By Sarah O'Donnell,
Edmonton Journal
October 5, 2010 9:05 PM
EDMONTON — A virus best known for the damage it does to the liver can also damage brain cells, University of Alberta researchers report in a new study.
The research into the impact of hepatitis C on the brain is significant, they say, because it marks the first time scientists have been able to show that the virus can infect the brain.
"It has been a question for a long time," said Pornpun Vivithanaporn, a post-doctoral fellow in the U of A's Faculty of Medicine and Dentistry and first author of the hepatitis C study, which was published last week in the Public Library of Science One Journal.
"It proves the virus has implications on neurological disease," she said Tuesday.
Hepatitis C infects about 170 million people globally and about 300,000 in Canada. It targets the liver, causing inflammation and cirrhosis.
Researchers already knew that severe liver disease can affect a person's brain, but more recent research suggested that hepatitis C patients without serious liver problems also could suffer from brain-related issues such as memory loss, trouble concentrating, apathy and depression.
The new study allowed a team of researchers to show precisely how the hepatitis C virus can infect brain cells on its own.
"That had never been shown before," said lead researcher Dr. Christopher Power, a neurologist who works in the U of A's Faculty of Medicine and Dentistry. "It gets in there, it infects and it replicates. For a virologist, that's a really core observation. You can see infection of the cells and you can see replication."
To show how the hepatitis C virus infects brain cells, Power pointed to a computer screen in his U of A lab on Tuesday.
On one side of the screen, pictures of two healthy brain cells appeared in red. On the other side, those same cells appeared peppered with green dots. And in this picture, green is bad since it represents a buildup of viral proteins that eventually damage and kill the cell. In a way, Power explained, the virus can cause brain cells to drown in their own garbage.
The discovery is important, Power said for a couple of reasons.
First, he said, there are immediate clinical implications. "It tells us we need to be vigilant for neurological problems for people who have hepatitis C," he said.
That would mean taking such steps as ensuring patients have assess to a neurologist or psychologist on their team of physicians as well as a liver specialist.
"The second issue is it underscores the importance (of) developing new treatment for hepatitis C so we can prevent infection of the brain," said Power, whose research is funded by Alberta Innovates — Health Solutions and the Canadian Institutes of Health Research.
There is now no vaccine to prevent hepatitis C. Researchers have uncovered some treatments that work for a portion of patients infected with hepatitis C, but those also can have serious side effects for some people.
Michael Harmsworth, a hepatitis C sufferer who counts Power among his five doctors, said Tuesday he was extremely interested to learn about the research team's discovery. He said he hadn't realized that hepatitis C had the potential to affect the brain until Power showed him computer images of infected tissue samples.
Harmsworth, who was diagnosed about 13 years ago, said it all points toward progress.
"It's making me think, 'Hey, I may still have my time left here,'" Harmsworth said. "My little girl is nine years old and I want to be here when she turns 16 and goes to the prom."
© Copyright (c) The Edmonton Journal
Source
October 5, 2010
Obama Administration's Pledge to Global Fund to Fight HIV/AIDS, Malaria and Tuberculosis
Office of the Spokesman
Washington, DC
October 5, 2010
As part of America’s leadership in saving lives and alleviating suffering around the world, the United States announced today that it intends to make an unprecedented three-year pledge of support to the Global Fund to Fight AIDS, Tuberculosis and Malaria. The pledge is tied to the call for smart investments and shared responsibility to reach the goal of saving more lives efficiently and effectively.
The Obama Administration intends to seek $4 billion for the Fund for 2011 through 2013 to continue America’s strong support for this important multilateral partner. This pledge is a 38% increase in the U.S. investment over the preceding three-year period – a substantial increase especially in light of the overall budget challenges and the largest increase by far of any donor nation this year.
This historic pledge has three goals:
Washington, DC
October 5, 2010
As part of America’s leadership in saving lives and alleviating suffering around the world, the United States announced today that it intends to make an unprecedented three-year pledge of support to the Global Fund to Fight AIDS, Tuberculosis and Malaria. The pledge is tied to the call for smart investments and shared responsibility to reach the goal of saving more lives efficiently and effectively.
The Obama Administration intends to seek $4 billion for the Fund for 2011 through 2013 to continue America’s strong support for this important multilateral partner. This pledge is a 38% increase in the U.S. investment over the preceding three-year period – a substantial increase especially in light of the overall budget challenges and the largest increase by far of any donor nation this year.
This historic pledge has three goals:
- To save more lives by driving needed reforms and ensuring smart, effective investments are being made: The Fund has demonstrated remarkable success over the past eight years in mobilizing and disbursing resources. We must build upon this success by driving needed reforms including better grants management; greater country-level collaboration to avoid duplication of efforts; closing gaps in services; reducing reporting burdens on host countries; better accountability for funds in grants to ensure proper use of scarce resources; and better monitoring and evaluation to ensure goals of grants are met. The U.S. calls upon the Global Fund Board to develop an action agenda in the near future that includes clear timelines and measures progress so all parties can be held accountable for clear action steps.
- To leverage other donor nations’ contributions in order to save more lives; increase life expectancies; and alleviate suffering: This commitment serves as a challenge to other donors. If other donors scale up their commitments at a similar rate, the Global Fund is expected to be able to proceed with new rounds of grants while continuing existing grants during 2011-2013.
- To continue to demonstrate U.S. leadership in the ultimate measurement of success – increasing the number of lives saved: The U.S. was the first and by far the largest contributor to the Fund, providing more than $5.1 billion to date. This pledge is part of a comprehensive approach to combating AIDS, TB, and malaria through President Obama’s Global Health Initiative (GHI), which supports coordinated interventions aimed at reducing lives lost from the three diseases and other health challenges.
