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ASGT 12th Annual Meeting: Incorporate Gene Therapy To Make Stem Cell Treatment Safer, More Effective
Gene therapy should be used in tandem with stem cell therapy to enhance the reliability of stem cells, provide an opportunity to limit adverse effects and increase treatment success, according to research presented at the American Society of Gene Therapy"s 12th Annual Meeting, May 30.
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Regulatory Affairs Professionals Society (RAPS) Opens RAPS Europe In Brussels
The Regulatory Affairs Professionals Society (RAPS), the world"s largest
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VYVANSE CII Provided Significant Efficacy At 14 Hours After Administration In Adults With ADHD In An Adult Simulated Workplace Environment
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced results from a Phase 3b study that found VYVANSE® (lisdexamfetamine dimesylate) CII demonstrated significant efficacy at 14 hours after administration during a simulated workplace environment study in adults with Attention Deficit Hyperactivity Disorder (ADHD). VYVANSE is the first approved stimulant for adults with ADHD to be evaluated in this setting, and these data were presented today at the 49th annual New Clinical Drug Evaluation Unit meeting in Hollywood, FL. VYVANSE is currently approved by the US Food and Drug Administration (FDA) for the treatment of ADHD in children age 6 to 12 years and in adults with ADHD.
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PanGenetics Receives Approval For Clinical Evaluation Of Anti-NGF Antibody In Patients With Chronic Pain

PanGenetics B.V. announced that the Competent Authority of the Netherlands has approved the Clinical Trials Application for a first-in-man study with antibody PG110. This humanized antibody is a member of the class of Nerve Growth Factor (NGF) inhibitors which represent a promising novel approach in the treatment of chronic pain. PG110 will be evaluated in patients suffering from pain caused by osteoarthritis (OA). The clinical trial is designed as a double blind, placebo controlled study and will be conducted in a single site in Utrecht, the Netherlands, in collaboration with Kendle International. The primary objective of the Phase I study is to evaluate the safety and tolerability of single ascending doses of PG110. In addition, the dosing in patients will allow the evaluation of pharmacodynamic and clinical parameters which will provide further insight into the activity of PG110. The results of the study, which includes an extended follow-up period, are expected in the second half of 2010. Kevin Johnson, CEO of PanGenetics, commented: "The class of NGF-inhibitors is the first real break-through in pain therapy for decades. Preclinical studies of PG110 demonstrated that it is a very potent and differentiated product in this class. We are looking forward to starting clinical studies of PG110. This will be our second clinical program initiation in the last 12 months and our anti-CD40 antibody PG102 is progressing well in a phase 1 study in psoriatic arthritis patients." About PG110 PG110 is a humanised antibody that binds to Nerve Growth Factor (NGF) with high affinity. NGF is the prototypical member of the family of neurotrophin growth factors, which are involved in the growth and survival of nervous tissue. PG110 prevents the interaction of NGF with both its receptors, the high-affinity receptor TrKA and the low affinity receptor p75. This interaction plays a key role in pain transduction mechanisms in the adult peripheral nervous system. PG110 does not cross-react with other neurotrophins and therefore is a highly specific function-blocking molecule that is able to neutralise NGF bioactivity, both in vitro and in vivo. The precursor to PG110 originated in Lay Line Genomics and after the program was acquired by PanGenetics a comprehensive CMC and preclinical development program was initiated. PanGenetics B.V.


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