Genaera Corporation

Plymouth Meeting, PA, United States

Genaera Corporation

Plymouth Meeting, PA, United States
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Hauber H.-P.,Research Center Borstel | Hauber H.-P.,McGill University | Lavigne F.,McGill University | Hung H.-L.,Genaera Corporation | And 2 more authors.
Journal of Cystic Fibrosis | Year: 2010

Correlations between expression of interleukin (IL)-9, the calcium-activated chloride channel hCLCA1 and mucus expression in cystic fibrosis (CF) airways have suggested a causal relationship. To verify this hypothesis mucosal tissue from upper airways of CF patients (N=5) was stimulated with the Th2 type cytokines IL-4, IL-9, or IL-13. Expression of hCLCA1 mRNA and protein as well as mucus and mucin (MUC5AC) gene expression was quantified using real time PCR, immunohistochemistry (hCLCA1) and PAS staining (mucus). Th2 type cytokines significantly increased hCLCA1 protein expression (P<0.05) whereas increase in hCLCA1 mRNA expression failed to reach statistical significance (P>0.05). Mucin protein and MUC5AC mRNA expression were not significantly changed (P>0.05). These data suggest that Th2 type cytokines may increase hCLCA1 expression in CF but may not have a significant effect on mucus expression. Therefore the role of hCLCA1 as a mediator of mucus overexpression in CF has to be questioned. © 2010.


News Article | March 2, 2017
Site: www.accesswire.com

BEDMINSTER, NJ / ACCESSWIRE / March 2, 2017 / CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases, today announced that John L. (Jack) Armstrong has been appointed Executive Vice President of Technical Operations and Head of Human Resources. Mr. Armstrong has been a consultant to CorMedix, serving in a similar role since October 2014, and now joins the company's recently expanded senior leadership team, bringing decades of broad pharmaceutical industry experience. Khoso Baluch, Chief Executive Officer of CorMedix, said, "A major factor for enabling our advancement of Neutrolin® toward potential U.S. approval has been aligning our internal resources to maximize our efficiency and productivity, and to this end Jack has proven invaluable. We believe completing our senior management team with CFO Robert Cook and CMO Dr. Judith Abrams, and now formalizing the appointment of Jack to oversee technical operations and HR, will further support successful execution of our Neutrolin Phase 3 program and other strategic initiatives designed to drive shareholder value." Jack Armstrong has more than 40 years of experience in the pharmaceutical industry, with broad cross-functional experience in all facets of supply chain and quality assurance, and has held a number of general management positions. Most recently, he was President of Correvio, a private company supplying product to more than 60 countries. Prior to that, Mr. Armstrong was President and CEO of Genaera Corporation, Senior Vice President of Urocor Corporation, CEO of Mills Biopharma, President of Endo (subsidiary of DuPont Merck), President of World-wide Manufacturing for DuPont Merck, and Vice President Operation for Marion/Marion Merrill Dow. He has also held roles in manufacturing, quality assurance, and integrated business systems development, all of which have led to significant experience in business development. CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin is currently in a Phase 3 clinical study in patients undergoing chronic hemodialysis via a central venous catheter. The company is planning to conduct its second Phase 3 study in patients with cancer receiving IV parenteral nutrition, chemotherapy and hydration via a chronic central venous catheter, subject to sufficient resources. If successful, the two pivotal studies may be submitted to the FDA for potential approval for both patient populations. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, contributing to potentially accelerated FDA review and up to 10 years of market exclusivity upon potential U.S. approval. It is already a CE Marked product in Europe and other territories. CorMedix is also seeking to unlock additional value for its taurolidine-based technology by establishing collaborative partnerships in oncology and medical device applications. For more information, visit: www.cormedix.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the ability to retain and hire necessary personnel to staff our operations appropriately; the cost, timing and results of the ongoing and planned Phase 3 trials for Neutrolin® in the U.S. and the resources needed to commence and complete those trials; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; and the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.


