Dunwoody, GA, United States
Dunwoody, GA, United States

Time filter

Source Type

News Article | December 16, 2016
Site: www.businesswire.com

CHICAGO--(BUSINESS WIRE)--Fitch Ratings has assigned an 'A' rating to the following bonds expected to be issued by the Hospital Authority of Hall County and the City of Gainesville (the authority) on behalf of Northeast Georgia Health System (NGHS): Fitch has also affirmed the 'A' rating on approximately $388 million of bonds issued by the authority on behalf of NGHS. Fitch has withdrawn the 'A' rating on the series 2014C bonds as the issuance was consolidated in with the series 2014B bonds. In addition to the series 2017A/C bonds, NGHS expects to issue approximately $188 million of series 2017B bonds. The series 2017B bonds, in addition to the security described below, will be secured by a limited property tax pledge by Hall County, GA of up to seven mills. Fitch will assign a separate rating on the series 2017B bonds based on this support. The series 2017A/B bonds are expected to be issued as fixed rate bonds and the series 2017C bonds are expected to be issued as variable rate bonds. Bond proceeds will be used to refund all or a portion of NGHS's outstanding series 2010A and series 2010B bonds, to fund various capital projects, to reimburse for prior capital expenditures and to pay costs of issuance. The series 2010A/B fixed rate refunding will be dependent upon market conditions at the time of pricing. The series 2010A/B debt service reserve funds are expected to be released upon refunding, reducing the refunding par. Pro forma maximum annual debt service (MADS) is expected to equal approximately $55.6 million and is level through 2047. The series 2017A/B/C bonds are expected to price the week of Jan. 9 through negotiation. The Rating Watch Evolving has been removed as the ratings on NGHS are not subject to a variation to the 'US Nonprofit Hospitals and Health Systems Rating Criteria'. Bond payments are secured by a pledge of the gross revenues of the obligated group and a leasehold mortgage on certain properties, including the NGMC - Gainesville. STRONG OPERATING CASH FLOW: NGHS's strong profitability is a key credit strength which helps to mitigate the system's heavy debt burden. Profitability remains strong, although at lower than historical levels, with operating EBITDA margin equal to 14% in fiscal 2016, easily exceeding Fitch's 'A' category median of 10.3%. STRONG MARKET POSITION: NGHS operates the only two hospitals in its primary service area (PSA) of Hall County, GA and holds a dominant 81.8% market share. Further, the service area has exhibited strong population growth which is expected to continue through 2020 at nearly double the rate of Georgia. HIGH DEBT BURDEN: NGHS's debt burden has moderated due to strong revenue growth but remains high with pro forma MADS equal to 5.3% of fiscal 2016 revenue. Despite the strong profitability, MADS coverage by EBITDA of 2.8x in fiscal 2016 is light relative to Fitch's 'A' category median of 4.5x. MIXED LIQUIDITY METRICS: Unrestricted liquidity increased 20% since fiscal 2014 to $795 million at Sept. 30, 2016 and will be bolstered by $75 million of reimbursement from the series 2017 bonds. Pro forma liquidity metrics are strong relative to operating expenses with 338 days cash on hand but are light relative to debt with 15.6x cushion ratio and 88.4% cash to pro forma debt. SUSTAINED STRONG CASH FLOW: Fitch expects that Northeast Georgia Health System will sustain its strong operating profitability, providing adequate cash flows to provide for consistent coverage metrics. A deterioration in cash flow and debt service coverage could result in negative rating pressure. NGHS, headquartered in Gainesville, GA, approximately 53 miles northeast of Atlanta, operates a total of 657 acute care beds under a single hospital license on two hospital campuses (NGMC - Gainesville and NGMC - Braselton). NGMC - Braselton opened in April 2015 on time and on budget and is located approximately 17 miles from NGMC - Gainesville and 45 miles northeast of Atlanta. Additional operations include an employed multispecialty physicians group, a physician-hospital organization (PHO) network and two skilled nursing facilities. Total consolidated operating revenues increased 35% since fiscal 2014 to $1.05 billion in fiscal 2016. The strong revenue growth reflects increased volumes, the strong population growth in the service area and the opening of NGMC - Braselton. The obligated group accounted for 87% of consolidated operating revenue and 96% of total consolidated assets in fiscal 2016. NGHS signed a definitive agreement to acquire Barrow Regional Medical Center, a 56 bed hospital located in Winder, GA. The transaction is expected to close on Dec. 31, 2016 after which the hospital will be renamed NGMC - Barrow. Operating profitability remains strong but has decreased from historical levels. Operating EBITDA margin averaged 17.8% between fiscal 2009 and fiscal 2014 but decreased to 12% in fiscal 2015 and 14% in fiscal 2016. Despite the compression, operating EBITDA margin remains strong, well exceeding Fitch's 'A' category median of 10.3%. The compression in fiscal 2015 reflects the start-up costs for NGMC - Braselton. Fiscal 2016 results reflect increased expenses related to the implementation of a new IT system. Management is projecting operating EBITDA