SAN DIEGO--(BUSINESS WIRE)--Taxus Cardium Pharmaceuticals Group Inc. (Trading Symbol: CRXM), today announced the publication of a review article entitled “Identifying and Overcoming Obstacles in Angiogenic Gene Therapy for Myocardial Ischemia,” authored by Gabor M. Rubanyi, M.D., Ph.D., Cardium’s Chief Scientific Officer, in the August 2014 issue of Journal of Cardiovascular Pharmacology.
The publication outlines advances in biological and medical knowledge about Generx® [Ad5FGF-4] alferminogene tadenovec angiogenic gene therapy pioneered by Cardium and others for the potential treatment of myocardial ischemia, including mechanistic and biological insights, optimization of clinical trial design, selection of target patient populations and meaningful efficacy endpoints. The publication also reports, for the first time, the results of studies performed by Cardium researchers in collaboration with Essen Biosciences (Ann Arbor, Michigan) demonstrating a synergistic interaction between fibroblast growth factor-4 (FGF-4), the therapeutic gene in Generx, and vascular endothelial growth factor (VEGF) in the promotion of neo-vessel formation. Evidence is presented that FGF controls angiogenesis upstream of VEGF. The abstract of the publication is now available online at the following link: http://journals.lww.com/cardiovascularpharm/Abstract/2014/08000/Identifying_and_Overcoming_Obstacles_in_Angiogenic.1.aspx. The Company will send the full article to interested parties upon request by contacting Cardium at 858-436-1000.
“In this publication, I have summarized the obstacles identified in the past decade that have impeded clinical success in the field of therapeutic angiogenesis for myocardial ischemia, as well as strategies to overcome those obstacles that have been incorporated into the design of the Generx ASPIRE pivotal Phase 3 gene therapy clinical study now underway in the Russian Federation,” stated Dr. Rubanyi. Before joining Cardium in March 2006, Dr. Rubanyi was vice president of gene therapy at Berlex Biosciences (a subsidiary of Berlex Laboratories, the U.S. pharmaceutical affiliate of the Schering AG Group, Germany). He played a leading role in the development of angiogenic gene therapy at Schering/Berlex in association with a strategic partnership with Collateral Therapeutics. In 2002, Schering acquired Collateral Therapeutics, and in 2005, Cardium Therapeutics acquired the technology and product candidates, including Generx, from Schering prior to the acquisition of Schering by Bayer.
Cardium recently announced positive safety and statistically significant efficacy data from a pre-specified interim analysis of the ASPIRE study’s primary registration endpoint of improvement in cardiac perfusion (blood flow) in patients treated with Generx compared to the control group. Myocardial perfusion was measured by single-photon emission computed tomography (SPECT), a sensitive technique for quantifying cardiac blood flow at rest and during stress. Blood flow under stress was inadequate in all patients entering the study, as it is in a large number of patients with heart disease worldwide. Patients were then randomized to receive the Generx product candidate or standard medical treatment for myocardial ischemia. Eight weeks following administration, the group of patients who received Generx were found to have significant improvements in myocardial blood flow under stress, as compared to the control group – and the degree of improvement in Generx patients was of a magnitude that is similar to that observed following coronary interventions such as bypass surgery, angioplasty or stenting.
About Generx
Generx (alferminogene tadenovec, Ad5FGF-4) is designed to be administered one time, by an interventional cardiologist on an out-patient basis during a brief angiogram-like procedure using a standard balloon catheter. The Generx angiogenic gene therapy product candidate is designed to stimulate the body’s natural healing response to ischemic coronary artery disease by promoting the growth of microvascular circulation in the heart in order to enhance blood flow (cardiac perfusion). Generx is intended as a treatment for patients with myocardial ischemia and persistent angina pectoris (chest pain) due to coronary artery disease, despite optimal medical therapy and bypass surgery or percutaneous coronary intervention (PCI). In addition, this therapy could potentially benefit patients who are diagnosed with cardiac microvascular insufficiency, defined as myocardial ischemia without large vessel disease sufficient to cause ischemia. This group of patients, consisting of about 10-20% of patients with angina pectoris, are not helped by bypass surgery or PCI because these techniques are only applicable to identifiable and treatable lesions in large vessels, and not the growth of smaller vessels.
About Taxus Cardium Pharmaceuticals Group
Taxus Cardium Pharmaceuticals Group Inc. (formerly Cardium Therapeutics, Inc.) is a development stage advanced regenerative therapeutics company that is focused on the late-stage clinical and commercial development of regenerative medicine therapeutics including (1) Generx®, an interventional cardiology, angiogenic gene therapy product candidate designed for the treatment of patients with cardiac microvascular insufficiency and myocardial ischemia due to advanced coronary artery disease; and (2) Excellagen®, an FDA-cleared flowable dermal collagen matrix designed as a professional-use advanced wound care product for the treatment of chronic non-healing diabetic foot, venous and pressure ulcers, which also has multiple additional potential tissue regeneration applications in combination with stem cells and other biologics (www.excellagen.com). For more information about Taxus Cardium's product development activities visit www.cardiumthx.com.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from expectations. For example, there can be no assurance that results or trends observed in one preclinical or clinical study or procedure will be reproduced in subsequent studies or in actual use; that new clinical studies will be successful or will lead to approvals or clearances from health regulatory authorities, or that approvals in one jurisdiction will help to support studies or approvals elsewhere; that the company can attract suitable commercialization partners for our products or that we or partners can successfully commercialize them; that our product or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive or blocked by third party proprietary rights or other means; that the products and product candidates referred to in this report or in our other reports will be successfully commercialized and their use reimbursed, or will enhance our market value; that new product opportunities or commercialization efforts will be successfully established; that third parties on whom we depend will perform as anticipated; that we can raise sufficient capital from partnering, monetization or other fundraising transactions to maintain our stock exchange listing or adequately fund ongoing operations; or that we will not be adversely affected by these or other risks and uncertainties that could impact our operations, business or other matters, as described in more detail in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
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