| South Alabama Medical Science Foundation
| Cash Receipts (for Projects over $2,000 only)
| October 1, 2014 - September 30, 2015
|
| Project
Dept | Number
Internal Medicine
Project Title
Responsible
Person
Source of
Funding
14-15
Receipts
| 63690
A Randomized, Double-Blind, Parallel Group, Multicenter Phase IIIb
Study to Compare Ticagrelor with Clopidogrel Treatment on the Risk of
Cardiovascular Death, Myocardial Infarction and Ischaemic Stroke in
Patients with Established Peripheral Artery Disease (EUCLID-Examining
Use of tiCAgreLor In paD)
Dr Awan, G
Duke University
5,180.00
| 63707
High Resolution Optical Imaging of Esophageal Tissue Using the Nvision
VLE Imaging System Registry
Dr Cash, B
NinePoint Medical
17,212.50
| 63714
A Multi-Center, Randomized, Open-Label, Controlled Study to Investigate
the Treatment Response of Intraveneous Injectafer (Ferric Carboxymaltose)
vs. Oral Iron to Baseline Hepcidin Levels in Patients with Iron Deficiency
Anemin (IDA) Secondary to Inflammatory Bowel Disease (IBD)
Dr Cash, B
Luitpold Pharmaceuticals
14,250.00
| 63738
A Phase III Study Evaluating the Efficacy and Safety of Remimazolam
(CNS 7056) Compared to Placebo and Midazolam in Patients Undergoing
Colonoscopy
Dr Cash, B
PAION UK Ltd
3,000.00
| 63759
Functional Dyspepsia Reduction Evaluation and Safety Trial (FDREST): A
Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety
and Efficacy of Fdgard, a Medical Food, in the Dietary Management of
Patients with Functional Dyspepsia
Dr Cash, B
IM Healthscience LLC
2,000.00
| 63603
Multi-center, Open-label, Extension Study to Evaluate the Long-term
Efficacy and Safety of Oral Tolvaptan Tablet Regimen in Subjects with
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Dr Culpepper, M
Otsuka Pharmaceutical
40,525.00
| 63717
TR02-A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm
Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCL ER
Tablets in Hemodialysis Patients with Uremic Pruritus
Dr Culpepper, M
Frenova, LLC
102,956.25
| South Alabama Medical Science Foundation
| Cash Receipts (for Projects over $2,000 only)
| October 1, 2014 - September 30, 2015
|
| Project
Dept | Number
Project Title
Responsible
Person
Source of
Funding
14-15
Receipts
| 63723
TR02Ext-An Open Label Extension Study of the Safety and Anti-Pruritic
Efficacy of Nalbuphince HCL ER Tablets in Hemodialysis Patients with
Uremic Pruritus.
Dr Culpepper, M
Frenova, LLC
39,112.50
| 63728
A Phase 3b, Multi-Center, Randomized-Withdrawal, Placebo-Controlled,
Double-Blind, Parallel-Group Trial to Compare the Efficacy and Safety of
Tolvaptan (45 to 120mg/day, Split-Dose) in Subjects with Chronic Kidney
Disease Between Late Stage 2 to Early Stage 4 Due to Autsomal Polycysic
Kidney Disease
Dr Culpepper, M
Otsuka Pharmaceuticals
4,500.00
| 63730
A Phase 3b, Multi-Center, Open-Label Trial to Evaluate the Long Term
Safety of Titrated Immediate-Release Tolvaptan (OPC 41061, 30 mg to
120 mg/day, Split Dose) in Subjects with Autosomal Dominant Polycystic
Kidney Disease
Dr Culpepper, M
Otsuka Pharmaceuticals
26,330.58
| 63739
A Phase 3, Multi-Center, Randomized, Open-Label, Active-Controlled
Study of the Efficacy and Safety of FG-4592 in the Treatment of Anemia
in Incident-Dialysis Patients
Dr Culpepper, M
Fibrogen, Inc
2,250.00
| 63743
A Phase 3,Open-Label, Randomized, Active-Controlled Study of the
Efficacy and Safety of Roxadustat (FG-4592) in the Maintenance
Treatment of Anemia in Subjects with End Stage Renal Disese (ESRD) on
Stable Dialysis
Dr Culpepper, M
Fibrogen, Inc
2,250.00
| 63628
A Postmarketing Observational Study to Assess Respiratory Tract Adverse