margin to equal 14.1% in fiscal 2017, reflecting dilution from the Barrow acquisition, and to incrementally increase each year to 16.6% in fiscal 2021. The system's strong operating profitability reflects effective cost management practices, increasing volumes and NGHS's leading market share in its service area. NGHS holds a dominant 81.8% market share in its PSA of Hall County, GA. No other hospital holds greater than 3% market share in the PSA. NGHS operates the only two hospitals in the PSA, with the closest competitor located 25 miles away. Hall County accounted for 43% of admissions in 2016. Additionally, NGHS holds a leading 26.3% market share in its secondary service area with Northside Hospital holding 16.3% market share. No other competitor holds greater than 10% market share. The system's total market share increased each year to 44.2% in 2016 from 36.7% in 2012. The growth reflects growth in both the SSA and the Braselton market. Despite the increase in pro forma debt, NGHS's debt burden is lower than historical levels due to the system's strong revenue growth. However, the pro forma debt burden remains high. NGHS's high debt burden reflects heavy capital spending to meet the growing population. Pro forma MADS is equal to 5.3% of fiscal 2016 revenue, nearly double Fitch's 'A' category median of 2.7%. In comparison, the system's prior MADS equaled 7.7% of fiscal 2013 revenues. The high debt burden requires the maintenance of strong cash flow to support coverage metrics. Despite the strong cash flow, MADS coverage by EBITDA and operating EBITDA of 2.8x and 2.6x in fiscal 2016 are light relative to Fitch's 'A' category medians of 4.5x and 3.9x, respectively. Approximately 42% of NGHS's pro forma debt is backed by a Hall County tax pledge, including the series 2017B bonds, series 2014A bonds and the series 2010B bonds (expected to be refunded by the series 2017B bonds). Pursuant to an intergovernmental agreement, the county is required to levy up to 7 mills to pay debt service if hospital system revenues are insufficient. Unrestricted cash and investments increased 20% since fiscal 2014 to $795 million at Sept. 30, 2016. The increase reflects the system's strong profitability and cash flows. Unrestricted liquidity will be further bolstered by $75 million of reimbursement proceeds from the series 2017C bonds, increasing pro forma liquidity to $870 million. Pro forma liquidity metrics, including reimbursement, are strong relative to operating expenses with 338 days cash on hand, exceeding Fitch's 'A' category median of 215.5. However, despite the growth over the past three years, pro forma liquidity remains light relative to NGHS's heavy debt burden with 15.6x cushion ratio and 88.4% cash to pro forma debt, comparing unfavorably with Fitch's 'A' category medians of 19.4x and 148.6%. Capital spending is expected to be moderate, averaging $143 million (141% of depreciation) over the next five years, allowing for further liquidity growth. Capital projects will be funded by approximately $75 million of series 2017C proceeds and cash flow. Unrestricted liquidity is projected to continue to increase over the next five years. Subsequent to the series 2017 bond issuance, NGHS will have approximately $984 million of bonds outstanding. Total pro forma par outstanding reflects the expected release of the series 2010A/B debt service reserve funds. Approximately 42% of NGHS's pro forma bonds outstanding are backed by the Hall County tax pledge. The pro forma debt profile will include approximately 66% underlying fixed rate bonds and 34% underlying variable rate bonds. NGHS is counterparty to three fixed payor swaps and a basis swap, including two fixed payor swaps entered into in October 2016, effectively converting approximately 19% of the total bonds to a synthetic fixed rate. No collateral was required to be posted at Sept. 30, 2016. NGHS covenants to provide annual and quarterly disclosure. Disclosure is provided through the Municipal Securities Rulemaking Board's EMMA system. Additional information is available at 'www.fitchratings.com'. ALL FITCH CREDIT RATINGS ARE SUBJECT TO CERTAIN LIMITATIONS AND DISCLAIMERS. PLEASE READ THESE LIMITATIONS AND DISCLAIMERS BY FOLLOWING THIS LINK: HTTPS://WWW.FITCHRATINGS.COM/UNDERSTANDINGCREDITRATINGS. IN ADDITION, RATING DEFINITIONS AND THE TERMS OF USE OF SUCH RATINGS ARE AVAILABLE ON THE AGENCY'S PUBLIC WEB SITE AT WWW.FITCHRATINGS.COM. PUBLISHED RATINGS, CRITERIA, AND METHODOLOGIES ARE AVAILABLE FROM THIS SITE AT ALL TIMES. FITCH'S CODE OF CONDUCT, CONFIDENTIALITY, CONFLICTS OF INTEREST, AFFILIATE FIREWALL, COMPLIANCE, AND OTHER RELEVANT POLICIES AND PROCEDURES ARE ALSO AVAILABLE FROM THE CODE OF CONDUCT SECTION OF THIS SITE. FITCH MAY HAVE PROVIDED ANOTHER PERMISSIBLE SERVICE TO THE RATED ENTITY OR ITS RELATED THIRD PARTIES. DETAILS OF THIS SERVICE FOR RATINGS FOR WHICH THE LEAD ANALYST IS BASED IN AN EU-REGISTERED ENTITY CAN BE FOUND ON THE ENTITY SUMMARY PAGE FOR THIS ISSUER ON THE FITCH WEBSITE. Copyright © 2016 by Fitch Ratings, Inc., Fitch Ratings Ltd. and its subsidiaries. 