With this U.S. commitment and scaled-up contributions from other donors, the Global Fund projects that it will be able to achieve the following results by 2015:
- A total of 4.4 million people on antiretroviral therapy, up from 2.5 million at the end of 2009
- 2.5 million orphans and vulnerable children provided with support annually, up from 1.4 million in 2009
- 610,000 HIV-positive pregnant women receiving prevention of mother-to-child transmission services annually, compared to 345,000 in 2009
- 3.9 million tuberculosis treatment regimens provided annually, up from 1.4 million in 2009
- 110 million insecticide-treated bed nets for malaria prevention distributed annually, up from 34 million in 2009.
CDC's 'Winnable Battles' Out of Step with Healthcare Reform and Achieving Health Equity for the American People, Says Ted Fang, Co-Founder, Hep B Free
Ending Liver Cancer Is The Most Winnable Battle In American Healthcare Today
SAN FRANCISCO, Oct. 5 /PRNewswire/ -- In response to the Centers for Disease Control (CDC) Director Dr. Thomas Frieden's declaration of "six winnable battles" as healthcare priorities, Ted Fang, Director, AsianWeek Foundation and Co-Founder, Hep B Free movement, released the following statement:
"CDC's new prioritization of 'six winnable battles' once again demonstrates their poor track record towards achieving health equity for all Americans.
By focusing on six specific diseases which mostly do not have medical solutions, the CDC has ignored many deadly diseases that can be completely and easily prevented, such as liver cancer.
Ending liver cancer is the most winnable battle in American healthcare today. Up to 80% of all liver cancers globally are caused by hepatitis B (HBV), while hepatitis C (HCV) is the greatest cause of liver cancer in the U.S. There is a vaccine that prevents hepatitis B infection and an actual cure for the hepatitis C virus. Hepatitis B and liver cancer are the greatest health disparity for Asian/Pacific Islander Americans, yet CDC has ignored their own data and in the past refused to even list hepatitis B as a leading American health disparity.
U.S. Speaker Nancy Pelosi has highlighted the Hep B Free model and President Barack Obama has singled out the priority of ending hepatitis B disease for Asian Pacific Americans. In addition, CDC has previously recognized hepatitis B interventions of the Hep B Free movement as 'one of the finest examples of community mobilization' in public health today.
Yet Dr. Frieden misses the boat and ignores up to 5 million Americans with chronic viral hepatitis. The health and well-being of the American people require that the CDC immediately recognize liver cancer and hepatitis B disease as the MOST WINNABLE BATTLE IN AMERICAN HEALTHCARE today."
The AsianWeek Foundation (http://www.asianweek.com/) is a non-profit dedicated to promoting and developing the identity and diversity of the Asian Pacific American community.
The Hep B Free (http://www.sfhepbfree.org/) movement started in San Francisco and is expanding to counties across America. It is a full-spectrum healthcare intervention program to end hepatitis B disease, and brings together community, healthcare, the private sector and government.
SOURCE The AsianWeek Foundation
Source
Also See:
-- NVHR: In Fighting for 'Six Winnable Battles,' CDC May Lose the Nation's Overall Public-Health War
-- CDC chief picks 6 'winnable battles' in health
SAN FRANCISCO, Oct. 5 /PRNewswire/ -- In response to the Centers for Disease Control (CDC) Director Dr. Thomas Frieden's declaration of "six winnable battles" as healthcare priorities, Ted Fang, Director, AsianWeek Foundation and Co-Founder, Hep B Free movement, released the following statement:
"CDC's new prioritization of 'six winnable battles' once again demonstrates their poor track record towards achieving health equity for all Americans.
By focusing on six specific diseases which mostly do not have medical solutions, the CDC has ignored many deadly diseases that can be completely and easily prevented, such as liver cancer.
Ending liver cancer is the most winnable battle in American healthcare today. Up to 80% of all liver cancers globally are caused by hepatitis B (HBV), while hepatitis C (HCV) is the greatest cause of liver cancer in the U.S. There is a vaccine that prevents hepatitis B infection and an actual cure for the hepatitis C virus. Hepatitis B and liver cancer are the greatest health disparity for Asian/Pacific Islander Americans, yet CDC has ignored their own data and in the past refused to even list hepatitis B as a leading American health disparity.
U.S. Speaker Nancy Pelosi has highlighted the Hep B Free model and President Barack Obama has singled out the priority of ending hepatitis B disease for Asian Pacific Americans. In addition, CDC has previously recognized hepatitis B interventions of the Hep B Free movement as 'one of the finest examples of community mobilization' in public health today.
Yet Dr. Frieden misses the boat and ignores up to 5 million Americans with chronic viral hepatitis. The health and well-being of the American people require that the CDC immediately recognize liver cancer and hepatitis B disease as the MOST WINNABLE BATTLE IN AMERICAN HEALTHCARE today."
The AsianWeek Foundation (http://www.asianweek.com/) is a non-profit dedicated to promoting and developing the identity and diversity of the Asian Pacific American community.
The Hep B Free (http://www.sfhepbfree.org/) movement started in San Francisco and is expanding to counties across America. It is a full-spectrum healthcare intervention program to end hepatitis B disease, and brings together community, healthcare, the private sector and government.
SOURCE The AsianWeek Foundation
Source
Also See:
-- NVHR: In Fighting for 'Six Winnable Battles,' CDC May Lose the Nation's Overall Public-Health War
-- CDC chief picks 6 'winnable battles' in health
Human Genome, Novartis Stop Development of Hepatitis C Treatment
By Jennifer Booton
Published October 05, 2010
FOXBusiness
Human Genome Sciences (HGSI: 30.12 ,+0.65 ,+2.21%) and partner Novartis (NVS: 57.74 ,+0.72 ,+1.26%) have terminated development of their Zalbin drug studied as a potential treatment for chronic hepatitis C.
Development was halted after Rockville, Maryland-based Human Genome received a “complete response letter” from the Food and Drug Administration, often seen as a request for more information regarding a drug application.
The company had a Biologics License Application for 900-mcg Zalbin dosed every two weeks.
In May, the company had said it did not expect to achieve FDA approval at its current dosage.
That view followed a “discipline review letter” in which the FDA voiced safety concerns about the specific dosage.
