
Therapeutic
area: Autoimmune diseases - Dermatological diseases - Inflammatory diseases
Country: Belgium, France, Germany, Republic of Korea, Russian Federation, USA
Trial
details: IFN-K-002 is a double-blind, randomized, placebo-controlled multicentric Phase IIb clinical trial designed to assess the efficacy and safety of IFNalpha-Kinoid in moderate to severe lupus patients. The trial has been initiated in September 2015. The trial is planned to include 178 patients in 21 countries in Latin America, Asia, Europe and USA. The co-primary endpoints for the trial are biogical efficacy and clinical efficacy nine months after first immunization with IFNalpha-Kinoid. Biological efficacy is defined as IFNalpha-signature neutralization, while clinical efficacy will be measured by the BILAG-based Composite Lupus Assessment (BICLA) response. (NCT02665364 )
Latest
news:
- • On November 7, 2016, Neovacs announced the enrolment of the first U.S. patient in its international phase IIb clinical study of IFNalpha Kinoid in lupus. A first clinical center has started to enrol patients in this study, initially planned to include 5 investigation centers. The study has attracted interest from a large number of American sites and autoimmune disease specialists. Due to this high demand, Neovacs will open additional centers, increasing the total number of trial sites to 15.
- • On April 28th, 2016, Neovacs announced that the company has received the approval “Investigational New Drug” (IND), from the FDA to extend its ongoing Phase IIb clinical trial of IFNalpha-Kinoid for the treatment of Lupus to the United States. This 18 months trial will now enroll 178 patients in 19 countries throughout Europe, Asia, Latin America, and now the United States. Full Phase IIb results are expected in mid-2017. They will be presented to the relevant health Authorities in Europe (EMA) and in the US (FDA) in order to validate the start into Phase III trial of IFNalpha-Kinoid in Lupus.
- • On April 14th , 2016, Neovacs announced that South Korea health authority approved its Investigational New Drug application for IFNalpha-Kinoid in phase IIb development in Lupus. Neovacs has signed a licensing and partnering agreement with the Korean company Chong Kun Dan Pharmaceuticals (CKD), leader in South Korea in the field of immunosuppressive drugs. This country is the only one of the OECD where Lupus disease fulfills the requirements to obtain the Orphan disease status. Within this agreement Neovacs will file in a near future for “Orphan Drug Designation”. In case of success of its Phase IIb trial the registration of the product and its launch in the Korean market could as consequence take place without a previous Phase III trial.
- • On September 24, 2015, Neovacs, a leader in active immunotherapies for the treatment of autoimmune diseases, announced it has begun enrolling patients in IFN-K-002, a Phase IIb clinical trial to evaluate the efficacy of IFNalpha-Kinoid, Neovacs’ lead active immunotherapy product candidate, to treat systemic lupus erythematosus. IFN-K-002 is a double-blind, randomized, placebo-controlled, multi-center Phase IIb clinical study to assess the biological and clinical efficacy of IFN?-Kinoid in patients suffering from SLE. The study aims to enroll 166 patients in Europe, Asia and Latin America. The co-primary endpoints for the trial are biogical efficacy and clinical efficacy nine months after first treatment with IFNalpha-Kinoid. Biological efficacy is defined as IFNalpha-signature neutralization, while clinical efficacy will be measured by the BILAG-based Composite Lupus Assessment (BICLA) response. The British Isles Lupus Assessment Group (BILAG) is a validated index to measure lupus disease activity listed in FDA guidance on lupus. Results of the clinical trial are expected in the first quarter of 2017.
- • On September 1, 2015, Neovacs announced that it has been granted first approvals by regulatory agencies and ethics commitees in several European countries for a Phase IIb clinical trial of IFNalpha-Kinoid in systemic lupus erythematosus. The upcoming trial was notably assessed favorably using the Voluntary Harmonization Procedure (VHP) of Europe’s Heads of Medicine Agencies, which allows for a harmonized assessement of clinical trials by relevant national health authorities. Acceptance by competent authorities enables Neovacs to initiate IFN-K-002, a Phase IIb clinical study to assess the biological and clinical efficacy of Neovacs’ lead active immunotherapy product candidate IFNalpha-Kinoid in patients suffering from lupus. Inclusion of first patients is expected to begin in the coming weeks. Approvals from other European, Asian and Latin American countries are expected in the second half of 2015. Regulatory and ethics committee approvals pave the way for a rapid initiation of the study IFN-K-002. These centers will begin screening and immunizing patients in the coming weeks.
Is
general: Yes