33 Whitehall Street, NY, NY 10004. Telephone: 1-800-753-4824, (212) 908-0500. Fax: (212) 480-4435. Reproduction or retransmission in whole or in part is prohibited except by permission. All rights reserved. In issuing and maintaining its ratings and in making other reports (including forecast information), Fitch relies on factual information it receives from issuers and underwriters and from other sources Fitch believes to be credible. Fitch conducts a reasonable investigation of the factual information relied upon by it in accordance with its ratings methodology, and obtains reasonable verification of that information from independent sources, to the extent such sources are available for a given security or in a given jurisdiction. The manner of Fitch’s factual investigation and the scope of the third-party verification it obtains will vary depending on the nature of the rated security and its issuer, the requirements and practices in the jurisdiction in which the rated security is offered and sold and/or the issuer is located, the availability and nature of relevant public information, access to the management of the issuer and its advisers, the availability of pre-existing third-party verifications such as audit reports, agreed-upon procedures letters, appraisals, actuarial reports, engineering reports, legal opinions and other reports provided by third parties, the availability of independent and competent third- party verification sources with respect to the particular security or in the particular jurisdiction of the issuer, and a variety of other factors. Users of Fitch’s ratings and reports should understand that neither an enhanced factual investigation nor any third-party verification can ensure that all of the information Fitch relies on in connection with a rating or a report will be accurate and complete. Ultimately, the issuer and its advisers are responsible for the accuracy of the information they provide to Fitch and to the market in offering documents and other reports. In issuing its ratings and its reports, Fitch must rely on the work of experts, including independent auditors with respect to financial statements and attorneys with respect to legal and tax matters. Further, ratings and forecasts of financial and other information are inherently forward-looking and embody assumptions and predictions about future events that by their nature cannot be verified as facts. As a result, despite any verification of current facts, ratings and forecasts can be affected by future events or conditions that were not anticipated at the time a rating or forecast was issued or affirmed. The information in this report is provided “as is” without any representation or warranty of any kind, and Fitch does not represent or warrant that the report or any of its contents will meet any of the requirements of a recipient of the report. A Fitch rating is an opinion as to the creditworthiness of a security. This opinion and reports made by Fitch are based on established criteria and methodologies that Fitch is continuously evaluating and updating. Therefore, ratings and reports are the collective work product of Fitch and no individual, or group of individuals, is solely responsible for a rating or a report. The rating does not address the risk of loss due to risks other than credit risk, unless such risk is specifically mentioned. Fitch is not engaged in the offer or sale of any security. All Fitch reports have shared authorship. Individuals identified in a Fitch report were involved in, but are not solely responsible for, the opinions stated therein. The individuals are named for contact purposes only. A report providing a Fitch rating is neither a prospectus nor a substitute for the information assembled, verified and presented to investors by the issuer and its agents in connection with the sale of the securities. Ratings may be changed or withdrawn at any time for any reason in the sole discretion of Fitch. Fitch does not provide investment advice of any sort. Ratings are not a recommendation to buy, sell, or hold any security. Ratings do not comment on the adequacy of market price, the suitability of any security for a particular investor, or the tax-exempt nature or taxability of payments made in respect to any security. Fitch receives fees from issuers, insurers, guarantors, other obligors, and underwriters for rating securities. Such fees generally vary from US$1,000 to US$750,000 (or the applicable currency equivalent) per issue. In certain cases, Fitch will rate all or a number of issues issued by a particular issuer, or insured or guaranteed by a particular insurer or guarantor, for a single annual fee. Such fees are expected to vary from US$10,000 to US$1,500,000 (or the applicable currency equivalent). The assignment, publication, or dissemination of a rating by Fitch shall not constitute a consent by Fitch to use its name as an expert in connection with any registration statement filed under the United States securities laws, the Financial Services and Markets Act of 2000 of the United Kingdom, or the securities laws of any particular jurisdiction. Due to the relative efficiency of electronic publishing and distribution, Fitch research may be available to electronic subscribers up to three days earlier than to print subscribers. For Australia, New Zealand, Taiwan and South Korea only: Fitch Australia Pty Ltd holds an Australian financial services license (AFS license no. 337123) which authorizes it to provide credit ratings to wholesale clients only. Credit ratings information published by Fitch is not intended to be used by persons who are retail clients within the meaning of the Corporations Act 2001

