Neuronewsletterspring

A Triannual Publication of Augusta Univesity

NEUROSCIENCE OUTLOOK News and Research from the Departments of Neurology and Neurosurgery

VOL. 13 | ISSUE 1

VOL. 13 | ISSUE 1 NEUROSCIENCE OUTLOOK

FROM THE CHAIRMEN

DEAR READERS, We offer you another installment of Neuroscience Outlook in

which we update you on news and notes from the departments of

Neurology and Neurosurgery from September to December 2015.

While our school of medicine retains the name Medical College of Georgia, our parent institution has undergone another name

change from Georgia Regents University to Augusta University.

In this issue we congratulate our pediatric hospital, Children’s

Hospital of Georgia, for achieving the number one rank in the

nation in safety and quality by the UHC consortium in 2014 (see News from the departments). Our commitment to teaching was From left: Cargill H. Alleyne, Jr., MD Professor and Marshall Allen Distinguished Chair of Neurosurgery David C. Hess, MD Professor and Presidential Distinguished Chair of Neurology

recognized with the presentation of Exemplary Teaching Awards

to 5 of our faculty (1 neurosurgeon and 4 neurologists) and the selection of our neurosurgery chief resident as a finalist for the Resident of the Year Award. In the clinical spotlight the

Amyotrophic Lateral Sclerosis center is featured. Our center is one of only 34 in the nation certified by the ALS Association as a Center of Excellence. We also feature the multi-

disciplinary Neuro-oncology program at our institution. Our donors (listed on page 13)

remain the lifeblood of many of our clinical and research initiatives and their contributions are greatly appreciated. In the Publications and Presentations section we list four months’

worth of academic productivity from our combined departments. Finally, we are saddened

to report the passing of Dr. Marshall Allen Jr. who led the then division of neurosurgery

for three decades (1965 to 1994). He has left an indelible mark on all his former residents and colleagues. His legacy is far-reaching and he will be missed greatly.

Cargill H. Alleyne, Jr., MD

David Hess, MD

Professor and Marshall Allen Distinguished Chair of Neurosurgery

Professor and Presidential Distinguished Chair of Neurology

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IN THIS ISSUE VOL. 13 | ISSUE 1

FACULTY & STAFF UPDATE________________4

Neuroscience Outlook is produced triannually by the

Medical College of Georgia Departments of Neurology

DEPARTMENT NEWS_____________________5

and Neurosurgery and the Augusta University Division of Communications and Marketing. Please direct comments or

PUBLICATIONS & PRESENTATIONS_________6

questions to marketing@augusta.edu.

SCHEDULES____________________________7 CLINICAL SPOTLIGHT: AUGUSTA UNIVERSITY AMYOTROPHIC LATERAL SCLEROSIS CLINIC__8

Editor-in-Chief: Cargill H. Alleyne, Jr., MD Assistant Editor: Julie Kurek, MD

CLINICAL SPOTLIGHT: NEURO-ONCOLOGY PROGRAM_____________________________10

Illustration: Colby Polonsky, MS Contributors: Michael Rivner, MD Frank E. Mott, MD, FACP

THANK YOU, DONORS___________________13 THE CLINICAL TEAM_____________________15 UPCOMING MEETINGS___________________16

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augustahealth.org/neuro VOL. 13 | ISSUE 1 NEUROSCIENCE OUTLOOK

VOL. 13 | ISSUE 1 NEUROSCIENCE OUTLOOK

FACULTY & STAFF UPDATE Cargill H. Alleyne Jr., MD (Department of Neurosurgery) published a third edition of Neurosurgery Board Review: Questions and Answers for Self-Assessment, in December 2015. His second children’s book, Bart’s Heart, won second place in the Fall 2015 Royal Dragonfly children’s book awards. He was also featured in Upscale magazine: Brain Power, October 2015.

Askiel Bruno, MD (Department of Neurology) was named the Amy G. Warren and Lamar Warren Distinguished Chair in Diabetes and Obesity in Radiology.

Krishnan Dhandapani, PhD (Department of Neurosurgery) was chair of the American Heart Association Brain 2 Review Panel in October and chair of the VA Neurobiology C Study Section in December.

Cole Giller, MD, PhD (Department of Neurosurgery) was a reviewer for the program for the 18th Gamma Knife Society Meeting in October. In November, he began a teaching position (0.05 FTE) with MCG, delivering Introduction to Neurosurgery to the second-year medical school class.

One of his patients (a 3-year-old adopted girl from China who underwent a hemispherotomy procedure lasting 15 hours) was featured during the Children’s Hospital of Georgia radiothon.

She has been seizure-free since that time with minimal new deficit. Her picture and story is at jagwire.gru.edu/archives/28368.

The Radiothon is the largest single Children’s Miracle Network Hospitals fundraiser for CHOG. David C. Hess, MD (Department of Neurology) was appointed to the editorial boards of Stroke and Vascular Neurology and the Journal of the Chinese Stroke Association and was appointed associate Editor of Translational Stroke Research. He was also an invited participant in the Stroke Therapy Academic Industry Roundtable (STAIR) meeting in Washington, D.C. in October 2015. In addition, he received an Exemplary Teaching Award (Undergraduate Medical Education) for 2015 by the MCG Faculty Senate.

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Sergei A. Kirov, PhD (Department of Neurosurgery) had a featured article (Steffensen AB, Sword J, Croom D, Kirov SA, MacAulay N: “Chloride cotransporters as a molecular mechanism underlying spreading depolarization-induced dendritic beading.” J Neurosci 35:12172-12187, 2015) in the Journal of Neuroscience (“This Week in The Journal”). This collaborative study between Kirov’s laboratory and one at University of Copenhagen reveals mechanisms of cytotoxic neuronal edema induced by spreading depolarizations in stroke and traumatic brain injury. Kirov was discussion leader/session co-chair, (“Basic mechanisms and Optical imaging II”) at the 17th Cooperative Studies on Brain Injury Depolarizations (COSBID) meeting in Elsinore, Denmark. He also participated in several study sections, including the American Heart Association (National Innovative Research Grant (IRG) Vascular Sciences (Brain) BSc1, National Institutes of Health [NIH ZRG1 F03A (20), Fellowships: Neurodevelopment, Synaptic Plasticity, Neurodegeneration Study Section; and NIH ZRG1 F03A (20), Fellowships: Neurodevelopment, Synaptic Plasticity, Neurodegeneration Study Section], and the National Science Foundation (Ad Hoc Reviewer).

