Upstate Medical Center
Upstate Medical Center
News Article | May 16, 2017
The Company estimates that it has sufficient cash in hand to last more than one year of operations at the current rate of expenditure. The Company estimates that the cash in hand is sufficient to enable us to perform initial human clinical trials of at least one of our drug candidates. The Company's expenditures during the reported period were on track with this expectation. The Company said its lead drug development program, namely topical skin cream for the treatment of shingles, is progressing satisfactorily, under its HerpeCide™ project. The drug candidates being advanced in the shingles program are variations of the drug candidates that were found to be highly effective against HSV-1 H129 in a lethal animal study with 80-100% of treated animals surviving fully as opposed to untreated animals showing 0% survival, as previously reported. The Company is pursuing at least four different indications with these drug candidates in its HerpeCide™ program, namely, (1) skin cream for the treatment of shingles caused by reactivation of the chickenpox virus (VZV, aka HHV-3), (2) skin cream for the treatment of cold sores (herpes labials) caused by the herpes simplex virus-1 (HSV-1), (3) skin cream for the treatment of genital ulcers caused by HSV-2, and (4) topical eye drops for the treatment of herpes keratitis (mostly caused by HSV-1). The Company recently reported that it has completed certain preliminary ex vivo human skin patch based efficacy studies for its initial drug candidates against shingles, and repeat studies to confirm the results are in progress. These studies were conducted in the laboratory of Professor Moffat at the State University of New York Upstate Medical Center in Syracuse, NY. The Company expects to report on these studies upon approval of the study investigators and their Institute. Further studies towards declaration of the final clinical drug candidate for shingles are continuing. We believe that these human skin patch studies should be highly predictive of human clinical trials success. The Company said its work on the scale-up of manufacturing of the drug candidates in the HerpeCide project is advancing successfully. We are currently working on production at approximately 200g to 500g scales. The Company has recently estimated, with its service providers and industry expert consultants, that a quantity of approximately 1kg of drug candidate will be sufficient for its proposed Safety/toxicology studies for the shingles drug candidate. The Company is on course to have the ability to produce such quantities in its own manufacturing facility once a clinical drug candidate is declared. The Company has continued to focus its work on studies needed for moving the shingles topical treatment towards human clinical trials stage as rapidly as it can. The Company is performing the Chemistry, Manufacture and Controls (CMC) studies needed for filing an Investigational Drug Application (IND) with the US FDA or equivalent application(s) in other countries including Australia, for the shingles drug candidate. In parallel, the Company is performing studies needed to finalize a clinical drug candidate out of several that have shown strong success in cell culture studies. There is no standard animal model for shingles. The Company has eight different drugs in development, including the four indications in the HerpeCide program described above. This deep and wide pipeline demonstrates the robustness of the nanoviricide® platform technology. NanoViricides, Inc. is one of a few bio-pharma companies that has all the capabilities needed from research and development to marketable drug manufacture in the small quantities needed for human clinical trials. Our new campus at 1 Controls Drive, Shelton, CT, has state of the art nanomedicines characterization facilities that enable us to perform IND-enabling nanomedicine analysis and characterization studies of any of our various drug candidates in house. All current topical drug candidates in our HerpeCide™ program are variants of the shingles drug further optimized for the specific herpesvirus and topical delivery constraints. These topical treatments are expected to provide a significantly faster path to human clinical stage than the other injectable and oral drugs in our pipeline. Topical treatments for the herpesvirus indications are important. Although the herpesviruses stay latent in a nerve ganglion, the pathology of an outbreak in a patient begins with reinfection in the skin layer from the reactivated virus, followed by further expansion of the virus in the skin layer. The newly produced virus then causes additional spread of the virus to more nerve cells, and would become latent there. Topical nanoviricide® treatment would stop further expansion of the virus at the site and therefore should also potentially decrease further recurrences. Also, topical treatment allows exposure of the virus to much higher concentrations of the drug locally, and thereby should produce greater effectiveness with less overall drug use, as compared to systemic treatments. There is no effective treatment for shingles and the shingles related PHN (post-herpetic neuralgia). The shingles associated debilitating pain usually lasts during the infection outbreak in most patients, but in some patients, PHN can develop, which can last 90 days to even a year in some cases after the skin has healed. Approved treatments for shingles and PHN