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NWHM-big 51,000 share buy at 12.75 this morning--way undervalued imho---g/l
RGS Energy (Nasdaq:RSOL), a nationwide leader of turnkey solar energy solutions for residential,
commercial, and utility customers, and Altus Power America Management, an investor in and manager
of solar power projects, formed a new joint venture, RGS Energy Asset Management LLC. The purpose
of the joint venture is to develop, finance and manage up to $150 million of commercial solar
projects.
"Our partnership with Altus is unique in that it takes advantage of best practices from both
organizations developed over many years of solar energy experience," said Andrew Zaref, vice
president of project finance at RGS Energy and president of RGS Energy Asset Management. "It also
represents RGS Energy's first foray into asset energy ownership and long-term asset management, as
well as creates a great platform to fuel growth and access to untapped and new markets."
The joint venture is designed to bring RGS Energy into the arena of energy asset ownership,
leveraging both organizations' expertise in developing, building and owning energy assets. The
partners will jointly manage the available pool of capital, so funds can be more quickly and
efficiently deployed to propel growth. Further, it allows RGS Energy to integrate credit
qualification and capital sourcing into its core operations. This integrated approach is expected
to streamline and improve RGS Energy's already industry leading customer acquisition, engineering,
construction and project monitoring capabilities.
"Altus and RGS Energy are working together to solve many of the issues that have prevented large
scale and repeatable deployment of affordable solar power," said Lars Norell, managing partner of
Altus Power America Management. "This joint venture is expected to allow us to identify attractive
solar power projects across the country and efficiently deploy capital throughout the US solar
market. We anticipate that this initial deployment of $150 million of capital will be the first of
many as we partner with RGS Energy, a leading solar company in the country, to create and enhance
value for both organizations."
Kam Mofid, RGS Energy's CEO, said: "This joint venture is an excellent example of how we are
broadening the reach and scope of our business activities to accelerate growth, enhance margins,
and to better serve our customers. It also provides us the future flexibility to deploy our own
capital through the joint venture, at the amount of our choosing, as we extend into the energy
asset ownership domain."
The joint venture will offer power purchase agreements and other financial solutions to customers.
The parties expect the first fully financed projects to be operational as early as the second
quarter of 2014.
RGS Energy's clean energy services are currently available in Arizona, California, Colorado,
Connecticut, Delaware, the District of Columbia, Maryland, Massachusetts, Oregon, New Jersey, New
York, Pennsylvania, Rhode Island, Texas, Vermont, Washington, and Puerto Rico.
About Altus Power America Management, LLC
Altus Power America Management, LLC is an Old Greenwich, Connecticut-based company that invests
in, owns and operates clean energy projects. The partners' financial expertise and backgrounds in
construction, engineering and design combined with the firm's institutional sponsorship provide an
efficient and scalable platform to provide renewable energy and solar solutions to commercial and
public sector clients. Visit www.altuspower.com
http://www.globenewswire.com/newsroom/ctr?d=10066793&l=8&a=www.altuspower.com&u=file%3A%2F%2F10.10.67.5%2Fnas01%2FAltus%2520Power%2FPR%2520and%2520Marketing%2FPress%2520Releases%2Fwww.altuspower.com
for more information.
About RGS Energy
RGS Energy (Nasdaq:RSOL) is one of the nation's pioneering solar energy companies serving
commercial, residential, and utility customers. Beginning with one of the very first photovoltaic
panels sold to the public in the U.S. in 1978, the company has installed more than 19,000 solar
power systems representing well over 170 megawatts of 100% clean renewable energy. RGS Energy
makes it very convenient for customers to save on their energy bill by providing a comprehensive
solar solution, from design, financing, permitting and installation to ongoing monitoring,
maintenance and support. As one of the nation's largest and most experienced solar power players,
the company has 17 offices across the West and the Northeast. For more information, visit
RGSEnergy.com, on Facebook at www.facebook.com/rgsenergy
http://www.globenewswire.com/newsroom/ctr?d=10066793&l=9&a=www.facebook.com%2Frgsenergy&u=http%3A%2F%2Fwww.facebook.com%2Frgsenergy
and on Twitter at www.twitter.com/rgsenergy
http://www.globenewswire.com/newsroom/ctr?d=10066793&l=9&a=www.twitter.com%2Frgsenergy&u=http%3A%2F%2Fwww.twitter.com%2Frgsenergy
. RGS Energy is a trade name and RGS Energy makes filings with the Securities and Exchange
Commission under its official name "Real Goods Solar, Inc."
