VITA Program

  

  

 

 

NHLBI Vascular Interventions/Innovations and Therapeutic Advances (VITA) Program

The Vascular Interventions/Innovations and Therapeutic Advances (VITA) Program is a new translational initiative of the National Heart, Lung, and Blood Institute (NHLBI) that enables and accelerates the development of promising diagnostic and therapeutic modalities for unmet and underserved medical needs. The VITA Program provides contract support for early-stage translational development of product candidates in the fields of vascular disorders, thrombotic diseases, and pulmonary hypertension.

The VITA program currently has nine projects, each with its own objective. To learn more about a project, click on the link provided.

1. Innovative drug/device combination for prevention of restenosis - University of California at San Francisco
2. Developing first-in-class anti-thrombotic monoclonal antibody - Sujana Biotech
3. Novel drug-based therapy for treatment of vascular leakage - University of Illinois at Chicago
4. Novel anti-thrombotic drug combination - University of Michigan
5. Novel non-invasive diagnosis of pulmonary arterial hypertension - Duke University
6. Anti-thrombotic therapy with minimal bleeding profile - DuPage Medical Technology, Inc. 
7. Novel therapy for pulmonary arterial hypertension - Vascumab, LLC
8. Innovative targeting therapy for reversal of limb ischemia - University of Miami
9. New drug for pulmonary arterial hypertension - University of Illinois at Chicago

VITA 2 (2016-2018)

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VITA Project Objective: Innovative drug/device combination for prevention of restenosis

The University of California at San Francisco 

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 cytotoxic compounds that retard rather than promote vessel wall healing.  Recent studies suggest that specialized bioactive lipid mediators govern the resolution of inflammation, and have beneficial activity in healing vascular tissues. The goal of this VITA Program contract is use this biology to develop a prototype medical drug/device that effectively prevents restenosis and reduces vascular scarring.

This project is led by Dr. Michael Conte, the E. J. Wylie Chair and Professor and Chief of Vascular and Endovascular Surgery at the University of California, San Francisco.  He is also the Co-Director of the UCSF Heart and Vascular Center and Director of the Noninvasive Vascular Laboratory. To learn more about Dr. Conte and his research at the University of California San Francisco please visit http://contelab.surgery.ucsf.edu/

 

VITA Project Objective: Developing first-in-class anti-thrombotic monoclonal antibody

Sujana Biotech

The objective of this project is to produce a first-in-class (novel target), anti-thrombotic monoclonal antibody (mAb) with improved safety (reduced bleeding risk) and improved or equivalent efficacy 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 60-300% increase bleeding rate and associated late mortality hazard.  Other programs exploiting alternative targets have not yet provided new, safer therapeutics. Unlike other drug discovery/development programs, the pathway from our lead, a well-characterized and effective polyclonal antibody, to a commercially acceptable clinical candidate - a fully humanized mAb - is relatively straightforward and low risk.

This project is led by Dr. Glen Gaughan of Sujana Biotech who has has almost 20 years of experience as a drug discovery scientist with Bristol-Myers Squibb.  He has contributed to programs searching for new medications for pain, obesity, sleep disorders, and depression, and for contrast agents for MRI. He is current a Project Manager at Sujana Biotech. To learn more about this project please visit http://www.sujanabio.com/

VITA Project Objective: Novel drug-based therapy for treatment of vascular leakage

University of Illinois at Chicago

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

This project is led by Dr. Yulia Komarova, an Associate Professor of Pharmacology at the  University of Illinois at Chicago. Her research focuses on the signaling mechanisms regulating the endothelial barrier function in health and disease. To learn more about Dr. Komarova and her research at the University of Illinois at Chicago please visit http://mcph.uic.edu/komarova

VITA Project Objective: Novel anti-thrombotic drug combination

University of Michigan Medical Center

Venous thromboembolic disease, both deep vein thrombosis and pulmonary embolism are serious and potentially fatal disorders causing significant morbidity, mortality and cost to the American public. Inflammation and thrombosis are coupled via common activation pathways and selectins are deeply involved in these processes.  In this project, we will determine if the combination of an E-selectin inhibitor and standard low molecular weight heparin therapy can effectively produce a significant decrease in thrombosis and inflammation without adverse bleeding.

