SAN DIEGO, Jan. 27, 2014 /PRNewswire/ -- Cardium Therapeutics Inc. (Ticker Symbol: CRXM) reported on the Company's strategic focus on its two advanced regenerative medicine therapeutics, based on encouraging preliminary findings from its Generx® Aspire International Phase 3 registration clinical study, and data on the utility of Excellagen® for wound healing and as a biologics delivery platform.
Based on these advancements, Cardium has announced that the major focus of the Company will be the clinical and commercial development of advanced regenerative therapeutics that include (1) Generx®, an interventional cardiology angiogenic gene therapy product candidate for the potential treatment of cardiac microvascular insufficiency due to advancing coronary artery disease, which is the subject of an international Phase 3 registration clinical study, and (2) Excellagen®, an FDA-cleared acellular biological skin substitute, which is designed as a professional-use advanced wound care product for the treatment of chronic non-healing diabetic foot, venous and pressure ulcers, and which new data suggest has additional potential applications for tissue regeneration using stem cells and other biologics. For more information about Cardium's business strategy, product development focus and key objectives and activities for 2014, please visit http://www.cardiumthx.com/CRXM-Presentation-2014.pdf
"Cardium is the leader in the field of cardiac gene therapy. Since our acquisition of Generx from Schering AG, Cardium now has the world's largest clinical and regulatory dossier for a cardiac gene therapy product candidate, which now includes four completed randomized and controlled clinical studies, with study data published in peer-reviewed journals that involves over 750 patients with advanced coronary artery disease at more than 100 medical centers in the United States, South America, Canada, Western Europe and the Russian Federation," noted Christopher Reinhard, Cardium's co-founder and chief executive officer. "With encouraging initial findings from our current ASPIRE clinical study, our Generx program is now a central focus for the Company and we are developing plans to accelerate the Generx product development program. Through this effort we seek to be in a position to provide an interim data analysis in mid-2014," he further reported.
With regard to the Generx® product candidate for coronary artery disease, the Company has received encouraging initial findings from its ASPIRE international clinical Phase 3 registration study that is evaluating Generx in patients with myocardial ischemia due to coronary artery disease who are unresponsive to optimal medical therapy and are not suitable candidates for traditional bypass surgery or percutaneous coronary intervention (PCI). This target patient population represents about 12% of patients with angina pectoris, and is estimated to total approximately 900,000 patients in the U.S. The ASPIRE trial is a randomized, 100 patient, multi-center study with two parallel arms, and is being conducted at leading medical centers in Moscow and Novosibirsk to supplement the four already completed clinical studies compiled in the Generx global clinical and regulatory dossiers.
Preliminary clinical data from the initial phase of the ASPIRE study shows that the product candidate Generx, together with Cardium's new catheter-based delivery protocol, appears to be safe and well tolerated, and suggests that a one-time non-surgical administration of Generx can induce substantially improved myocardial perfusion as measured by changes in the reversible perfusion defect size (RPDS) quantified by single-photon emission computed tomography (SPECT) imaging. Improvement in RPDS at eight weeks following administration of the Generx product candidate is the primary efficacy endpoint of the ASPIRE study. These initial findings are supportive of results observed in the Generx AGENT 2 clinical study, and the response is similar in order of magnitude to those reported in medical literature for patients undergoing bypass surgery and PCI. The ASPIRE clinical study has been designed to integrate new delivery techniques based on discoveries by Cardium researchers and to build upon findings from the AGENT clinical studies in the U.S. and Europe. The successful completion of the AGENT 2 clinical study served as the basis for Schering's acquisition of Collateral Therapeutics, a predecessor-in-interest of Cardium.
With regard to its Excellagen® advanced wound care product, the Company has also received positive findings from a European study that evaluated the role of Excellagen in a diabetic wound model, with and without stem cells. The results demonstrated that Excellagen had significant independent potential for wound healing, and also showed that Excellagen is capable of potentiating the effects of stem cells. The study was conducted by researchers led by Professor Timothy O'Brien at the National University of Ireland in Galway and Orbsen Therapeutics Ltd., and evaluated the medical utility of Excellagen as a delivery agent for Orbsen's proprietary human mesenchymal stem cells (MSC) for the potential treatment of diabetic wounds.
The research was sponsored by the European-funded ReddStar initiative. The study showed that Excellagen alone (in a control arm) had significant wound healing capability – confirming and extending results observed regarding the use of Excellagen for the treatment of diabetic wounds. In addition, microscopic and biological analyses demonstrated that human MSCs integrated well into Excellagen's three-dimensioned fibrillar scaffold, with the stem cells retaining positive biological activities and exhibiting increased wound healing potential in the presence of Excellagen. Cardium expects that a manuscript providing the details of these important new research findings will be submitted for publication in a peer-reviewed journal in 2014. The findings with human MSCs also open possibilities for the use of Excellagen in combination with stem cells for advanced wound healing applications, and potentially other applications in the emerging stem cell field.
Effective January 1, 2014, Excellagen was assigned a unique Q code ("skin substitute") product reimbursement designation by the U.S. Centers for Medicare and Medicaid Services (CMS) for the treatment of diabetic foot ulcers and a broad array of other wounds. Cardium further reported that regarding a planned CE mark for Excellagen, all information requested has been provided to the notified body, BSI, and the Company believes this process should lead to CE mark certification for its FDA-cleared advanced wound care product, a key step in enabling commercialization in Europe.
Cardium is an 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 cardiac microvascular insufficiency due to advancing coronary artery disease, and (2) Excellagen®, an FDA-cleared acellular biological skin substitute 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 based on stem cells and other biologics (www.excellagen.com). For more information about Cardium's product development actions visit http://www.cardiumthx.com/CRXM-Presentation-2014.pdf
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 is no assurance that the Company will be successful in advancing, capitalizing and partnering or monetizing its businesses and technology platforms; that the Company can raise sufficient capital to support its product development and commercialization efforts; that planned product development efforts and clinical studies can be performed in an efficient and effective manner; that results or trends observed in one 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 or its partners will be successful in developing and marketing its products or that any intellectual property developed in the area will be effective for excluding potential competitors; that we can raise sufficient capital from partnering, monetization or other fundraising transactions to adequately fund ongoing operations; 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 our or our licensor's intellectual property can be successfully developed and enforced and that we will not be accused of infringing on intellectual property developed by third parties; 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 third parties on whom we depend will perform as anticipated; or that the Company will not be adversely affected by 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.
Cardium Therapeutics®, Generx®, Excellagen®, LifeAgain®, BlueMetric™, Decision Rule Adaption™, ADAPT™, Angionetic Therapeutics™, Activation Therapeutics™, MedPodium™ and Nutra-Apps™ are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company. Other trademarks belong to their respective owners.