Tuesday, July 25, 2006

Breakthroughs in cardiovascular diseases

Todays Headlines from across the DailyUpdates network
  • Featured Journal Article (from DailyUpdates-Cardiovascular Diseases): Promising approach to acute limb ischemia As highlighted in our recent feature Acute Limb Ischemia (ALI) this condition is associated with high mortality especially in individuals with diabetes. Treatment options are limited and amputation is unfortunately the primary clinical approach to patients presenting with ALI. More conservative approaches represent a clearly unmet area, especially since hemorrhage represents a real risk in ALI patients treated with thrombolytics. Moreover, streptase (which is no longer available) was the only approved agent for the use in the periphery. A number of next generation thrombolytics are however under development in an attempt to reduce the risk of hemorrhage. The number of patients with ALI is difficult to determine with the commonly quoted figure of 40,000 in the US being very conservative; the ALI market thus represents a lucrative and largely under-exploited area. Today‚Äôs featured study represents one novel candidate approach to ALI. Kusumanto and colleagues report that intramuscular administration of phVEGF(165) (vascular endothelial growth factor gene-carrying plasmid) improved hemodynamic performance and reduced skin ulcers and pain in diabetic patients with ALI. Although the primary end-point of reduced amputation was not met, larger studies are warranted especially given the lack of adverse effects Hum Gene Ther. 2006 May 2; [Epub ahead of print]
  • Featured News Item (from DailyUpdates-Cardiovascular Diseases): Cardiome reports promising data on atrial fibrillation candidate In April, 2006 we highlighted Cardiome Pharma's announcement that the company's co-development partner, Astellas Pharma, had submitted an NDA to the FDA seeking approval to market the intravenous formulation of RSD1235, an investigational new drug for the acute conversion of atrial fibrillation. LeadDiscovery's brand new report on emerging pharmacological approaches to atrial and ventricular fibrillation (click here) concludes that RSD1235 is one of the most promising new candidates for patients with atrial fibrillation. The NDA is based on a 5-year clinical development program for RSD1235. RSD1235 is also being investigated as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. Phase I data concerning this indication were released by Cardiome on May 5th, 2006). A Phase 2a pilot study for oral RSD1235 was initiated in December 2005 and interim results from this study have now been released. The data show that RSD1235 is well-tolerated and give the first indications of efficacy. Just as important, during the 28 days of oral dosing, serious adverse events occurred at a similar rate in placebo and RSD1235 treated patients, while, contrasting with other antiarrhythmics no cases of drug-related Torsades de Pointes were observed [source: Cardiome]


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