Thursday, 21 February 2013

Clinical trial for heart failure

A team of cardiovascular researchers from the Florida Hospital Pepin Heart Institute and Dr. Kiran C. Patel Research Institute, affiliated with the University of South Florida announced yesterday the enrolment of the first two patients into a Phase II clinical trial for heart failure followed by ischemic injury. Purpose of the placebo controlled study is to assess the efficacy and safety of a drug called JVS-100 for treating the aforementioned condition.

The drug is produced by Juventas Therapeutics. According to the company's website, JVS-100 encodes the Stromal cell-Derived Factor 1 protein (SDF-1) which in turn promotes tissue regeneration by recruiting endogenous stem cells in the damaged area, preventing cell death, and restoring blood flow. Essentially, the drug acts as a homing beacon that attracts stem cells to the injured site, enhancing the body's stem cell-based repair capacity .



Video of Rahul Aras, President and Chief Executive Officer of Juventas Therapeutics


The trial will span in 10 different U.S sites and will enrol a total of 90 patients. The drug will be administered by Dr. Charles Lambert directly into the the heart via injection.

Juventas Therapeutics reported earlier this year the results of the Phase I clinical trial for JVS-100 in ischemic heart failure patients. During the Phase I clinical trial the researchers injected three different  doses of JFS-100 (5mg, 15mg or 30mg) into the hearts of 17 patients presenting with symptomatic heart failure. Their progress was followed for 12 months.  The study showed that JVS-100 is safe to use and no serious adverse effects were reported. Additionally and one year after the treatment, the participants showed significant improvements in exercise levels. According to the study four months post op the participants:
  • Had improved their average distance by 40 meters during a six-minute walking test
  • Reported improved quality of life. 
  • Their heart's pumping ability had improved, especially the groups that had received the highest doses of JVS-100
At 12 months all improvements  were maintained.


Dr. Leslie Miller, national principal investigator for the trial said:

“Targeted gene and cell therapies delivered directly into the heart hold promise for helping to regenerate tissue, reduce injury and restore heart function. USF Health, working with our partners, will find new ways to diagnose and treat patients, with the aim of reducing and ultimately harnessing the global impact of heart disease.”



Heart failure (HF) occurs when the heart is unable to provide sufficient pump action to distribute blood flow to meet the needs of the body. The condition is usually the result of inadequate blood flow to the heart resulting from chronic or acute cardiovascular disease, including heart attacks. It is estimated that in developed countries, around 2% of adults have heart failure, however the ratio increases to 6–10% for people older than 65 years of age. Some common symptoms of heart failure are the following:
  • Shortness of breath (dyspnea) 
  • Fatigue and weakness 
  • Swelling  in the legs, ankles and feet 
  • Rapid or irregular heartbeat 
  • Reduced ability to exercise 

Image showing the major symptoms of heart failure
Image showing the major symptoms of heart failure



References
Penn, M., Mendelsohn, F., Schaer, G., Sherman, W., Farr, M., Pastore, J., Rouy, D., Clemens, R., Aras, R., & Losordo, D. (2013). An Open Label Dose Escalation Study to Evaluate the Safety of Administration of Non-Viral SDF-1 Plasmid to Treat Symptomatic Ischemic Heart Failure Circulation Research DOI: 10.1161/CIRCRESAHA.111.300440

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