Date: 2017-07-19
Type of
information: Clinical trial authorisation
phase: 2a
Announcement: clinical trial authorization
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 (self-polyclonal antibodies) 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.
Disease: dermatomyositis
Therapeutic
area: Autoimmune diseases - Dermatological diseases - Rare diseases
Country: France, Germany, Italy, Switzerland USA
Trial
details:
- This study is a Proof of Concept study aiming to evaluate the production of anti-IFN? antibodies (immune response) in adult subjects with dermatomyositis. (NCT02980198)
Latest
news:
- • On July 19th, 2017, Neovacs announced that the FDA has cleared its Investigational New Drug (IND) application
for IFN? Kinoid in the treatment of dermatomyositis, which allows the company to initiate in the US its Phase IIa clinical trial already on-going in European countries. This Phase IIa clinical trial is a multicenter study currently being conducted in Europe (France, Italy, Germany, and Switzerland) in 30 adult patients. The objective of the study is to evaluate the immunogenicity, tolerability, and biological and clinical efficacy of IFN? Kinoid in this new indication. The results of this study are expected to support the design and execution of a pivotal study.
- • On June 16, 2015, Neovacs announced the launch of its clinical development program in dermatomyositis, an orphan skin and muscular condition with significant unmet medical need. Neovacs is extending its IFN?-Kinoid clinical program beyond lupus to include adult and pediatric dermatomyositis – an indication where a positive IFN? signature plays a decisive role. The decision follows a recommendation earlier this year by the Company’s Scientific Advisory Board to pursue IFN?-Kinoid as a potential treatment for dermatomyositis and extensive due diligence in researching IFN-related diseases that could benefit from this treatment modality. Neovacs plans to conduct a multicentric phase I/IIa trial of IFN?-Kinoid in adult dermatomyositis in 15 patients which is anticipated to launch in early 2016 in France and other European countries.
- To sustain and support it in this endeavor, Neovacs has formed a cross disciplinary Clinical Advisory Board (CAB) composed of leading experts in dermatomyositis:
- - Prof. Olivier Benveniste, Hôpital Pitié-Salpêtrière, Paris
- Prof. Eric Hachulla, CHRU de Lille
- - Dr. Jean-David Bouaziz, Hôpital Saint-Louis, Paris
- - Prof. Werner Stenzel, Charité Universitätmedizin Berlin
- - Prof. Ingrid Lundberg, Karolinska Universitetssjukhuset, Stockholm.
- These board members will be instrumental not only in bringing their expertise to Neovacs in preparing for and defining the metholodology, target population, and evaluation criteriafor the DM trial; but also in assisting with trial development and patient recruitment.
- The IFN?-Kinoid program in DM could be initiated as early as 2016.
Is
general: Yes
