Cardium Therapeutics, a company focused on acquiring and developing new biomedical products, today announced it has received clearance from the Russian Ministry of Health and Social Development to start the phase III registration study for the company’s Generx™ biological product candidate.
Generx is a DNA-based therapy designed to treat myocardial ischemia caused by coronary artery disease. For marketing and sales purposes in Russia, the Russian Health Authority will brand Generx as the therapeutic drug trade name Cardionovo™.
The company noted that coronary heart disease mortality is a global issue and that more than 80 percent of the future increases in the disease are expected to occur outside the United States.
“With the exception of sub-Saharan Africa, cardiovascular disease is the leading cause of death in the developing world as a result of accelerating tobacco use, diet and lifestyle changes. There is a need for innovative and cost-effective advanced cardiovascular care to meet the accelerating levels of cardiovascular disease affecting global markets,” Christopher J. Reinhard, Cardium’s chairman and CEO stated in the press release. “We believe that Generx may offer the potential for a one-time, non-surgical cost-efficient treatment option for patients with myocardial ischemia due to coronary artery disease.”
The phase III study will evaluate the safety and efficacy of Generx using SPECT imaging to measure improvements in microvascular cardiac perfusion following a one-time, non-surgical, catheter-based administration of Generx. The clinical study is expected to involve approximately 100 men and women with myocardial ischemia caused by coronary artery disease at up to three leading medical centers in Moscow.
The study will represent the fifth clinical study under Generx’s clinical development program involving patients at more than 100 medical centers throughout the U.S., Canada, South America, Western Europe and Russia.
Cardium’s Russian sponsor and development partner Advanced Biosciences Research, said that based on today’s announced clearance, it may consider submitting an application for the marketing and sales of Generx in the Russian Federation, as well as surrounding areas.
For more information visit www.cardiumthx.com