S. Dion Macomson, MD (Department of Neurosurgery) received an Exemplary Teaching Award (Graduate Medical Education) for 2015 by the MCG Faculty Senate.

Nancy McNair, MD (Department of Neurology) received an Exemplary Teaching Award (Undergraduate Medical Education) for 2015 by the MCG Faculty Senate.

Fenwick Nichols, MD (Department of Neurology) received an Exemplary Teaching Award (Graduate Medical Education) for 2015 by the MCG Faculty Senate.

J. Ned Pruitt, MD (Department of Neurology) received an Exemplary Teaching Award (Undergraduate Medical Education) for 2015 by the MCG Faculty Senate.

NEWS from the DEPARTMENTS (September-December 2015)

Neurosurgery chief resident nominated Resident of the Year M. Neil Woodall, MD was one of 11 residents nominated for MCG Resident of the Year 2015-16.

Our Children’s Hospital ranks #1 in the nation Children’s Hospital of Georgia was ranked first in the nation in quality and safety in 2014 by the University HealthSystem Consortium (UHC) – an alliance of 122 nonprofit academic medical centers. The 154-bed not-for-profit CHOG is the secondlargest children’s hospital in the state, providing the highest level of pediatric critical care and neonatal intensive care (including neurological and neurosurgical care), as well as a wide range of general and complex health care for children.

Five faculty receive Exemplary Teaching Awards for 2015 by MCG Faculty Senate One neurosurgeon and four neurologists received Exemplary Teaching Awards for Undergraduate or Graduate Medical Education (UME or GME). They were neurosurgeon S. Dion Macomson, MD (GME), and neurologists Ned Pruitt, MD, Nancy McNair, MD, David C Hess, MD (UME), and Fenwick Nichols, MD (GME) (See faculty updates).

Neurology faculty given Distinguished Chair title Askiel Bruno, MD was named the Amy G. Warren and Lamar Warren Distinguished Chair in Diabetes and Obesity in Radiology. The donor, Dr. Earl L. Warren, of Swainsboro, Georgia, graduated from the Medical College of Georgia in 1925 and practiced radiology in Paterson, New Jersey for 30 years. Warren served on the staff and medical board of the Greater Paterson General Hospital. He was a long time, active member of the Radiological Society of North America, the New Jersey Medical Society and the American Medical Society.

Warren passed in 1979. According to the charitable request (and as modified by the Warren Commission), the Distinguished Chair is named after Warren’s wife and brother. (See faculty update).

New Neurology faculty welcomed Mary Gregory, MD, PhD joined the Pediatric Neurology and Pediatric Epilepsy programs in October 2015. Dr. Gregory recently completed an epilepsy fellowship at Johns Hopkins Hospital, and prior to that completed a neurodevelopmental medicine fellowship at the Kennedy Krieger Institute/Johns Hopkins Hospital.

Gregory graduated from the Medical Scientist Training MD-PhD Program at the Medical University of South Carolina. She will also play a major role in undergraduate education.

Neurosurgery Board review book published The third edition of Neurosurgery Board Review: Questions and Answers for Self-Assessment, was published in December 2015 (Alleyne CH, Citow JS, MN Woodall: Neurosurgery Board Review: Questions and Answers for Self-Assessment, 3rd ed., New York, Thieme Medical Publishers, Inc., December 2015). The first edition was written in 1995 when Dr. Cargill H. Alleyne Jr., neurosurgery chairman, was still a resident at Emory. This essential board prep review mirrors the exam’s multiple-choice format and seven sections: neurosurgery, clinical neurology, neuroanatomy, neurobiology, neuropathology, neuroradiology, and clinical skills/ critical care. Chief resident M. Neil Woodall, MD was instrumental in helping with this revision which is presented in a new and improved layout and encompasses the numerous advances in neurosurgery since the 2004 edition was published.

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VOL. 13 | ISSUE 1 NEUROSCIENCE OUTLOOK

PUBLICATIONS & PRESENTATIONS

Members of the Augusta University Neurology and Neurosurgery departments are shown in bold

(September to December 2015) PRESENTATIONS:

Alleyne C.H., Vaibhav K, Baban B, Hoda MN, Dhandapani KM: Remote ischemic conditioning improves neurovascular outcomes after intracerebral hemorrhage in mice. Congress of Neurosurgical Surgeons Meeting, New Orleans, LA, Sepr 2015 Steffensen AB, Sword J, Croom D, Kirov SA, MacAulay N: Mechanisms underlying spreading depolarization‐induced dendritic beading. 17th COSBID meeting, Elsinore, Denmark, Sep 2015 Nguyen K, Todnem N, Choudhri HF, Macomson SD: The intercostal nerve as a target for diagnostic biopsy. Congress of Neurological Surgeons Meeting, New Orleans, LA, Sep 2015 Gupta R, Sukumari-Ramesh S, Dhandapani K, Vender J: Ginkgolic acid decreases glioma cell survival and may overcome chemoresistance to temozolomide. Dean’s Summer Research Program, MCG at Georgia Regents University, Augusta, GA, Sep 2015 (poster).

Todnem N, Kilianski J, Nguyen K, Rahimi SY: Two cases of arteriogenic thoracic outlet syndrome presenting as cervical radiculopathy. Congress of Neurological Surgeons Meeting New Orleans, LA, Sep 2015.

Vender JR: Brain Trauma. NURO 8082 course, Georgia Regents University, Augusta, GA, Sep 2015.

Dhandapani K: Remote ischemic conditioning: Harnessing endogenous repair mechanisms after brain injury. Department of Neurosurgery Grand Rounds, Emory University, Atlanta, GA, Oct 2015 Kirov SA: Window into the injured brain: Live imaging of pathological depolarizations and their impact on the integrity of synaptic circuitry. Loma Linda University Integrated Biomedical Sciences Seminar Series, Loma Linda, CA, Oct, 2015.

Alleyne CH: A career in Neurosurgery. Neurosurgery Interest Group, Georgia Regents University, Augusta, GA, Nov 2015.