News Article | December 5, 2016
Site: www.eurekalert.org

SAN DIEGO, CA - A combination of two targeted agents - one approved by the Food and Drug Administration and one undergoing testing - has demonstrated safety as well as encouraging signs of effectiveness in a phase 1 clinical trial in patients with relapsed or hard-to-treat chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL). Dana-Farber Cancer Institute researchers will report the findings at the 58th annual meeting of the American Society of Hematology (ASH). The combination of the approved drug ibrutinib and the novel agent TGR-1202 is being tested in patients to determine if the two agents can be safely given at the same time and whether they lead to more durable remissions in CLL and MCL compared to ibrutinib alone. While ibrutinib, which targets the cell protein BTK, often reduces the amount of cancer in patients with relapsed or drug-resistant CLL or MCL, it rarely eliminates the cancer or generates long-lasting results in MCL or high-risk forms of CLL. By pairing it with TGR-1202, which blocks the P13K-delta protein, researchers hope to disable two key parts of cancer cells' growth circuitry. As of late July, investigators had treated 28 patients - 17 with CLL, 11 with MCL - with the tandem therapy. The regimen was shown to be safe, with an 800 mg dose of TGR-1202 found to be suitable for further study. "The efficacy of the combination looks promising as well," said Dana-Farber's Matthew Davids, MD, principal investigator of the investigator-initiated trial. Davids will present the findings Monday, December 5, at 8 a.m. in Room 5AB of the San Diego Convention Center. "We have already seen a complete response - no evidence of cancer - in one patient with CLL, and several other patients are approaching complete response," Davids added. Another potential benefit of the two-drug combination is that it could offer greater flexibility in treatment, Davids remarked. Patients who need to discontinue one of the drugs because of temporary complications could continue with the other and resume the two-drug regimen when the complications subside. While enrollment of patients with CLL in the trial is complete, openings remain for patients with MCL, and the study is open at several sites across the country through the Blood Cancer Research Partnership, a Dana-Farber-led hematologic malignancies research consortium funded through the Leukemia & Lymphoma Society. The senior author of the study is Jennifer Brown, MD, PhD, of Dana-Farber. Co-authors are Haesook Kim, PhD, Alyssa Nicotra, Alexandra Savell, Karen Francoeur, RN, Jeffrey Hellman, PA-C, Caron Jacobson, MD, and David C. Fisher, MD, of Dana-Farber; Hari Miskin, MS, and Peter Sportelli of TG Therapeutics, New York, N.Y.; Asad Bashey, MD, PhD, of Northside Hospital, Atlanta, Ga.; Laura Stampleman, MD, of Pacific Cancer Care, Monterey, Cal.; Jens Rueter, MD, of Eastern Maine Medical Center; Adam Boruchov, MD, of Saint Francis Hospital and Medical Center, Hartford, Conn.; and Jon Arnason, MD, of Beth Israel Deaconess Medical Center. Research funding for the study was provided by TG Therapeutics (New York, NY). From achieving the first remissions in childhood cancer with chemotherapy in 1948, to developing the very latest new therapies, Dana-Farber Cancer Institute is one of the world's leading centers of cancer research and treatment. It is the only center ranked in the top 4 of U.S. News and World Report's Best Hospitals for both adult and pediatric cancer care. Dana-Farber sits at the center of a wide range of collaborative efforts to reduce the burden of cancer through scientific inquiry, clinical care, education, community engagement, and advocacy. Dana-Farber/Brigham and Women's Cancer Center provides the latest in cancer care for adults; Dana-Farber/Boston Children's Cancer and Blood Disorders Center for children. The Dana-Farber/Harvard Cancer Center unites the cancer research efforts of five Harvard academic medical centers and two graduate schools, while Dana-Farber Community Cancer Care provides high quality cancer treatment in communities outside Boston's Longwood Medical Area. Dana-Farber is dedicated to a unique, 50/50 balance between cancer research and care, and much of the Institute's work is dedicated to translating the results of its discovery into new treatments for patients locally and around the world.

News Article | November 29, 2016
Site: www.prweb.com

Florida Hospital Physician Group (FHPG) is pleased to announce the addition of Craig W. Burns, D.O. to the team. Dr. Burns is a board certified family medicine physician who provides comprehensive care for patients of all ages, from newborns to adults. Dr. Burns earned his medical degree from the Kirksville College of Osteopathic Medicine in Kirksville, Missouri before completing his internship and residency in family medicine at the Northside Hospital Family Medicine Residency program in St. Petersburg, Florida. Dr. Burns provides a comprehensive range of care from preventative medicine, pediatrics and geriatric care to acute and chronic disease management and spinal consultations. Florida Hospital Physician Group physicians and staff focus on compassionate, whole-person care with extensive knowledge and expertise to diagnose and treat medical conditions with a patient-focused approach. “We are very excited to have Dr. Burns join FHPG to provide family medicine services in our new North Pinellas Medical Center in Palm Harbor. His experience and expertise in caring for patients of all ages helps us continue to meet the primary care needs of families and patients throughout the North Pinellas area,” shared Chris Jenkins, President of Florida Hospital Physician Group. Dr. Burns is located at 4705 Alternate 19, Suite B, Palm Harbor, Florida 34683, and is currently accepting new patients. For more information, or to schedule an appointment, please call (727) 935-6477 or visit http://www.FHPhysicianGroup.com. About Florida Hospital Physician Group Florida Hospital Physician Group (FHPG) is a multi-specialty physician group, dedicated to improving the health and wellness of communities throughout the greater Tampa Bay region with more than 160 providers operating in over 45 locations representing over 25 medical specialties. FHPG offers patients the highest level of compassionate and multidisciplinary care through a broad range of medical and surgical services, as well as direct access to five local Florida Hospitals, a Long Term Acute Care facility, imaging centers, specialty and urgent care centers, rehabilitation facilities and home care agencies located throughout Hillsborough, Pasco and Pinellas counties. Part of the Adventist Health System, Florida Hospital is a leading health network comprised of 26 hospitals throughout the state. For more information, visit http://www.FHPhysicianGroup.com.