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements relating to matters that are not historical
facts. Forward-looking statements may be identified by the use of words such as "expect,"
"intend," "believe," "will," "should" or comparable terminology or by discussions of strategy.
While Real Goods Solar, Inc. believes its assumptions and expectations underlying forward-looking
statements are reasonable, there can be no assurance that actual results will not be materially
different. Risks and uncertainties that could cause materially different results include, among
others, our ability to successfully source and complete solar power projects under this joint
venture, realizing synergies and other benefits from the Mercury merger, introduction of new
products and services, completion and integration of acquisitions, possibility of negative
economic conditions and other risks and uncertainties included in Real Goods Solar, Inc.'s filings
with the Securities and Exchange Commission. Real Goods Solar, Inc. assumes no duty to update any
forward-looking statements.
CONTACT: Media and Investor Relations Contact
Ron Both
Liolios Group, Inc.
Tel 1-949-574-3860
RSOL@liolios.com
For Reuters Top News page click the following link:
http://activetrader.schwab.com/ReutersNewsRedirect.aspx?vAnUSHeRl3nny5haw=781hmnBHYajoIt8wxH120PgtYuUecBLHG0818
RGS Energy (Nasdaq:RSOL), a nationwide leader of turnkey solar energy solutions for residential,
commercial, and utility customers, and Altus Power America Management, an investor in and manager
of solar power projects, formed a new joint venture, RGS Energy Asset Management LLC. The purpose
of the joint venture is to develop, finance and manage up to $150 million of commercial solar
projects.
"Our partnership with Altus is unique in that it takes advantage of best practices from both
organizations developed over many years of solar energy experience," said Andrew Zaref, vice
president of project finance at RGS Energy and president of RGS Energy Asset Management. "It also
represents RGS Energy's first foray into asset energy ownership and long-term asset management, as
well as creates a great platform to fuel growth and access to untapped and new markets."
The joint venture is designed to bring RGS Energy into the arena of energy asset ownership,
leveraging both organizations' expertise in developing, building and owning energy assets. The
partners will jointly manage the available pool of capital, so funds can be more quickly and
efficiently deployed to propel growth. Further, it allows RGS Energy to integrate credit
qualification and capital sourcing into its core operations. This integrated approach is expected
to streamline and improve RGS Energy's already industry leading customer acquisition, engineering,
construction and project monitoring capabilities.
"Altus and RGS Energy are working together to solve many of the issues that have prevented large
scale and repeatable deployment of affordable solar power," said Lars Norell, managing partner of
Altus Power America Management. "This joint venture is expected to allow us to identify attractive
solar power projects across the country and efficiently deploy capital throughout the US solar
market. We anticipate that this initial deployment of $150 million of capital will be the first of
many as we partner with RGS Energy, a leading solar company in the country, to create and enhance
value for both organizations."
Kam Mofid, RGS Energy's CEO, said: "This joint venture is an excellent example of how we are
broadening the reach and scope of our business activities to accelerate growth, enhance margins,
and to better serve our customers. It also provides us the future flexibility to deploy our own
capital through the joint venture, at the amount of our choosing, as we extend into the energy
asset ownership domain."
The joint venture will offer power purchase agreements and other financial solutions to customers.
The parties expect the first fully financed projects to be operational as early as the second
quarter of 2014.
RGS Energy's clean energy services are currently available in Arizona, California, Colorado,
Connecticut, Delaware, the District of Columbia, Maryland, Massachusetts, Oregon, New Jersey, New
York, Pennsylvania, Rhode Island, Texas, Vermont, Washington, and Puerto Rico.