Choudhri HF: Tips and tricks to reduce complications in cervical spine surgery. 5th Egyptian Spine Society Meeting, Aswan, Egypt, Nov 2015.

Choudhri HF: Management of complex mass lesions at the craniocervical junction.

5th Egyptian Spine Society Meeting, Aswan, Egypt, Nov 2015.

Choudhri HF: Management of sacral tumors. 5th Egyptian Spine Society Meeting, Aswan, Egypt, Nov 2015.

Choudhri HF: Tips and tricks to reduce complications in cervical spine surgery. 5th MASSIN/Jordanian Society of Neurological Surgeons Meeting, Dead Sea, Jordan, Nov 2015.

Choudhri HF: Management of complex mass lesions at the craniocervical junction.

5th MASSIN/Jordanian Society of Neurological Surgeons Meeting, Dead Sea, Jordan, Nov 2015.

Choudhri HF: Management of sacral tumors. 5th MASSIN/Jordanian Society of Neurological Surgeons Meeting, Dead Sea, Jordan, Nov 2015.

Choudhri HF: Tips and tricks to reduce complications in cervical spine surgery. 9th Asia Pacific Cervical Spine Society Meeting, Dubai, United Arab Emirates, Nov 2015.

Choudhri HF: Management of complex mass lesions at the craniocervical junction.

9th Asia Pacific Cervical Spine Society Meeting, Dubai, United Arab Emirates, Nov 2015.

Choudhri HF: Plenary Session: Should neurosurgeons perform scoliosis surgery?

1st Dandy Quadrennial Meeting, Dubai, United Arab Emirates, Nov 2015.

Hess DC: The world is flat: A brief future of stroke. Wake Medical Stroke Conference, Raleigh, NC, Nov 2015.

Giller CA: Surgery for Parkinson’s Disease and Essential Tremor. Finding hope for Parkinson’s Disease and Essential Tremor, Augusta University, Augusta, GA, Dec 2015.

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Viers A, Vender J: Glossopharyngeal neuropathy with hemodynamic instability and syncope treated with stereotactic radiosurgery. Case report and review of the literature. Georgia Neurosurgical Society Meeting, Greensboro, GA, Dec 2015.

PUBLICATIONS: Alleyne CH, Woodall MN, Citow JS: Neurosurgery Board Review: Questions and answers for self-assessment. Third edition. New York, Thieme Medical Publishers Inc., Dec 2015.

Hess DC, Blauenfeldt RA, Andersen G, Hougaard KD, Hoda MN, Ding Y, Ji X: Remote ischaemic conditioning-a new paradigm of self-protection in the brain. Nat Rev Neurol 11:698-710, 2015.

Hess DC, Khan MB, Morgan JC, Hoda M: Remote ischemic conditioning: A treatment for vascular cognitive impairment. Brain Circ 1:133-9, 2015.

Steffensen AB, Sword J, Croom D, Kirov SA, MacAulay N: Chloride cotransporters as a molecular mechanism underlying spreading depolarization-induced dendritic beading. J Neurosci 35:12172-12187, 2015.

Kim KJ, Iddings JA, Stern JE, Blanco VM, Croom D, Kirov SA, Filosa JA: Astrocyte contributions to flow/pressure-evoked parenchymal arteriole vasoconstriction. J Neurosci 35(21), 8245-8257, 2015.

Simon DK, Simuni T, Elm J, Clark-Matott J, Graebner AK, Baker L, Dunlop SR, Emborg M, Kamp C, Morgan JC, Ross GW, Sharma S, Ravina B: Peripheral biomarkers of Parkinson’s Disease progression and Pioglitazone effects. J Parkinson’s Dis. 2015 Oct 3. [Epub ahead of print].

Cohen EV, Hagestuen R, González-Ramos G, Cohen HW, Bassich C, Book E, Bradley KP, Carter JH, Di Minno M, Gardner J, Giroux M, González MJ, Holten S, Joseph R, Kornegay DD, Simpson PA, Tomaino CM, Vandendolder RP, WaldeDouglas M, Wichmann R, Morgan JC: Interprofessional education increases knowledge, promotes team building, and changes practice in the care of Parkinson’s disease. Parkinsonism Relat Disord. 2015 Nov 6. pii: S1353-8020(15)30024-9 [doi: 10.1016/j.parkreldis.2015.11.001, Epub ahead of print].

Silver MR, Sethi KD, Mehta SM, Nichols FT, Morgan JC: Case report of optic atrophy in in dentatorubropallidoluysian atrophy (DRPLA). BMC Neurol 15:260, 2015 [doi:10.1186/s12883-015-0520-0].

Sukumari Ramesh S, Alleyne CH Jr, Dhandapani KM: The histone deacetylase inhibitor suberoylanilide hydroxamic acid (SAHA) confers acute neuroprotection after intracerebral hemorrhage in mice. Trans Stroke Res, ePub Sept 4, 2015 [DOI: 10.1007/s12975-015-0421-y].

Soni C, Tyagi S, Todnem N, Givvimani S, Pushpakumar S, Villafane J, Maldonado C: Hyperhomocysteinemia alters sinoatrial and atrioventricular nodal function: Role of magnesium in attenuating these effects. Cell Biology and Biophysics, Sep 2015 pp. 1-7 [DOI: 10.1007/s12013-015-0711-8].

