In this issue of the CTSC Newsletter we highlight:

• SUNY Downstate CTSC-hosted clinical trials and clinical research
• SUNY Downstate Biotechnology Park
• Testing of an HIV vaccine candidate developed by the International AIDS Vaccine Initiative (IAVI)

The CTSC: Contributing to the Growth and Success of the SUNY Downstate University of Health Sciences Research Enterprise

The Clinical and Translational Science Center (CTSC) will soon celebrate its third anniversary.  Established in 2017 with the generous support of the College of Medicine and University Hospital of Brooklyn, the CTSC currently has more than forty authorized users comprised of faculty from the Downstate’s College of Medicine, School of Public Health, and School of Health Professions.  Since its establishment, the CTSC has hosted more than 55 studies including NIH- and industry-sponsored clinical trials and clinical research projects. Translational research, including pre-clinical studies, is also a focus of several authorized users of the CTSC. Translational scientists benefit from the networking and collaborative opportunities (basic scientists and clinicians) facilitated by regularly scheduled meetings and workshops sponsored by the CTSC.

Below, we highlight currently active and recently completed studies led by Downstate faculty who are CTSC authorized users.

Andrew Mamalis, Department of Dermatology
Photobiomodulation of skin for the treatment of psoriasis

Vatcharapan Umpaichitra, Department of Pediatrics
A randomized, multicenter, double-blind, parallel-group, placebo-controlled study to investigate the efficacy and safety of canagliflozin in children and adolescents with Type 2 Diabetes Mellitus

Jessica Yager, Department of Medicine
The role of non-broadly neutralizing antibodies targeting gp41 structural epitopes in long term non-progression of HIV infection

Working with HIV clinics to adopt addiction treatments using implementation facilitation

Evaluating Barriers and Facilitators of Transition from Adolescent to Adult Care Among Persons Living with HIV

John Danias, Department of Ophthalmology
Understanding how specific environmental factors interact with certain genes to lead to the development and progression of glaucoma.

Jeanette Jakus, Department of Dermatology
A phase 3, multi-center, randomized, placebo-controlled, double-blind study of the efficiency and safety of Apremilast in subjects with moderate to severe psoriasis of the scalp

Multicenter, double-blind, randomized, placebo-controlled study to evaluate safety, tolerability, and efficacy of Ixekizumab in patients from 6 to less than 18 years of age with moderate-to-severe plaque psoriasis

Yi-Chun Lee, Department of Obstetrics & Gynecology
Phase II study of four concentrations of Intraperitoneal NanoPac® plus six cycles of IV Carboplatin and Paclitaxel in patients with platinum-sensitive recurrent Stage III epithelial ovarian cancer undergoing second cytoreductive surgery

Olga Dvorkina, Department of Medicine
A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Abatacept or placebo on a background of Mycophenolate Mofetil and corticosteroids in subjects with active class III or IV Lupus Nephritis

Ivan Bodis-Wollner, Department of Neurology
A 12-month, dose-level blinded study investigating the safety and efficacy of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s disease patients with motor response fluctuations

A phase 3, randomized, double-blind, placebo-controlled study investigating the efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s disease patients with motor response fluctuations

Ellen Ginzler, Department of Medicine

Multi-center, randomized clinical trial aimed at understanding how different treatments for rheumatoid arthritis affect cardiac inflammation (The TARGET Trial)

Lupus Erythematosus international collaborating clinics registry for atherosclerosis in SLE

A phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Belimumab plus standard of care versus placebo plus standard of care in adult subjects with active Lupus nephritis protocol

A randomized, double-blind, placebo controlled, multi-center study to evaluate the safety and efficacy of Obinutuzumab in patients with ISN/RPS 2003 CLASS III or IV Lupus nephritis protocol

Michele and Carlos Pato, Department of Psychiatry
The Genomic Psychiatry Cohort (GPC) research is focused on
identifying genetic factors that contribute to the development of neuropsychiatric disorders, including schizophrenia, bipolar disorder, and obsessive compulsive disorder (OCD)

Tonya Taylor, Department of Medicine
Use of mixed research methods to assess the sexual health needs of men with and without HIV and identify those the individual and contextual determinants of sexual risk that impact HIV+ men’s sexual health as they age.

