Business Development

A game-changing innovation has been generated by the founders of NangioTx, Inc. It is a proprietary injectable drug, V-10, that creates new blood vessels in ischemic muscles and thus offers a revolutionary treatment for peripheral artery / vascular disease (PVD / PAD) for which there is currently no FDA-approved effective therapy. PVD is characterized by poor blood flow to the legs, which leads to tissue damage and ultimately limb amputation/death. V-10 is injected locally into muscle by a minimally invasive, cost effective procedure. V-10 does not distribute into systemic circulation but locally stimulates the growth of new blood vessels that leads to a full recovery of functionality of the treated muscle.


Mission Statement :

Based on its invention, NangioTx aims to develop blood-vessel regenerative therapies for a range of indications, with initially focusing on diabetes-associated vascular insufficiency (e.g., diabetic foot ulcer) and claudication consequence of PAD.

Problem:

PVD in general results from an atherosclerotic process that causes stenosis and occlusion of non-cerebral and non-coronary arteries. It affects 8 million Americans, and more than a quarter of a billion people globally. The global prevalence of PAD increased by 24% from 2000 to 2010, from 164 million to 202 million. The increase in PVD in wealthier regions of the world occurred mainly in Europe, with 40.5 million cases reported in 2010, with North America accounting for 14.3 million. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)61249-0/abstract].[http://www.medpagetoday.com/cardiology/peripheralarterydisease/40803]. For these patients, obstructed arteries result in poor blood flow (ischemia) to cardiac and peripheral tissues that manifests itself in pain while walking (intermittent claudication). Prolonged ischemia inhibits wound healing, starves the muscles of oxygen and nutrients, and causes muscle wasting (atrophy) or death (necrosis). Given the high rate of surgical failure, the inevitable prognosis for advanced-stage PAD (critical limb ischemia, CLI) is amputation (at 30%) and death (at 25%). The extent of disease, co-morbidities – diabetes, cardiovascular disease – prior surgery and age further preclude many patients over the age of 60 from current surgical interventions. In the absence of an FDA-approved blood-vessel regeneration (revascularization) therapy, patients are limited to palliative treatments that mitigate acute complications, rather than reverse or cure the disease.

Similarly, vascular complications that develop in diabetic patients could be resolved by revascularization of muscles involved (e. g., as in diabetic foot ulcers). Both indications are being currently addressed by NangioTx since preclinical and drug-manufacturing requirements are identical. Specifics are being considered for when possible therapies are tested in humans.

Solution:

V-10 is an injectable peptide that self-assembles into a hydrogel at the site of injection to direct the formation of novel, robust, and mature blood vessels that restore normal limb function. V-10 is delivered by a simple syringe injection in multiple sites in the calf.

Proof of Concept:

Preclinical efficacy of V-10 has been shown in C57BL/6 mice. Using two 25 µL [10 mg/mL V-10] bolus injections in an acute hind-limb ischemia model in mice, V-10 was fast acting, with blood vessels and enhancement of blood flow of limbs in aged/ geriatric (8 month and 13 month old) being seen in mice in just 7 days. Both adult (6 month) and old (13 month) mice showed marked significant (p<0.05) improvement in perfusion and treadmill endurance over vehicle-only control, and also in comparison to recently published data.

Rationale:

Published data show that exercise increases capillarity via angiogenesis and that exercise lessens symptoms of intermittent claudication. Taken together, this provides a strong rationale for the use of proangiogenic therapy of V-10 to increase capillarity of ischemic muscle and thus to provide a significant benefit to patients suffering from intermittent claudication. V-10 therapy could be used alone or as an adjunct therapy to surgically opening blocked arteries.

Proprietary Position:

V-10 is the product of over a decade of basic science and translational research at Rice University. V-10 utilizes patent pending “biomimicry” to selectively regenerate robust and mature blood vessels. A patent has been filed – Multidomain peptides for promoting angiogenesis. U.S. Utility App. 14/454,802. 2014.

Market:

Over $10 Billion is spent annually on PVD treatment in the US alone, with a compound annual growth rate (CAGR) of 10.8%. The estimated worldwide prevalence of almost 10% has been predicted to rise to 15-20% in people over 70 years of age, and consequently affecting around 27 million people in Europe and North America alone. Critical limb ischemia—the most severe manifestation of the disease—can lead to limb loss or even death if not treated promptly. Each year, 500-1000 new cases of critical limb ischemia are diagnosed per million of the population, with an estimated annual cost to the NHS of more than £200m (€255m; $314m). [http://www.bmj.com/content/345/bmj.e5208]

Funding:

NangioTx’s aim is to develop a V-10-based therapeutic product to treat PVD- associated conditions. Building on our proof of concept, our current target is to complete preclinical investigation (ADMET) to demonstrate the safety of administering V-10, to develop manufacturing methods and controls (CMC) and to plan first-in-human clinical studies to obtain an FDA Investigation New Drug (IND) designation for V-10. Subsequent Phase 1 to Phase 3 clinical studies will be conducted which, when successful, will form a basis of our New Drug Application (NDA) application.

Our Strategy:

In order to translate our technology platform to a therapeutic product we need to

  • Obtain initial funding of US$ 2-3 million
  • Use the funding to perform
    • cGLP preclinical studies evaluating the safety and toxicity of our API (V-10) (ADMET)
    • cGLP/cGMP chemistry, manufacturing and control (CMC) studies to establish production of clinical-quality V-10 API
    • Prepare clinical plan for testing V-10 API in humans
  • Using data from the above studies, prepare an application to the FDA and other regulatory agencies in order to obtain a Investigational New Drug designation for V-10 API
  • With the IND in place, carry out the initial first-in-man clinical study in PVD patients
  • Obtain additional funding, and possibly a partner for completing necessary clinical studies towards obtaining an NDA for V-10 API
  • Conduct additional Phase 1 clinical studies, followed by Phase 2 and Phase 3 studies in order to obtain market approval for V-10 product
  • With a pharmaceutical company/partner, launch the approved V-10 product on the therapeutic market.

Business model

NangioTx Inc. has so far operated in a “virtual mode” to obtain a proof of concept for its novel PVD therapy. Going forward, NangioTx will continue in part as a virtual company and serving as a “think-tank” for conducting studies necessary for an IND application. The company plans to avail itself of US Government SBIR grants that require that from 50 to 70% of the grant needs to be spent on in-house company activities; for this reason, the company will build up its staff and facility in order to conduct essential non-GLP pre-clinical and CMC (chemistry – manufacturing –control) studies, with the cGLP and CGMP studies being sub-contracted to CRO (contract research organizations). In time, the company will build up its staff in the area of regulatory affairs and clinical-studies performance as to be fully functional for performing, evaluating and presenting studies needed for a successful NDA (New Drug Application) application.

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