NEUROSURGERY CONFERENCE SCHEDULE January - April 2016 January 1 Holiday January 8 11 a.m. Resident Meeting 12 p.m. Case Conference January 15 Interviews January 22 11 a.m. Journal Club 12 p.m. M&M January 29 11 a.m. Visiting Professor 12 p.m. Faculty Meeting February 5 10 a.m. Anatomy 11 a.m. Business (Dr. Giller) 12 p.m. Case Conference

February 19 10 a.m. Radiology 11 a.m. Functional (Dr. Giller) 12 p.m. Case Conference February 26 9 a.m. Pathology 10 a.m. Resident Meeting 11 a.m. Journal Club 12 p.m. M&M

March 4 Skull Base Course Amphitheater

March 11 Written Exam

March 18 10 a.m. Neuro 101 ( June Yowtak) 11 a.m. Functional (Dr. Giller) 12 p.m. Case Conference

March 25 9 a.m. Pathology 10 a.m. Resident Meeting 11 a.m. Journal Club 12 p.m. M&M April 1 10 a.m. Anatomy 11 a.m. Neuro 101 (Nathan Todnem) 12 p.m. Case Conference April 15 10 a.m. Radiology 11 a.m. Functional (Dr. Giller) 12 p.m. Case Conference

April 22 9 a.m. Pathology 10 a.m. Resident Meeting 11 a.m. Journal Club 12 p.m. M&M

February 12 10 a.m Oral Board Review 11 a.m. Neuro 101 (Angela Viers) 12 p.m. Visiting Professor

NEUROLOGY GRAND ROUNDS SCHEDULE

UPCOMING MEETINGS

January - April 2016

January - April 2016

January 7

Dr. Tom Swift: Case Presentation

February 15-16:

January 21

Dr. Yong Park: Epilepsy Dr. Ned Pruitt:

Dr. Askiel Bruno: Resident Rank Meeting

February 17-19: International Stroke Conference,

Los Angeles, California

Dr. Tom Swift: Case Presentation

March 2-5:

Southern Neurosurgical Society, San Antonio, Texas

Dr. Ed Hartmann: Neuromuscular

March 16-19:

AANS/CNS Section on Disorders of the Spine & Peripheral Nerves, Orlando, Florida

Dr. Tom Swift: Case Presentation

April 15-21:

American Academy of Neurology, Vancouver, Canada

Dr. Elizabeth Sekul: Child Neurology

April 18-20:

American Board of Neurological Surgery Oral Boards, Houston, Texas

NO GRAND ROUNDS

April 29:

60th Anniversary MCG Neurosurgery Alumni reunion, Augusta, Georgia

NO GRAND ROUNDS

April 30-May 4: American Association of Neurological

Surgeons, Chicago, Illinois

January 14 January 28

February 4

February 11

February 18 February 25 March 3

March 10 March 18

March 25 March 31 April 7

April 14 April 21

April 28

Dr. Anthony Murro: Epilepsy

Dr. Julie Kurek: Movement Disorders Dr. Debra Moore-Hill: Epilepsy Dr. Jeff Switzer: Stroke Dr. Nancy McNair

Dr. David Hess: Stroke

Dr. Michael Rivner: Neuromuscular 7

AANS/CNS Section on Cerebrovascular Surgery, Los Angeles, California

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CLINICAL SPOTLIGHT

AUGUSTA UNIVERSITY AMYOTROPHIC LATERAL SCLEROSIS CLINIC ALS, also known as Lou Gehrig’s disease, is a devastating neuromuscular disease causing muscle deterioration that is usually fatal within 5 years from the initial symptoms. The cause for this disease is unknown. While there is no effective cure, supportive treatments can improve longevity and quality of life. The Augusta University ALS clinic, established over 10 years ago, offers patients afflicted with ALS comprehensive treatment. Initially, the clinic was a half day each month. Within two years, demand for our services expanded the clinic to a whole day each month. In November 2007, our clinic became the 31st ALSA Certified ALS Center of Excellence indicating that our clinic met the rigorous criteria for formal certification. Starting January 2016, the clinic will be expanded to two days a month to accommodate our patients better. The clinic director, Dr. Michael Rivner, Charbonnier Professor of Neurology, also runs an ALS clinic in Macon at the Navicent Rehabilitation Hospital to serve patients living in southwest and middle Georgia. This clinic which was started 5 years ago is now expanding to two days a month as well because of the need for its services. Over 150 ALS patients are followed at both of these clinics.

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Both the Augusta and Macon ALS clinics are multidisciplinary clinics designed to enable patients to have all their needs taken care of during a single visit. During a typical visit, patients will see not only our ALS specialist, Dr. Rivner, but also physical, occupational, speech and respiratory therapists, a social worker, a dietary advisor, equipment vendors and representatives from both the ALS Association and Muscular Dystrophy Association. A dedicated team consisting of about 20 specialists provide the care needed by these patients with diverse needs. Studies have shown that patients treated in ALS clinics have better outcomes because of early interventions. In addition, these patients have day to day problems that need attention. Once patients are diagnosed with ALS, we become their primary source of medical care as many physicians are unfamiliar with ALS. The dedicated staff of the EMG Laboratory handles many of the needs of the patients making sure that they get needed equipment and proper care. Our goal is to have patients and families feel that they can always count on us to help them through all stages of this disease.

ALS remains a clinical diagnosis as no test exists to identify it. As such, patients who are suspected of having ALS need a proper and thorough examination. Our ALS specialists spend up to three hours with patients on their initial visit and we are committed to seeing potential patients within a one month time frame. Our new patient diagnostic clinics occur weekly at Augusta University.

discovered and it was hoped at that time that this would lead to the discovery of the cause of Sporadic ALS. Unfortunately, 22 years later a staggering 126 gene mutations have been associated with ALS but we still do not know what the cause of this disease is. A disease model patterned after the SOD1 mouse has not been productive in finding the cause or treatment for this disease and there is a consensus that there is no one single cause for ALS. We are looking for ways to distinguish the different varieties of ALS. Our lab, in conjunction with Dr. Lin Mei, Chairman Department of Neuroscience and Regenerative medicine, has discovered antibodies that are present in approximately 10 percent of patients with ALS. The proteins that these antibodies are directed against are important in cell to cell communication and its breakdown may play a role in the production of ALS. Research is ongoing to see if these antibodies can produce pathology that can cause this disease.

In addition to clinical care, our center is very active in both clinical and basic research trials as our hope is to increase the survival time and improve the quality of life for ALS patients and ultimately find a drug that will reverse or stop disease progression. At present, only one drug, riluzole, is effective in prolonging life and its benefit is only modest. Our center is a member of the NEALS ALS consortium which is a group of ALS centers that work together to perform high quality ALS clinical trials. Currently, our center is involved in several clinical ALS trials One is with the drug tirasemtiv. It is a novel drug that works directly on the muscle to improve its strength. We had participated in an earlier Phase II trial that showed that this drug might improve respiratory function in ALS patients and are now participating in a larger Phase III trial designed to show if this drug improves the outcome of patients with ALS.