Mary Ann Banerji, Department of Medicine
Glycemia reduction approaches in diabetes: A comparative effectiveness study

Sergios-Orestis Kolokotronis, Department of Epidemiology & Biostatistics
Evolutionary genomic epidemiology of infectious diseases; eco-epidemiology; microbiomes; Lyme disease; MRSA; tuberculosis; retroviruses; bioinformatics; genomics

Mariana Markell, Department of Medicine
Effects of Yoga in patients with Type 2 diabetes: A pilot feasibility study

Bernice Porjesz, Department of Psychiatry
Collaborative Study on the Genetics of Alcoholism

Deborah Gustafson, Department of Neurology
Patient-provider interactions and engagement in HIV care

Adrian Marchidann, Department of Neurology
Platelet-oriented inhibition in new TIA and minor ischemic stroke (POINT) Trial

Yalini Senathirajah, Department of Medical Informatics
Finding the Safer Way: Novel Interaction Design for Health IT Safety

Steven Levine, Department of Neurology
Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

Jared Jagdeo, Department of Dermatology
LED-Red Light Phototherapy for Skin Scarring Prevention

Harris Huberman, Department of Pediatrics
Folinic acid treatment of young children with Autism Spectrum Disorder

Michael Reinhardt, Department of Psychiatry
Imaging dementia: Evidence for amyloid scanning

Michael Augenbraun, Department of Medicine
A randomized, open label, multi-center, comparative trial, to assess the efficacy and safety of Pritelivir versus Foscarnet for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised adults

Subodh Saggi, Department of Medicine
A phase 3 randomized, open-label (sponsor-blind), active controlled, parallel-group, multi-center, event driven study in dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to recombinant human erythropoietin, following a switch from erythropoietin-stimulating agents

Jason Lazar, Department of Medicine
Evaluation of HIV-associated Cardiac Dysfunction in Women

Shahriar Zehtabchi, Department of Emergency Medicine
Established Status Epilepticus Treatment Trial (ESETT) A multicenter, randomized, blinded, comparative effectiveness study of fosphenytoin, valproic acid, or levetiracetam in the emergency department treatment of patients with benzodiazepine-refractory status epilepticus

Translation Research:
From Laboratories to Market

Translation refers to the application of the results of basic biomedical research to the practice of medicine.  Converting discoveries made in the laboratory into clinical interventions that provide a direct benefit to human health has generally been viewed as a complex and protracted one, lacking clearly defined start and end points. Bridging the divide that separates biomedical research from clinical applications has always been difficult. Addressing that difficulty has given rise to Translational Research as a field in its own right, aided in large part by the National Institutes of Health (NIH) Roadmap for Medical Research.  Emerging biotechnology companies have also facilitated the process of shepherding biomedical discoveries into clinical application.

SUNY Downstate Biotechnology Park is making a significant contribution to the ‘laboratory-to-market’ imperative needed achieve the goals of translational research. It offers wet laboratory and office space for start-ups and early-stage biotech companies at the three Brooklyn locations:

• A Biotechnology Incubator 
• Tech @ 710, a commercial synthetic chemistry facility 
• BioBAT at the Brooklyn Army Terminal

Companies at all three sites have access to Downstate’s Entrepreneurship Program and Downstate Medical Center resources. These include research core facilities, seminars, collaborations with scientists, medical/scientific library, students for internships, and implementation of IRB-approved clinical trials.

For more information about the SUNY Downstate Biotechnology Park and the growing number of companies that benefit from using its facilities, infrastructure, and networking opportunities working with Downstate faculty, visit their SUNY Downstate Biotech website.

Did you know?

The International AIDS Vaccine Initiative (IAVI) is designed to create novel immunogens, develop viral vectors, evaluate potency and advance promising candidates to clinical evaluation. IAVI, which uses laboratory facilities at SUNY Downstate’s Biotechnology Park, recently announced the start of a Phase I clinical trial (IAVI W001) to test a novel HIV vaccine candidate, BG505 SOSIP.664 gp140. The aim of the trial is to assess the safety of the candidate and to determine if vaccination induces the human immune system to produce proteins known as neutralizing antibodies. For additional information, visit www.clinicaltrials.gov

Q:  I am an authorized user of the CTSC and would like to know if I can reserve more than one subject room at any given time?

A: Yes. Using the space scheduling program to which all authorized users have access (AppointmentPlus), you can reserve more than one room at any given time. 

CTSC Authorized Users

HOW TO BECOME AN AUTHORIZED USER OF THE CTSC
AT SUNY DOWNSTATE

The CTSC is a division of the Downstate Institute for Genomic Health (IGH), Dr. Michele Pato, Executive Director. SUNY Downstate faculty are welcome to apply to become authorized users of the CTSC. There are no fees associated with becoming an authorized user. For additional information, visit CTSC

Questions? Email Dr. Richard Coico, CTSC Director, richard.coico@downstate.edu

Clinical and Translational Science Center
MSC 131, Nursing Station 52
SUNY Downstate Health Sciences University
445 Clarkson Avenue
Brooklyn NY 11203

Tel. 718.270.2017
Email: CTSC@downstate.edu
CTSC

The CTSC facility at SUNY Downstate Health Sciences University is located on the 5th floor of

University Hospital of Brooklyn