Source
Published October 05, 2010
FOXBusiness
Human Genome Sciences (HGSI: 30.12 ,+0.65 ,+2.21%) and partner Novartis (NVS: 57.74 ,+0.72 ,+1.26%) have terminated development of their Zalbin drug studied as a potential treatment for chronic hepatitis C.
Development was halted after Rockville, Maryland-based Human Genome received a “complete response letter” from the Food and Drug Administration, often seen as a request for more information regarding a drug application.
The company had a Biologics License Application for 900-mcg Zalbin dosed every two weeks.
In May, the company had said it did not expect to achieve FDA approval at its current dosage.
That view followed a “discipline review letter” in which the FDA voiced safety concerns about the specific dosage.
Source
Profectus BioSciences, Inc. Receives $4.4M in Grants to Develop an HIV Prophylactic Vaccine
October 05, 2010 08:30 AM Eastern Daylight Time
Funding will support further evaluation of the TSV approach that has generated significant protective responses in several pre-clinical models of HIV
BALTIMORE--(BUSINESS WIRE)--Profectus BioSciences, Inc., a technology based vaccine company devoted to the treatment and prevention of chronic viral diseases, today announced the award of a Fast Track SBIR from the Division of AIDS, National Institutes of Health for $3.1M to support the development of the Company’s Transition State Vaccine (TSV) technology for a prophylactic HIV Vaccine. This new award builds upon the $1.3M that the Company has also received through collaborative grants awarded to Dr. Robert Gallo, Director of the Institute of Human Virology (IHV) of the University of Maryland School of Medicine, with his co-workers Drs. George Lewis and Anthony DeVico from the National Cancer Institute and other groups. Profectus BioSciences is dedicated to harnessing the immune system to treat and prevent viral diseases and cancers through the delivery of proprietary prime/boost vaccines.
Originally developed at the IHV, the TSV strategy targets the adaptive immune response to the most protected portions of HIV envelope spikes that are considered the “Achilles heel” of all HIV isolates. The TSV is being developed as a subunit protein and also for delivery utilizing the Company’s plasmid DNA and recombinant Vesicular Stomatitis Virus vaccine vectors. Thus far, the TSV approach has generated significant protective responses in several non-human primate models for HIV. This data was presented at the 2010 AIDS Vaccine Conference in Atlanta, GA. John Eldridge, Chief Scientific Officer of Profectus BioSciences, commented, “Awards such as these are central to our ability to pursue an effective prophylactic vaccine against HIV.”
About Profectus BioSciences, Inc.
Profectus BioSciences, Inc. is a technology based vaccine company devoted to the treatment and prevention of chronic viral diseases with a goal of reducing morbidity and mortality. Since its inception in 2003, the Company’s strategic intent has been to develop and acquire the technologies needed to deliver on that mission within high value markets. The foundation of Profectus Biosciences’ approach is the premise that effective management of inflammation and immunity can dramatically improve clinical outcomes. The Company has in-licensed a group of vaccine-based technologies from Wyeth Vaccines that greatly accelerate its’ ability to deliver highly effective therapeutic vaccines based on a “prime-boost” strategy. This strategy uses the delivery of a best-in-class plasmid DNA (pDNA) vaccine to “prime” the immune system, followed by a first-in-class “boost” using a recombinant Vesicular Stomatitis Virus (rVSV) vector. Current disease and virus targets include Hepatitis C Virus (HCV), Human Papilloma Virus (HPV), Herpes Simplex Virus type 2 (HSV-2), and Human Immunodeficiency Virus (HIV), and Malaria.
Source
Funding will support further evaluation of the TSV approach that has generated significant protective responses in several pre-clinical models of HIV
BALTIMORE--(BUSINESS WIRE)--Profectus BioSciences, Inc., a technology based vaccine company devoted to the treatment and prevention of chronic viral diseases, today announced the award of a Fast Track SBIR from the Division of AIDS, National Institutes of Health for $3.1M to support the development of the Company’s Transition State Vaccine (TSV) technology for a prophylactic HIV Vaccine. This new award builds upon the $1.3M that the Company has also received through collaborative grants awarded to Dr. Robert Gallo, Director of the Institute of Human Virology (IHV) of the University of Maryland School of Medicine, with his co-workers Drs. George Lewis and Anthony DeVico from the National Cancer Institute and other groups. Profectus BioSciences is dedicated to harnessing the immune system to treat and prevent viral diseases and cancers through the delivery of proprietary prime/boost vaccines.
Originally developed at the IHV, the TSV strategy targets the adaptive immune response to the most protected portions of HIV envelope spikes that are considered the “Achilles heel” of all HIV isolates. The TSV is being developed as a subunit protein and also for delivery utilizing the Company’s plasmid DNA and recombinant Vesicular Stomatitis Virus vaccine vectors. Thus far, the TSV approach has generated significant protective responses in several non-human primate models for HIV. This data was presented at the 2010 AIDS Vaccine Conference in Atlanta, GA. John Eldridge, Chief Scientific Officer of Profectus BioSciences, commented, “Awards such as these are central to our ability to pursue an effective prophylactic vaccine against HIV.”
About Profectus BioSciences, Inc.
Profectus BioSciences, Inc. is a technology based vaccine company devoted to the treatment and prevention of chronic viral diseases with a goal of reducing morbidity and mortality. Since its inception in 2003, the Company’s strategic intent has been to develop and acquire the technologies needed to deliver on that mission within high value markets. The foundation of Profectus Biosciences’ approach is the premise that effective management of inflammation and immunity can dramatically improve clinical outcomes. The Company has in-licensed a group of vaccine-based technologies from Wyeth Vaccines that greatly accelerate its’ ability to deliver highly effective therapeutic vaccines based on a “prime-boost” strategy. This strategy uses the delivery of a best-in-class plasmid DNA (pDNA) vaccine to “prime” the immune system, followed by a first-in-class “boost” using a recombinant Vesicular Stomatitis Virus (rVSV) vector. Current disease and virus targets include Hepatitis C Virus (HCV), Human Papilloma Virus (HPV), Herpes Simplex Virus type 2 (HSV-2), and Human Immunodeficiency Virus (HIV), and Malaria.
