Vascular Interventions/Innovations and Therapeutic Advances (VITA) Program

Project began
2014
Points of contact
Zorina Galis, Ph.D.;Marc Charette, Ph.D.

What is the goal of the VITA Program?

The NHLBI funds translational research programs, such as the VITA Program, to enable and accelerate the development of promising diagnostics and treatments for unmet and underserved medical needs. Translation is the process of turning research findings into useful diagnostics, interventions, procedures, or treatments. It also involves sharing the findings with the public and health professionals to implement medical advances and improve public health.

The goal of the VITA Program is to support pre-clinical translational development of new diagnostics and treatments in the fields of vascular disorders such as aortic aneurysm; thrombotic diseases such as deep vein thrombosis; and pulmonary hypertension. Pre-clinical research involves developing and testing interventions using cell or animal models of disease; samples of human or animal tissues; or other research models of drug, device, or diagnostic interactions with living systems. Pre-clinical research connects the basic science of disease with human medicine.

AT A GLANCE
  • VITA’s first phase included nine pre-clinical and early stage clinical projects from 2014 to 2016.
  • The first VITA researchers published over 15 scientific articles from their VITA work during the program.
  • VITA’s first phase led to 16 patent applications and helped license a new drug technology.
  • The first phase led to two clinical trials and helped two applications enter the FDA regulatory process.
  • The first VITA investigators have formed a new collaboration and one non-profit start-up.
  • VITA’s second phase, which began in November of 2016, includes nine pre-clinical and early stage clinical projects.

How does the VITA Program contribute to scientific discoveries?

In 2016 NHLBI released its Strategic Vision, which will guide the Institute’s research activities for the coming decade. VITA’s mission helps realize one of NHLBI’s strategic goals: to facilitate innovation and accelerate research translation across the entire research spectrum, bridging basic to clinical, clinical to practice, and population to health impact. VITA supports several NHLBI Strategic Vision objectives.

More Information

The VITA program focuses on early and late-stage translational research:

  • Early-stage: concept to proof-of-principle studies
  • Late-stage: proof-of-principle to investigational new drug (IND) or investigational new device (IDE) studies

Currently, VITA is supporting research on a variety of medical challenges and developing new diagnostics and treatments to address these challenges, including:

  • Prevention of post-operative vascular injury
  • Novel anti-thrombotic therapy with improved safety
  • Drug therapy for vascular leakage
  • Pulmonary arterial hypertension diagnosis and therapy
  • Therapy for reversal of limb ischemia

 

How does the VITA Program work?

VITA promotes translation of research discoveries by using a contract mechanism and a milestone-based approach. VITA provides research and development contract funding and operational support for up to three years for early-stage product candidate development by academic researchers or small businesses. VITA supports a framework to enable the success of pre-clinical translational projects by providing funding and access to resources such as:

  • NHLBI project funding and support
  • An external advisory committee that provides guidance and expert advice for new product development
  • A program coordinating center that provides project management support and regulatory advice
  • An investigators’ forum for productive exchange of scientific expertise and collaboration
  • Access to other NHLBI/NIH resources and services

More Information

VITA facilitates partnerships among government, industry, not-for-profit groups, professional associations, and consortia to address research needs and barriers identified by the scientific community, including:

  • Medical needs not met by industry for several diseases and conditions
  • Early product concepts and ideas that are untested
  • Scarcity of funding for early product concepts or not enough NIH funds for basic research
  • Challenges some researchers experience when pursuing early product development
  • Lack of knowledge of or local access to needed resources

What are the current VITA (2016–2018) projects?

Innovative drug/device combination for prevention of restenosis

Michael S. Conte, M.D.
The University of California at San Francisco

The goal of this VITA Program contract is to use this biology to develop a prototype medical drug or device that effectively prevents restenosis and reduces vascular scarring. The problem of vascular injury is pervasive throughout cardio-vascular surgical procedures, including vascular access, angioplasty, stenting and bypass surgery. Failure due to restenosis and vascular scarring is a continuing complication of most vascular interventions, creating an unmet medical need. Despite advances in drug‐eluting devices, most restenosis-blocking agents are harmful to cells and inhibit rather than promote vessel wall healing.  Recent studies suggest that specialized bioactive lipid mediators help resolve inflammatory reactions and have beneficial activity in healing vascular tissues.

Developing first-in-class anti-thrombotic monoclonal antibody

Glen Gaughan, Ph.D., M.B.A.
Sujana Biotech

The goal of this project is to produce a first-in-class, or novel target, anti-thrombotic monoclonal antibody with improved safety such as a reduced risk of bleeding and improved or equivalent effectiveness compared to current medicines. While the current FDA-approved platelet inhibitors and anticoagulants are effective in reducing ischemic events, they are also associated with a 60 to 300 percent higher bleeding rate and with an increased risk of later death. Other programs exploiting alternative targets have not yet provided new, safer therapeutics. This project hopes to capitalize on a promising, well-characterized and effective polyclonal antibody to develop a commercially acceptable clinical candidate—a fully humanized monoclonal antibody.

Novel drug-based therapy for treatment of vascular leakage

Yulia Komarova, Ph.D.
University of Illinois at Chicago

The goal of this application is to develop a highly effective drug-based therapy for the treatment of vascular leakage and accompanying inflammation in the lungs of patients with Acute Respiratory Distress Syndrome (ARDS). ARDS is a life-threatening condition characterized by severe leakage of plasma proteins into the interstitium and accumulation of inflammatory cells into the alveolar space. ARDS is associated with pneumonia, sepsis and septic shock, trauma, and the need for a lung transplant and multiple transfusions. ARDS can lead to pulmonary insufficiency and eventually multisystem organ failure or death.

