Taxus Cardium Pharmaceuticals Group
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, as illustrated in the following video: https://www.youtube.com/watch?v=pjUndFhJkjM&feature=email, 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 Taxus Cardium's product development activities please visit http://www.cardiumthx.com/CRXM-Presentation-2014.pdf.
About Shanxi Taxus Pharmaceuticals
Shanxi Taxus Pharmaceuticals Co., Ltd. (Shanxi Taxus) is a pharmaceutical company engaged in research and development focused on the natural resource cultivation and manufacture of paclitaxel, an anti-cancer medication. Headquartered in Jinzhong City, Shanxi Province, China, Shanxi Taxus has several lines of business including natural resource management, retail pharmacy and healthcare product manufacturing. Principals of Shanxi Taxus have interests in banking and finance that includes a private equity arm. Shanxi Taxus initiatives are aimed at securing strategic partners with access to the U.S. and other markets whereby both parties can expand their markets and gain access to capital and technical expertise to develop new and innovative medical products.
Cardium Announces Strategic Focus On Advanced Regenerative Therapeutics Based On Generx http://finance.yahoo.com/news/cardium-announces-strategic-focus-advanced-140000722.htmlClinical Findings
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.