Nogra Pharma Limited

University of Miami

Giuliani International Limited

Giuliani Internaitonal Limited

Giovanni Monteleone

Francesca Viti

Salvatore Bellinvia

Camillo D Ricordi

Luca Inverardi

Alice Tomei

Antonello Pileggi

Peter Buchwald

Sergio Baroni

Viti Francesca

The present invention relates to methods of treating, preventing or managing intestinal fibrosis by inhibiting SMAD7. The invention is also directed to methods of monitoring effectiveness of treatment or management of intestinal fibrosis using a SMAD7 antisense oligonucleotide, as well as methods of regulating SMAD7 antisense oligonucleotide treatment, based on analysis of Transforming Growth Factor-&#x3b2; (TGF-&#x3b2;) levels, &#x3b1;-Smooth Muscle Actin (a-SMA) levels, and/or phosphorylated Mothers Against Decapentaplegic Homolog 3 (p-SMAD3) levels.

Methods of treating intestinal fibrosis using SMAD7 inhibition

The invention relates to antisense oligonucleotidic sequences (ODN) against Smad7 suitably modified, and their uses in medical field as therapeutic biological agents, in particular in the treatment of chronic inflammatory bowel disease, such as Crohn's disease and ulcerative colitis.

Antisense oligonucleotides (ODN) against SMAD7 and uses thereof in medical field

Methods of treating a subject with IBD with an anti-SMAD7 therapy, such as a SMAD7 antisense oligonucleotide, to reduce CRP levels are disclosed. Methods of treating and managing IBD in a subject using an anti-SMAD7 therapy, such as a SMAD7 antisense oligonucleotide, based on CRP levels are also disclosed. Also disclosed are methods of determining whether a subject with IBD is responsive or likely to be responsive to treatment an anti-SMAD7 therapy. Reduction of CRP levels may correlated with IBD remission or decreases in CDAI score. The present invention also relates to treatment of IBD using an anti-SMAD7 therapy (e.g., an antisense oligonucleotide) in combination with an additional agent. The invention also features related pharmaceutical compositions and kits.

Methods for treating inflammatory bowel disease

Disclosed herein are methods for treating/and or preventing diabetes using a specific inhibitor of SMAD7 expression or function. Also disclosed are methods of promoting organ and/or cell, e.g., pancreatic islet cell, survival after transplantation using a specific inhibitor of SMAD7 expression or function.

Methods of treating diabetes and/or promoting survival of pancreatic islets after transplantation

The present invention relates to treatment of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis) using antisense nucleotides that are directed against polymorphic forms (e.g., those containing single nucleotide polymorphisms) of the SMAD7 mRNA. The invention thus relates to treatment methods for subjects having polymorphic forms of SMAD7 and antisense oligonucleotides that specifically target SMAD7 mRNA transcripts containing polymorphisms.

Methods and compositions for treating a subject with a SMAD7 antisense oligonucleotide

Antisense oligonucleotides (ODN) against Smad7 and uses thereof in medical field

Disclosed herein are methods for treating/and or preventing colorectal cancer using a specific inhibitor of SMAD7 expression or function. Also disclosed are pharmaceutical compositions containing an inhibitor of SMAD7 for treating and/or preventing colorectal cancer and manufacture of medicaments containing an inhibitor of SMAD7 to be used in treating and/or preventing colorectal cancer.

Methods of treating colorectal cancer

Methods for monitoring whether a subject will be sensitive or resistant to treatment with an anti-SMAD7 therapy are disclosed. The methods are based on the determining of the amount of CCR9+ FOXP3+ T cells, CCR9+ IFN-gamma+ T cells, CCR9+ IL17A+ T cells, FOXP3+ T cells, IFN-gamma+ T cells, and/or IL17A+ T cells in a sample from the subject. Measurement of T cell populations may be determined by flow cytometry, immunohistochemistry, and/or ELISA.

Growing community of inventors

Grottaferrata, Italy

Giovanni Monteleone