include acyclovir related nucleoside analogs that are given in very high doses systemically for a week but with limited effect. A new nucleoside analog called FV-100 is in Phase 3 clinical trials. FV-100 development was previously abandoned by Bristol-Myers-Squibb and is now undertaken by a small pharma. There is also a vaccine for shingles that may reduce occurrence of shingles as a preventive, but not as a treatment after a breakout occurs. Another vaccine is in development. The chickenpox vaccine is now standard for children. However, the incidence of shingles in adolescents and young adults is rising, although shingles generally occurs in older people due age related decrease in immune function, and in patients with immune function compromising conditions from stress to organ transplant to other infections and HIV/AIDS. Although in most patients shingles is debilitating during the outbreak but not life-threatening, in a small percentage of patients, it can cause eye infections that can lead to blindness. There is no topical treatment for shingles. We believe this is an unmet medical need. The market size for a successful topical treatment for shingles could be in the billion dollar range. All of the biological testing and characterization of our drug candidates continues to be performed by external academic or institutional collaborators and contract research organizations (CRO). However, we now have our own capabilities to perform initial cell culture based drug candidate screening for BSL2 viruses, which includes herpesviruses. We believe that this is speeding up our drug development programs against such viruses significantly by removing the latencies of external testing in the earlier drug screening and the later drug optimization stages. The Company has established additional collaborations towards IND-enabling development of drug candidates against the four HerpeCide program indications listed above. We now have collaboration agreements with the CORL at the University of Wisconsin, and the Campbell Lab at the University of Pittsburgh, for the evaluation of its nanoviricides® drug candidates in models of ocular herpesvirus and adenovirus infections. TransPharm Preclinical Solutions, a CRO, will continue to perform testing of our anti-herpes drug candidates in dermal infection models. In addition, we have a collaboration with Professor Moffat Lab at SUNY-UMC to study our drug candidates against shingles. The nanoviricides® mechanism of action is believed to mimic a natural host cell receptor using which the virus binds and infects cells; binding of a nanoviricide nanomicelle to the virus is expected to render it non-infectious. A nanoviricide would thus stop the spread of the viral infection to new uninfected cells. This mechanism is different from that of currently available anti-Herpesvirus drugs. The Company therefore believes that it is able to develop broad-spectrum anti-herpes nanoviricide drugs. About NanoViricides: NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission.. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/nanoviricides-files-quarterly-report-for-period-ending-2017-03-31-300458329.html
News Article | May 8, 2017
The International Association of HealthCare Professionals is pleased to welcome Patrick J. Lynch, Radiologist to their prestigious organization with his upcoming publication in The Leading Physicians of the World. Dr. Patrick J. Lynch is a highly trained and qualified physician with a vast expertise in all facets of his work, especially women’s imaging, mammography, ultrasonography, and breast MRI. He has been in practice for nearly three decades and is currently serving patients within CNY Diagnostic Imaging Associates in Syracuse, New York. Dr. Lynch’s career in medicine began in 1985, when he graduated from the University of Massachusetts Medical School. Upon receiving his Medical Degree, he completed an internship in Internal Medicine at the Bay State Medical Institute in 1986, before undertaking his residency in Diagnostic Radiology at the SUNY Upstate Medical Center. Dr. Lynch is certified by the American Board of Radiology, and maintains a professional membership with the American College of Radiology and the Radiological Society of North America, allowing him to stay current with the latest advances in his field. He attributes his successful career to his continuous hard work and motivation for doing what he loves. When he is not assisting his patients, Dr. Lynch enjoys swimming, traveling, and spending time with his family. Learn more about Dr. Patrick J. Lynch here: http://www.cnydiagnosticimaging.com/ and be sure to read his upcoming publication in The Leading Physicians of World. FindaTopDoc.com is a hub for all things medicine, featuring detailed descriptions of medical professionals across all areas of expertise, and information on thousands of healthcare topics. Each month, millions of patients use FindaTopDoc to find a doctor nearby and instantly book an appointment online or create a review. FindaTopDoc.com features each doctor’s full professional biography highlighting their achievements, experience, patient reviews and areas of expertise. A leading provider of valuable health information that helps empower patient and doctor alike, FindaTopDoc enables readers to live a happier and healthier life. For more information about FindaTopDoc, visit http://www.findatopdoc.com
News Article | December 12, 2016