About Altus Power America Management, LLC
Altus Power America Management, LLC is an Old Greenwich, Connecticut-based company that invests
in, owns and operates clean energy projects. The partners' financial expertise and backgrounds in
construction, engineering and design combined with the firm's institutional sponsorship provide an
efficient and scalable platform to provide renewable energy and solar solutions to commercial and
public sector clients. Visit www.altuspower.com
http://www.globenewswire.com/newsroom/ctr?d=10066793&l=8&a=www.altuspower.com&u=file%3A%2F%2F10.10.67.5%2Fnas01%2FAltus%2520Power%2FPR%2520and%2520Marketing%2FPress%2520Releases%2Fwww.altuspower.com
for more information.
About RGS Energy
RGS Energy (Nasdaq:RSOL) is one of the nation's pioneering solar energy companies serving
commercial, residential, and utility customers. Beginning with one of the very first photovoltaic
panels sold to the public in the U.S. in 1978, the company has installed more than 19,000 solar
power systems representing well over 170 megawatts of 100% clean renewable energy. RGS Energy
makes it very convenient for customers to save on their energy bill by providing a comprehensive
solar solution, from design, financing, permitting and installation to ongoing monitoring,
maintenance and support. As one of the nation's largest and most experienced solar power players,
the company has 17 offices across the West and the Northeast. For more information, visit
RGSEnergy.com, on Facebook at www.facebook.com/rgsenergy
http://www.globenewswire.com/newsroom/ctr?d=10066793&l=9&a=www.facebook.com%2Frgsenergy&u=http%3A%2F%2Fwww.facebook.com%2Frgsenergy
and on Twitter at www.twitter.com/rgsenergy
http://www.globenewswire.com/newsroom/ctr?d=10066793&l=9&a=www.twitter.com%2Frgsenergy&u=http%3A%2F%2Fwww.twitter.com%2Frgsenergy
. RGS Energy is a trade name and RGS Energy makes filings with the Securities and Exchange
Commission under its official name "Real Goods Solar, Inc."
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements relating to matters that are not historical
facts. Forward-looking statements may be identified by the use of words such as "expect,"
"intend," "believe," "will," "should" or comparable terminology or by discussions of strategy.
While Real Goods Solar, Inc. believes its assumptions and expectations underlying forward-looking
statements are reasonable, there can be no assurance that actual results will not be materially
different. Risks and uncertainties that could cause materially different results include, among
others, our ability to successfully source and complete solar power projects under this joint
venture, realizing synergies and other benefits from the Mercury merger, introduction of new
products and services, completion and integration of acquisitions, possibility of negative
economic conditions and other risks and uncertainties included in Real Goods Solar, Inc.'s filings
with the Securities and Exchange Commission. Real Goods Solar, Inc. assumes no duty to update any
forward-looking statements.
CONTACT: Media and Investor Relations Contact
Ron Both
Liolios Group, Inc.
Tel 1-949-574-3860
RSOL@liolios.com
For Reuters Top News page click the following link:
http://activetrader.schwab.com/ReutersNewsRedirect.aspx?vAnUSHeRl3nny5haw=781hmnBHYajoIt8wxH120PgtYuUecBLHG0818
NWHM-IPO'ed last Friday-more upscale homebuiler-The homes that we and our unconsolidated joint ventures are building range in price from approximately $300,000 to $3.2 million, with home sizes ranging from approximately 800 to 5,300 square feet. Customer-focused community creation and product development, as well as exemplary customer service, are key components of the lifestyle connection we seek to establish with each homebuyer.
Read more: http://www.nasdaq.com/markets/ipos/company/new-home-co-llc-908836-72802#ixzz2sMDdkkEi
NWHM-IPO'ed last Friday-more upscale homebuiler-The homes that we and our unconsolidated joint ventures are building range in price from approximately $300,000 to $3.2 million, with home sizes ranging from approximately 800 to 5,300 square feet. Customer-focused community creation and product development, as well as exemplary customer service, are key components of the lifestyle connection we seek to establish with each homebuyer.