News Article | November 7, 2016
Site: www.eurekalert.org

Ovarian cancer growth inhibited by nanoparticle delivery of EGFR siRNA, allowing chemotherapy to starkly shrink or eliminate tumors in mice In the fight against cancer, doctors dish out combination-blows of surgery, chemotherapy and other drugs to beat back a merciless foe. Now, scientists have taken early steps toward adding a stinging punch to clinicians' repertoire. A novel targeted therapy using nanoparticles has enabled researchers at the Georgia Institute of Technology to purge ovarian tumors in limited, in vivo tests in mice. "The dramatic effect we see is the massive reduction or complete eradication of the tumor, when the 'nanohydrogel' treatment is given in combination with existing chemotherapy," said chief researcher John McDonald. That nanohydrogel is a minute gel pellet that honed in on malignant cells with a payload of an RNA strand. The RNA entered the cell, where it knocked down a protein gone awry that is involved in many forms of cancer. In trials on mice, it put the brakes on ovarian cancer growth and broke down resistance to chemotherapy. That allowed a common chemotherapy drug, cisplatin, to drastically reduce or eliminate large carcinomas with very similar speed and manner. The successful results in treatment of four mice with the combination of siRNA and cisplatin showed little variance. The therapeutic short interfering RNA (siRNA) developed by McDonald and Georgia Tech researchers Minati Satpathy and Roman Mezencev, thwarted cancer-causing overproduction of cell structures called epidermal growth factor receptors (EGFRs), which extend out of the wall of certain cell types. EGFR overproduction is associated with aggressive cancers. The researchers from Georgia Tech's School of Biological Sciences published their results on Monday, November 7, 2016, in the journal Scientific Reports. Research was funded by the National Institutes of Health's IMAT Program, the Ovarian Cancer Institute, the Deborah Nash Endowment Fund, the Curci Foundation and the Markel Foundation. The new treatment has not been tested on humans, and research would be required by science and by law to demonstrate consistent results - efficacy - among other things, before preliminary human trials could become possible. The current in vivo success strengthens the idea that knocking out EGFR at the RNA level may be a worthy goal to explore in the fight against carcinomas in general. The same patented nanohydrogel packed with other types of therapeutic RNA is currently being tested for the treatment of other types cancers. EGFRs are receptors found in epithelial cells, which line organs throughout the body: Lungs, mouth, throat, intestines and others. In women, it also lines reproductive organs: Ovaries, uterus and cervix. They are long proteins that poke through the cell membrane, connecting the cell's interior with the outside. They look like squiggly worms with tiny mouths on the outside that take up a messenger protein. In a healthy cell, those messenger molecules cause EGFRs to trigger long chains of biochemical reactions that lead to the activation of genes involved in a variety of cellular functions. In carcinoma cells, the number of EGFRs present typically skyrockets. "In many cancers, EGFR is overexpressed," McDonald said. "The problem is that because of this overexpression, many cellular functions, including cell replication and resistance to certain chemotherapy drugs, are dramatically cranked up." The cell goes haywire, metabolizes too much sugar, divides too much, and resists chemotherapy. The cancer grows into a tumor and can spread through the body. An overabundance of EGFRs found in a biopsy is usually a sign the cancer is aggressive, and that patient prognosis is poor. "In 70 percent of ovarian cancer patients, EGFR is overexpressed at very high levels," McDonald said. EGFR overexpression also makes cancer cells resistant to chemotherapy by thwarting a natural defense mechanism. "The platinum-based chemotherapies used to treat ovarian cancers cause DNA damage, which switches on apoptosis," McDonald said. Apoptosis is cell suicide. When cells can't repair DNA damage, they're programmed to kill themselves to keep the damaged cells from spreading. The primary chemotherapy used to treat ovarian cancer works by coaxing cancer cells to trigger the suicide program, but having too many epidermal growth factor receptors gets in the way. "EGFR overexpression hinders apoptosis; they won't die. By knocking down EGRF, we make the cell hypersensitive to the drug. Apoptosis is reactivated," McDonald said. Existing EGFR targeted drugs called tyrosine-kinase inhibitors disrupt an EGFR function, but their success in treating ovarian cancer has been limited. "Clinicians have tried EGFR inhibitors to treat ovarian cancers for some years, and they only get about 20% of patients responding to it," McDonald said. "Apparently, the particular EGFR function inhibited by these drugs is not critical to ovarian cancer." The short interfering (si) RNA designed by the Georgia Tech researchers attacks the cancer much closer to its root. To make the protein for EGFR, RNA has to transfer its genetic code from DNA. The researchers' siRNA binds to the cell's RNA and stops it from working. "We're knocking down EGFR at the RNA level," McDonald said. "Since EGFR is multi-functional, it's not exactly clear which malfunctions contribute to ovarian cancer growth. By completely knocking out its production in ovarian cancer cells, all EGFR functions are blocked." The nanohydrogel that delivers the siRNA to the cancer cells is a colloid ball of a common, compact organic molecule and about 98 percent water. Another molecule is added to the surface of the nanohydrogel as a guide. It makes the pellets adhere to the cancer cells like sticky cluster bombs. Cancerous tissue may also be aiding the nanohydrogel in targeting it. "When you get into a tumor, there are a lot of blood vessels, and many are broken," McDonald said. "This may help the nanoparticles get passively trapped in the neighborhood of tumorous tissues." In the in vivo trials, the siRNA, which contained a fluorescent tag, allowed researchers to observe nanoparticles successfully honing in on the cancer cells. "We originally selected to target the EGFR gene because its activity is easily measured, and we wanted to use it simply as an indicator that our nanoparticle siRNA delivery system was working," McDonald said. "The fact that the EGFR knockdown so dramatically sensitized the cells to standard chemotherapy came as a bit of a surprise." At first, his team observed how the tumors responded to chemotherapy alone. Then they combined it with the nanoparticle treatment. "When we gave the chemotherapy alone, the response was moderate, but with the addition of the nanoparticles, the tumor was either significantly reduced or completely gone," McDonald said. But he tempered enthusiasm with caution. "Further work will be required to see if the treatment completely destroyed every trace of cancer cells in the tumors that disappeared, or if future recurrence is possible." If the researchers' continuing studies further prove to be consistent, the combination of the nanohydrogel with other therapeutic RNAs could represent a significant advancement in the treatment of a wide spectrum of cancers. Georgia Tech's Lijuan Wang and Dr. Benedict Benigno from Atlanta's Northside Hospital coauthored the paper. Research was funded by the National Institutes of Health's Program for Innovative Molecular Analysis Technologies Program (grant 1R21CA155479-01), the Ovarian Cancer Institute at Northside Hospital, the Deborah Nash Endowment Fund, the Curci Foundation, and the Markel Foundation. Any opinions, findings and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the sponsoring agencies.