SOUTH SAN FRANCISCO, Calif., Dec. 12, 2016 (GLOBE NEWSWIRE) -- FLX Bio, Inc., a biopharmaceutical company focused on the discovery and development of novel immuno-oncology agents, announced today that it has appointed Linda Kozick to its board of directors. Linda brings more than 25 years of experience in the biopharmaceutical industry, including 15 years of strategic commercial leadership in oncology, specializing in immuno-oncology. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/a90c227f-b0d7-49cf-993c-8d76d11a5177. "We are delighted to welcome Linda to the FLX Bio board as the company advances its growing immuno-oncology and targeted oncology pipeline. Linda’s leadership in developing commercial strategies for key immuno-oncology therapies makes her an ideal candidate to help FLX Bio navigate clinical and commercial opportunities with our strong pipeline of product candidates,” said Dr. Brian Wong, CEO of FLX Bio. “FLX Bio has a strong discovery platform and has built a highly differentiated pipeline of immuno-oncology and targeted oncology compounds,” said Ms. Kozick. “I am delighted to join the FLX Bio Board of Directors to work alongside FLX Bio’s outstanding executive team, Board of Directors and Scientific Advisory Board members to realize the company’s goal of bringing best-in-class, next generation oncology therapies to patients." Ms. Kozick recently retired from Bristol-Myers Squibb (BMS) after 26 years. Most recently, she served as Vice President and Head of Immuno-Oncology/Oncology Product & Portfolio Strategy, and Opdivo and Yervoy Life Cycle Management. Prior to that, Ms. Kozick held several key positions including Vice President, Commercial Lead for Opdivo and Immuno-Oncology Platform Strategy, and was instrumental in establishing BMS’s International Immuno-Oncology Network (II-ON). Ms. Kozick received her Bachelor of Science and Master of Science degrees from Upstate Medical Center, and her Master’s in Business Administration from Chapman University. Founded in 2015 following the acquisition of its predecessor company, Flexus Biosciences, Inc., by Bristol-Myers Squibb, FLX Bio, Inc. is a privately-held biopharmaceutical company focused on the discovery, development and commercialization of novel immuno-oncology agents. The company leverages its unique insights in cancer biology and the immune system to discover and develop novel oral medicines that activate immune responses to eliminate cancer cells. Located in South San Francisco, Calif., and funded by leading investors, including Kleiner Perkins Caufield & Byers (KPCB), The Column Group (TCG) and Celgene, FLX Bio has assembled a management and R&D leadership team with a proven track record of success and an advisory group and team of scientists with substantial knowledge and expertise in drug discovery and translational areas essential to execute on this approach. For more information, please visit www.flxbio.com.
Fiese B.H.,University of Illinois at Urbana - Champaign |
Winter M.A.,University of Rochester |
Botti J.C.,Upstate Medical Center
Child Development | Year: 2011
Family mealtimes have the potential to promote healthy child development. This observational study of 200 family mealtimes examined the relation between child health in a group of children (ages 5 to 12) with persistent asthma and 3 dimensions of mealtime interaction: Action, Behavior Control, and Communication. Percent time spent in Action and Positive Communication varied by asthma severity, child quality of life, and sociodemographic variables. Positive communication during mealtimes predicted child quality of life. Significant interactions between demographic variables and behavior control suggested that higher levels of behavior control affected child quality of life in the context of lower maternal education. Guidance is offered for practitioners and policy makers toward promoting healthy family mealtimes as a public health priority. © 2011 The Authors. Child Development © 2011 Society for Research in Child Development, Inc.
Asselin B.L.,University of Rochester |
Devidas M.,University of Florida |
Wang C.,University of Florida |
Pullen J.,University of Mississippi Medical Center |
And 4 more authors.
Blood | Year: 2011
The Pediatric Oncology Group (POG) phase 3 trial 9404 was designed to determine the effectiveness of high-dose methotrexate (HDM) when added to multiagent chemotherapy based on the Dana-Farber backbone. Children with T-cell acute lymphoblastic leukemia (T-ALL) or advanced lymphoblastic lymphoma (T-NHL) were randomized at diagnosis to receive/not receive HDM (5 g/m2 as a 24-hour infusion) at weeks 4, 7, 10, and 13. Between 1996 and 2000, 436 patients were enrolled in the methotrexate randomization. Five-year and 10-year event-free survival (EFS) was 80.2% ± 2.8% and 78.1% ± 4.3% for HDM (n = 219) versus 73.6% ± 3.1% and 72.6% ± 5.0% for no HDM (n = 217; P = .17). For T-ALL, 5-year and 10-year EFS was significantly better with HDM (n = 148, 5 years: 79.5% ± 3.4%, 10 years: 77.3% ± 5.3%) versus no HDM (n = 151, 5 years: 67.5% ± 3.9%, 10 years: 66.0% ± 6.6%; P = .047). The difference in EFS between HDM and no HDM was not significant for T-NHL patients (n = 71, 5 years: 81.7% ± 4.9%, 10 years: 79.9% ± 7.5% vs n = 66, 5 years: 87.8% ± 4.2%, 10 years: 87.8% ± 6.4%; P = .38). The frequency of mucositis was significantly higher in patients treated with HDM (P = .003). The results support adding HDM to the treatment of children with T-ALL, but not with NHL, despite the increased risk of mucositis. © 2011 by The American Society of Hematology.