Read more: http://www.nasdaq.com/markets/ipos/company/new-home-co-llc-908836-72802#ixzz2sMDdkkEi
NWHM-IPO'ed Friday-up .30 on a bad red DOW day-going to fly when the DOW goes green
.
jmho
NWHM-IPO'ed Friday-up .30 on a bad red DOW day-going to fly when the DOW goes green
.
jmho
NWHM-at 12.00-radar this housing stock-IPO'ed Friday-undervalued imho--it was supposed to ipo at 15.00 to 17.00 but bad market last week it opened at 11.00--jmho
NWHM-at 12.00-radar this housing stock-IPO'ed Friday-undervalued imho--it was supposed to ipo at 15.00 to 17.00 but bad market last week it opened at 11.00--jmho
NWHM, IPO'ed Friday at 11.50- Builder makes tons of money by selling the extremely expensive houses in CA. Better buy the stock and live in TX.
NWHM, IPO'ed Friday at 11.50- Builder makes tons of money by selling the extremely expensive houses in CA. Better buy the stock and live in TX.
NWHM Homebuilder IPO'ed today--bought some at 12.00- eom
NWHM Homebuilder IPO'ed today--bought some at 12.00- eom
DRWI-ut-now 10k bid at 1.60--dd it-great China contract etc. the last 4 weeks--
DRWI-ut-now 10k bid at 1.60--dd it-great China contract etc. the last 4 weeks--
DRWI-1.57 x 1.58---11,000 x 200- dd it-eom
DRWI-1.57 x 1.58---11,000 x 200- dd it-eom
DRWI-radar close-read all the great news last 4 weeks--load point imho--eom
DRWI-radar close-read all the great news last 4 weeks--load point imho--eom
DRWI---a little dd--inside--
http://finance.yahoo.com/news/dragonwave-introduces-harmony-trunk-c-130000953.html
http://finance.yahoo.com/news/dragonwave-gogo-enabling-connectivity-30-130000747.html
http://finance.yahoo.com/news/dragonwave-xian-potevio-communications-establish-130000137.html
http://www.dragonwaveinc.com/
very big CHINA news
they beat their Q recently-
should be a very good stock this year--jmho--g/l
DRWI---a little dd--inside--
http://finance.yahoo.com/news/dragonwave-introduces-harmony-trunk-c-130000953.html
http://finance.yahoo.com/news/dragonwave-gogo-enabling-connectivity-30-130000747.html
http://finance.yahoo.com/news/dragonwave-xian-potevio-communications-establish-130000137.html
http://www.dragonwaveinc.com/
very big CHINA news
they beat their Q recently-
should be a very good stock this year--jmho--g/l
DRWI--chipping at HOD 1.59--dd it---eom
DRWI--chipping at HOD 1.59--dd it---eom
DRWI--a must dd--look at all the news last 3 or 4 weeks---eom
DRWI--a must dd--look at all the news last 3 or 4 weeks---eom
DRWI--a must dd--look at all the news last 3 or 4 weeks---eom
DRWI---dd it---eom
HOV-at HOD--6.06--great 2014 for housing stocks--jmho
HOV-at HOD--6.06--great 2014 for housing stocks--jmho
DRWI-load 1.50's and wait on the next big press--dd it---eom
DRWI-load 1.50's and wait on the next big press--dd it---eom
DRWI-load 1.50's and wait on the next big press--dd it---eom
DRWI-load 1.50's and wait on the next big press--dd it---eom
DRWI-load point-jmho-look at all the news the last 2 weeks--China etc.
DRWI-load point-jmho-look at all the news the last 2 weeks--China etc.
CLSN-410k pre market volume-average is 500k-nice news out--eom
CLSN-big news out--elsion Corporation Announces Updated Overall Survival Results from Phase III HEAT Study of ThermoDox(R) in Primary Liver Cancer
Latest Data from Large Subgroup of Patients Shows that the Combination of ThermoDox(R) and Optimized RFA Provides a Statistically Significant Survival Improvement of Over 50%
Provides Basis for Further Development of ThermoDox(R) in HCC Patients
PR Newswire
LAWRENCEVILLE, N.J., Jan. 27, 2014
LAWRENCEVILLE, N.J., Jan. 27, 2014 /PRNewswire/ -- Celsion Corporation ( NASDAQ: CLSN) today announced that the latest overall survival data from its post-hoc analysis of results from the Company's Phase III HEAT Study of ThermoDox(R), Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radio frequency ablation (RFA), supports the continued clinical development of ThermoDox(R) in a prospective pivotal Phase III Study, subject to regulatory review and agreement. This analysis followed the announcement on January 31, 2013, that the HEAT Study did not meet its primary endpoint, progression-free survival (PFS). As provided for in the HEAT Study's Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), the Company continues to follow patients for overall survival, the secondary endpoint of the Study. Data from four quarterly reviews of overall survival have been evaluated since the announcement of top line PFS data.
