OmegaGenesis product development investments are turning the early research work in angiogenesis and anti-angiogenesis into applications and products to accelerate cellular-based biologic therapies to control blood vessel growth. Today, the company's product development efforts are testing nano-scale materials that work on the cellular and sub-cellular level to control angiogenesis, the growth of new blood vessels.

The OmegaGenesis technology platform is based upon the idea of using the angiogenic properties of these nano-materials in therapeutic applications. These nano-materials will enable doctors to treat disease the condition with local targeted drug delivery directed at the affected tissues, versus at the systemic level as with conventional therapies, which is less invasive to the patient.

Applications

Angiogenesis is important for several pathophysiological scenarios including wound healing and cardiovascular diseases.

The OmegaGenesis nano-medicine platform has tremendous therapeutic potential for a variety of medical applications ranging from healing of common wounds to controlling the growth and spread of cancer. Rare earth element nano-materials can potentially be used for wound healing, the treatment of diabetic foot ulcers, repair of ischemic heart damage and promoting bone formation.

On the other hand, anti-angiogenic nano-materials may effectively treat cancer by inhibiting a tumor's ability to form new blood vessels, depriving the tumor of oxygen and nutrition needed to grow and spread to neighboring tissues. Rare earth element nano-materials may also have additional applications in medical imaging and diagnostics.

Product Development Pipeline

OmegaGenesis is engaged in research and product development to create the nano-material formulation and process required for the first set of Angiogenesis applications. These activities are closely linked to the test cycle for material applicability, pre-clinical proof of concept (POC), and the initiation of the clinical trial process required for each application.

OmegaGenesis has established, in laboratory tests, the non-toxicity of a particular nano material for human applications. Additionally our research has shown the material produces new blood capillary by sprouting endothelial layer of the blood vessel. OmegaGenesis is developing medical applications based on this characteristic of the material. Nano materials are currently proceeding to pre-clinical (POC) stage for applications addressing wound healing in the treatment of diabetic foot ulcers to reduce the frequency of amputation and bone healing.

Pre-clinical animal studies will conclude in the second half of 2009 with clinical trial preparation anticipated to commence in the first half of 2010. Our clinical trials will initiate in India and conclude with multiple sites in the U.S. and several other countries. Simultaneous approval is planned in the trial countries to speed up the drug availability.

Amputation Prevention Molecule

To prevent amputations resulting from diabetic foot ulcers, OmegaGenesis is developing a topical formulation of novel pro-angiogenic inorganic nanoparticles. A topical formulation of nanorods is periodically applied to diseased tissues to promote and improve local microvascular circulation and thereby, speed healing of tissues directly affected. A liquid suspension of nanorods will be formulated in a cream or gel using GRAS ingredients to enhance healing and ease application.

Hair Growth

OmegaGenesis is developing a nanotechnology solution to treat hair loss resulting from natural or medically induced causes. Based on the newly discovered angiogenic properties of inorganic nanorod materials, we are developing a topical product to treat hair loss. The product enhances blood supply to hair follicle, stimulates the hair roots and invigorates the growth cycle of hair.

A topical cream or gel will be applied to the scalp similar to other topical hair loss treatments. The nanorods are a size that allows penetration into the follicle cavity thereby allowing absorption in the dermal papilla. Data have shown both para- and intracellular transport of the nanorods indicating good percutaneous permeability characteristics.

Wound Healing

OmegaGenesis is developing formulations of novel pro-angiogenic inorganic nanoparticles to aid healing in a variety of wound types. A formulation of nanorods is periodically applied to injured tissues to promote and improve local micro vascular circulation and thereby, speed wound healing. The OmegaGenesis wound healing technology is based on the concept of triggering the patient's own vasculature to regenerate the tissue of wounds. The custom designed physicochemical features of the nanoparticles are engineered to optimize the therapeutic process.

Several wound types from deep surgical incisions to shallow cuts may be treated using the OmegaGenesis novel bioactive nanotechnology. Surgical wounds include: (1) post-surgical incisions, including dental extraction, (2) suture site wounds, (3) donor site wounds such as in blood donation, (4) IV site wounds, (5) skin graft wounds, (6) periostomy skin wounds, and (7) peritracheotomy wounds.

Cardiovascular Ischemia

Cardiovascular ischemia is a leading cause of illness and death in the United States. Pro-angiogenesis nanorods can be used to enhance blood flow through collateral vessel formation. The physicochemical and biological properties of the OmegaGenesis inorganic nanorods may be exploited to avoid the pathological side-effectS seen with pro-angiogenic biologics such as vascular endothelial cell growth factor (VEGF) and basic fibroblast growth factor (BFGF). Using the same approach, ischemic neuronal tissue resulting from stroke may be reperfused by increasing blood flow in brain tissue.

Bone Healing

Bone healing may be promoted through tissue engineering such as scaffolding or stimulation of growth factors. Inorganic nanoparticles such as colloidal silver, have been investigated for their potential to promote bone growth. Three advantages using anoparticles in biological systems, that is the focus of OmegaGenesis research are the generation of nanoparticle-composite scaffolds to provide increased mechanical strength for bone graft, the fabrication of nanofibrous scaffolds to support cell growth and differentiation through morphologically-favored architectures, and novel delivery technologies to carry genetic material or biologics such as osteogenic growth factors.

Anti-Angiogenesis and Diagnostic Applications

OmegaGenesis scientists are also studying natural and synthetic angiogenesis inhibitors called anti-angiogenesis agents, with the expectation these materials will prevent or slow down the growth of cancer and malignancies by blocking the formation of new blood vessels. We are exploring applications in the following areas:

1. Anti-Angiogenesis: Reduce or stop blood cell growth to control destructive outcomes in tissues and organs.

2. Medical Imaging: Provide precise, fast and effective imaging materials for diagnostic and analysis applications.

3. Diagnostic agents: Facilitate diagnostics by intracellular penetration of nano materials for applications such as; blood flow, bone density, pathological tissue imaging such as tumors and organ functioning data and characteristics.

OmegaGenesis nanorods have been shown to permeate through cell walls. Due to the small size of the nanorods, OmegaGenesis is developing technologies to carry active drug substance to the subcellular site of action and retain the drug locally through controlled release by diffusion or metabolic action. Bioconjugates of active pharmaceutical ingredients and/or simple mass transfer systems are the subject of OmegaGenesis research using nanorods in drug delivery.

Medical Imaging

Further, we are investigating the use of inorganic nanoparticles in various imaging modalities (MRI, fluorescence) for diagnosis of cancers and bone diseases or fractures. Inorganic nanolayers can be deposited on the surface of organs, tumors or bone tissues to improve imaging contrast and visualize microfractures in bone or abbarrant tissue morphology such as tumors.

Drug Delivery

The unique properties given by nanoscale technologies serve as a drug delivery platform for a number of applications. Anti-angiogenic therapies are being enabled using inorganic nanoparticles as carriers of anti-angiogenic substances.

Product Overviews

OmegaGenesis Product Overview - Hair Growth
OmegaGenesis Product Overview - Amputation Prevention Molecule
OmegaGenesis Product Overview - Wound Healing