Bied A.M.,Upstate Medical Center |
Kim J.,Emory University |
Schwartz T.L.,Emory University
Expert Review of Clinical Pharmacology | Year: 2015
The selegiline transdermal system (STS) is the first antidepressant transdermal medication approved by the US FDA for the treatment of major depressive disorder. Its unique antidepressant delivery system allows for steady release of selegiline over 24 h with minimal fluctuation in drug serum levels. It is able to deliver high enough central nervous system concentrations required for an antidepressant effect without substantially inhibiting Monoamine oxidase-A in the gastrointestinal and hepatic system, thereby reducing the risk of tyramine hypertensive crises especially at the lowest doses. Patient adherence theoretically could be improved due to ease of use and once-daily dosing when compared to oral counterparts' need for multiple daily doses. Clinical trials have established that doses between 6 and 12 mg over 24 h have been effective for major depressive disorder and tolerated among patients. Episodes of hypertensive crisis with STS have been minimally reported thus far. Overall, STS appears to be an effective agent for major depressive disorder when held to regulatory standards and post marketing analyses. This paper reviews the pharmacologic characteristics of STS and results of studies investigating its clinical efficacy and safety. © 2015 Taylor & Francis.
Ray T.,Ramakrishna Vedanta Ashrama of Phoenix |
Ray T.,Upstate Medical Center
F1000Research | Year: 2013
This article offers an explanation for the apparent lack of Na, K-ATPase activity in parietal cells although ouabain has been known to inhibit gastric acid secretion since 1962. The gastric H, K-ATPase (proton-pump) seems to be acting in altered states, thus behaving like a Na, K-ATPase (Na-pump) and/or Ca-ATPase (Ca-pump) depending on cellular needs. This conclusion is based on the following findings. First, parietal cell fractions do not exhibit Na, K-ATPase activity at pH 7.0 but do at pH 8.5. Second, the apical plasma membrane (APM) fraction exhibits a (Ca or Mg)-ATPase activity with negligible H, K-ATPase activity. However, when assayed with Mg alone in presence of the 80 k Da cytosolic proton-pump activator (HAF), the APM fraction reveals remarkably high H, K-ATPase activity, suggesting the observed low affinity of Ca (or Mg)-ATPase is an altered state of the latter. Third, calcium (between 1 and 4 μM) shows both stimulation and inhibition of the HAF-stimulated H, K-ATPase depending on its concentration, revealing a close interaction between the proton-pump activator and local Ca concentration in gastric H, K-ATPase function. Such interactions suggest that Ca is acting as a terminal member of the intracellular signaling system for the HAF-regulated proton-pump. It appears that during resting state, the HAF-associated H, K-ATPase remains inhibited by Ca (>1 μM) and, prior to resumption of acid secretion the gastric H, K-ATPase acts temporarily as a Ca-pump for removing excess Ca from its immediate environment. This conclusion is consistent with the recent reports of immunochemical co-localization of the gastric H, K-ATPase and Ca-ATPase by superimposition in parietal cells, and a transitory efflux of Ca immediately preceding the onset of acid secretion. These new perspectives on proton-pump function would open new avenues for a fuller understanding of the intracellular regulation of the ubiquitous Na-pump. © 2013 Ray T.
