INV-06 Platform
InVasc's Premier platform.
InVasc is capitalizing upon an opportunity to lead the market in producing drugs which exemplify effective and efficient diabetes and hypertension therapy.
Diabetes is a massive health burden that industrialized nations will continue to face in the next several decades. Patients who have diabetes, especially when associated with high blood pressure, can suffer from serious heart complications known as target organ complications including diabetic neuropathy (nerve diseases), retinopathy (blindness), nephropathy (kidney disease) and atherosclerosis (hardening and narrowing of the arteries).
Hypertension and diabetes often occur concomitantly, and current treatment focuses primarily on medications administered to control blood pressure, blood glucose and cholesterol individually. This complex drug regimen results in mixed success, at best, in arresting the progression of target organ complications in most diabetics. Thus, there is significant opportunity to provide effective, as well as efficient, medication to both patients and their physicians.
InVasc’s primary drug development platform, INV-06, is comprised of two drugs, INV-064 and INV-065. These products are patented and fully owned by InVasc.
InVasc has selected its initial products for development based on the following criteria:
- Products with targeted action that meet pre-specified secret toxicity criteria which are safe and effective; treating multiple diseases, each of which contain multiple targets
- Meets the needs of large markets: particularly atherosclerosis, anti-aging and inflammatory conditions
- Ease of production and scale-up without technology risk
- Expedited path towards approval by regulatory bodies
 |
 INV-064
INV-064, is a combination of two proven generic compounds—both have been used in humans—with great safety and efficacy. InVasc’s preliminary human clinical studies (designed for proof of concept), have shown that INV-064 has more potent anti-inflammatory and anti-oxidative effects than either of the compounds when taken alone. This is particularly valuable because diabetes and atherosclerosis are considered to be inflammatory and pro-oxidative disorders. Beneficial effects on high blood pressure, neuropathy and nephropathy have also been demonstrated.
This unique anti-diabetes combination product with beneficial effects on high blood pressure, neuropathy, and nephropathy is anticipated to reduce the onset of diabetes-induced neuropathy as well as nephropathy by 50% while concurrently reducing blood pressure.
InVasc has a provisional patent on INV-064 and is filing for a full patent on this combination compound. A pilot Phase II clinical trial of INV-064 is underway with results expected in Q4 2008.
Combination therapies are among the new treatment paradigms expected in diabetes management, demonstrating the potential to achieve even greater efficacy through their synergistic relationships. Significant value to the marketplace, a single pill with multiple drugs offers convenience to patients, many of whom have to take many drugs every day. InVasc, recognizing the viability and value of combination therapies, is creating compounds that will address diabetes-related target organ complications, thus improving patient outcomes, costs, and quality of care. |
|
INV-065
As the follow-up compound to INV-064, InVasc’s premier compound INV-065 is currently undergoing extensive preclinical testing. INV-065 will constitute a new class of drugs called ICICLE. InVasc is poised to introduce ICICLE drugs that, through a multitude of mechanisms referred to as ”Switchblade” Technology, will represent an incremental approach in the treatment of diabetic related target organ complications. InVasc plans to conduct a pre-IND meeting with the FDA in Q4 2008 to discuss plans for INV-065 clinical trials.
While embodying the same overall characteristics as INV-064, this compound has been additionally designed to:
- deliver nitric oxide while concurrently preventing the conversion of angiotensinogen to angiotensin
- reduce inflammation, a major contributor to the development of vulnerable plaque, by delivering new generation antioxidants that are molecularly incorporated to provide additional antioxidant/anti-inflammatory properties
- reduce platelet aggregation
This compound has already shown evidence of efficacy and limited safety in early testing. Further development, including pharmacokinetics, pharmacodynamics, carcinogenicity, and toxicity data will be generated for an IND application.
|
|
