SAN DIEGO, Nov. 20, 2014 /PRNewswire/ -- Taxus Cardium Pharmaceuticals Group Inc. (Trading Symbol: CRXM) and its advanced regenerative medicine business units today reported results for the third quarter ended September 30, 2014 and corporate development activities.
Based on the current business strategy, the Company has announced the formation of two business units to coordinate the independent monetization and funding activities of the Company’s core products and technologies. The Angionetics unit will be responsible for the late-stage clinical development and commercialization of the Company’s Generx® angiogenic gene therapy product candidate, and the Activation Therapeutics unit will focus on the commercialization of the Excellagen® FDA-cleared wound care product and the joint clinical development of Excellagen product line extensions as an advanced biologic delivery platform for new and innovative wound healing therapeutics.
The Company reported that it is in discussions with respect to a variety of potential deal structures intended to facilitate and unlock the potential underlying economic value of the products and technologies within the Taxus Cardium Pharmaceuticals Group. The Company believes these products and technologies are essentially undervalued within the current portfolio company structure although there can be no assurances that such intended transactions will be completed.
Angionetics Operating Unit Focus: Generx®
The Generx product candidate [Ad5-FGF-4] alferminogene tadenovec, is an angiogenic gene therapy that is being developed as a pioneering 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). Patients with CMI are no longer responsive to medical therapy, and are not considered suitable candidates for traditional revascularization procedures, either because of their overall medical condition or because they continue to have persistent exertional angina despite having satisfactory large coronary artery blood flow based on an angiographic evaluation. Coronary Microvascular Dysfunction (CMD) is a well-recognized clinical condition that describes functional and structural abnormalities of the microvasculature that can lead to myocardial ischemia in the absence of large artery/obstructive disease (microvascular angina), and therefore encompasses CMI.
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. However, many patients (1) have CAD that is not limited to large vessels, (2) continue to experience angina after CABG or PCI, and/or (3) are not suitable candidates for surgical interventions. It is believed that patients with CMI have insufficient microvascular blood flow (i.e. within medium to smaller blood vessels) during exertion due to their advanced coronary artery disease and may benefit from Generx therapy to biologically enhance cardiac perfusion by the promotion of collateral vessel formation. Company researchers believe that biologically enhanced perfusion offers the opportunity to reduce angina attacks and improve quality of life for patients with advanced CAD, and large-scale studies and clinical reviews have now shown that increased perfusion can be cardio-protective and improve outcomes following a major adverse cardiac event.
Following a one-time intracoronary catheter-based delivery by an interventional cardiologist in a routine out-patient procedure (similar to an angiography procedure), Generx is designed to drive the localized, short-term cellular expression of FGF-4 protein, which in turn stimulates the release and action of other key growth factors to orchestrate and promote the growth of cardiac microvascular circulation (functional collateral network) in ischemic cardiac tissue through the enlargement of pre-existing collateral arterioles (arteriogenesis) and the formation of new capillary vessels (angiogenesis). An independent long-term prospective study has demonstrated the importance of collateral circulation beyond simply the relief of angina and provided further support of the potential for long term benefits from Generx therapy. [Meier et al., Circulation 2007;116:975-83]
In the second quarter 2014, Cardium reported positive interim Phase 3 data from the 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.
Upon completion of the ongoing ASPIRE international clinical study, Generx will have been the subject of five randomized and controlled multi-center clinical studies involving approximately 780 patients at over 100 medical centers in the United States, Canada, Western Europe, South America and the Russian Federation. The combined clinical study data will represent one of the largest clinical and regulatory gene therapy dossiers in the world, and suggests that Generx appears to be safe and well tolerated, and is potentially capable of improving myocardial perfusion in patients with myocardial ischemia due to advanced coronary artery disease.
Based on the recent formation of the Angionetics operating unit and plans to independently monetize and fund the Generx product development program, the Company has recently engaged a new contract research organization to conduct the ASPIRE clinical study and plans to advance forward with the study following completion of the strategic partnering or independent funding of Angionetics. To learn more about the Generx angiogenic gene therapy product candidate visit http://www.cardiumthx.com/generx.html.
Activation Therapeutics Operating
Unit Focus: Excellagen®
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’s FDA clearance provides for very broad labeling including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds.
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. Effective January 1, 2014, the Centers for Medicare and Medicaid Services (CMS) assigned Excellagen a unique, product-specific Q code (Q4149), classifying Excellagen as a skin substitute, indicated for the treatment of hard to heal wounds such as diabetic foot ulcers and pressure ulcers as well as other dermal wounds. Consistent with the Company’s long-term business strategy, as previously reported, we do not plan to establish an internal marketing and sales force for commercialization of Excellagen, but rather to fully credentialize Excellagen in preparation for the completion of strategic partnerings within various vertical channel market opportunities or asset monetization. For more information, visit www.excellagen.com.
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 planned clinical studies.
Financial Report for Third Quarter 2014
The attached schedule reports on the summary financial results for the third quarter 2014 based on the Company’s report on Form 10-Q which is on file with the Securities and Exchange Commission. Based on the current business strategy, overall recurring operating costs have been substantially reduced as the Company advances forward with its plans to independently monetize and fund clinical development and commercialization activities of its product, clinical study product candidates and technology platform through its recently formed Angionetics and Activation Therapeutics operating units.
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