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"There are no approved therapies to treat the underlying pathophysiology in neuropathy, and current symptomatic treatment options for patients suffering from the extremely debilitating and painful disease of sarcoidosis are often ineffective and/or injurious," commented Dr. Daniel Culver of The Cleveland Clinic, the principal investigator of the trial and lead author of the paper.  "The magnitude of effect in only 28 days is remarkable, and suggests that cibinetide has the potential to become a transformative disease modifying therapy for sarcoidosis patients as well as for other diseases characterized by chronic inflammation and persistent tissue injury." "We are excited about the trial's positive results which were the basis for a recently-completed successful end-of-phase 2 meeting with the FDA. We look forward to taking the next step in clinical development for both neuropathic pain and disease modification indications. As cibinetide has also demonstrated positive results for both nerve regeneration and symptomatic improvements in diabetic peripheral neuropathy, our clinical program will include a broad neuropathic population," said Dr. Daiva Bajorunas, Chief Medical Officer of Araim. Sarcoidosisi,ii,iii is a chronic systemic granulomatous disease of unknown etiology, affecting young-to-middle-age individuals. The disease is chronic and progressive in more than a third of cases, leading to clinically significant organ impairment, including small nerve fiber loss, and significant, disabling neuropathic symptoms, with pain as the most common complaint. While variable for each patient, the symptoms often cause major loss in quality of life and inability to participate in the work force.  Morbidity in sarcoidosis is significant and multifactorial. Mortality is infrequent, but may be increasing over the years. Araim Pharmaceuticals, Inc. is a clinical stage drug development company with a novel platform technology designed to address devastating injuries and chronic diseases underserved by current therapies. With their discovery of the Innate Repair Receptor (IRR), Araim has identified the target for activating tissue repair and recovery from inflammatory and other injuries.   Their novel peptide library of IRR specific ligands activates tissue protective, reparative and anti-inflammatory signaling pathways. Araim has an ongoing, active and promising preclinical program in a wide array of conditions involving tissue damage and repair, including neuropathy, cardiovascular damage, diabetes complications, wound healing and aging. Cibinetide is a first-in-class synthetic 11-amino acid peptide IRR agonist. The most advanced clinical program with cibinetide is in sarcoidosis-related small fiber neuropathy.  Cibinetide has been granted US and EU Orphan Drug Designation for the treatment of sarcoidosis, and has received US Orphan Drug and Fast Track designations for the treatment of neuropathic pain in patients with sarcoidosis.  Cibinetide was granted EU Orphan Medicinal Product designation for prevention of graft loss in pancreatic islet transplantation, and US Orphan Drug Designation for treatment to increase survival and improve functioning of pancreatic islets following transplantation.  A pilot study evaluating the safety and efficacy of cibinetide in diabetic macular edema is currently ongoing at Queen's University Belfast. www.araimpharma.com i Ianuzzi MC, Rybicki BA, Teirstein AS. Sarcoidosis. N Engl J Med 2007;357:2153-65. ii Tavee J, Culver D. Sarcoidosis and Small-fiber Neuropathy. Curr Pain Headache Rep 2011;15:201-206. iii Gerke AK. Morbidity and Mortality in Sarcoidosis. Curr Opin Pulm Med 2014;20(5):472-478. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/araim-pharmaceuticals-cibinetide-ara-290-regenerates-small-nerve-fibers-and-improves-neuropathic-clinical-symptoms-in-the-orphan-disease-of-sarcoidosis-300452818.html


Patent
Araim Pharmaceuticals | Date: 2014-04-08

The present invention is directed to novel tissue protective peptides. The tissue protective peptides of the invention may bind to a tissue protective receptor complex. In particular, the present invention is drawn to tissue protective peptides derived from or sharing consensus sequences with portions of cytokine receptor ligands, including Erythropoietin (EPO), that are not involved in the binding of the ligand to the receptor complex, e.g., to the EPO receptor homodimer. Accordingly, the tissue protective peptides of the invention are derived from the amino acid sequences of regions of cytokine receptor ligands that are generally located on or within the region of the ligand protein that is opposite of the receptor complex, i.e., are generally derived from amino acid sequences of regions of the ligand protein that face away from the receptor complex while the ligand is bound to the receptor. The invention is further directed to the consensus sequences for use in engineering a synthetic tissue protective peptide. These tissue protective peptides also include fragments, chimeras, as well as peptides designed to mimic the spatial localization of key amino acid residues within the tissue protective receptor ligands, e.g., EPO. The invention further encompasses methods for treating or preventing a disease or disorder using tissue protective peptides of the current invention. The invention also encompasses methods for enhancing excitable tissue function using tissue protective peptides of the current invention.


The present invention provides peptides and peptide analogs that have tissue protective activities while having little or no potentially undesirable hematopoietic effects. The peptides and peptide analogs are useful in preventing and treating a variety of diseases and disorders associated with tissue damage.


The present invention provides peptides and peptide analogs that have tissue protective activities while having little or no potentially undesirable hematopoetic effects. The peptides and peptide analogs are useful in preventing and treating a variety of diseases and disorders associated with tissue damage.


The invention provides a pharmaceutical composition for use in a method for preventing, treating, ameliorating or managing cancer or a neoplastic disorder, or for preventing or treating cachexia, wherein the composition comprises an isolated peptide and a pharmaceutically acceptable carrier, wherein the isolated peptide has a length of 14, 15, 16, 17, 18, 19, 20, 21, 23, 24, 25, 26, 27, 28 or 29 amino acids, and wherein the peptide comprises the amino acid sequence of WEHVNAIQEARRLL (SEQ ID NO: 114), or the amino acid sequence WEHVNAIQEARRLL (SEQ ID NO: 114) comprising one or two conservative or non-conservative amino acid substitutions or amino acid equivalents.