Source
Celsion Receives Positive FDA Guidance for its New Drug Application for ThermoDox to Treat Primary Liver Cancer
From the PharmaLive.com News Archive - Oct. 04, 2010
FDA confirms Celsion's preclinical studies are sufficient to support NDA submission
COLUMBIA, Md., Oct. 4 /PRNewswire/ -- Celsion Corporation (Nasdaq: CLSN), a leading oncology drug development company, announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) that the requirements for non-clinical studies have been met for the New Drug Application (NDA) of ThermoDox.
The FDA has provided written guidance that the Company is not required to conduct any additional non-clinical pharmacology, safety pharmacology and general toxicology studies assuming the results of current studies are adequate. The results of these current studies will be reviewed at the time of NDA submission. This agreement takes advantage of an NDA application known as a 505(b)2 which allows a company to reference existing data regarding doxorubicin and other liposomal drugs currently approved by the FDA.
As previously announced, the FDA has granted Fast Track Development for the Company's 600 patient pivotal Phase III clinical trial (the HEAT study) of its investigational drug, ThermoDox®, in combination with radiofrequency ablation (RFA), The Fast Track Development Program provides for expedited regulatory review including frequent interactions between the FDA. Celsion is eligible to submit its NDA on a rolling basis and review sections of the NDA with the FDA in advance of submitting the complete submission. The HEAT study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
"We are very pleased with the FDA's continued willingness to work closely with the Company to identify the most expeditious regulatory pathway forward for ThermoDox® in HCC, a life threatening disorder," stated Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Our past consultation with the FDA regarding Chemistry Manufacturing and Controls (CMC) has permitted Celsion to implement and validate process improvements to its manufacturing methods used to produce ThermoDox at commercial scale."
About ThermoDox® and the Phase III HEAT Study
ThermoDox® is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers. In the HEAT study, ThermoDox is administered intravenously in combination with RFA. A thermal zone created by the RFA releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially at the targeted tumor.
For primary liver cancer, ThermoDox® is being evaluated in a 600 patient global Phase III study at 75 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival (PFS) with a secondary confirmatory endpoint of overall survival. A pre-planned, interim efficacy analysis will be performed by an independent Data Monitoring Committee when enrollment in the trial is complete and 50 percent of the PFS events are realized in the study population. Additional information on the Company's ThermoDox® clinical studies may be found at http://www.clinicaltrials.gov/
About Primary Liver Cancer
Primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer is approximately 20,000 cases per year in the United States and has a worldwide incidence of approximately 650,000 cases, due to the high prevalence of Hepatitis B and C in developing countries. The standard first line treatment for liver cancer is surgical resection of the tumor; however 80% to 90% of patients are ineligible for surgery. Radio frequency ablation (RFA) has increasingly become the standard of care for non-resectable liver tumors, but the treatment becomes less effective for larger tumors. There are few non-surgical therapeutic treatment options available as radiation therapy and chemotherapy are largely ineffective in the treatment of primary liver cancer.
About Celsion
Celsion is a leading oncology company dedicated to the development and commercialization of innovative cancer drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System. For more information on Celsion, visit our website: http://www.celsion.com/.
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission.
Click here to view the associated table
SOURCE Celsion Corporation
CONTACT: Marcy Nanus, The Trout Group, +1-646-378-2927, mnanus@troutgroup.com
Web Site: http://www.celsion.com/
Source
Also See:
Celsion Receives Fast Track Designation for ThermoDox® Development Program to Treat Primary Liver Cancer
FDA confirms Celsion's preclinical studies are sufficient to support NDA submission
COLUMBIA, Md., Oct. 4 /PRNewswire/ -- Celsion Corporation (Nasdaq: CLSN), a leading oncology drug development company, announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) that the requirements for non-clinical studies have been met for the New Drug Application (NDA) of ThermoDox.
The FDA has provided written guidance that the Company is not required to conduct any additional non-clinical pharmacology, safety pharmacology and general toxicology studies assuming the results of current studies are adequate. The results of these current studies will be reviewed at the time of NDA submission. This agreement takes advantage of an NDA application known as a 505(b)2 which allows a company to reference existing data regarding doxorubicin and other liposomal drugs currently approved by the FDA.
As previously announced, the FDA has granted Fast Track Development for the Company's 600 patient pivotal Phase III clinical trial (the HEAT study) of its investigational drug, ThermoDox®, in combination with radiofrequency ablation (RFA), The Fast Track Development Program provides for expedited regulatory review including frequent interactions between the FDA. Celsion is eligible to submit its NDA on a rolling basis and review sections of the NDA with the FDA in advance of submitting the complete submission. The HEAT study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
"We are very pleased with the FDA's continued willingness to work closely with the Company to identify the most expeditious regulatory pathway forward for ThermoDox® in HCC, a life threatening disorder," stated Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer. "Our past consultation with the FDA regarding Chemistry Manufacturing and Controls (CMC) has permitted Celsion to implement and validate process improvements to its manufacturing methods used to produce ThermoDox at commercial scale."
About ThermoDox® and the Phase III HEAT Study
ThermoDox® is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers. In the HEAT study, ThermoDox is administered intravenously in combination with RFA. A thermal zone created by the RFA releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially at the targeted tumor.
For primary liver cancer, ThermoDox® is being evaluated in a 600 patient global Phase III study at 75 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival (PFS) with a secondary confirmatory endpoint of overall survival. A pre-planned, interim efficacy analysis will be performed by an independent Data Monitoring Committee when enrollment in the trial is complete and 50 percent of the PFS events are realized in the study population. Additional information on the Company's ThermoDox® clinical studies may be found at http://www.clinicaltrials.gov/
About Primary Liver Cancer
Primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer is approximately 20,000 cases per year in the United States and has a worldwide incidence of approximately 650,000 cases, due to the high prevalence of Hepatitis B and C in developing countries. The standard first line treatment for liver cancer is surgical resection of the tumor; however 80% to 90% of patients are ineligible for surgery. Radio frequency ablation (RFA) has increasingly become the standard of care for non-resectable liver tumors, but the treatment becomes less effective for larger tumors. There are few non-surgical therapeutic treatment options available as radiation therapy and chemotherapy are largely ineffective in the treatment of primary liver cancer.