Events in Pulmonary Arterial Hypertension Patients Treated with Tyvaso
(treprostinil) Inhalation Solution
Dr Fagan, K
United Therapeutics Corporation
5,937.50
| 63740
A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled
Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension
Dr Fagan, K
Gilead Sciences
2,500.00
| 63744
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Phase 3
Study to Assess the Efficacy and Safety of Oral BPS-314d-MR Added-on
to Treprostinil, Inhaled (Tyvaso) in Subjecs with Pulmonary Arterial
Hypertension
Dr Fagan, K
Lung Biotechnology Inc
5,000.00
| South Alabama Medical Science Foundation
| Cash Receipts (for Projects over $2,000 only)
| October 1, 2014 - September 30, 2015
|
| Project
Dept | Number
Project Title
Responsible
Person
Source of
Funding
14-15
Receipts
| 62963
P05063-45, Long-Term Follow-Up of Subjects in a Phase 2 or 3 Clinical
Trial in which SCH 503034 was Administered for the Treatment of
Chronic Hepatis C
Dr Herrera, J
Schering-Plough Research Institute
7,517.00
| 63552
A Multicenter, Randomized, Double-Blind, Parallel Group, ActiveControlled Study to Evaluate the Efficacy and Safefy of Both Aliskiren
Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to
Enalapril Monotherapy, on Morbidity and Mortality in Patients with
Chronic Heart Failure (NYHA Class II-IV)
Dr Massey, C
Novartis Pharmaceuticals
5,893.39
| 63680
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to
Evaluate the Effect of SAR236553/REGN727 on the Occurrence of
Cardiovascular Events in Patients Who Have Recently Experienced an
Acute Coronary Syndrome
Dr Massey, C
Sanofi US Services Inc
18,705.00
| 63753
An Open Label, Randomized Study to Determine the Rate of
Cardiovascular Events at 1 Year for Patients with Elevated Troponins Post
Major Non-Cardiac Surgery and the Impact of Ticagrelor Versus Aspirin
on the Occurrence of Cardiovascular Events Named INTREPID:
INvestigationg TicagRElor Treatement in Patients with Myocardial Injury
Post non-carDiac Surgery
Dr Omar, B
The Cleveland Clinic Foundation
4,000.00
| 63696
BLI800-203 A Pilot Evaluation of an Experimental BLI800 Formulation
for Bowel Preparation in Adult Patients Undergoing Colonoscopy
Dr Rodriguez, R
Braintree Laboratories
14,000.00
| 63758
BLI400-301 A Safety and Efficacy Evaluation of BLI400 Laxative in
Constipated Adults
Dr Rodriguez, R
Braintree Laboratories
2,000.00
Total Internal Medicine
$
325,119.72
Surgery
| 63669
Comparison of a Hemostatic Textile Dressing to Standard of Care for
Control of Bleeding at Skin Graft Donor and Recipient Sites at Time of
Surgical Grafting
Dr Gulati, S
Beeken Biomedical LLC
19,107.50
| South Alabama Medical Science Foundation
| Cash Receipts (for Projects over $2,000 only)
| October 1, 2014 - September 30, 2015
|
| Project
Dept | Number
Project Title
Responsible
Person
Source of
Funding
14-15
Receipts
| 63716
MEDIHONEY Versus Standard of Care for the Treatment and Outcome of
Second Degree Superficial and Indeterminate Burns
Dr Gulati, S
Derma Sciences, Inc
3,278.00
| 63732
A Multicenter, Multinational, Randomized, Controlled, Blinded Study,
Performed in Subjects with Thermal Burns to Evaluate the Efficacy and
Safety of NexoBrid as Compared to Standard of Care (SOC) Treatment
Dr Gulati, S
MediWound Ltd
5,500.00
| 63677
Phase 3 Study of Efficacy and Safety of Topical E-101 Solution to Prevent
Incisional Infections Among Colorectal Surgery Patients
Dr Rider, P
Excited States LLC
52,212.00
Total Surgery
$
80,097.50
Pediatrics
| 62926
A Multicenter, Prospective, Long-term, Observational Registry of Pediatric
Patients with Inflammatory Bowel Disease
Dr Crissinger, K
Centocor, Inc.
