Taxus Cardium's Excellagen® Selected For Use With Stem Cells In European Union-Funded Human Clinical Study

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May 12, 2014, 09:00 ET

SAN DIEGO, May 12, 2014 /PRNewswire/ -- Taxus Cardium Pharmaceuticals Group Inc. (Trading Symbol: CRXM) today announced that the Company's Excellagen^® flowable dermal matrix in combination with Orbsen Therapeutics' mesenchymal stromal stem cell therapy Cyndacel-M™ has been selected for clinical evaluation in a Phase 1b safety study for the potential treatment of chronic diabetic wounds to be funded by the European Union under EU Framework 7 (FP7). The project, known by the acronym "REDDSTAR" (Repair of Diabetic Damage by Stromal Cell Administration), is being coordinated by Professor Timothy O'Brien, Dean of Medicine and Director of Ireland's Regenerative Medicine Institute (REMEDI) at National University of Ireland Galway (NUI).

In the initial phase of the project, academic and clinical research teams in Galway, Berlin, Belfast, Munich and Porto tested Orbsen Therapeutics' stem cell product (called Cyndacel-M™) against the current standard cell therapy. An independent panel at the Steno Diabetes Centre in Copenhagen decided to use Cyndacel-M™ for a clinical study in patients with chronic diabetic ulcers, in preference to the current cell technology. The Cyndacel-M™ stem cell product candidate consists of a population of highly characterized stromal cells and is designed to provide improved clinical safety and efficacy compared to other cell-based therapies.

Taxus Cardium's Excellagen^® product, which has been cleared by the FDA for the treatment of chronic non-healing dermal wounds, has previously been shown to be capable of stimulating the rapid regeneration of granulation tissue, and to provide a matrix capable of supporting the viability of cells and other biologics. The REDDSTAR preclinical studies therefore evaluated the use of Taxus Cardium's Excellagen^® and an alternative collagen-based product to promote the maintenance of stem cell viability. The combination of Cyndacel-M™ and Excellagen^® improved wound closure and neo-vascularization in a diabetic dermal wound healing model. Based on those results, Excellagen^® was selected to be used with Cyndacel-M™ in the human clinical study.

"This transatlantic collaboration between Orbsen and Cardium represents an exciting development that brings Cardium's significant commercial expertise in the wound healing market to the REDDSTAR project," stated Dr. Timothy O'Brien.

"In addition to Excellagen's FDA-cleared uses for the treatment of chronic non-healing dermal wounds, its pharmaceutically formulated flowable dermal matrix has been engineered as a platform technology, enabling multiple therapeutic product extensions for tissue regeneration based on stem cells, biologics, peptides and small molecule drugs. We are pleased to have Excellagen^® be selected for this stem cell based clinical study, and believe it could potentially be used to enable and enhance the effectiveness of a variety of stem cell and other clinical applications," stated Christopher J. Reinhard, Chief Executive Officer of Taxus Cardium.

Excellagen^® - FDA-Cleared Flowable Dermal Matrix

Excellagen^® is a flowable dermal matrix in the form of a physiologically formulated homogenate of purified bovine dermal collagen (Type I) in its native 3-dimensional fibrillar configuration, supplied as a sterile professional-use syringe-based product, and capable of providing a structural scaffold for cellular infiltration and wound granulation. Excellagen^® can activate platelets, triggering release of essential growth factors and is believed to function as an acellular biological modulator to activate the wound healing process and significantly accelerate the growth of granulation tissue. Excellagen^® has been designated to be a skin substitute (bearing a unique Q Code), in accordance with the standards established by the U.S. Centers for Medicare and Medicaid Services (CMS). Excellagen^® is intended for professional use following standard debridement procedures in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors. Excellagen's unique fibrillar collagen formulation is topically applied through easy-to-control, pre-filled sterile syringes and is designed for application at one-week intervals. Excellagen^® is indicated for the treatment of hard to heal wounds such as diabetic foot ulcers and pressure ulcers as well as other dermal wounds. The Company has continued to pursue CE mark certification for Excellagen^®, responding to all information requested by the Notified Body, and looks forward to completing this process. For more information, visit www.excellagen.com.

Excellagen^® - Tissue Engineering & Delivery Platform

Excellagen's pharmaceutically formulated, aseptically-manufactured, three-dimensional fibrillar collagen, has been engineered to serve as a cell and biologics delivery platform, enabling multiple device, tissue scaffolding and therapeutic product extensions for tissue regeneration based on stem cells, biologics, peptides and small molecule drugs. As a delivery platform, the use of allogeneic mesenchymal stem cells offers the opportunity to further potentiate Excellagen's already established biological capacity to stimulate rapid regeneration of granulation tissue. In addition to the REDDSTAR initiative, Taxus Cardium is collaborating with researchers at Boston Children's Hospital, to assess the medical utility of Excellagen^® as a delivery scaffold to seed autologous mesenchymal fetal stem cells for ex-vivo engineering of tissue grafts for transplantation into infants to repair prenatally diagnosed birth defects. Autologous mesenchymal fetal stem cells are derived prenatally from infants with a medical defect requiring life-saving tissue repairs. These stem cells are sourced from amniotic fluid, the placenta or umbilical cord blood. The stem cells are then seeded into a scaffold to promote the growth of an engineered tissue graft. These grafts will potentially be used to surgically repair, either in the fetus or immediately following birth, certain prenatally diagnosed birth defects that could include congenital diaphragmatic hernia, tracheal and chest wall defects, bladder extrophy and various cardiac anomalies.

About REDDSTAR and REMEDI

REDDSTAR is funded under the European Union FP7-Health-2012.2.4.3-1: Innovative approach to manage diabetes work program. Alongside the research program will be an active outreach and dissemination initiative to ensure the outcomes of the projects are available to all European citizens. For more information visit www.reddstar.eu. The Regenerative Medicine Institute (REMEDI) is a SFI-funded Strategic Research Cluster, led by NUI Galway (one of Ireland's foremost centers of academic excellence) and with partners in University College Cork and NUI Maynooth. REMEDI is a partnership between scientists, clinicians and industry and it is the leading center in the area of stem cell and regenerative medicine in Ireland. For more information visit www.nuigalway.ie/remedi/.

About Orbsen Therapeutics

Orbsen Therapeutics is Ireland's leading stem cell therapy company. It is privately owned and was founded as a commercialization vehicle for REMEDI. The company is based on-campus in NUI Galway and has successfully developed a proprietary range of stem cell isolation technologies and a pipeline of related cell therapies. For further information visit www.orbsentherapeutics.com.

About Taxus Cardium Pharmaceuticals Group

Taxus Cardium Pharmaceuticals Group Inc. (formerly Cardium Therapeutics) 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 with myocardial ischemia due to advanced coronary artery disease; and (2) Excellagen^®, an FDA-cleared flowable dermal 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 based on 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.

Cardium Therapeutics^®, Generx^®,Cardionovo^®, Tissue Repair™, Excellagen^®, Excellarate™, Genedexa™, and LifeAgain™, are trademarks of Cardium Therapeutics, Inc., Tissue Repair Company or LifeAgain Insurance Solutions Inc. Other trademarks belong to their respective owners.

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SOURCE Taxus Cardium Pharmaceuticals Group