About Celsion
Celsion is a leading oncology company dedicated to the development and commercialization of innovative cancer drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System. For more information on Celsion, visit our website: http://www.celsion.com/.
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission.
Click here to view the associated table
SOURCE Celsion Corporation
CONTACT: Marcy Nanus, The Trout Group, +1-646-378-2927, mnanus@troutgroup.com
Web Site: http://www.celsion.com/
Source
Also See:
Celsion Receives Fast Track Designation for ThermoDox® Development Program to Treat Primary Liver Cancer
Microarchitecture of the liver: A Jigsaw puzzle
Marcos Rojkinda, George Philipsb, Anna Mae Diehlb
Received 27 August 2010; accepted 1 September 2010. published online 04 October 2010.
Uncorrected Proof
COMMENTARY ON:
Prediction and validation of cell alignment along microvessels as order principle to restore tissue architecture in liver regeneration. Hoehme S, Brulport M, Bauer A, Bedawy E, Schormann W, Hermes M, Puppe V, Gebhardt R, Zellmer S, Schwarz M, Bockamp E, Timmel T, Hengstler JG, Drasdo D. Proc Natl Acad Sci USA 2010 Jun 8;107(23):10371–10376. Copyright (2010) by the National Academy of Sciences; USA. Abstract reprinted with permission from the National Academy of Sciences.
Only little is known about how cells coordinately behave to establish functional tissue structure and restore microarchitecture during regeneration. Research in this field is hampered by a lack of techniques that allow quantification of tissue architecture and its development. To bridge this gap, we have established a procedure based on confocal laser scans, image processing, and three-dimensional tissue reconstruction, as well as quantitative mathematical modeling. As a proof of principle, we reconstructed and modeled liver regeneration in mice after damage by CCl(4), a prototypical inducer of pericentral liver damage. We have chosen the regenerating liver as an example because of the tight link between liver architecture and function: the complex microarchitecture formed by hepatocytes and microvessels, i.e. sinusoids, ensures optimal exchange of metabolites between blood and hepatocytes. Our model captures all hepatocytes and sinusoids of a liver lobule during a 16day regeneration process. The model unambiguously predicted a so-far unrecognized mechanism as essential for liver regeneration, whereby daughter hepatocytes align along the orientation of the closest sinusoid, a process which we named “hepatocyte-sinusoid alignment” (HSA). The simulated tissue architecture was only in agreement with the experimentally obtained data when HSA was included into the model and, moreover, no other likely mechanism could replace it. In order to experimentally validate the model of prediction of HSA, we analyzed the three-dimensional orientation of daughter hepatocytes in relation to the sinusoids. The results of this analysis clearly confirmed the model prediction. We believe our procedure is widely applicable in the systems biology of tissues.
a Department of Biochemistry and Molecular Biology, George Washington University Medical Center, Washington, DC, United States
b Division of Gatroenterology, Duke University Medical Center, Durham, NC, United States
Corresponding author.
PII: S0168-8278(10)00846-9
doi:10.1016/j.jhep.2010.09.004
© 2010 Published by Elsevier Inc.
Source
Received 27 August 2010; accepted 1 September 2010. published online 04 October 2010.
Uncorrected Proof
COMMENTARY ON:
Prediction and validation of cell alignment along microvessels as order principle to restore tissue architecture in liver regeneration. Hoehme S, Brulport M, Bauer A, Bedawy E, Schormann W, Hermes M, Puppe V, Gebhardt R, Zellmer S, Schwarz M, Bockamp E, Timmel T, Hengstler JG, Drasdo D. Proc Natl Acad Sci USA 2010 Jun 8;107(23):10371–10376. Copyright (2010) by the National Academy of Sciences; USA. Abstract reprinted with permission from the National Academy of Sciences.
Only little is known about how cells coordinately behave to establish functional tissue structure and restore microarchitecture during regeneration. Research in this field is hampered by a lack of techniques that allow quantification of tissue architecture and its development. To bridge this gap, we have established a procedure based on confocal laser scans, image processing, and three-dimensional tissue reconstruction, as well as quantitative mathematical modeling. As a proof of principle, we reconstructed and modeled liver regeneration in mice after damage by CCl(4), a prototypical inducer of pericentral liver damage. We have chosen the regenerating liver as an example because of the tight link between liver architecture and function: the complex microarchitecture formed by hepatocytes and microvessels, i.e. sinusoids, ensures optimal exchange of metabolites between blood and hepatocytes. Our model captures all hepatocytes and sinusoids of a liver lobule during a 16day regeneration process. The model unambiguously predicted a so-far unrecognized mechanism as essential for liver regeneration, whereby daughter hepatocytes align along the orientation of the closest sinusoid, a process which we named “hepatocyte-sinusoid alignment” (HSA). The simulated tissue architecture was only in agreement with the experimentally obtained data when HSA was included into the model and, moreover, no other likely mechanism could replace it. In order to experimentally validate the model of prediction of HSA, we analyzed the three-dimensional orientation of daughter hepatocytes in relation to the sinusoids. The results of this analysis clearly confirmed the model prediction. We believe our procedure is widely applicable in the systems biology of tissues.
a Department of Biochemistry and Molecular Biology, George Washington University Medical Center, Washington, DC, United States
b Division of Gatroenterology, Duke University Medical Center, Durham, NC, United States
Corresponding author.
PII: S0168-8278(10)00846-9
doi:10.1016/j.jhep.2010.09.004
© 2010 Published by Elsevier Inc.
