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Promising Antimicrobial Attacks Virus, Stimulates Immune System
A promising antimicrobial agent already known to kill bacteria can also kill viruses and stimulate the innate immune system, according to researchers at National Jewish Health. In a paper appearing online June 4 in the Journal of Investigative Dermatology, Michael Howell, PhD, Assistant Professor of Pediatrics, and his colleagues demonstrated that the synthetic compound CSA-13 can kill vaccinia virus in cell cultures and in mice. Additionally, they showed that CSA-13 stimulates cells to produce their own antimicrobial proteins.
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Insights Into Failed HIV-1 Vaccine Trial: Study
Following the disbandment of the STEP trial to test the efficacy of the Merck HIV-1 vaccine candidate in 2007, the leading explanation for why the vaccine was ineffective - and may have even increased susceptibility to acquiring the virus - centered on the hypothesis that high levels of baseline Ad5-specific neutralizing antibodies may have increased HIV-1 acquisition among the study subjects who received the vaccine by increasing Ad5-specific CD4+ T-cells that were susceptible to HIV-1 infection.
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Cardium Presents Gene Activated Matrix Technology And Update On Excellarate Clinical Development Program At ASGT Annual Meeting
Cardium Therapeutics (NYSE Amex: CXM) and its subsidiary Tissue Repair Company (TRC) announced a presentation entitled "Phase 2b Study of GAM501 (Ad5PDGF-B/Collagen) in the Treatment of Diabetic Ulcers" at the Late Stage Industry Clinical Trials Symposium at the American Society of Gene Therapy (ASGT) Annual meeting in San Diego, California, on May 27, 2009. Dr. Barbara K. Sosnowski, Cardium"s Vice President of Biologics Development and the Chief Operating Officer of Cardium"s Tissue Repair Company Operating Unit, provided an update on TRC"s Phase 2b MATRIX clinical trial and the new formulation of the Excellarate(TM) product candidate, as well as an overview of the prior clinical study of Excellarate.
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Versartis Publishes Preclinical Abstracts For Two Product Candidates At 2009 American Diabetes Association Scientific Sessions

Versartis, Inc., a new company developing novel biologics with enhanced properties for patients with metabolic diseases, published abstracts for preclinical data on its two product candidates, VRS-859 (exenatide-rPEG) and VRS-808 (glucagon-rPEG), at the American Diabetes Association Scientific Sessions annual meeting beginning today in New Orleans. Versartis, through a unique licensing agreement with Amunix, Inc., uses the proprietary Amunix recombinant PEGylation (rPEG) technology to extend the half life of established biologics. The Versartis compounds in development have the potential for significantly less frequent dosing and fewer side effects than those products currently on the market or in development. "With VRS-859, we have a product candidate that may become a "best in class" GLP-1 analog for the treatment of type 2 diabetes. This compound has similar preclinical efficacy to exenatide in animal models; and the pharmacokinetics in four species support monthly dosing in humans. VRS-859 can also be administered in a small volume with a small gauge needle," said Jeffrey L. Cleland, Ph.D., Founder and Chief Executive Officer of Versartis. "VRS-808 has the potential to prevent nocturnal hypoglycemia in type 1 diabetes, an unmet medical need," Dr. Cleland continued. "VRS-859 and VRS-808 did not have significant toxicology at very high doses in preclinical studies, including a lack of immunogenicity in all studies. We look forward to moving these products rapidly into human clinical trials to benefit diabetes patients." ABSTRACTS Exenatide: 1994-PO -- "An Extended Half-life Exenatide Construct for Weekly Administration in the Treatment of Diabetes Mellitus" The current approved regimen of exenatide for the treatment of type 2 diabetes mellitus requires administration twice a day and is effective in reducing hemoglobin A1c and body weight. Common side effects of this treatment regimen for exenatide include nausea and hypoglycemia, possibly caused by the high peak levels (Cmax) of exenatide after each injection. The ideal dosage form of exenatide would maintain the exenatide blood level in the therapeutic window for at least one week without a high Cmax, which commonly occurs with depot dosage forms. We designed an extended half-life exenatide construct that contains a long unstructured tail of hydrophilic amino acids referred to as rPEG (Exenatide-rPEG; VRS-859). The rPEG tail both increases the serum half-life and provides a slower rate of absorption, thus reducing the peak-trough ratio significantly from the levels seen with twice daily injection of unmodified exenatide. Attachment of rPEG to a model protein (26.9 kDa) increased serum half-life to 75 hrs with a 99% absolute bioavailability following subcutaneous administration in cynomolgus monkeys. A similar half-life extension is expected with exenatide, enabling weekly or every two week dosing in humans. The preclinical efficacy, pharmacokinetics, and immunogenicity of VRS-859 will be presented. The results of these studies will enable rapid progress of the construct into human clinical trials. Glucagon: 2001-PO -- "An Extended Half-life Glucagon Construct for the Prevention of Nocturnal Hypoglycemia" Nocturnal hypoglycemia is a common problem for type I diabetics, especially children, often leading to death. Glucagon is typically used to treat acute hypoglycemia, but the short half-life of glucagon ( Versartis


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