This project is led by Drs. Daniel Meyers and Thomas Wakefield. Dr. Myers is the Director of the Conrad Jobst Vascular Research Laboratories at the U-M Medical School. His research focus is the development of  translational animal models. Dr. Wakefield is the Stanley Professor and Section Head in Vascular Surgery at the U-M Medical Center. His research focus is on venous disease and coagulation issues. To learn more about their research at the University of Michigan Medical Center please visit http://jobst.lab.medicine.umich.edu/myers-lab and http://surgery.med.umich.edu/vascular/patient/team/thomasww.shtml

VITA Project Objective: Novel non-invasive diagnosis of pulmonary arterial hypertension

Duke University School of Medicine

Non-invasive diagnosis and monitoring of pulmonary vascular disease (PVD) remains a serious challenge. The proposed work seeks to advance a novel technology that uses inhaled xenon gas MRI to enable non-invasive imaging of pulmonary gas exchange. The objective of this study is to apply an integrated structural and functional MRI protocol to detect regional gas exchange abnormalities associated with PVD. We seek to identify imaging features that permit PVD to be discerned in the setting of other comorbidities such as heart and lung disease. Successful development of such a technology could provide a sensitive and specific means of non-invasively diagnosing and monitoring pulmonary vascular disease during a brief MRI exam.

This project is led by Drs. Sudarshan Rajagopal and Bastiaan Driehuys. Dr. Rajagopal is an Assistant Professor of Medicine at the Duke University School of Medicine. His research program is on receptor signaling and new approaches for the diagnosis and management of pulmonary hypertension. Dr. Driehuys is a Professor of Radiology and Biomedical Engineering at the Duke University School of Medicine. His research program is geared around developing hyperpolarized gases to drive novel applications in MR imaging.  To learn more about their research at Duke University School of Medicine please visit https://medicine.duke.edu/faculty/sudarshan-rajagopal-md and https://bme.duke.edu/faculty/bastiaan-driehuys

VITA Project Objective: Anti-thrombotic therapy with minimal bleeding profile

DuPage Medical Technology

Cardiovascular disease, mainly thrombotic disease, is a leading cause of death in the United States. Arterial thrombosis is common in our aging population and causes ischemia in vital organs. Currently, the major drugs used to treat arterial thrombosis have a common adverse event of bleeding, potentially life-threatening. The question is whether it is possible to develop anti‐thrombotic drugs that do not cause bleeding. The goal of this VITA Program project is to develop a new generation of anti-thrombotic agents that potently inhibit occlusive thrombosis but have minimal bleeding side effect. 

This project is led by Drs. Minyi Gu and Xiaoping Du. Dr. Gu is Chief Operating Officer at DuPage Medical Technology, Inc. Her research focus is on the development of anti-thrombotic drugs. Dr. Du is a Professor in the Department of Pharmacology at the University of Illinois at Chicago. Research interests are thrombosis, hemostasis, & vascular biology. To learn more about the research underlying this project from the University of Illinois at Chicago please visit http://mcph.uic.edu/du

VITA Project Objective: Novel therapy for pulmonary arterial hypertension

Vascumab

Pulmonary arterial hypertension (PAH) is a complex disease characterized by proliferative vascular remodeling that obstructs the lumen of resistance pulmonary arteries leading to right ventricular (RV) failure and death. Despite significant therapeutic progress, PAH remains a deadly disease. Currently approved therapies act mainly as vasodilators, in a disease not characterized by vasoconstriction, without much direct impact on the adverse vascular remodeling that does drive the disease. They do not reverse the disease or improve survival. Our approach is not another vasodilator instead targets the adverse remodeling directly with disease modifying potential.

This project is led by Drs. Paul Da Silva Jardine and Hyung Chun. Dr. Jardine was formerly the Vice President of Cardiovascular and Metabolic Research at Pfizer and has more than 25 years of drug discovery and development experience. He is the founder and Chief Scientific Officer of Vascumab. Dr. Chun is an Associate Professor of Medicine at Yale University. His research focuses on the underlying biology of vascular diseases including pulmonary arterial hypertension. His lab pioneered the basic science underlying this program. To learn more about the research underlying this project please visit http://medicine.yale.edu/lab/chun/

VITA Project Objective: Innovative targeting therapy for reversal of limb ischemia

The University of Miami School of Medicine

Critical limb ischemia is a severe blockage of the arteries that supply the limbs and represents an advanced stage of peripheral arterial disease. Bone marrow-derived tissue repair cells (TRC) have been identified as a new therapeutic option to induce therapeutic angiogenesis. Our goal is to develop novel gene- and cell-based therapeutic strategies that will improve both tissue microenvironment and precision targeting of TRC to accelerate neovascularization in ischemia limb. We 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. 

This project is led by Drs. Omaida Velazquez and Zhao-Jun Liu of the University of Miami Medical Center. Dr. Velazquez is the Chair of the Dept. of Surgery at the Miller School of Medicine at the University of Miami. Her research focus is in the area of new treatments for lower extremity arterial occlusive disease. Dr. Liu is an Associate Professor of Surgery at University of Miami Miller School of Medicine. His research focuses on therapeutic angiogenesis and precision cell therapy.