Our clinic, along with Robert Yu, PhD (Department of Neuroscience and Regenerative Medicine and Department of Neurology) are also looking at abnormalities in gangliosides in ALS. We are measuring these antibodies in ALS patients and found abnormalities in a significant number of ALS patients.

We are in the process of learning about the significance of these findings in ALS.

A second clinical trial is exploring retigabine (ezogabine) an antiepileptic drug which reduces motor neuron excitability. One of the theories about ALS is that over excitation of the motor neuron leads to its death. In this trial, we will be developing new methods of measuring motor neuron excitability in the hopes of developing better tools for measuring the benefits of potential ALS medications. This involves the measurement of muscle excitability to both nerve and brain stimulation.

We are also collaborating with ALS investigators at other centers on the ALS Untangled project. This project is designed to look at untested treatments for ALS to see if they are of any value.

Our clinic is funded in part by grants from the ALS association and also by our annual fund raising campaigns, the annual Beat Feet for ALS Walk in September and our annual Lou Gehrig Golf Classic in May. The funds raised by these events help us hire the staff needed to run our clinic which includes services that are not funded by Insurance or Medicare and fund the ALS research done here at Augusta University. To donate please visit our website at https://giving.gru.edu/als or to find out more about our clinic http://www.alsgru.com

Here at Augusta University we are working hard to make a difference, both in improving our patients’ lives but also in furthering advancements in the field of ALS.

A third clinical trial will test the drug, mexiletine on ALS. Preliminary data indicates that this drug may benefit patients with ALS. We will also be looking at nerve excitability measurements in this clinical trial.

Our clinic is also active in basic science research in the hopes of finding the cause and cure for ALS. While 90 percent of ALS patients do not have a genetic cause and are called “sporadic,” 10 percent of ALS patients have a familial cause. Twentytwo years ago, SOD1, the first gene associated with ALS was

Staff of Augusta University ALS Clinic pictured on page 8: Michael Rivner, M.D. (Medical Director), Khalelah Mosley, AA (Clinic Coordinator), Michelle Coleman, CNCT (EMG Staff), Rebecca Fulmer, CNCT (EMG Staff), Loreen Ingram-Moore, CNCT (EMG Staff), Brandy Quarles BS (Research Coordinator), Nicole Smalley, AA (Research Assistant), Jane Willson, SLP (Speech Therapist), Carol Helmerich, RPT (Physical Therapist), Charlotte Chatto, RPT (Physical Therapist), Stephanie Johnson, OTR (Occupational Therapist), Ashlee Inman, OTR (Occupational Therapist), Christa Butler, RN (Nurse Manager), Sarah Schmidt, RD (Dietician), Jennifer Anderson, RRT (Respiratory Therapy), Juanita Joyner (ALSAGA), Tammy Wallace (MDA), Tanieka Ward (ALSASC), Integrity Medical—Julie Saylor, Brian Byler, Tobi-Dynavox—Marivic Beebe, Care Medical--Drew Cantrell, Neuroscience Practice Site Staff—Kristine Cordero LPN, Edwina Heath LPN, Carole Goff LPN, Brenda Mccollum MA, Shannon Watkins MA, Kdreona Glover CNA, Cynthia Passmore CNA, Meka Brown, Dana Jones and Amanda Hooper.

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CLINICAL SPOTLIGHT

NEURO-ONCOLOGY PROGRAM Neuro-oncology, or tumors of the central nervous system, includes a broad range of primary and metastatic malignancies. Treatment of these tumors requires a multidisciplinary approach to manage and integrate the appropriate surgical, radiation and chemotherapy options as well as the necessary supportive care. The Georgia Cancer Center at Augusta University Neuro-oncology team provides such components. The team consists of neurosurgeons, radiation oncologists, medical oncologists, nurse navigators, research nurses, social workers, and psycho-oncologists.

Patients are evaluated by members of the team and their cases discussed at tumor board conferences where the neuro-radiologists and pathologists review the imaging and pathology, respectively, and treatment plans are formulated.

Even with “good� prognosis patients, response to front-line therapy is often of limited duration. Standard therapy for relapsed or refractory tumors is usually with bevacizumab. Cure is not likely in these situations. Thus the quest for better therapies in both the front line and relapsed setting has led to a number of clinical trials at the Georgia Cancer Center at Augusta University. Many of these approaches are investigating methods to manipulate the immune response to tumors and either directly impact the tumor or aid the concurrent chemotherapy or radiotherapy treatments that are being administered.

Special treatment options include minimally invasive surgical approaches, stereotactic and gamma knife radiotherapy, intensity modulated radiotherapy (IMRT), chemotherapy with standard of care and research protocol opportunities.

A recent addition to the team is psycho-oncology, which provides patients with comprehensive psychosocial support as they deal with the often devastating neurologic and emotional complications of their disease.

One of the most common malignant brain tumors is grade IV glioma or glioblastoma multiforme. Median survival for grade IV gliomas is less than a year in many cases. Standard treatment consists of surgical resection up front, with patients who obtain gross total removal of the tumor faring better than patients who are only able to undergo partial resection or less.

Post-operatively, patients are treated with radiation therapy and often with concurrent administration of chemotherapy, usually with an oral drug called temozolamide, which is then continued after the radiation for 6-12 months, depending on response and tolerance to therapy. Pathology can help define patients who may have better prognosis and/or response to treatment with the use of several biomarkers such as isocitrate dehydrogenase 1 (IDH1) mutations, co-deletion of chromosomes 1p/19q, and hypermethylation of the enzyme methyl guanine methyltransferase (MGMT).

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Vaccine therapies are directed at specific targets that are either unique to the tumor or expressed at higher concentrations or activities compared to background normal tissue. A recent trial at Augusta University involved first-line vaccine therapy for patients with resected glioblastomas that were positive for an EGFRvIII mutation, present in about one-third of all glioblastomas. Patients whose tumor carried this mutation received standard radiation and temozolamide therapy after surgery and then were treated with either placebo or rindopepimut, an anti-EGFRvIII vaccine along with the standard maintenance temozolamide. This randomized trial has since closed to accrual; however, while awaiting the follow-up results, a compassionate use trial is still available for patients whose tumor carries the EGFRvIII mutation. Another vaccine trial is currently going through IRB approval and is expected to open in the near future. This trial will use a similar schema as the EGFRvIII vaccine trial, but will be directed at a different target, anti-HLA A2 on glioblastomas.