McDermott S.,University of South Carolina |
Turk M.A.,Upstate Medical Center
Disability and Health Journal | Year: 2011
The concept of disability has medical, functional, and social components. We review the frameworks for the definition of disability and endorse a multidimensional approach that is parsimonious and has utility for epidemiology. We need to be able to count people with disabilities to quantify service and support needs, to study the life course of people with specific disabilities, and to accurately target prevention strategies. In addition, it is important to have some precise measures of disability so comparisons can be made between impairments, to identify disparities and differences, and to measure changes over time. We need to ensure that there is no confusion about cause and effect (attributing associated conditions as outcomes of disability when they are in fact the cause of the functional limitation) and that comparisons to people without disabilities are fair. If people who experience disability due to a condition such as obesity are included in the case definition of disability, then we cannot say people with disability are more likely to be obese. The credibility of disability epidemiology and the disability field is at stake. © 2011 Elsevier Inc. All rights reserved.
Bratslavsky G.,Upstate Medical Center |
Cheng J.-S.,Massachusetts General Hospital
Urology | Year: 2015
Objective To describe a case of robotic-assisted radical nephrectomy (RARN) with level III retrohepatic vena caval tumor thrombectomy (11 cm) and extended retroperitoneal lymph node dissection (RPLND) for renal cell carcinoma (RCC). Materials and Methods A 52-year-old woman with a large right renal mass, 11-cm (level III) inferior vena cava (IVC) thrombus, with a negative metastatic workup presented to our clinic and was consented to undergo RARN. Intraoperative ultrasound confirmed the presence of tumor thrombus. After the division of the renal artery, control of the vena cava above and below the tumor thrombus as well as contralateral renal vein was obtained. A cavotomy was performed, the thrombus was removed, and the cavotomy was repaired. Additionally, an extended RPLND was performed with robotic assistance. Results Total operative time was 6 hours and 6 minutes. Estimated blood loss was 1200 cc. The final pathology demonstrated an 8.5-cm, Fuhrman grade 3, clear cell RCC with sarcomatoid features and negative surgical margins. All 44 lymph nodes removed (hilar, paracaval, precaval, retrocaval, interaortocaval, and preaortic) were negative. Final staging was pT3b, N0, M0. The patient was discharged to home 36 hours postoperatively and experienced no perioperative or postoperative complications. Conclusion RARN with retrohepatic (level III) vena caval tumor thrombectomy and extended RPLND is technically feasible and has potential benefits. Robotic assistance may allow for improved intracorporal repair of the IVC and shortened recovery time, while maintaining oncologic principles. © 2015 Elsevier Inc.
News Article | December 9, 2016
Mediaplanet today announces distribution of the latest edition of “Transplants,” a cross-platform campaign that raises awareness for organ transplantation while encouraging readers to sign up as an organ donor for the 123,000 people in the United States who are currently waiting for a lifesaving organ transplant. An organ donor can save up to 8 saves through organ donation and enhance many others through tissue donation, however thousands die every year waiting for a donor organ that never comes. Throughout the campaign we look at the impact an organ and/or bone marrow donation can make while highlighting the best resources and services available that are working to make sure we continue to see progress in the transplant field. Actress & Organ Donation Advocate, Katherine Heigl, speaks out about her family’s tragic loss of her brother and the compassionate act that saved four lives in the print and digital campaign. In an exclusive interview with Mediaplanet, Katherine and her mother, Nancy Heigl, share their story in hopes to continue to spread awareness on organ donation. “We knew that a young man got his heart and two people got their sight back,” she says. “Who received them didn’t matter other than that they saved other lives.” The family’s act gave 4 different people another chance and while the decision was tough they knew it was the right one. “Even in the midst of unimaginable pain and sorrow, I knew that we needed to have as much compassion for others as we had for ourselves”, Nancy Heigl adds. The print component of “Transplants” is distributed within the December 9th issue of USA Today in New York, LA, Boston, Chicago, Washington D.C./Baltimore, St. Louis, and Philadelphia with a circulation of approximately 250,000 copies and an estimated readership of 750,000 readers. The digital component is distributed nationally, through a vast social media strategy, and across a network of top news sites and partner outlets. To explore the digital version of the campaign, click here. This edition of “Transplants” was made possible with the support of the American Society of Transplantation, UNOS, Donate Life, UPMC, UW Health, Katherine & Nancy Heigl, DKMS, University of Utah Health Care, SUNY Upstate Medical Center, American College of Cardiology, Chris Klug Foundation, University Colorado Health, Syncardia, Transplant Solutions and many more. About Mediaplanet: Mediaplanet is the leading independent publisher of content-marketing campaigns covering a variety of topics and industries. We turn consumer interest into action by providing readers with motivational editorial, pairing it with relevant advertisers, and distributing it within top newspapers and online platforms around the world.