Source
Clinical trial: oral zinc in hepatic encephalopathy
Aliment Pharmacol Ther. 2010 Sep 3. doi: 10.1111/j.1365-2036.2010.04448.x. [Epub ahead of print]
Takuma Y, Nouso K, Makino Y, Hayashi M, Takahashi H.
Department of Gastroenterology, Kurashiki Central Hospital, Okayama, Japan. Department of Internal Medicine, National Hospital Organization Iwakuni Center, Yamaguchi, Japan. Department of Molecular Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan. Department of Clinical Research, National Hospital Organization Iwakuni Clinical Center, Yamaguchi, Japan.
Abstract
Background Hepatic encephalopathy has a negative effect on patient health-related quality of life (HRQOL). Zinc supplementation has been effective with regard to altered nitrogen metabolism. Aim To investigate the effectiveness of oral zinc supplementation on hepatic encephalopathy and HRQOL. Methods Seventy-nine cirrhotic patients with hepatic encephalopathy were randomized to receive 225 mg of polaprezinc in addition to standard therapies of a protein-restricted diet including branched-chain amino acid and lactulose, or to continue only standard therapies for 6 months. The change of HRQOL by Short Form-36, hepatic encephalopathy grade, laboratory parameters, and neuropsychological (NP) tests were compared at baseline and at 6 months. We also evaluated via multivariate analysis whether zinc supplementation and clinical variables correlated with the changes in physical component scale (PCS) and mental component scale (MCS) between the two visits. Results Zinc supplementation significantly improved the PCS (P = 0.04), but not the MCS (P = 0.95). Zinc supplementation significantly decreased hepatic encephalopathy grade and blood ammonia levels (P = 0.03 and P = 0.01), and improved Child-Pugh score and NP tests compared with standard therapy (P = 0.04 and P = 0.02). In multivariate analysis, zinc supplementation was significantly associated with improvement in PCS (P = 0.03), whereas it was not significantly associated with change in MCS (P = 0.98). Conclusion Zinc supplementation is effective in hepatic encephalopathy and consequently improves patients HRQOL.
PMID: 20822500 [PubMed - as supplied by publisher]
Source
Takuma Y, Nouso K, Makino Y, Hayashi M, Takahashi H.
Department of Gastroenterology, Kurashiki Central Hospital, Okayama, Japan. Department of Internal Medicine, National Hospital Organization Iwakuni Center, Yamaguchi, Japan. Department of Molecular Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan. Department of Clinical Research, National Hospital Organization Iwakuni Clinical Center, Yamaguchi, Japan.
Abstract
Background Hepatic encephalopathy has a negative effect on patient health-related quality of life (HRQOL). Zinc supplementation has been effective with regard to altered nitrogen metabolism. Aim To investigate the effectiveness of oral zinc supplementation on hepatic encephalopathy and HRQOL. Methods Seventy-nine cirrhotic patients with hepatic encephalopathy were randomized to receive 225 mg of polaprezinc in addition to standard therapies of a protein-restricted diet including branched-chain amino acid and lactulose, or to continue only standard therapies for 6 months. The change of HRQOL by Short Form-36, hepatic encephalopathy grade, laboratory parameters, and neuropsychological (NP) tests were compared at baseline and at 6 months. We also evaluated via multivariate analysis whether zinc supplementation and clinical variables correlated with the changes in physical component scale (PCS) and mental component scale (MCS) between the two visits. Results Zinc supplementation significantly improved the PCS (P = 0.04), but not the MCS (P = 0.95). Zinc supplementation significantly decreased hepatic encephalopathy grade and blood ammonia levels (P = 0.03 and P = 0.01), and improved Child-Pugh score and NP tests compared with standard therapy (P = 0.04 and P = 0.02). In multivariate analysis, zinc supplementation was significantly associated with improvement in PCS (P = 0.03), whereas it was not significantly associated with change in MCS (P = 0.98). Conclusion Zinc supplementation is effective in hepatic encephalopathy and consequently improves patients HRQOL.
PMID: 20822500 [PubMed - as supplied by publisher]
Source
Cal State Long Beach gets grant to study faster HIV, syphilis, hepatitis C tests
By Kelly Puente, Staff Writer
Posted: 10/04/2010 04:12:08 PM PDT
Updated: 10/04/2010 04:59:32 PM PDT
LONG BEACH - Cal State Long Beach has been awarded a $1.7 million research grant to study the accuracy and acceptability of rapid tests for HIV, hepatitis C and syphilis, officials said.
Through rapid testing a patient is able to receive results on the same day they are tested.
Currently, there are no rapid tests available in the United States for syphilis or combined tests for HIV and hepatitis C. While the there are rapid tests available for HIV, newer, more accurate tests have been developed and are awaiting approval from the Federal Drug Administration.
Officials say rapid testing could increase the number of those receiving test results and could in turn help prevent the spread of infectious diseases.
"Traditional testing for infectious diseases requires clients to return for their test results one or two weeks after providing a sample. But, there are many people who don't return to get their results," said Dennis Fisher, director of behavioral research at Cal State Long Beach. "We believe this project can have a significant impact on the future of screening for infectious diseases in the U.S."
The project, which started on Thursday, will help the FDA gain a better understanding of who selects rapid tests and why. It could lead to the FDA's approval of the experimental tests, officials said.
The project will examine the accuracy and acceptability of six rapid tests for HIV, syphilis, and/or hepatitis C among high-risk groups including gay men, bisexual men and injection drug users.
Fisher believes the combined test for HIV and hepatitis C could be especially helpful in preventing the spread of disease among injected-drug users because it encourages HIV testing in the population.
The four-year grant for the school's Center for Behavioral Research and Services was funded by the National Institute on Drug Abuse.
kelly.puente@presstelegram.com, (562) 499-1305
Source
Posted: 10/04/2010 04:12:08 PM PDT
Updated: 10/04/2010 04:59:32 PM PDT
LONG BEACH - Cal State Long Beach has been awarded a $1.7 million research grant to study the accuracy and acceptability of rapid tests for HIV, hepatitis C and syphilis, officials said.