News Article | February 21, 2017
Site: www.eurekalert.org

ATLANTA--Having high levels of a certain biomarker is linked to poor prognosis in African-American patients with triple-negative breast cancer, while the same biomarker doesn't influence disease outcomes in white patients, according to a new study. Racial disparities in disease, particularly breast cancer, continue to pose a major challenge in healthcare. African-American breast cancer patients are more likely to suffer from a more aggressive course of disease and higher mortality compared to other racial groups. In particular, African-American patients with triple-negative breast cancer have a dismal prognosis. The dire outcome of this group could indicate that high-risk, African-American breast cancer patients are not being identified as such using standard clinical prognostic tools and aren't being prescribed sufficiently aggressive treatment. Therefore, it's critical to find novel biomarkers that could identify differences in tumor biology between racial groups and serve as risk predictors to help alleviate health disparity in disease outcomes. In this study, a research team led by Georgia State University examined whether a biomarker called nuclear KIFC1, which has been associated with worse outcomes in breast cancer, can predict risk in triple-negative breast cancer, a subtype that disproportionately affects African-American women. The researchers assessed the nuclear KIFC1 biomarker in triple-negative breast cancer tissue samples from 163 African-American patients and 144 white patients who were treated between the years 2003-2008 at Grady Memorial and Emory University hospitals, 2005-2013 at Northside Hospital and 2001-2012 at Baylor Scott & White Medical Center. Race information in medical records was self-declared by patients. The findings are published in the online journal Scientific Reports. "We looked at the levels of nuclear KIFC1 in their tumors, and interestingly, we found that African-American women had slightly higher levels, but it was only within African-American patients that the levels mattered for their outcome," said Angela Ogden, lead author of the study and a Ph.D. candidate in Dr. Ritu Aneja's laboratory in Georgia State's Biology Department. "African-American women with high nuclear KIFC1 levels tended to do poorly, whereas in white women, it didn't matter if they had high or low levels. It had no effect on their outcomes." The researchers further investigated why the biomarker only seems to matter in African-American patients by studying triple-negative breast tumor cells from African-American and white patients. "We found that if we silence the KIFC1 gene, it had a greater impact on the migration of the African-American cells than it did on the white cells," Ogden said. "It may be that for whatever reason, in African-American breast cancer tumors, KIFC1 helps the cells to migrate and spread to other parts of the body. And for reasons that we currently don't know, that's not the case in white tumors. Ultimately, it may even be that African-American patients could potentially be treated with a KIFC1 inhibitor to help prevent metastasis, but that's for future studies." The study is multi-institutional with tumor samples from breast cancer patients treated at four different hospitals, so the results can likely be generalized. To ensure certain factors didn't confound the results, the researchers adjusted for tumor stage, age at diagnosis, receipt of chemotherapy and the hospital where patients received chemotherapy. They found nuclear KIFC1 had a significant effect on outcomes in African-American patients, even after adjusting for these factors. Biomarkers of relevance to specific racial groups are starting to be explored more in scientific studies, Ogden said. "The approach of treating all patients the same, regardless of their racial or ethnic background, may not be the best approach as genetic ancestry matters," she said. "There may be biomarkers and treatments that work better for people of a certain ancestry, race or ethnicity, instead of a one-size-fits-all approach." Co-authors of the study include Chakravarthy Garlapati, Ravi Chakra Turaga, Nikita Wright, Shristi Bhattarai, Karuna Mittal, Dr. Remus Osan, Ansa Riaz, Sergey Klimov and Dr. Aneja of Georgia State; Dr. Ceyda S?nmez Wetherilt of Georgia State and Emory University School of Medicine; Dr. Padmashree C. G. Rida of Georgia State and Novazoi Theranostics; Drs. Xiaoxian (Bill) Li, Gabriela Oprea-Ilies, Uma Krishnamurti, Michelle D. Reid and Sonal Pattni of Emory University School of Medicine; Mildred Jones and Dr. Guilherme Cantuaria of Northside Hospital Cancer Institute; Dr. Meenakshi Gupta of West Georgia Medical Center; and Dr. Arundhati Rao of Scott and White Medical Center, BSWHealth in Temple, Texas. The study was funded by the National Cancer Institute and the National Institute on Minority Health and Health Disparities of the National Institutes of Health.