19,577.40
| 63661
A Phase 2 Multicenter, 36-Week Study to Assess the Safety and
Effectiveness of Daily Oral Administration of Dexlansoprazole DelayedRelease Capsules for Healing of Erosive Esophagitis and Maintenance of
Healed Erosive Esophagitis and Relief of Heartburn, in Adolescent
Subjects Aged 12 to 17 Years
Dr Crissinger, K
Takeda Global Research & Development Center
4,333.10
| 63748
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled,
Parallel-Group Study to Evaluate the Efficacy and Safety of Ribipansel
(GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized
Subjecs with Sickle Cell Disease
Dr Imran, H
Pfizer
3,000.00
| 63722
A Multcentre, Randomised, Placebo-Controlled, Double-Blind Study of the
Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric
Subjects Aged 6 or Greater to Less than or Equal to 18 Years with
Functional Constipation
Dr Ponnamballam, A
Sucampo Pharma Americas, LLC
2,876.25
| South Alabama Medical Science Foundation
| Cash Receipts (for Projects over $2,000 only)
| October 1, 2014 - September 30, 2015
|
| Project
Dept | Number
Project Title
Responsible
Person
Source of
Funding
UAB
11,000.00
Mast Therapeutics Inc
31,030.00
Selexys Pharmaceuticals
14,487.80
| 63726
SAMSF/UAB : Healthy Active Living Sessions with ACHIA
Dr Preud'Homme, D
| 63678
Evaluation of Purified Poloxamer 188 in Children in Crisis (EPIC): A
Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter
Clinical Trial of ANX-188 (purified poloxamer 188) Injection in Children
with Sickle Cell Disease Experiencing Vaso-Occlusive Crisis
Dr Siddiqui, A
| 63720
A Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Blind,
12-Month Study to Assess Safety and Efficacy of SelG1 with or without
Hydroxyurea Therapy in Sickle Cell Disease Patients with Sickle-Cell
Related Pain Crises
Dr Wilson, F
Total Pediatrics
14-15
Receipts
$
86,304.55
OBGYN
| 63646
A Clinical Field Study to Evaluate the Clinical Performance of the
SEQureDx Trisonomy 21 Test in the Detection of the Relative Quantity of
Chromosome 21 in Circulating Cell Free DNA extracted from Maternal
Blood Plasma Obtained from Pregnant Women with High Risk Indicatiors
for Fetal Chromosome 21 Aneuploidy
Dr Lewis, D
Sequenom
7,437.50
| 63719
SQNM-T21-107 - Collection of Whole Blood Speciment from Pregnant
Women at Increased Risk for Fetal Chromosomal Abnormality for Use in
Development of a Noninvasive Prenatal Test in the Detection of the
Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA
Extracted from Maternal Plasma
Dr Lewis, D
Sequenom
20,500.00
| 63734
Prospective Randomized Double-Blind, Placebo-Controlled Evaluation of
the Pharmokinetics, Safety and Efficacy of Recombinant Antithrombin
Versus Placebo in Preterm Preeclampsia (PRESERVE-1), Protocol no. RB
AT PPE 01-13
Dr Lewis, D
rEVO Biologics
106,698.75
Total OBGYN
$
134,636.25
| South Alabama Medical Science Foundation
| Cash Receipts (for Projects over $2,000 only)
| October 1, 2014 - September 30, 2015
|
| Project
Dept | Number
Project Title
Responsible
Person
Source of
Funding
14-15
Receipts
USAMCI
| 63504
An International Multi-Centre Open-Label 2-Arm Phase III Trial of
Adjuvant Bevacizumab in Triple Negative Breast Cancer, Protocol No.
BO20289 and Roche Sample Repository Research Projec, Protocol No.
