25 Jun 2014, Narayanan Suresh, BioSpectrum
San Diego, 24 June 2014: Millions of patients with myocardial ischemia due to coronary artery disease can look forward better days ahead. Generx Ad5FGF-4, a new gene therapy developed by Taxum Cardium Pharmaceuticals, based here in San Diego, has shown significant results in treating this condition that leads to excessive blood flow leading to cardiac arrest.
Sharing the preliminary results of a global clinical study ASPIRE which involved more than 780 patients at the BIO convention here, Dr Timothy Henry, chief of Cardiology at the Cedars-Sinai Heart Institute said, "The new data from the study further supports findings of safety and efficacy from the four prior and published Generx angiogenic gene therapy (AGENT) clinical studies that have been conducted at over 100 medical centers worldwide."
This represents another important step forward in the development of an innovative biology-based microvascular gene therapy tool for the interventional cardiologist designed to broaden the cycle of care for a large number of patients worldwide with myocardial ischemia, Dr Henry added in a press statement.
"Heart disease is a leading global medical concern and is expected to be so for generations to come. Here at Cardium, we are focused on developing an effective and universally affordable cardiovascular gene therapy for ease of use within the current practice of medicine that can potentially be accessible to millions of patients with ischemic heart disease worldwide," said Dr Christopher Reinhard, Taxus Cardium's CEO and co founder of Cardium Therapeutics.
New treatments to counter heart diseases have emerged every decade, starting with diagnostic coronary angiography in 1958, by pass surgery in 1969, reintroduction of angioplasty in 1979 and general use of bare metal stents in 1994. Drug eluting stents followed in 2002. "We are working to develop Generx microvascular gene therapy as the next big transformative innovation for the fields of gene therapy and interventional cardiology," Dr Reinhard added.
Generx is designed to stimulate the body's natural healing response to ischemic coronary artery disease by promoting microvascular angiogenesis and arteriogenesis. These together enhance cardiac perfusion( blood flow). The product is likely to be submitted for regulatory approval in the US, Russia, Commonwealth of Independent states and other parts of the world in the near future. Cardium's contract manufacturing partner SAFC based in Carlsbad, California is expected to start commercial manufacture of Generx soon.