To learn more about the research underlying this project please visit http://med.miami.edu/news/dr.-omaida-c.-velazquez-named-chair-of-department-of-surgery

VITA Project Objective: New drug for pulmonary arterial hypertension

The University of Illinois at Chicago

Pulmonary arterial hypertension (PAH) is a debilitating disease that involves remodeling of the arterial blood vessels of the lung resulting in heart failure and death. There is no available cure for this fatal disease; current treatment targets symptomatic vasoconstriction by producing pulmonary vasodilation rather than focusing on the cellular dysfunction that induces pulmonary vascular remodeling. In this project we will be inhibiting a pathway which contributes to the pulmonary vascular remodeling and assessing the potential of those inhibitors as new drugs for PAH.

This project is led by Drs. Tom Dryer and Roberto Machado. Dr. Dryer is an Associate Professor of Chemistry at the University of Illinois at Chicago. His research is focused on the development of new methods to transform simple substrates into functionalized molecules. Dr. Machado is an Associate Professor of Medicine and Director of the Pulmonary Hypertension Program at UIC. His research focus is on the development of therapeutics for advanced lung diseases. To learn more about their research at the University of Illinois at Chicago please visit http://www2.chem.uic.edu/driver/ and http://chicago.medicine.uic.edu/cms/One.aspx?portalId=506244&pageId=10942552

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VITA 1 (2014-2016)

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The VITA program currently has nine projects, each with its own objective. To learn more about a project, click on the link provided.

1. New methodology and tools for monitoring pulmonary arterial hypertension
2. Innovative bioengineered vascular graft substitute for peripheral arterial disease
3. New pharmacological therapy for vascular malformations
4. Novel drug treatment for pulmonary arterial hypertension
5. New anti-thrombotic therapy with minimal bleeding profile
6. Novel anti-thrombotic drug for deep vein thrombosis
7. Innovative drug/device combination for prevention of restenosis
8. New mechanism-of-action drug for treatment of hypertension
9. Novel therapeutic adjuvant for pulmonary arterial hypertension therapy

VITA Project Objective: New methodology and tools for monitoring pulmonary arterial hypertension

Pulmonary arterial hypertension (PAH) is an incurable and often fatal disease with significant clinical progression that may accelerate unpredictably. Standard clinical assessments fail to sufficiently identify a patient's PAH status and future risk; so many patients remain undertreated and prone to sudden and rapid disease progression. Prognostic identification of these "rapid progressors" would allow the clinician to escalate PAH therapy appropriately, thereby improving overall survival. The goal of this VITA Program contract is to create and test several novel PAH prognostic tools which combine ambulatory hemodynamic monitoring with advanced imaging technologies and a unique integrative learning software.

This project is led by Dr. Raymond L. Benza. To learn more about Dr. Benza and his research at the Allegheny Singer Research Institute please visit https://www.ahn.org/allegheny-health-network-research/our-research-institutes/cardiovascular-institute

VITA Project Objective: Innovative bioengineered vascular graft substitute for peripheral arterial disease

Humacyte, Inc. has developed an acellular, human collagen investigational vascular graft to provide a possible alternative to synthetic materials and to autologous grafts for the creation of vascular access for dialysis and for use in peripheral vascular bypass surgery. The design parameters of the investigational graft include the following research and development targets: high long-term patency rates, minimal intimal hyperplasia, absence of immune response, integration with native tissue, and off-the-shelf availability in a range of sizes for multiple clinical applications. This VITA program contract will support a phase I study of this investigational graft in 20 patients with above knee peripheral arterial disease who require a vascular graft bypass and who lack suitable autologous veins. The study will be conducted at four sites in the United States.

This project is led by Dr. Allison Pilgrim. To learn more about Humacyte and its technologies please visit Humacyte.com

VITA Project Objective: New pharmacological therapy for vascular malformations

Vascular malformations are rare developmental defects of blood vessels that can cause serious and sometimes fatal medical complications. The current treatment for patients with localized vascular malformations includes surgical removal or ablation techniques. However, many patients experience limited benefit from these procedures or are not amenable to these therapies due to the type or location of the vascular malformation. There is a need for alternative or pharmaco-therapeutic interventions for these vascular malformations. The goal of this VITA contract is to refine and develop a lead drug candidate from a family of compounds that have recently been identified as having therapeutic potential to treat vascular malformations.

