Noveratech L.L.C. — Department of Health and Human Services SBIR Phase I: 200

Description

DESCRIPTION provided by applicant This proposal is submitted in response to the new NIDDK announcement PA calling for development of new diagnostic monitoring and therapeutics technologies for the complications of type diabetes T D An estimated of the million diabetic patients in this country will develop diabetic foot ulcers DFU at some point in their lives Currently even the best available treatments achieve only a healing rate for these wounds and this healing is often only temporary with a high chance of recurring Although the causes of non healing chronic wounds are multifactorial one critical pathophysiology is ischemia a deficient blood supply Ischemia may not be the initiating factor for DFU because most ulcers start from a combination of neuropathy pressure loading and or trauma However tissue ischemia is the main cause that hinders healing wounds do not heal in tissue that does not bleed whereas they always heal in tissue that bleeds extensively The most critical consequence of ischemia is a decreased cellular energy supply because energy is required in every aspect of the wound healing process from protein synthesis to cell migration proliferation and functioning Our company has developed a technique to encapsulate Mg ATP into very small unilamellar lipid vesicles for intracellular delivery ATP vesicles or VitaSolTM When we use this new technique in animal wound models not only healing is enhanced but also produces an unprecedented result Granulation tissue starts to appear in less than hours It continues to grow and covers the whole wound within days Massive cell accumulation and proliferation occur not only on the wound wall but also in the wound cavity where no blood supply exists We have never seen this phenomenon in humans or any other land animals nor has it been reported in the literature by any other treatment strategy The effect seems even more pronounced in long term months or longer diabetic plus ischemic wounds Although the granulation tissue growth is rapid it shows a self limiting feature which results in no hypertrophic scar formation or any other overgrowth even after years Like many other wound care specialists when we first saw this unprecedented result we did not believe it because it seemed too good to be true However this novel healing response has been confirmed in more than rabbits over wounds In this phase I proposal we will compare VitaSolTM with Regranex the only FDA approved prescription growth factor for wound care in a diabetic wound model without skin contraction and perform a preliminary toxicity study The accomplishment of these two goals will bring the project one step closer to IND application Our technique of intracellular energy delivery has consistently been viewed as innovative If successful it will provide an inexpensive and easy to use dressing for DFU treatment something not yet achieved despite thousands of dressings developed or proposed The potential impact is high PUBLIC HEALTH RELEVANCE Diabetic foot ulcer is a major and disabling complication but no effective treatment is currently available We have developed an intracellular energy delivery technique for wound care In animal tests it causes granulation tissue to appear in less than hours and covers wound cavity quickly The effect is more prominent in long term diabetic plus ischemic wounds The elimination of the traditional lag time in wound healing process and the ability to nourish massive cells in wound cavities devoid of blood supply are two features never achieved with any other treatments This phase I project will compare the effectiveness of this new treatment with the only FDA approved prescription growth factor for wound care Regranex in diabetic wounds and perform a preliminary toxicity tests in male and female rabbits The success of this phase I project will pave the way for more extensive tests in phase II and prepare the technique for IND application The final success will benefit the millions of diabetic patients with unmanageable chronic wounds and will also have the potential to be applied to other areas of medicine where ischemia is involved