News Article | October 28, 2016
Site: www.prweb.com

Continuing to scale its innovative and effective approach to workforce development, Year Up Greater Atlanta (YUGA) announced today that Stacey Ollinger is joining its Board of Directors. Ollinger is a community volunteer who specializes in planning charitable events. Ollinger and her husband Paul will host a fundraiser for YUGA on October 26, 2016 from 6:30 pm to 8:30 pm on the rooftop at Spanx by Sara Blakely, located at 3035 Peachtree Road NE in Atlanta. One hundred guests are expected to attend. “Stacey is a phenomenal leader who is known for her creativity and philanthropic impact. We are super excited to have her join our Greater Atlanta Board as we continue to grow and provide opportunity for Atlanta’s young adults,” said Kim Williams Executive Director of YUGA. Year Up is a national nonprofit organization providing education, career training and corporate internships for young adults 18-24 year old. The 12 month workforce development program is enabling disconnected young adults to gain access to careers in Information Technology and Business. Nearly 90% of YUGA graduates are employed or attending college full-time within four months of completing the yearlong program, with average starting salaries of $36,000/year. “Year Up has a proven track record in helping young adults launch careers at top companies — and transforming their lives in the process,” said Ollinger. “I’m excited to join the board and support Year Up’s philanthropic goals through fundraising events that grow the bottom line.” A veteran of the hospitality industry where she held sales leadership positions for luxury hotels in Los Angeles and New York City, Ollinger has served as a volunteer for Children’s Healthcare of Atlanta, co-chairing high profile events, including the Spring Backyard Bash, Art Meets Music and their largest fundraiser, Hope & Will Ball in 2015. She has also held chair positions with Northside Hospital’s Cancer Institute's Wine Women & Shoes event and Fix Georgia Pets Red Carpet Fete. Ollinger lives in Brookhaven with her two children, author and comedian husband Paul and French Bulldog, Colonel Tom Parker Ollinger. Year Up partners with companies looking to hire a talented and diverse workforce. Currently, the organization enrolls 280 annually at two locations in Midtown Atlanta and Alpharetta for post-secondary education and professional skills training. In Atlanta, more than 800 alumni have graduated from the program, since 2010. About Year Up Inc. Year Up's mission is to close the Opportunity Divide by providing urban young adults with the skills, experience, and support that will empower them to reach their potential through professional careers and higher education. Year Up achieves this mission through a high support, high expectation model that combines marketable job skills, stipends, internships and college credits. Its holistic approach focuses on students' professional and personal development to place these young adults on a viable path to economic self-sufficiency. Year Up currently serves more than 3,000 students a year at sites in Arizona, Atlanta, Baltimore, Boston, Chicago, Jacksonville, the National Capital Region, New York City, Philadelphia, Providence, Puget Sound, San Francisco Bay Area, and South Florida. To learn more, visit http://www.yearup.org or http://www.youtube.com/yearupinc.

Brister K.J.,Beth Israel Deaconess Medical Center | Singh R.S.,Northside Hospital | Wang H.H.,Beth Israel Deaconess Medical Center
Diagnostic Cytopathology | Year: 2015

Background: The Bethesda System for Reporting Thyroid Cytopathology was published in 2008 and was implemented at Beth Israel Deaconess Medical Center (BIDMC) in June, 2010. Prior to this date, our diagnostic scheme was similar to the Bethesda System, except for the category of "Atypia/Follicular Lesion of Undetermined Significance" (AUS). This study evaluates the impact of the Bethesda System on the rate and the positive predictive value (PPV) of the diagnostic categories at BIDMC. Methods: We performed a retrospective review of all thyroid fine-needle aspirations (FNAs) during the time periods January, 2006 to November, 2008 and June, 2010 to July, 2011 and the subsequent thyroidectomy specimens. Results: Post-Bethesda System, diagnoses that are equivocal for diverse reasons and which have wide-ranging PPVs are now all grouped into the AUS category, and the proportion of cases that are in the atypical/AUS category rose from 3.7% in the pre-Bethesda period to 12% in the post-Bethesda period. Conclusion: The AUS category has a PPV approaching 50% in our lab. This creates uncertainty regarding the appropriate management for this category and may cause unnecessary overuse of molecular testing for cases in the AUS category. © 2014 WILEY PERIODICALS, INC.