B020289RG
Dr Butler, T
Hoffman-La Roche, Inc
10,231.00
| 63560
A Randomized, Phase III, Double-Blind, Placebo-Controlled Multicenter
Trial of Everolimus in Combination with Trastuzumab and Paclitaxel, as
First Line Therapy in Women with HER2 Positive Locally Advanced or
Metastatic Breast Cancer
Dr Butler, T
Novartis Pharmaceuticals
31,048.57
| 63718
A Multicenter Phase 3 Randomized, Open-Label Study of Bosutinib
Versus Imatinib in Adult Patients with Newly Diagnosed Chronic Phase
Chronic Myelogenous Leukemia
Dr Butler, T
Avillion Development
5,000.00
| 63685
A Phase 3, Randomized, Open Label Trial of
Lenalidomide/Dexamethasone with or without Elotuzumab in Subjects with
Previously Untreated Multiple Myeloma
Dr Clarkson, D
Bristol Myers Squibb
20,511.00
| 63715
A Randomized, Double-Blind, Multicenter, Parallel-Group, Phase III Study
to Evaluate Efficacy and Safety of DCV AC/Pca versus Placebo in Men
with Metastatic Castration Resistant Prostate Cancer Eligible for 1 st Line
Chemotherapy
Dr Clarkson, D
SOTIO
6,500.00
| 63745
A Phase 3, Double-Blind Randomized Study to Compare the Efficacy and
Safety of Rituxlmab Plus Lenalldomide (CC-5013) Versus Rituxlmab Plus
Placebo in Subjects with Relapsed/Refractory Indolent Lymphoma
Dr Clarkson, D
Celgene Corporation
6,500.00
| 63746
Multicentre, Randomised, Double-Blind, Phase III Trial to Investigate the
Efficacy and Safety of Oral Nintedanib Plus Docetaxel Therapy Compared
to Placebo Plus Docetaxel Therapy in Patients with Stage IIIB/IV or
Recurrent, Adenocarcinoma Subtype Non-Small Cell Lung Cancer After
Failure of First Line Chemotherapy
Dr Clarkson, D
Boehringer Ingelheim Pharmaceuticals
6,000.00
| South Alabama Medical Science Foundation
| Cash Receipts (for Projects over $2,000 only)
| October 1, 2014 - September 30, 2015
|
| Project
Dept | Number
Project Title
Responsible
Person
Source of
Funding
14-15
Receipts
| 63749
A Phase 3 Study Comparing Daratumumab, Lenalidomide, and
Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in
Subjects with Previously Untreated Multiple Myeloma Who Are Ineligible
for High Dose Therapy
Dr Clarkson, D
Janssen Research & Development
6,000.00
| 63757
A Phase 3, Randomized, Study to Assess the Efficacy and Safety of
Ubiituxlmab in Combination with Ibrutinib Compared to Ibrutinib Alone,
in Patients with Previously Treated High-Risk Chronic Lymphocytic
Leukemia (CLL)
Dr Clarkson, D
TG Therapeutics, Inc
6,500.00
| 63710
Multi Institutional Neo-Adjuvant Therapy Mammaprint Project (MINT)
Dr Dyess, L
Agendia, Inc
2,400.00
| 63689
A Registry of Caris Life Sciences Molecular Intelligence Service
(Biomarker Assessment Results) Intended for Correlation with Cancer
Clinical Outcomes
Dr Finan, M
Caris
7,700.00
| 63666
A Phase III Randomized, Double Blind, Placebo-Controlled Study of
BKM120 with Fulvestrant, in Postmenopausal Women with Hormone
Receptor-Positive HER2-Negative Locally Advanced or Metastatic Breast
Cancer Which Progressed on or after Aromatase Inhibitor Treatment
Dr Norden, C
Novartis Pharmaceuticals
17,681.35
| 63701
An Observational Cohort Study of Treatment Patterns and Outcomes in
Patients with HER2 Positive (HER2+) Metastatic Breast Cancer
Dr Norden, C
Genentech
7,896.14
| 63721
A Multicenter, Multinational, Phase II Study to Evaluate Pertuzumab in
Combination with Trastuzumab and Standard Neoadjuvant AnthracyclineBased Chemotherapy in Patients with HER2-Positive, Locally Advanced,
Inflammatory, or Early-Stage Breast Cancer
Dr Norden, C
Genentech Inc