News Article | March 2, 2017
Site: marketersmedia.com

BEDMINSTER, NJ / ACCESSWIRE / March 2, 2017 / CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases, today announced that John L. (Jack) Armstrong has been appointed Executive Vice President of Technical Operations and Head of Human Resources. Mr. Armstrong has been a consultant to CorMedix, serving in a similar role since October 2014, and now joins the company's recently expanded senior leadership team, bringing decades of broad pharmaceutical industry experience. Khoso Baluch, Chief Executive Officer of CorMedix, said, "A major factor for enabling our advancement of Neutrolin® toward potential U.S. approval has been aligning our internal resources to maximize our efficiency and productivity, and to this end Jack has proven invaluable. We believe completing our senior management team with CFO Robert Cook and CMO Dr. Judith Abrams, and now formalizing the appointment of Jack to oversee technical operations and HR, will further support successful execution of our Neutrolin Phase 3 program and other strategic initiatives designed to drive shareholder value." Jack Armstrong has more than 40 years of experience in the pharmaceutical industry, with broad cross-functional experience in all facets of supply chain and quality assurance, and has held a number of general management positions. Most recently, he was President of Correvio, a private company supplying product to more than 60 countries. Prior to that, Mr. Armstrong was President and CEO of Genaera Corporation, Senior Vice President of Urocor Corporation, CEO of Mills Biopharma, President of Endo (subsidiary of DuPont Merck), President of World-wide Manufacturing for DuPont Merck, and Vice President Operation for Marion/Marion Merrill Dow. He has also held roles in manufacturing, quality assurance, and integrated business systems development, all of which have led to significant experience in business development. CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin is currently in a Phase 3 clinical study in patients undergoing chronic hemodialysis via a central venous catheter. The company is planning to conduct its second Phase 3 study in patients with cancer receiving IV parenteral nutrition, chemotherapy and hydration via a chronic central venous catheter, subject to sufficient resources. If successful, the two pivotal studies may be submitted to the FDA for potential approval for both patient populations. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, contributing to potentially accelerated FDA review and up to 10 years of market exclusivity upon potential U.S. approval. It is already a CE Marked product in Europe and other territories. CorMedix is also seeking to unlock additional value for its taurolidine-based technology by establishing collaborative partnerships in oncology and medical device applications. For more information, visit: www.cormedix.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the ability to retain and hire necessary personnel to staff our operations appropriately; the cost, timing and results of the ongoing and planned Phase 3 trials for Neutrolin® in the U.S. and the resources needed to commence and complete those trials; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; and the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. BEDMINSTER, NJ / ACCESSWIRE / March 2, 2017 / CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases, today announced that John L. (Jack) Armstrong has been appointed Executive Vice President of Technical Operations and Head of Human Resources. Mr. Armstrong has been a consultant to CorMedix, serving in a similar role since October 2014, and now joins the company's recently expanded senior leadership team, bringing decades of broad pharmaceutical industry experience. Khoso Baluch, Chief Executive Officer of CorMedix, said, "A major factor for enabling our advancement of Neutrolin® toward potential U.S. approval has been aligning our internal resources to maximize our efficiency and productivity, and to this end Jack has proven invaluable. We believe completing our senior management team with CFO Robert Cook and CMO Dr. Judith Abrams, and now formalizing the appointment of Jack to oversee technical operations and HR, will further support successful execution of our Neutrolin Phase 3 program and other strategic initiatives designed to drive shareholder value." Jack Armstrong has more than 40 years of experience in the pharmaceutical industry, with broad cross-functional experience in all facets of supply chain and quality assurance, and has held a number of general management positions. Most recently, he was President of Correvio, a private company supplying product to more than 60 countries. Prior to that, Mr. Armstrong was President and CEO of Genaera Corporation, Senior Vice President of Urocor Corporation, CEO of Mills Biopharma, President of Endo (subsidiary of DuPont Merck), President of World-wide Manufacturing for DuPont Merck, and Vice President Operation for Marion/Marion Merrill Dow. He has also held roles in manufacturing, quality assurance, and integrated business systems development, all of which have led to significant experience in business development. CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin is currently in a Phase 3 clinical study in patients undergoing chronic hemodialysis via a central venous catheter. The company is planning to conduct its second Phase 3 study in patients with cancer receiving IV parenteral nutrition, chemotherapy and hydration via a chronic central venous catheter, subject to sufficient resources. If successful, the two pivotal studies may be submitted to the FDA for potential approval for both patient populations. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, contributing to potentially accelerated FDA review and up to 10 years of market exclusivity upon potential U.S. approval. It is already a CE Marked product in Europe and other territories. CorMedix is also seeking to unlock additional value for its taurolidine-based technology by establishing collaborative partnerships in oncology and medical device applications. For more information, visit: www.cormedix.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the ability to retain and hire necessary personnel to staff our operations appropriately; the cost, timing and results of the ongoing and planned Phase 3 trials for Neutrolin® in the U.S. and the resources needed to commence and complete those trials; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; and the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.


