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Cardium Therapeutics, Inc. Remains in Limbo as FDA Approval for Excellagen Remains Questionable

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It has been nearly a year since Cardium Therapeutics, Inc. (AMEX: CXM) submitted their FDA 501(k) application for approval to market and sell their wound care management topical gel product Excellagen and investors are getting antsy as the delay continues to leave the company’s stock in limbo, sitting around the 0.46 – 0.49 range which is right around the 50-day moving average of 0.51 and 200-day moving average of 0.49.

While there are many that expect Excellagen to get the nod from the FDA it may not be when they expect it. The reasoning behind this could go back to the Phase IIb study which had actually been set up to test the efficacy and safety of a completely different product, Excellerate, which coupled the collagen gel found in Excellagen with a gene therapy-like drug as a specific treatment for diabetic foot ulcers.

Because the study showed that the topical gel Excellagen alone actually healed the wounds better than the combination that made up Excllerate the company opted to move forward with Excellagen. So now the question becomes does the FDA have enough information on Excellagen to give approval. As most investors know the FDA doesn’t just hand out approvals and if there is any doubt in their minds they will simply request Cardium produce further results, a request that could cost a substantial amount of money and time.

Cardium doesn’t see it going that route as Chairman and CEO Christopher J. Reinhard stated in an Oct. 13 press release “We look forward to the market launch of Excellagen planned for this year, upon clearance by the FDA of our pending 510(k) notification, and to the development of new product extensions based on our custom formulated collagen product platform for additional wound healing applications.” That seems a bit optimistic but with shares sitting flat he may have been looking to drum up some attention.

That being said Excellagen does appear to produce very favorable results as the Phase IIb study showed the topical gel had complete wound closure by 12 weeks at 45%, significantly higher than the 34% produced by Regranex, the main product on the market today for the treatment of diabetic foot ulcers. Excellagen also appears to be safer than Regranex which carries with it a warning label concerning the risk to develop cancer. If Excellagen is able to make it to market and compete directly with Regranex then Cardium could be sitting on a goldmine.

Not only would Excellagen be a first line treatment for the estimated 1.26 million annual foot ulcers suffered by diabetics but it could also be used as a treatment in the much broader scope of wound healing. Last month the company revealed Excellagen actually activated platelet release of platelet-derived growth factor (PDGF) locally at the wound site.  This growth factor has been shown to play an essential role in the wound healing process, not exclusive to diabetic foot ulcers.

Tapping into the broader market offers Cardium the opportunity to make significant financial gains and their approach, following FDA approval, is to license the Excellagen product line with the goal of pacing it within a larger organization or with partners who have existing commercialization, sales and marketing resources. This approach could bring about much faster returns as Cardium a fully integrated sales and marketing organization.

Making Cardium even more attractive is their “exclusive access to commercial development rights for certain novel supramacromolecular polymer complexes enabling regulatable and localized topical delivery of nitric oxide for prolonged periods of one to three weeks,” something the company has said will “broaden and expand” their wound healing and tissue regeneration portfolio. More specifically, they would be able to develop a greater variety of wound healing products utilizing nitric oxide, “a physiological mediator that has been shown to play an important role in enhancing wound healing.” These products could include “granulated and powder dressings, topical creams and gels, thin films and aqueous formulations, as well as electrospun fibers for dressings and bandages.”

Reinhard said the potential that exists in the development of nitric oxide therapy for wound healing and tissue regeneration could be substantial as it “opens the door for us to develop product extensions based on our formulated collagen product platform and to develop new products for other wound healing applications and in other medical settings that could include acute applications for military and emergency medical services.”

Also in the works for Cardium is their DNA-based angiogenic cardiovascular biologic Generx designed for patients with coronary artery disease. Having already gone through a series of trials Generx goal is “to stimulate the growth of supplemental collateral blood vessels in the heart in order to enhance myocardial blood flow (perfusion) in patients who have insufficient blood flow due to atherosclerotic plaque build up in the coronary arteries.”

The global market for the treatment of heart disease continues to grow and Cardium feels that it is positioning itself to become a viable option as it relates to coronary artery disease. Generx has been approved by the FDA for a Phase III trial in the U.S. for women with late stage coronary artery disease who are unresponsive to traditional drug therapy and are not appropriate candidates for mechanical revascularization. Earlier this week Cardium was awarded a cash grant of approximately $245,000 under the U.S. Government’s Qualifying Therapeutic Discovery Project (“QTDP”) program to further its Generx clinical development program.

One day after announcing they had received the cash grant Cardium announced the launch of their MedPodium healthy lifestyle product platform which is being developed as a portfolio of “premium, science-based, easy to use medicinals, neurologics, metabolics, nutraceuticals and aesthetics designed to promote and manage personal health.” These products concentrate on podiatry care but there are plans to expand the line to “address the lifestyle issues confronting the large and growing newly-emerging adult market.” That expansion is said to begin taking form over the next 12 months. The products under the MedPodium portfolio will be available through the MedPodium Web boutique as well as sold through affiliate partners with plans to eventually reach select distributors and/or retailers in the United States.

While there are many investors sitting back and waiting to hear from the FDA regarding Excellagen as well as see the company’s financial results due out in November it appears as if Cardium is positioning itself to advance regardless. Even if the FDA calls for further studies it doesn’t look as if Cardium would fall apart as it seems an approval will come at some point. Add that to the impressive lineup of products already developed and those in the works and the relatively low share price for an active biostock company becomes pretty attractive.

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