Patent
Araim Pharmaceuticals | Date: 2013-01-02

The present invention is directed to novel tissue protective peptides. The tissue protective peptides of the invention may bind to a tissue protective receptor complex. In particular, the present invention is drawn to tissue protective peptides derived from or sharing consensus sequences with portions of cytokine receptor ligands, including Erythropoietin (EPO), that are not involved in the binding of the ligand to the receptor complex, e.g., to the EPO receptor homodimer. Accordingly, the tissue protective peptides of the invention are derived from the amino acid sequences of regions of cytokine receptor ligands that are generally located on or within the region of the ligand protein that is opposite of the receptor complex, i.e., are generally derived from amino acid sequences of regions of the ligand protein that face away from the receptor complex while the ligand is bound to the receptor. The invention is further directed to the consensus sequences for use in engineering a synthetic tissue protective peptide. These tissue protective peptides also include fragments, chimeras, as well as peptides designed to mimic the spatial localization of key amino acid residues within the tissue protective receptor ligands, e.g., EPO. The invention further encompasses methods for treating or preventing a disease or disorder using tissue protective peptides of the current invention. The invention also encompasses methods for enhancing excitable tissue function using tissue protective peptides of the current invention.


Patent
Araim Pharmaceuticals | Date: 2015-02-10

The present invention is directed to novel tissue protective peptides. The tissue protective peptides of the invention may bind to a tissue protective receptor complex. In particular, the present invention is drawn to tissue protective peptides derived from or sharing consensus sequences with portions of cytokine receptor ligands, including Erythropoietin (EPO), that are not involved in the binding of the ligand to the receptor complex, e.g., to the EPO receptor homodimer. Accordingly, the tissue protective peptides of the invention are derived from the amino acid sequences of regions of cytokine receptor ligands that are generally located on or within the region of the ligand protein that is opposite of the receptor complex, i.e., are generally derived from amino acid sequences of regions of the ligand protein that face away from the receptor complex while the ligand is bound to the receptor. The invention is further directed to the consensus sequences for use in engineering a synthetic tissue protective peptide. These tissue protective peptides also include fragments, chimeras, as well as peptides designed to mimic the spatial localization of key amino acid residues within the tissue protective receptor ligands, e.g., EPO. The invention further encompasses methods for treating or preventing a disease or disorder using tissue protective peptides of the current invention. The invention also encompasses methods for enhancing excitable tissue function using tissue protective peptides of the current invention.


Patent
Araim Pharmaceuticals | Date: 2016-05-05

The present invention is directed to novel tissue protective peptides. The tissue protective peptides of the invention may bind to a tissue protective receptor complex. In particular, the present invention is drawn to tissue protective peptides derived from or sharing consensus sequences with portions of cytokine receptor ligands, including Erythropoietin (EPO), that are not involved in the binding of the ligand to the receptor complex, e.g., to the EPO receptor homodimer. Accordingly, the tissue protective peptides of the invention are derived from the amino acid sequences of regions of cytokine receptor ligands that are generally located on or within the region of the ligand protein that is opposite of the receptor complex, i.e., are generally derived from amino acid sequences of regions of the ligand protein that face away from the receptor complex while the ligand is bound to the receptor. The invention is further directed to the consensus sequences for use in engineering a synthetic tissue protective peptide. These tissue protective peptides also include fragments, chimeras, as well as peptides designed to mimic the spatial localization of key amino acid residues within the tissue protective receptor ligands, e.g., EPO. The invention further encompasses methods for treating or preventing a disease or disorder using tissue protective peptides of the current invention. The invention also encompasses methods for enhancing excitable tissue function using tissue protective peptides of the current invention.


Patent
Araim Pharmaceuticals | Date: 2013-05-22

The present invention is directed to novel tissue protective peptides. The tissue protective peptides of the invention may bind to a tissue protective receptor complex. In particular, the present invention is drawn to tissue protective peptides derived from or sharing consensus sequences with portions of cytokine receptor ligands, including Erythropoietin (EPO), that are not involved in the binding of the ligand to the receptor complex, e.g., to the EPO receptor homodimer. Accordingly, the tissue protective peptides of the invention are derived from the amino acid sequences of regions of cytokine receptor ligands that are generally located on or within the region of the ligand protein that is opposite of the receptor complex, i.e., are generally derived from amino acid sequences of regions of the ligand protein that face away from the receptor complex while the ligand is bound to the receptor. The invention is further directed to the consensus sequences for use in engineering a synthetic tissue protective peptide. These tissue protective peptides also include fragments, chimeras, as well as peptides designed to mimic the spatial localization of key amino acid residues within the tissue protective receptor ligands, e.g., EPO. The invention further encompasses methods for treating or preventing a disease or disorder using tissue protective peptides of the current invention. The invention also encompasses methods for enhancing excitable tissue function using tissue protective peptides of the current invention.


Patent
Araim Pharmaceuticals | Date: 2012-04-16

Provided herein are tissue protective peptides derived from or sharing consensus sequences with portions of cytokine receptor ligands, including Erythropoietin (EPO), that are generally located on or within the region of the cytokine receptor ligand that faces away from a receptor complex while the ligand is bound to the receptor. Also provide herein are fragments, chimeras, as well as peptides designed to mimic the spatial localization of key amino acid residues within the tissue protective receptor ligands, e.g., EPO; methods for treating or preventing a disease or disorder using tissue protective peptides; and methods for enhancing excitable tissue function using tissue protective peptides.

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