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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.
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/
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/