58,052.70
| 63735
A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)
in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative
Breast Cancer
Dr Norden, C
Celldex Therapeutics
7,000.00
| South Alabama Medical Science Foundation
| Cash Receipts (for Projects over $2,000 only)
| October 1, 2014 - September 30, 2015
|
| Project
Dept | Number
| 63673
Project Title
A Phase III, Randomized, Double-Blind, Active Comparator-Controlled
Parallel-Group Study, Conducted Under In-House Blinding Conditions, to
Examine the Efficacy and Safety of a Single 150mg Dose of Intravenous
Fosaprepitant Dimeglumine for the Prevention of Chemotherapy-Induced
Nausea and Vomiting (CINV Associated with Moderately Emetogenic
Chemotherapy
Responsible
Person
Source of
Funding
14-15
Receipts
Dr Rocconi, R
Merck
8,494.00
| 63725
Modular Phase II Study to Link Targeted Therapy to Patients with Pathway
Activated Tumors: Module 3 - MEK 162 for Patients with RAS/RAF/MEK
Activated Tumors
Dr Rocconi, R
Novartis Pharmaceuticals
7,500.00
| 63752
Double-Blind, Placebo Controlled Phase III Trial of Maintenance FANG
(bi-shRNA and GMCSF Augmented Autologous Tumor Immunotherapy)
for High Risk Stage III/IV Ovarian Cancer
Dr Rocconi, R
Gradalis, Inc
5,000.00
| 63755
A Phase I, Open-Label, Multiple-Ascending Dose Trial to Investigate the
Safety, Tolerability, Pharmokinetics, Biological and Clinical Activity of
MSB0010718C in Subjects with Metastatic or Locally Advanced Solid
Tumors and Expansion to Selected Indications
Dr Rocconi, R
EMD Serono, Inc
6,500.00
| 63731
A Phase 3b, Multicenter, Open-Label, Single-Arm, Expanded Access
Protocol of Talimogene Laherparepvec for the Treatment of Subjects with
Unresected, Stage IIIB to IVM1a Melanoma
Dr Tan, M
Amgen
12,268.00
| 63682
STEAM (Sequencing Triplet with Avastin and Maintenance) :
FOLFOXIRI/Bevacizumab Regiments (Concurrent and Sequential) vs.
FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer
Dr Taylor, W
Genentech
21,117.33
| 63693
Prospective International Observational Cohort Non-Comparative Study
Describing the Safety and Efficacy of ZALTRAP Administered in
Combination with FOLFIRI for the Treatment of Patients with Metastatic
Colorectal Cancer in Current Clinical Practice: A Post-Authorisation Safety
Study (PASS)
Dr Taylor, W
Sanofi US Services Inc
4,675.00
| South Alabama Medical Science Foundation
| Cash Receipts (for Projects over $2,000 only)
| October 1, 2014 - September 30, 2015
|
| Project
Dept | Number
Project Title
Responsible
Person
| 63742
A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated
Recombinant Human Hyaluronidase) Combined with nab-Paclitaxel Plus
Gemcitabine Compared with nab-Paclitaxel Plus Gemcitabine in Subjects
with Stage IV Previously Untreated Pancreatic Cancer
Dr Taylor, W
| 63724
A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing
Vellparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of
Standard Chemotherapy in Subjects Receiving First Cytotoxic
Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell
Lung Cancer (NSCLC) and Who Are Current or Former Smokers
Dr Vu, M
Source of
Funding
14-15
Receipts
Halozyme, Inc
7,500.00
AbbVie Inc
6,075.00
Total USAMCI
$
278,150.09
Total All Departments
$
904,308.11
Other Research Related Revenue: Royalties & Licensing Fees
Ayling/Bailey
Merck Eprova
Ayling/Bailey
Merck Eprova- Reimb for Legal
187,407.90
Intellect USA Licensing
32,500.00
QED
5,960.00
Pappolla/Poegller
Various
2,380,353.00
Total Other Research
$
2,606,220.90
Total
$
3,510,529.01