This project is led by Dr. Ramani Ramchandran. To learn more about Dr. Ramchandran and his research at the Medical College of Wisconsin please visit www.chw.org/vascularbiology

VITA Project Objective: Novel drug treatment for pulmonary arterial hypertension

Pulmonary arterial hypertension (PAH) is a significant unmet medical need; mortality is high and most current therapies do not address the underlying cause of the disorder. One promising therapeutic approach involves inhibition of the PDGF receptor. However, systemic administration of PDGF receptor inhibitors results in off-target side effects, including bone marrow suppression, gastrointestinal effects, edema, and others. The PDGF receptor inhibitors currently in development by Pulmokine are intended to reduce these side effects and improve the therapeutic window by delivering the drug substance using inhalation technologies. This VITA Program contract provides support for a series of IND-enabling studies to further the development of this promising new therapeutic approach for treatment of PAH.

This project is led by Dr. Lawrence Zisman.

VITA Project Objective: New anti-thrombotic therapy with minimal bleeding profile

Cardiovascular disease, mainly thrombotic disease, is a leading cause of death in the United States. Arterial thrombosis is common in our aging population and causes ischemia in vital organs. Currently, the major drugs used to treat arterial thrombosis have a common adverse event of bleeding, potentially life-threatening. The question is whether it is possible to develop anti-thrombotic drugs that do not cause bleeding. The goal of this VITA Program project is to develop a new generation of anti-thrombotic agents that potently inhibit occlusive thrombosis but have minimal bleeding side effect.

This project is led by Dr. Xiaoping Du. To learn more about Dr. Du and his research at the University of Illionois at Chicago please visit http://mcph.uic.edu/du

 

 

 

VITA Project Objective: Novel anti-thrombotic drug for deep vein thrombosis

Venous thromboembolism (VTE) is a serious and potentially fatal disorder associated with high mortality, accounting for ~300,000 deaths out of the 900,000 VTE cases reported annually in the US. Deep vein thrombosis and pulmonary embolism are the predominant clinical manifestations of VTE. An ideal clinical therapy for VTE would be an anti-thrombotic that does not cause bleeding. The goal of this VITA contract is to fund several Phase I clinical studies for initial assessment of a promising novel anti-thrombotic treatment without associated bleeding side effects.

This project is led by Drs. Suman Sood and Thomas Wakefield. To learn more about Drs. Sood and Wakefield and their research at the University of Michigan please visit http://www.experts.umich.edu/expert.asp?n=Suman+Sood&u_id=4461 and http://surgery.med.umich.edu/portal/research/faculty/thomasww.shtml

VITA Project Objective: Innovative drug/device combination for prevention of restenosis

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 cytotoxic compounds that retard rather than promote vessel wall healing. Recent studies suggest that specialized bioactive lipid mediators govern the resolution of inflammation, and have beneficial activity in vascular tissues. The goal of this VITA Program contract is to develop prototype medical drug/devices that effectively prevent restenosis, reduce vascular scarring, and improve vascular surgical outcomes.

This project is led by Dr. Michael Conte. To learn more about Dr. Conte and his research at the University of California San Francisco please visit http://contelab.surgery.ucsf.edu/(link is external)

VITA Project Objective: New mechanism-of-action drug for treatment of hypertension

Hypertension occurs in 30% of the US population. Despite the fact that this disease is so common, the etiology is unknown with renal, vascular, and central nervous system causes all implicated. Free radicals, inflammation, and the adaptive immune system also contribute to the development of hypertension. Researchers at Vanderbilt have recently identified a new class of anti-hypertensive drug candidates that act by scavenging disease-promoting isoketals that are formed by free radical catalysis. The goal of this VITA contract is to screen, evaluate, and select a lead drug candidate from this class of promising compounds for eventual evaluation in hypertension clinical trials.

This project is led by Drs. L. Jackson Roberts and David G. Harrison. To learn more about Drs. Roberts and Harrison and their research at Vanderbilt University please visit https://my.vanderbilt.edu/toxicology/home/cv/l-jackson-roberts-ii/ and http://www.mc.vanderbilt.edu/root/vumc.php?site=dgh

VITA Project Objective: Novel therapeutic adjuvant for pulmonary arterial hypertension therapy

Vascular Biosciences is developing a cyclic peptide (CAR) as a therapeutic adjuvant for targeting drugs to the vasculature for pulmonary arterial hypertension (PAH), a serious and often fatal lung disorder. CAR specifically targets the diseased pulmonary vascular endothelium of blood vessels such as those that occur in the pulmonary arteries in PAH patients. Animal models of PAH have shown that CAR selectively targets the pulmonary vasculature and that co-administration of CAR peptide with currently-used PAH drugs results in enhanced pharmacological activity and significant reductions in PAH symptoms. The objective of this VITA contract is to explore the therapeutic utility of CAR peptide for targeting PAH and to develop a novel strategy for an effective intervention for this currently incurable disease.

This project is led by David Mann. To learn more about Vascular BioSciences and its technologies please visit http://vascularbiosciences.com/

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February 2017