Roitman M.F.,University of Illinois | Wescott S.,University of Illinois | Cone J.J.,University of Illinois | McLane M.P.,Genaera Corporation | Wolfe H.R.,Genaera Corporation
Pharmacology Biochemistry and Behavior | Year: 2010

Many therapies designed to reduce food intake and body weight act, in part, by blocking the dopamine transporter (DAT) - a protein responsible for clearing extracellular dopamine (DA) after release thereby terminating its action. Here, we found that a single injection of the drug trodusquemine (MSI-1436) decreased food intake in rats. To assess the effects of MSI-1436 on DAT function, fast-scan cyclic voltammetry was used to measure DA concentration changes in the ventral striatum. DA release was evoked by electrical stimulation of the ventral tegmental area every 5. min. After 3 baseline measurements, rats were injected with MSI-1436 (10. mg/kg), the known DAT blocker bupropion (80. mg/kg) or saline and evoked DA release and reuptake were monitored for an additional hour. Neither saline nor MSI-1436 caused a significant change in the magnitude of evoked release from baseline values whereas bupropion caused a significant increase. In addition, neither saline nor MSI-1436 significantly increased DA decay rates while such an increase was observed with bupropion. Thus, over a time course when MSI-1436 suppresses food intake it does not affect DAT function. The results support MSI-1436 as an anti-obesity treatment which spares DAT. © 2010 Elsevier Inc.


Lantz K.A.,Genaera Corporation | Hart S.G.E.,Genaera Corporation | Planey S.L.,Genaera Corporation | Roitman M.F.,University of Illinois at Chicago | And 3 more authors.
Obesity | Year: 2010

Trodusquemine (MSI-1436) causes rapid and reversible weight loss in genetic models of obesity. To better predict the potential effects of trodusquemine in the clinic, we investigated the effects of trodusquemine treatment in a murine model of diet-induced obesity (DIO). Trodusquemine suppressed appetite, reduced body weight (BW) in a fat-specific manner, and improved plasma insulin and leptin levels in mice. Screening assays revealed that trodusquemine selectively inhibited protein-tyrosine phosphatase 1B (PTP1B), a key enzyme regulating insulin and leptin signaling. Trodusquemine significantly enhanced insulin-stimulated tyrosine phosphorylation of insulin receptor (IR) Β and STAT3, direct targets of PTP1B, in HepG2 cells in vitro and/or hypothalamic tissue in vivo. These data establish trodusquemine as an effective central and peripheral PTP1B inhibitor with the potential to elicit noncachectic fat-specific weight loss and improve insulin and leptin levels.


Patent
Genaera Corporation | Date: 2012-11-28

The invention relates to select squalamine salts, methods of their synthesis, their therapeutic use and their advantages relating to manufacturing, product stability and toxicity. More specifically, this application is directed to various forms of the dilactate salt of squalamine and their utility in inhibiting neovascularization and endothelial cell proliferation


The present invention relates to the use of an antibody, which is an anti-interleukin-9 antibody or an anti-interleukin-9 receptor antibody, that blocks interleukin-9 binding to the interleukin-9 receptor, for the preparation of a medicament for the reduction of bronchial hyper-responsiveness in a patient.


PubMed | Genaera Corporation
Type: Journal Article | Journal: Obesity (Silver Spring, Md.) | Year: 2010

Trodusquemine (MSI-1436) causes rapid and reversible weight loss in genetic models of obesity. To better predict the potential effects of trodusquemine in the clinic, we investigated the effects of trodusquemine treatment in a murine model of diet-induced obesity (DIO). Trodusquemine suppressed appetite, reduced body weight (BW) in a fat-specific manner, and improved plasma insulin and leptin levels in mice. Screening assays revealed that trodusquemine selectively inhibited protein-tyrosine phosphatase 1B (PTP1B), a key enzyme regulating insulin and leptin signaling. Trodusquemine significantly enhanced insulin-stimulated tyrosine phosphorylation of insulin receptor (IR) beta and STAT3, direct targets of PTP1B, in HepG2 cells in vitro and/or hypothalamic tissue in vivo. These data establish trodusquemine as an effective central and peripheral PTP1B inhibitor with the potential to elicit noncachectic fat-specific weight loss and improve insulin and leptin levels.

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