Another Phase I/II trial at the Georgia Cancer Center is for patients with relapsed glioblastoma or for those who progressed on standard treatment. This study is based on research conducted

by Drs. David Munn, Andrew Mellor and Ted Johnson at Augusta, looking at the role of indole 2,3 deoxyamine (IDO) in the response of the immune system toward the tumor. The trial uses an IDO-inhibitor in combination with standard temozolamide therapy. Even in patients who progressed on prior temozolamide therapy, responses have been seen. Results of the Phase I portion of this trial have been presented at this year’s American Society of Clinical Oncology (ASCO) and Society of Neurologic Oncology (SNO) meetings. The study is moving to Phase II. Continued on page 12.

Poster #59

A Phase 1b/2 Study of the Combination of the IDO Pathway Inhibitor Indoximod and Temozolomide for Adult Patients With Temozolomide-refractory Primary Malignant Brain Tumors: Safety Analysis and Preliminary Efficacy of the Phase 1b Component Howard Colman,1,* Frank Mott,2 Alexander I. Spira,3 Theodore S. Johnson,2 Yousef Zakharia,4 Nicholas N. Vahanian,5 Charles J. Link,5 Eugene Paul Kennedy5, Ramses F. Sadek,2 David Munn,2 Olivier Rixe6

*Presenting author.

Huntsman Cancer Institute, Salt Lake City, UT; 2Georgia Regents University Cancer Center, Augusta, GA; 3Virginia Cancer Specialists Research Institute, US Oncology Research, Fairfax, VA; 4University of Iowa Hospitals and Clinics, Iowa City, IA; 5NewLink Genetics Corporation, Ames, IA; 6University of New Mexico Cancer Center, Albuquerque, NM.

⦁ Recurrent glioblastoma multiforme (GBM) is associated with poor survival; a standard of care has not been clearly established – Treatment for newly diagnosed glioblastoma typically involves maximal surgical resection followed by concurrent radiotherapy with temozolomide (TMZ), an oral DNA-alkylating agent, followed by ≥6 months of adjuvant TMZ – Bevacizumab, an antiangiogenic monoclonal antibody, is also used to target highly vascularized brain tumors1 • Median progression-free survival (PFS) is 2.5 months in adults with bevacizumabrefractory GBM2 ⦁ Indoleamine 2,3-dioxygenase (IDO) is a key immunomodulatory enzyme of acquired immune tolerance in normal and pathologic conditions, particularly in the tumor microenvironment, that allows tumors to thwart the host immune response3 – IDO inhibits CD8+ T cells, and enhances the suppressor activity of regulatory T cells (Tregs) ⦁ IDO is expressed in a large proportion of solid tumors, including 50% to 90% of GBM, and high IDO expression is correlated with poor prognosis in GBM4 – Therefore, the IDO pathway is an attractive target for cancer drug development ⦁ This phase 1b/2 study is designed to determine the safety profile and maximal tolerated dose (MTD) of the IDO inhibitor indoximod (1-methyl-D-tryptophan/D-1MT) in combination with TMZ in recurrent refractory malignant brain tumors, with subsequent expansion into a phase 2 portion to evaluate the efficacy of the combination – Here, we present the safety analysis and preliminary efficacy of the phase 1b component

Murine Glial Tumor Model ⦁ IDO inhibitors, such as indoximod, can improve antitumor T cell response, which slows the tumor growth in vivo5,6 – In a murine glioblastoma model, antitumor response was measured at baseline, after a single-dose of TMZ plus 500 cGy fraction of radiation, and with the addition of indoximod to TMZ and radiation therapy (Figure 1)

– The antitumor response triggered by indoximod was fundamentally different than that of chemoradiotherapy and characterized by the following: • Widespread vascular activation • Complement deposition • Tumor necrosis with improved survival ⦁ A synergistic effect of indoximod was demonstrated when combined with TMZ and radiation in a syngeneic orthotopic brain tumor model7

METhODS

Table 1. Phase 1 Study Schema of Indoximod Dose Escalation Indoximod (oral)*

TMZ (oral)

1

600 mg BID × 28 days

150 mg/m2 × 5 days

2

1,000 mg BID × 28 days

150 mg/m2 × 5 days

3

1,200 mg BID × 28 days

150 mg/m2 × 5 days

TMZ, temozolomide; BID, twice daily. *Indoximod is administered in 200-mg capsules (ie, 3, 5, and 6 capsules, respectively for each dose level), and should be taken with water 1 hour before breakfast and 1 hour before dinner.

OBjECTIvES

TMZ, temozolomide; RT, radiation therapy; IDO, idoleamine 2,3-dioxygenase.

Figure 1. The antitumor response of indoximod plus chemoradiotherapy in a murine glioblastoma model.

Antitumor Activity

Patients ⦁ Twelve patients received escalating doses of indoximod in combination with TMZ – Three patients received indoximod 600 mg BID; three patients received indoximod 1,000 mg BID; six patients received indoximod 1,200 mg BID ⦁ Baseline demographic characteristics are summarized in Table 2

Table 2. Patient Demographic and Baseline Characteristics

⦁ This is a prospective, phase 1b, dose-escalation study in adult patients with progressive GBM or gliosarcoma ⦁ Inclusion criteria – Patients 16 to 70 years of age with histologically proven intracranial GBM (World Health Organization grade III-IV glioma) or gliosarcoma – Confirmation of tumor progression or regrowth on imaging, with and without gadolinium contrast – Patients must have completed a course of radiation therapy – Corticosteroid dose <2 mg of dexamethasone daily (or equivalent) – Eastern Cooperative Oncology Group performance status of 0 or 1, Karnofsky performance status ≥70%, and life expectancy >6 months ⦁ Exclusion criteria – More than 3 prior regimens for recurrent GBM or gliosarcoma – Active systemic infection requiring treatment – Active or history of autoimmune disease ⦁ Indoximod was administered at 3 dose levels in combination with a fixed dose of TMZ (Table 1) – Twelve patients were required to fully enroll all 3 dose cohorts with no regimen-limiting toxicities (RLTs) that required cohort expansion at lower doses

