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NEOVACS SCIENTIFIC ADVISORY BOARD ENDORSES COMPANY'S UPDATED IFNα-KINOID DEVELOPMENT PLAN - Seite 2
in Europe, Latin-America and Asia. The SAB also made recommendations
regarding trial protocol and recruitment criteria, which have been
discussed with the Clinical Lupus Board and integrated into the study
design. This Phase IIb study is expected to begin mid 2015. A second Phase
I/IIa trial for SLE using IFNα-Kinoid in the U.S. is
planned to commence by early 2016.
Extension of IFNα-Kinoid development program to include dermatomyositis
As a result of the positive safety profile and encouraging results from
IFNα-Kinoid thus far, the SAB recommended broadening Neovacs' scope of
IFNα-Kinoid treatment targets to dermatomyositis, another indication where
a positive IFNα signature plays a decisive role. Clinical trials conducted
in this indication further validate the scientific consensus in this
matter.
Dermatomyositis (DM) is a severe, sometimes fatal, disease affecting mainly
children (60 percent of the patient population), with significant unmet
medical need as no biological treatment has been registered to date in this
indication. Dermatomyositis is considered an orphan disease both in North
America and in Europe, where there are fewer than 20,000 affected patients
respectively.
Following this recommendation, Neovacs is working to rapidly integrate DM
in both adult and pediatric patients into the Company's clinical
development plan for IFNα-Kinoid. Because of the recognized orphan status
of DM, Neovacs estimates that clinical development of active immunotherapy
in this indication could be considerably shortened (phase III trials may
not be necessary), with the potential to bring a treatment to market in a
few years.
Final Review of TNF-Kinoid Phase IIb results in Rheumatoid Arthritis (RA)
The final outcome of the February Neovacs' SAB meeting was the analysis of
the Company's TNF-Kinoid development plan that led to the December 2014
Phase IIb results in RA. Findings included:
- Preclinical results of TNF-Kinoid in a mouse model of arthritis showed
significant binding and neutralizing antibody responses, and clinical
efficacy nearly identical to the comparator (infliximab), justifying
fully the start of clinical development (Delavallée et al., 2009
Arthritis Research & Therapy)
- The results of the Phase IIa RA trial in 40 patients demonstrated a
good tolerance of the product, as well as a significant increase of
IFNα-Kinoid thus far, the SAB recommended broadening Neovacs' scope of
IFNα-Kinoid treatment targets to dermatomyositis, another indication where
a positive IFNα signature plays a decisive role. Clinical trials conducted
in this indication further validate the scientific consensus in this
matter.
Dermatomyositis (DM) is a severe, sometimes fatal, disease affecting mainly
children (60 percent of the patient population), with significant unmet
medical need as no biological treatment has been registered to date in this
indication. Dermatomyositis is considered an orphan disease both in North
America and in Europe, where there are fewer than 20,000 affected patients
respectively.
Following this recommendation, Neovacs is working to rapidly integrate DM
in both adult and pediatric patients into the Company's clinical
development plan for IFNα-Kinoid. Because of the recognized orphan status
of DM, Neovacs estimates that clinical development of active immunotherapy
in this indication could be considerably shortened (phase III trials may
not be necessary), with the potential to bring a treatment to market in a
few years.
Final Review of TNF-Kinoid Phase IIb results in Rheumatoid Arthritis (RA)
The final outcome of the February Neovacs' SAB meeting was the analysis of
the Company's TNF-Kinoid development plan that led to the December 2014
Phase IIb results in RA. Findings included:
- Preclinical results of TNF-Kinoid in a mouse model of arthritis showed
significant binding and neutralizing antibody responses, and clinical
efficacy nearly identical to the comparator (infliximab), justifying
fully the start of clinical development (Delavallée et al., 2009
Arthritis Research & Therapy)
- The results of the Phase IIa RA trial in 40 patients demonstrated a
good tolerance of the product, as well as a significant increase of
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