Cardium Therapeutics, a San Diego based medical technology company, working with Michigan based Essen Bioscience, Inc., has come up with an important new bio-assay potency test for use with Generx, the company's advanced clinical stage product candidate. For use by interventional cardiologists, Generx is a gene therapy that utilizes the body's natural healing potential to grow microvascular blood vessels in the hearts of patients suffering from coronary artery disease.
An article in San Diego Biotechnology Connection describes how the new bio-assay and visualization test measures the formation and growth of blood vessels from Generx-derived proteins in cell cultures. Although Cardium has already developed the necessary tests for product release, the new test goes beyond FDA guidelines and supports Cardium's ongoing efforts to commercialize Generx. Specifically, the new assay evaluates and confirms the actual biological angiogenic capacity of each Generx production batch, and sets a new global standard in the field of regenerative medicine that now encompasses gene, cell, and stem cell therapies.
Generx is designed as a one-time non-surgical product, delivering a DNA-based biologic to the heart using an angiographic catheter. It's an approach of special value in countries with high cardiovascular death rates, where the infrastructure and economics needed for more costly and invasive surgical revascularization procedures, such as coronary artery bypass surgery and angioplasty/stents, may not be readily available. Cardium is currently focusing their commercialization efforts for Generx on Russia and other parts of the international market. Generx is currently being evaluated in the Phase 3 ASPIRE trial in medical centers in Moscow and St. Petersburg. Clinical sites are currently enrolling the 100 heart disease patients needed for the trial.
The European Medicines Agency's Committee for Medicinal Products recently recommended the authorization of Glybera, a first for a gene therapy product, which offers encouragement for products like Generx.
For additional information, visit www.CardiumTHX.com
Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html