In its release on
-Announced positive interim Phase 3 data from Cardium's international ASPIRE clinical study showing significant potential efficacy of Generx angiogenic gene therapy for myocardial ischemia due to coronary artery disease. Statistically significant improvement in the study's primary efficacy endpoint was observed, as measured by changes after eight weeks in the reversible perfusion defect size (RPDS), determined using rest/stress single-photon emission computed tomography (SPECT) imaging. This improvement in RPDS was consistent with the RPDS improvement previously reported in the Phase 2 Generx AGENT clinical study, and of a magnitude similar to that observed following large vessel revascularization procedures, such as by-pass surgery or percutaneous coronary intervention.
-Following completion of an independent detailed preclinical assessment, Excellagen flowable dermal matrix in combination with Orbsen Therapeutics' mesenchymal stromal stem cell therapy Cyndacel- M was selected for clinical evaluation in a Phase 1/2 clinical safety study for the potential treatment of patients with chronic diabetic wounds. This new clinical study will be funded by the
-The Company presented the positive interim Phase 3 primary efficacy data and an overview of the Generx clinical development program at the 2014
-Reported publication of a scientific article, entitled "Identifying and Overcoming Obstacles in Angiogenic Gene Therapy for Myocardial Ischemia," by Gabor M. Rubanyi, M.D., Ph.D., Cardium's Chief Scientific Officer, in the
-The Company has continued activities relating to the strategic partnering process and monetization of Cardium's
-In support of CE Mark registration for Cardium's Excellagen FDA- cleared flowable dermal wound care matrix, the Company responded to a request from the notified body BSI for additional information and looks forward to the completion of this process and to issuance of an international CE Mark registration.
-Continued to advance forward with the commercialization of our non-core LifeAgain advanced medical data analytics business investment, which is focused on the development, marketing and sale of "survivable risk" term life insurance for cancer survivors or others with medical conditions who are currently considered uninsurable based on traditional underwriting standards. The Company may seek to support the growth and development of this non-core business and technology platform through the sale of a minority stake in our LifeAgain business to a strategic partner or financial investors. The LifeAgain website address is www.lifeagain.com.
-The sale of Cardium's non-core
The Generx product candidate (alferminogene tadenovec, Ad5FGF-4) is an angiogenic gene therapy that is being developed as a treatment for Cardiac Microvascular Insufficiency or CMI in patients with myocardial ischemia and symptomatic chronic stable angina pectoris due to advanced coronary artery disease (CAD).
Traditional surgical approaches such as coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) are designed to address blockages in the large vessels of the heart that can be reached using such methods.
Excellagen FDA-Cleared Wound Care Product
Excellagen is a flowable homogenate of pharmaceutically formulated, 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 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 fibrillar collagen formulation is topically applied through easy-to-control, pre-filled sterile syringes and is designed for application at one-week intervals.
In addition to its application for the treatment of chronic non- healing dermal wounds, Excellagen's pharmaceutically formulated collagen has been engineered to serve as a 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. It is believed that the application of Excellagen as a mesenchymal stem cell delivery platform can facilitate wound healing, which is the subject of ongoing preclinical studies.
Financial Report for Second Quarter 2014
For the three months ended
Cardium continued to maintain its reduced overall operating cost structure as it primarily focuses on the clinical and commercial development of its innovative gene therapy and regenerative medicine product and technology platform. As a result, the Company reduced cash-based operating expenses by 48 percent from
The Company's research and development costs for the three months ended
The Company's research and development costs for the six months ended
For the six months ended
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In its release on