Novel anti-thrombotic drug combination

Daniel Myers, Jr., D.V.M., M.P.H. and Thomas Wakefield, M.D.
University of Michigan

The goal of this project is to determine if the combination of an E-selectin inhibitor and standard low molecular-weight heparin therapy can significantly reduce thrombosis and inflammation without increasing adverse bleeding. Venous thromboembolism, which includes deep vein thrombosis and pulmonary embolism, is a serious and potentially fatal set of conditions that can cause significant morbidity and mortality. This project is exploring E-selectin inhibitors because selectins are involved in the interrelated processes of inflammation and thrombosis.

Novel non-invasive diagnosis of pulmonary vascular disease

Sudarshan Rajagopal, M.D., Ph.D. and Bastiaan Driehuys, Ph.D.
Duke University

The goal of this project is to identify imaging features that permit pulmonary vascular disease (PVD) to be identified in patients who also may have heart and lung diseases. This project will apply an integrated structural and functional magnetic resonance imaging (MRI) protocol to detect regional gas exchange abnormalities associated with PVD. It will do so by advancing a novel technology that uses inhaled xenon gas MRI, a test that takes images of the body’s organs without using x-rays, to enable non-invasive imaging of pulmonary gas exchange. The successful development of such a technology could provide a sensitive and specific means of non-invasively diagnosing and monitoring PVD during a brief MRI exam. Non-invasive diagnosis and monitoring of PVD remains a serious challenge.

Novel therapy for pulmonary arterial hypertension

Paul De Silva Jardine, Ph.D. and Hyung Chun, M.D.
Vascumab, LLC

The goal of this project is to develop novel therapies for pulmonary arterial hypertension (PAH) that target the disease processes underlying PAH, possibly reverse disease, or improve survival rates. Pulmonary arterial hypertension (PAH) is a debilitating disease that involves remodeling of the arterial blood vessels in the lungs, and it can lead to heart failure or death. There is no available cure for this potentially life-threatening disease. Current treatments alleviate symptomatic vasoconstriction through their vasodilation properties, but they do not target the underlying diseases processes that drive pulmonary vascular remodeling in PAH.

New drug for pulmonary arterial hypertension

Tom Driver, Ph.D. and Roberto Machado, M.D.
University of Illinois at Chicago

This project will inhibit a pathway involved in pulmonary vascular remodeling and assess the potential of these inhibitors as possible new medicines for pulmonary arterial hypertension (PAH). Pulmonary arterial hypertension (PAH) is a debilitating disease that involves remodeling of the arterial blood vessels in the lungs, and it can lead to heart failure or death. There is no available cure for this potentially life-threatening disease. Current treatments alleviate symptomatic vasoconstriction through their vasodilation properties, but they do not target the underlying diseases processes that drive pulmonary vascular remodeling in PAH.

Innovative targeting therapy for reversal of limb ischemia

Omaida C. Velazquez, M.D. and Zhao-Jun Liu, Ph.D., M.D.
University of Miami

The goal of this project is to develop novel gene- and cell-based therapeutic strategies that will improve both tissue microenvironment and precision targeting of bone marrow-derived tissue repair cells (TRCs) to accelerate new vascular growth in the limbs of patients who have suffered critical limb ischemia. Critical limb ischemia is a severe blockage of the arteries that supply blood to the limbs and represents an advanced stage of peripheral arterial disease (PAD), a type of cardiovascular disease. Bone marrow-derived TRCs have been identified as a new therapeutic option to induce therapeutic angiogenesis. The researchers propose to test feasibility and efficacy of adhesion molecule-based extracellular and cellular components in mouse limb ischemia and gangrene models. This preclinical study is translatable for developing and optimizing safe and effective gene- and stem cell-based therapies for clinical trials.

Anti-thrombotic therapy with minimal bleeding profile

Minyi Gu, M.D. and Xiaoping Du, M.D., Ph.D.
DuPage Medical Technology, Inc.

The goal of this project is to develop a new generation of anti-thrombotic agents that inhibit occlusive thrombosis but also have minimal bleeding side effects. Currently, the major drugs used to treat arterial thrombosis have a common and potentially life-threatening adverse event of bleeding. Arterial thrombosis, which causes ischemia in vital organs, is common in older adults, and the disease is expected to increase with an aging U.S. population. 

What were the previous VITA (2014–2016) projects?

New methodology and tools for monitoring pulmonary arterial hypertension
Raymond L. Benza, M.D.
The Allegheny Singer Research Institute

Innovative bioengineered vascular graft substitute for peripheral arterial disease
Allison Pilgrim, BM, B.Ch., D.Phil.
Humacyte, Inc.

New pharmacological therapy for vascular malformations
Ramani Ramchandran, Ph.D.
The Medical College of Wisconsin

Novel drug treatment for pulmonary arterial hypertension
Lawrence Zisman, M.D.
Pulmokine, Inc.

New anti-thrombotic therapy with minimal bleeding profile
Xiaoping Du, M.D., Ph.D.
The University of Illinois at Chicago

Novel anti-thrombotic drug for deep vein thrombosis
Suman Sood, M.D.
Thomas Wakefield, M.D.
The University of Michigan

Innovative drug/device combination for prevention of restenosis
Michael S. Conte, M.D.
The University of California at San Francisco

New mechanism-of-action drug for treatment of hypertension
L. Jackson Roberts, II, M.D.
David G. Harrison, M.D.
Vanderbilt University

Novel therapeutic adjuvant for pulmonary arterial hypertension therapy
David M. Mann
Vascular BioSciences, Inc.