Excellagen® Receives USPTO Notice Of Allowance For A New Patent Application Covering Blood Platelet Activation & Endogeneous Growth Factor Release For Wound Repair And Tissue Regeneration

SAN DIEGO, June 13, 2017 /PRNewswire/ -- Taxus Cardium Pharmaceuticals Group Inc. (Trading Symbol: CRXM) and its operating unit Activation Therapeutics today announced that a Notice of Allowance has been received from the U.S. Patent and Trademark Office (USPTO) for a new patent application (U.S. Application No. 13/648,255) entitled "Flowable Formulations for Tissue Repair and Regeneration." The patent application includes claims covering methods to utilize formulations encompassing Excellagen [2.6%] as a topically applied flowable fibrillar collagen matrix for wound repair by promoting localized release of platelet derived growth factors and providing an in situ microstructural scaffold for cell migration. 

Excellagen is an FDA-cleared, aseptically manufactured, syringe-based, skin substitute wound care dressing consisting of a stabilized formulation of renatured atelopeptide bovine fibrillar tropocollagen that is designed for professional use. Excellagen, and related formulations covered by the patent application, are designed to possess key structural and biological functions to effectively promote wound repair and tissue regeneration, and also provides a platform technology for delivery of a variety of biologics and wound healing agents for tissue repair and regeneration.

In accordance with the FDA-cleared instructions for use, Excellagen is applied topically to a chronic dermal wound immediately following surgical debridement, a standard practice used by medical professionals to remove necrotic tissue, resulting in a bleeding wound bed. As covered in the U.S. patent, the application of Excellagen following debridement, in the presence of a small amount of blood, promotes platelet activation and endogenous release of key wound healing growth factors, including platelet derived growth factor-BB (PDGF-BB). The PDGF-BB protein is the active ingredient of becaplermin gel [0.01%] (tradename Regranex®) which is FDA approved for the treatment of lower extremity diabetic neuropathic ulcers.  

Excellagen® Advanced Dermal Wound Matrix
Excellagen® is an FDA-cleared, flowable [2.6%] dermal matrix wound care dressing indicated for the treatment of hard to heal wounds such as diabetic foot ulcers and pressure ulcers as well as other dermal wounds. Excellagen is aseptically manufactured, and supplied in prefilled syringes, in the form of a physiologically formulated stabilized homogenate of purified bovine dermal atelopeptide collagen (Type I) in its native 3-dimensional fibrillar configuration. Excellagen® has shown to activate blood platelets, triggering endogenous release of essential growth factors, and also provides a structural scaffold for cellular infiltration and migration, significantly accelerating the growth of granulation tissue in chronic lower extremity neuropathic diabetic ulcers. Excellagen's unique fibrillar collagen formulation is topically applied through easy-to-control, pre-filled syringes and is designed for application at one-week intervals. Excellagen® has been designated as a skin substitute (bearing a unique product Q Code), in accordance with the standards established by the U.S. Centers for Medicare and Medicaid Services (CMS). For more information about Excellagen, visit https://www.youtube.com/watch?v=D2GYCYc_8JE.

In clinical studies of chronic, diabetic foot ulcers, a single application of Excellagen, applied following debridement and in the presence of a small influx of blood, resulted in immediate acceleration of healing and reductions in wound size compared to standard of care [Blume et al., "Formulated collagen gel accelerates healing rate immediately after application in patients with diabetic neuropathic foot ulcers." Wound Repair Regen. 2011, 19(3):302-8].

Excellagen has also been developed as a technology platform for the delivery of small molecule drugs, peptides, proteins, and potential advanced wound healing biologics that include genes, stem cells and exosomes. In preclinical animal studies of wound healing, Excellagen has demonstrated localization of adenoviral-based growth factor gene therapies to the site of application and negligible immunogenicity, as well as wound healing responses [Gu et al., "Adenovirus encoding human platelet-derived growth factor-B delivered in collagen exhibits safety, biodistribution, and immunogenicity profiles favorable for clinical use." Mol. Ther. 2004; 9(5):699-711]. Similar safety, immunogenicity and biodistribution profiles were observed in a small Phase 1/2 gene therapy study in diabetic foot ulcers [Mulder et al., Treatment of nonhealing diabetic foot ulcers with a platelet-derived growth factor gene-activated matrix (GAM501): Results of a Phase 1/2 trial." Wound Repair Regen. 2009; 17(6):772-9].

In addition, in vitro studies have demonstrated superior performance of Excellagen in supporting stem cell viability, when compared to reconstituted, granulated collagen preparations, and efficacy of Excellagen-stem cell formulations have been demonstrated in preclinical animal models of wound healing. 

Taxus Cardium Pharmaceuticals Group
Taxus Cardium Pharmaceuticals Group Inc. is a holding company that manages and operates a portfolio of equity-based and potential royalty-driven investments as follows: (1) Angionetics, a majority-owned business unit focused on the clinical advancement and commercialization of Generx®, an interventional cardiology, angiogenic gene therapy Phase 3 product candidate designed for the potential treatment of patients with cardiac microvascular insufficiency and myocardial ischemia due to advanced coronary artery disease (www.angionetics.com); (2) Activation Therapeutics, a business unit focused on the commercialization of 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 additional potential tissue regeneration applications based on stem cells and other biologics; (3) LifeAgain, an advanced medical data analytics ADAPT® technology platform focused on developing new and innovative products for the life insurance and healthcare sectors; and (4) Healthy Brand Collective, a functional food and nutraceutical company which acquired Taxus Cardium's To Go Brands® business (www.healthybrandsco.com). For more information about Taxus Cardium, visit the Company's website www.taxuscardium.com).

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Cardium Therapeutics^®, Generx^®, Excellagen^®, and LifeAgain™, are trademarks of Cardium Therapeutics, Inc., Tissue Repair Company or LifeAgain Insurance Solutions Inc. Regranex® is a registered trademark of Smith & Nephew, Inc. Other trademarks belong to their respective owners.

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