Through rapid testing a patient is able to receive results on the same day they are tested.
Currently, there are no rapid tests available in the United States for syphilis or combined tests for HIV and hepatitis C. While the there are rapid tests available for HIV, newer, more accurate tests have been developed and are awaiting approval from the Federal Drug Administration.
Officials say rapid testing could increase the number of those receiving test results and could in turn help prevent the spread of infectious diseases.
"Traditional testing for infectious diseases requires clients to return for their test results one or two weeks after providing a sample. But, there are many people who don't return to get their results," said Dennis Fisher, director of behavioral research at Cal State Long Beach. "We believe this project can have a significant impact on the future of screening for infectious diseases in the U.S."
The project, which started on Thursday, will help the FDA gain a better understanding of who selects rapid tests and why. It could lead to the FDA's approval of the experimental tests, officials said.
The project will examine the accuracy and acceptability of six rapid tests for HIV, syphilis, and/or hepatitis C among high-risk groups including gay men, bisexual men and injection drug users.
Fisher believes the combined test for HIV and hepatitis C could be especially helpful in preventing the spread of disease among injected-drug users because it encourages HIV testing in the population.
The four-year grant for the school's Center for Behavioral Research and Services was funded by the National Institute on Drug Abuse.
kelly.puente@presstelegram.com, (562) 499-1305
Source
A conversation with Dr. Grace McComsey, Rainbow Babies pediatric HIV/AIDS researcher
Published: Tuesday, October 05, 2010, 4:00 AM Updated: Tuesday, October 05, 2010, 6:32 AM
Angela Townsend, The Plain Dealer
A Q&A with Dr. Grace McComsey, chief Pediatric Infectious Diseases, Rheumatology, and Global Health at University Hospitals Rainbow Babies & Children's Hospital.
What is the life expectancy of a child born with HIV/AIDS?
The answer is not known. It's still short of the normal population because of co-morbidities like heart disease, liver disease, kidney disease. Any patient who is compliant with treatments is expected to live [a relatively normal life expectancy.] But the two big co-morbidities are heart disease and cancers.
Is HIV preventable in unborn babies?
Yes. Pediatric HIV is 100 percent preventable. That's why screening is so important. If a mother takes her medications and complies with treatment, yes.
What is the status of HIV studies involving children?
Any research of kids and HIV always lags behind adults.
For cardiovascular disease, my group tried to get ahead of the curve. Initially, we had a hard time getting funding [because of] all of this skepticism of the cardiovascular disease risk in kids. But we've already generated several papers and we've really changed the mentality of doctors treating patients.
Is there really a cardiovascular risk in children?
The youngest person [at Rainbow] who had a heart attack was a 24-year-old with HIV. It's true that a 10- or 15-year-old is not having a heart attack, but a 24-year-old with no risk factor had a huge heart attack. This was 4-5 years ago. At that time, we were not as aware as we are now.
Who are the pediatric HIV patients in your study? [Note: McComsey is leading a four-year study that is trying to determine the causes of heart problems in HIV-positive children].
All but one was born with HIV. They all started medication early on. They average [nine years of taking medication] by the time the study started.
Their viral loads are very low. They are doing well from an HIV point of view.
Their CD4 count (the number of CD4 cells a blood sample; the higher the number, the better one's immune system is able to fight off the disease) is very good. This is a good population, a compliant population. No opportunistic infections.
A lot of (the patients) were obese. People have worried so much about wasting that now they don't watch what they eat. They're at the other extreme now.
[Note: Wasting is a condition marked in AIDS patients by the loss of at least 10 percent of one's body weight, and/or severe diarrhea, weakness and fever.]
What have been some of the medical gains in diagnosing and treating newborns and babies?
The diagnosis used to be that you can't really rule out HIV until the child is 18 months of age. You could carry the antibody and [not have it show up] until 18 months. Now we can diagnose by 3 months. I can tell 100 percent if they have it or not when they are born with a blood test when they're born, another blood test at 1 month and a third test at 3 months.
[Note: HIV testing at birth is not done automatically. Parental consent must be provided before the test can be administered.]
Is there a typical regimen of drugs for kids?
There are three different medications, sometimes four, to start. They have to take them twice a day, in contrast with adults who could take one pill, once a day.
At Rainbow, the youngest kid in the study was treated at 9 days old, as soon as he was diagnosed with HIV. You don't want the immune system to take a hit. We can give them oral medications through a tube.
How does treating children differ from treating adults?
Taking care of HIV-infected kids is harder. There are very few drugs in suspension (liquid) form. Domestically, they're not available. All of the money for pediatric HIV [care] is going overseas. We still have a domestic issue.
How do the drugs and the HIV itself impact other areas of health in children?
The long term complications of HIV treatment in kids and adults include lipodystrophy (an abnormal change in body composition with either fat loss or fat build up) due to old medications such as AZT. It also causes mitochondrial toxicity (damage that decreases the number of mitochondria, which provide the body's cells with energy) which is shown to increase depression and decrease quality of life.
Kids stop taking their meds because of lipodystrophy. These meds are keeping them alive but there are complications. In adults we're using newer drugs but in kids we are obligated to use the older drugs.
Tenofovir has really replaced AZT but it does not come in suspension form for kids.
How did you get into this field?
I trained at Case in infectious diseases at a time when we had a lot of sick HIV patients. During my training we lost five HIV kids. Sometimes some cases really hit you. One was a 10-year-old, so cute! I just saw him wasting and wasting, and then dying. He was a hemophiliac and got it through a blood transfusion. It just broke my heart.
HIV is really my passion. I wanted to make a difference. That's why I got into that field.
-- Angela Townsend
Source
Angela Townsend, The Plain Dealer
A Q&A with Dr. Grace McComsey, chief Pediatric Infectious Diseases, Rheumatology, and Global Health at University Hospitals Rainbow Babies & Children's Hospital.
What is the life expectancy of a child born with HIV/AIDS?