Dose level (cohort)

RESULTS

⦁ To determine the MTD of indoximod in combination with TMZ in recurrent refractory malignant brain tumors for use in the phase 2 study – MTD was defined as the dose of indoximod that does not induce RLT in more than 1 of 6 patients who were treated with TMZ ⦁ To evaluate the adverse event (AE) profile, including type, incidence, severity, duration, causality, and treatment intervention, and identify RLTs of combination therapy with indoximod plus TMZ

Characteristic

Indoximod + TMZ (n = 12)

Gender, n (%) Female Male

5 (41.7) 7 (58.3)

Race, n (%) White Black/African American

9 (75.0) 3 (25.0)

Median age (range), years

48.5 (27-62)

Diagnosis GBM Oligodendrioglioma Anaplastic astrocytoma

10 (83.3) 1 (8.3) 1 (8.3)

⦁ Four (33%) patients remained on study and 9 (75%) patients were alive at the time of this analysis ⦁ One (8%) patient demonstrated a partial response, which is ongoing, after exhibiting stable disease for 10 months – This patient was a 42 year old African-American female initially diagnosed with a left frontoparietal GBM in September 2012 – Underwent surgical biopsy in September 2012, but definitive surgical resection was not performed due to tumor extension involving corpus callosum and contralateral lesions – Received standard chemoradiotherapy (60 Gy over 6 weeks with TMZ [75mg/m2/day]) followed by maintenance TMZ – However, after 5 cycles of maintenance TMZ, disease progression occurred in June 2013 – Subsequently received single-agent bevacizumab but demonstrated disease progression again in January 2014, and the patient was subsequently taken off bevacizumab – Upon starting the NLG2102 study treatment in March 2014, the patient experienced stable disease with slow but modest reduction in tumor size from March 2014 to January 2015 – By March 2015, the patient demonstrated a partial response by Response Assessment in Neuro-Oncology (RANO) Criteria as demonstrated on selected MRI images (Figure 2) ⦁ Four (33%) patients demonstrated stable disease ranging from 4 to 11 months ⦁ Among the 5 patients with responses better than progressive disease, 4 (80%) had a diagnosis of GBM

CONCLUSIONS ⦁ The combination of chemotherapy and immunotherapy can have additive or synergistic effects ⦁ Indoximod is a potent inhibitor of the IDO pathway, and is currently in phase 1/2 development for the treatment of solid tumors ⦁ The MTD for indoximod in combination with TMZ was 1,200 mg BID ⦁ No patients have experienced a reduction or delay in TMZ dosing due to the addition of indoximod nor an idoximod-related serious AE ⦁ Expansion into the phase 2 portion of the study is proceeding according to the schema shown in Figure 3 ⦁ The primary objective of the phase 2 study is to assess the efficacy of indoximod and TMZ with or without bevacizumab or stereotactic radiosurgery (SRS), as measured by 6-month PFS ⦁ Secondary objectives include overall response, overall survival, safety, and tolerability in the various cohorts: – Indoximod + TMZ in patients with progressive GBM – Indoximod + TMZ and bevacizumab in patients with GBM who progressed during therapy with a bevacizumab-based regimen – Indoximod + TMZ and SRS in patients with GBM who may benefit from tumor debulking

TMZ, temozolomide; GBM, glioblastoma multiforme.

Phase 2 expansion into 3 cohorts

Safety and Tolerability ⦁ The MTD of indoximod in combination with TMZ was 1,200 mg BID ⦁ A summary of AEs is presented in Table 3; the most frequently (>25%) reported AEs were headache, diarrhea, vomiting, nausea, fatigue, and dizziness ⦁ No patients have experienced a reduction or delay in TMZ dosing due to the addition of indoximod ⦁ Six (50%) of 12 patients experienced ≥1 treatment-related AE – Only 1 treatment-related AE was grade 3 (fatigue); the remainder were either grade 1 or grade 2 events

Baseline (4/25/2014)

INTRODUCTION

Number of patients, n (%)

STRATIFICATION Based on prior therapy (bevacizumab-naïve or bevacizumab-failure) and potential indication for SRS Cohort 2a Patients not currently on bevacizumab

Cohort 2b Patients currently on bevacizumab

Cohort 2c SRS indicated

Indoximod + TMZ

Indoximod + TMZ and bevacizumab

Indoximod + TMZ and SRS

SRS, stereotactic radiosurgery; TMZ, temozolomide.

Figure 3. Phase 2 study schema.

Table 3. Summary of AEs for Indoximod + TMZ (n = 12) Number of patients, n (%)

Grade ≥3 AEs Fatigue Hyperglycemia Seizure Arm pain

2 (17) 1 (8) 1 (8) 1 (8)

Vomiting Insomnia Extremity pain

1 (8) 1 (8) 1 (8)

Treatment-related AEs* Nausea Fatigue Edema

4 (33) 2 (17) 1 (8)

Pruritus Vomiting

1 (8) 1 (8)

References On Treatment (3/4/2015)

1

1. Shrimali RK, et al. Cancer Res. 2010;70(15):6171-6180.

2. Chamberlain MC. Expert Rev Neurother. 2012;12(8):929-936.

3. Johnson TS, Munn DH. Immunol Invest. 2012;41(6-7):765-797.

4. Mitsuka K, et al. Neurosurgery. 2013;72(6):1031-1038.

5. Hou DY, et al. Cancer Res. 2007;67(2):792-801.

6. Muller AJ, et al. Nat Med. 2005;11(3):312-319.

7. Li M, et al. Presented at: 26th Annual Meeting of the American Society of Pediatric Hematology/Oncology (ASPHO); April 24-27, 2013; Miami, FL. Abstract 701.

Acknowledgments and Funding

AE, adverse event; TMZ, temozolomide. *All treatment-related AEs were grade 1 or 2 events except for fatigue, in which 1 patient had a grade 3 event.

Figure 2. MRI images demonstrating partial response of one patient following treatment with indoximod + TMZ.

The authors would like to acknowledge the support of all trial investigators, clinical trial support staff, and all patients and their families who are participating in this trial.