Gudeman J.,Ther Rx Corporation | Jozwiakowski M.,Ther Rx Corporation | Chollet J.,Ther Rx Corporation | Randell M.,Northside Hospital
Drugs in R and D | Year: 2013

Pharmacy compounding involves the preparation of customized medications that are not commercially available for individual patients with specialized medical needs. Traditional pharmacy compounding is appropriate when done on a small scale by pharmacists who prepare the medication based on an individual prescription. However, the regulatory oversight of pharmacy compounding is significantly less rigorous than that required for Food and Drug Administration (FDA)-approved drugs; as such, compounded drugs may pose additional risks to patients. FDA-approved drugs are made and tested in accordance with good manufacturing practice regulations (GMPs), which are federal statutes that govern the production and testing of pharmaceutical products. In contrast, compounded drugs are exempt from GMPs, and testing to assess product quality is inconsistent. Unlike FDA-approved drugs, pharmacy-compounded products are not clinically evaluated for safety or efficacy. In addition, compounded preparations do not have standard product labeling or prescribing information with instructions for safe use. Compounding pharmacies are not required to report adverse events to the FDA, which is mandatory for manufacturers of FDA-regulated medications. Some pharmacies engage in activities that extend beyond the boundaries of traditional pharmacy compounding, such as large-scale production of compounded medications without individual patient prescriptions, compounding drugs that have not been approved for use in the US, and creating copies of FDA-approved drugs. Compounding drugs in the absence of GMPs increases the potential for preparation errors. When compounding is performed on a large scale, such errors may adversely affect many patients. Published reports of independent testing by the FDA, state agencies, and others consistently show that compounded drugs fail to meet specifications at a considerably higher rate than FDA-approved drugs. Compounded sterile preparations pose the additional risk of microbial contamination to patients. In the last 11 years, three separate meningitis outbreaks have been traced to purportedly 'sterile' steroid injections contaminated with fungus or bacteria, which were made by compounding pharmacies. The most recent 2012 outbreak has resulted in intense scrutiny of pharmacy compounding practices and increased recognition of the need to ensure that compounding is limited to appropriate circumstances. Patients and healthcare practitioners need to be aware that compounded drugs are not the same as generic drugs, which are approved by the FDA. The risk-benefit ratio of using traditionally compounded medicines is favorable for patients who require specialized medications that are not commercially available, as they would otherwise not have access to suitable treatment. However, if an FDA-approved drug is commercially available, the use of an unapproved compounded drug confers additional risk with no commensurate benefit. © 2013 The Author(s).

Benigno B.B.,Northside Hospital
International Journal of Gynecological Cancer | Year: 2013

Background: Gestational trophoblastic disease usually follows a molar pregnancy but can occur also after an abortion or a term pregnancy. In only 10% of cases will treatment be required; and usually, single-agent chemotherapy will suffice. In high-risk disease, the multiagent regimen EMA-CO is usually used; and if that fails, most oncologists will use the EMA-EP regimen. If this does not produce a remission, there is no unanimity of opinion as to how to proceed. Numerous salvage regimens are in current use, and some centers do not consider high-dose chemotherapy. Case: A young woman presented 4 months after a normal spontaneous delivery with an elevated human chorionic gonadotropin level and multiple pulmonary metastases. She failed both the EMA-CO and EMA-EP regimens as well as additional standard chemotherapy. She was then treated with 4 separate courses of high-dose chemotherapy with autologous stem cell support, which produced a complete remission. Conclusion: Even patients with high-risk gestational trophoblastic disease are usually cured with standard chemotherapy. Patients who fail such treatment should be considered for high-dose chemotherapy. Copyright © 2013 by IGCS and ESGO.

Feuer G.A.,Northside Hospital | Lakhi N.,Northside Hospital | Barker J.,Northside Hospital | Salmieri S.,Northside Hospital | Burrell M.,Northside Hospital
Gynecologic Oncology | Year: 2013

Objective To evaluate the feasibility and efficacy of robotic-assisted management of epithelial ovarian cancer. Methods Retrospective review of robotic-assisted or abdominal ovarian cancer cases presenting with pelvic mass, initial staging, or debulking after neoadjuvant chemotherapy performed by a single surgeon (2008-2012). Patient characteristics and outcomes were compared using chi-squared or Student's t-tests. Results There were 63 robotic and 26 abdominal cases. Patient characteristics were similar for age, uterine weight, and BMI, with prior abdominal surgery more common in the abdominal group (p = 0.0257). Robotic operative time was longer (p < 0.0001), while blood loss (p < 0.0001) and hospital stay (p = 0.0009) were reduced. Major complication rates (16% vs. 23%, p = 0.4209) and lymphadenectomy yields (13 vs. 11 nodes, p = 0.2310) were similar. Neoadjuvant chemotherapy was more common in the robotic group (52% vs. 15%, p = 0.0013). Residual disease rates for all cases (73% vs. 50%, p = 0.880) and for Stage II-IV cases (61% vs. 40%, p = 0.929) were equivalent. Follow-up was longer for the abdominal group; however, an equivalent percentage of patients had at least 1 year of follow-up (57% vs. 77%, p = 0.0789). At 1 year, survival and no evidence of disease (NED) rates were equivalent for all cases (survival: 97% vs. 90%, p = 0.2501; NED: 81% vs. 85%, p = 0.6773) and for Stage II-IV cases (survival: 96% vs. 88%, p = 0.3080; NED: 76% vs. 81%, p = 0.6920). Conclusions A robotic approach for the management of epithelial ovarian cancer, including patients treated with neoadjuvant chemotherapy, is feasible and effective. Debulking, recurrence, and survival rates were similar to laparotomy at 1 year. © 2013 Elsevier Inc.

Loading Northside Hospital collaborators
Loading Northside Hospital collaborators