The answer is not known. It's still short of the normal population because of co-morbidities like heart disease, liver disease, kidney disease. Any patient who is compliant with treatments is expected to live [a relatively normal life expectancy.] But the two big co-morbidities are heart disease and cancers.
Is HIV preventable in unborn babies?
Yes. Pediatric HIV is 100 percent preventable. That's why screening is so important. If a mother takes her medications and complies with treatment, yes.
What is the status of HIV studies involving children?
Any research of kids and HIV always lags behind adults.
For cardiovascular disease, my group tried to get ahead of the curve. Initially, we had a hard time getting funding [because of] all of this skepticism of the cardiovascular disease risk in kids. But we've already generated several papers and we've really changed the mentality of doctors treating patients.
Is there really a cardiovascular risk in children?
The youngest person [at Rainbow] who had a heart attack was a 24-year-old with HIV. It's true that a 10- or 15-year-old is not having a heart attack, but a 24-year-old with no risk factor had a huge heart attack. This was 4-5 years ago. At that time, we were not as aware as we are now.
Who are the pediatric HIV patients in your study? [Note: McComsey is leading a four-year study that is trying to determine the causes of heart problems in HIV-positive children].
All but one was born with HIV. They all started medication early on. They average [nine years of taking medication] by the time the study started.
Their viral loads are very low. They are doing well from an HIV point of view.
Their CD4 count (the number of CD4 cells a blood sample; the higher the number, the better one's immune system is able to fight off the disease) is very good. This is a good population, a compliant population. No opportunistic infections.
A lot of (the patients) were obese. People have worried so much about wasting that now they don't watch what they eat. They're at the other extreme now.
[Note: Wasting is a condition marked in AIDS patients by the loss of at least 10 percent of one's body weight, and/or severe diarrhea, weakness and fever.]
What have been some of the medical gains in diagnosing and treating newborns and babies?
The diagnosis used to be that you can't really rule out HIV until the child is 18 months of age. You could carry the antibody and [not have it show up] until 18 months. Now we can diagnose by 3 months. I can tell 100 percent if they have it or not when they are born with a blood test when they're born, another blood test at 1 month and a third test at 3 months.
[Note: HIV testing at birth is not done automatically. Parental consent must be provided before the test can be administered.]
Is there a typical regimen of drugs for kids?
There are three different medications, sometimes four, to start. They have to take them twice a day, in contrast with adults who could take one pill, once a day.
At Rainbow, the youngest kid in the study was treated at 9 days old, as soon as he was diagnosed with HIV. You don't want the immune system to take a hit. We can give them oral medications through a tube.
How does treating children differ from treating adults?
Taking care of HIV-infected kids is harder. There are very few drugs in suspension (liquid) form. Domestically, they're not available. All of the money for pediatric HIV [care] is going overseas. We still have a domestic issue.
How do the drugs and the HIV itself impact other areas of health in children?
The long term complications of HIV treatment in kids and adults include lipodystrophy (an abnormal change in body composition with either fat loss or fat build up) due to old medications such as AZT. It also causes mitochondrial toxicity (damage that decreases the number of mitochondria, which provide the body's cells with energy) which is shown to increase depression and decrease quality of life.
Kids stop taking their meds because of lipodystrophy. These meds are keeping them alive but there are complications. In adults we're using newer drugs but in kids we are obligated to use the older drugs.
Tenofovir has really replaced AZT but it does not come in suspension form for kids.
How did you get into this field?
I trained at Case in infectious diseases at a time when we had a lot of sick HIV patients. During my training we lost five HIV kids. Sometimes some cases really hit you. One was a 10-year-old, so cute! I just saw him wasting and wasting, and then dying. He was a hemophiliac and got it through a blood transfusion. It just broke my heart.
HIV is really my passion. I wanted to make a difference. That's why I got into that field.
-- Angela Townsend
Source
Hepatitis C Drugs Rated By Consumer Reports
10/4/2010 11:44 AM ET
(RTTNews) - Consumer Reports has published recommendations regarding two drugs used in the treatment of Hepatitis C.
Consumer Reports analyzed the evidence for PegIntron and Pegasys, and found that neither has been shown to be more effective than the other. The magazine said that the two drugs do vary considerably, however, when it comes to price.
PegIntron could save consumers hundreds to thousands of dollars over Pegasys, depending on the dose and length of treatment.
The pegylated interferons can help eliminate the virus from the body, but they are very expensive, costing between $15,000 and $30,000 for a course of treatment.
These drugs can also cause a wide range of side effects, Consumer Reports points out, including flu-like symptoms such as muscle aches, fever, fatigue, depression, diarrhea, nausea, and rashes or other skin-related problems. Life-threatening or fatal problems are rare but include suicide, relapse of drug abuse or overdose and liver failure.
Hepatitis C, which afflicts an estimated four million people in the U.S., can lead to liver damage and death. It is contracted by exposure to contaminated blood and other bodily fluids.
by RTT Staff Writer
For comments and feedback: contact editorial@rttnews.com
Source
(RTTNews) - Consumer Reports has published recommendations regarding two drugs used in the treatment of Hepatitis C.
Consumer Reports analyzed the evidence for PegIntron and Pegasys, and found that neither has been shown to be more effective than the other. The magazine said that the two drugs do vary considerably, however, when it comes to price.
PegIntron could save consumers hundreds to thousands of dollars over Pegasys, depending on the dose and length of treatment.
The pegylated interferons can help eliminate the virus from the body, but they are very expensive, costing between $15,000 and $30,000 for a course of treatment.
These drugs can also cause a wide range of side effects, Consumer Reports points out, including flu-like symptoms such as muscle aches, fever, fatigue, depression, diarrhea, nausea, and rashes or other skin-related problems. Life-threatening or fatal problems are rare but include suicide, relapse of drug abuse or overdose and liver failure.
Hepatitis C, which afflicts an estimated four million people in the U.S., can lead to liver damage and death. It is contracted by exposure to contaminated blood and other bodily fluids.
by RTT Staff Writer
For comments and feedback: contact editorial@rttnews.com
Source
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