The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE). The authors received no direct compensation related to the development of the poster. Writing, editorial support, and formatting assistance for this poster were provided by Melissa Brunckhorst, PhD, of MedErgy, which was contracted and compensated by NewLink Genetics for these services. NewLink Genetics was given the opportunity to review the poster for medical and scientific accuracy, as well as intellectual property considerations.

Copies of this poster obtained through Quick Response (QR) Code are for personal use only and may not be reproduced without permission from ASCO® and the author of this poster.

POSTER PRESENTED AT THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO); MAY 29-JUNE 2, 2015; CHICAGO, ILLINOIS.

NEURO-ONCOLOGY CLINICAL TRIALS AT GEORGIA CANCER CENTER Celldex CDX110-04: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma (closed to new patient accrual, compassionate use trial available) Celldex Therapeutics Inc.: EXPANDED ACCESS (COMPASSIONATE USE) TREATMENT PROTOCOL RINDOPEPIMUT (CDX-110) NewLink Genetics / A Phase I/II Study of the Combination of Indoximod and Temozolomide for Adult Patients with Temozolomide-Refractory Primary Malignant Brain Tumors A Phase III Randomized Double-blind, Controlled Study of ICT-107 with Maintenance Temozolomide (TMZ) in newly diagnosed Glioblastoma following Resection and concomitant TMZ chemoradiotherapy (anticipated opening January 2016)

Frank E. Mott, MD, FACP Georgia Cancer Center

GEORGIA CANCER CENTER NEURO-ONCOLOGY TEAM Neurosurgery Neuro-Cognitive Nurse Navigator Cargill H. Alleyne Jr., MD John Morgan, MD, PhD Sheila Hall, RN John Vender, MD

Samuel D. Macomson, MD Radiation Oncology Research Nurse Scott Rahimi, MD Waleed Mourad, MD Christine Sanchez, RN Haroon Choudhri, MD Feng-Ming Kong, MD, PhD Cole Giller, MD, PhD Catherine Ferguson, MD Neuro-pathology Ian Heger, MD Amyn Rojiani, MD Neuroradiology Suash Sharma, MD Medical Oncology Julio Araque, MD Frank Mott, MD Ramon Figueroa, MD Neuro-Epilepsy

Bruce Gilbert, MD Debra Moore-Hill, MD Nurse Practitioner Scott Forseen, MD Anthony Murro, MD Brittany Frankhouser, NP Nestor Nieves, MD Yong Park, MD

Psycho-Oncology Amy Allison, PhD

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CASE REPORT Continued from page 10.

The attached figure shows MRI scans of a patient at baseline and after one year on the IDO-inhibitor study. This is a 41-year-old AfricanAmerican female who presented with complaints of headache, dizziness and nausea and a brain CT revealing a heterogeneous ill-defined mass in the left frontal area. A subsequent MRI revealed a left frontal lobe mass lesion, and biopsy confirmed glioblastoma. She was not a candidate for surgical resection and was treated with radiation therapy and concurrent temozolamide followed by monthly maintenance temozolamide. She developed progression after five cycles and was started on bevacizumab. She again progressed after seven months of bevacizumab and was enrolled on the trial. Her disease stabilized after four cycles and regressed after six cycles. She continued to show gradual response with stable imaging and good performance status.

She continues on study, now 24 months since entry on the trial.

IN MEMORIAM

MARSHALL B. ALLEN, JR., MD former chief of Neurosurgery at Medical College of Georgia On November 13, 2015 our Neurosurgery family lost a leader, mentor, friend and colleague. Dr. Marshall Allen was born on October 19, 1927 in Long Beach, Mississippi. He attended University of Mississippi for college and his medical training was begun at University of Mississippi and finished at Harvard Medical School. He completed his neurosurgery residency at University of Mississippi and in 1965, soon after taking his oral Board examinations, he was recruited to Medical College of Georgia to take the position of chief of Neurosurgery. He remained in this position until his retirement in 1994.

Dr. Allen was a workaholic who worked tirelessly to improve the quality of the residency and the education of the residents and to maintain certification of the program. He trained or helped train 32 residents, of which 12 practiced or still practice in GA, and five took teaching/academic 12

positions. During his 30-year tenure Dr. Allen made numerous contributions to the neurosurgical literature, including coediting the textbook Essentials of Neurosurgery: A Guide to Clinical Practice. Dr. Allen also found time to write two fiction novels based on one of his patients. He belonged to numerous medical societies including the American Association of Neurological Surgeons, Society of University Neurosurgeons (serving as president in 1992), and Georgia Neurosurgical Society (serving as president in 1969). Another legacy was his generous donation to the MCG Foundation to endow the new Chair of Neurosurgery in 1999. His friendship and mentorship will be sorely missed.

He is survived by his wife, Dotty, of 58 years; daughter, Lori Athey (Mark) of Fort Worth, Texas; sons Marshall B. Allen III (Kim) of Augusta, and George Allen of Savannah, Georgia; 2 grandsons and 2 granddaughters.

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Dr. Vender in the Gamma Knife suite

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THE CLINICAL TEAM ALS CLINIC Michael H. Rivner, MD EPILEPSY CENTER Cole A. Giller, MD, PhD Mary Gregory, MD, PhD Debra Moore-Hill, MD Anthony M. Murro, MD Yong Park, MD Gregory Lee, PhD GAMMA KNIFE CENTER Cargill H. Alleyne, Jr., MD Cole A. Giller, MD, PhD John R. Vender, MD MEMORY DISORDERS John C. Morgan, MD, PhD MOVEMENT DISORDERS Cole A. Giller, MD, PhD Julie A. Kurek, MD John C. Morgan, MD, PhD Kapil D. Sethi, MD MULTIPLE SCLEROSIS CENTER Suzanne H. Smith, MD

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THE DEPARTMENT OF NEUROSURGERY IS CELEBRATING THEIR 60TH ANNIVERSARY!

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Join us for a 60th anniversary Neurosurgery Reunion, with lunch and an afternoon CME course.

Friday, April 29, 2016 Noon to 4:00 p.m.

At the MCG Neurosurgery Amphitheatre For questions, contact MCG Alumni Affairs at 706-723-0140 or mcgalumni@gru.edu