Data from the updated HEAT Study analysis suggests that ThermoDox(R) may significantly improve overall survival, compared to control, in patients whose lesions undergo RFA treatment for 45 minutes or more. These findings apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients (41% of the patients in the HEAT Study). Updated OS data from this subgroup of patients is summarized below:
-- In the patient subgroup treated in the ThermoDox(R) arm, whose RFA
procedure lasted longer than 45 minutes (285 patients or 63% of single
lesion patients) clinical results indicate a 55% improvement in overall
survival, a Hazard Ratio of 0.64 (95% CI 0.41 -- 1.00) and a P-value =
0.0495. Median overall survival for this subgroup has not yet been
reached.
-- In contrast, the patient subgroup treated with ThermoDox(R) whose RFA
procedure lasted less than 45 minutes in duration (167 patients or 37% of
single lesion patients) indicated a Hazard Ratio of 1.12 (95% CI 0.68 --
1.86) and a P-value = 0.66. Median overall survival for this subgroup
has not yet been reached.
-- The Hazard Ratios reported above warrants additional clinical development
and should be viewed with caution since they are based on a retrospective
analysis and the HEAT Study has not reached its median point for overall
survival analysis. Celsion will continue to follow patients in the HEAT
Study to the secondary endpoint, overall survival, and will update the
subgroup analysis based on RFA heating duration.
"The HEAT Study post-hoc data is compelling. The combination of ThermoDox(R) and an optimized RFA treatment appears to have a significant improvement in overall survival in HCC patients," stated Dr. Nicholas Borys, Celsion's Chief Medical Officer. "While this conclusion is reached based on a post-hoc evaluation, it is nonetheless supported by the consistency of the data seen over a one year follow-up period, and by what is now a statistically significant outcome for overall survival. Our investigators are convinced that RFA can and should be optimized in future trials."
The HEAT Study and prior post-hoc analyses were presented at three medical conferences in 2013, including the World Conference on Interventional Oncology in May; the European Conference on Interventional Oncology in June and the International Liver Cancer Association Annual Conference in September. Presentations were made by some of the most highly recognized liver cancer researchers and key HEAT Study investigators. Quarterly overall survival data analyses have been conducted with the full support of these researchers and clinical investigators.
Additionally, Celsion has been consulting with its clinical advisors, regulatory and expert statistician consultants and the FDA regarding the study design and statistical plan for its proposed pivotal Phase III clinical trial. The Company anticipates initiating a multicenter global trial in the first half of 2014.
"These data continue to support our strong interest in ThermoDox(R) and its potential as a first line treatment for a significant percentage of the world's 750,000 newly diagnosed HCC patients," noted Michael H. Tardugno, Celsion's President and Chief Executive Officer. "In addition to the FDA, the Company is pursuing regulatory approval of its new Phase III clinical trial in multiple countries, particularly those where HCC's prevalence represents an important health issue. In parallel with this effort, we are recruiting key CRO partners to initiate the Study rapidly following regulatory agency agreement. With our strong financial resources and the support of the global HCC community, we are confident in our ability to conduct a timely and cash efficient pivotal program."
About Celsion Corporation
Celsion is dedicated to the development and commercialization of innovative cancer drugs, including tumor-targeting treatments using focused heat energy in combination with heat-activated liposomal drug technology. Celsion has research, license or commercialization agreements with leading institutions, including the National Institutes of Health, Duke University Medical Center, University of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the Kyungpook National University Hospital, the Beijing Cancer Hospital and the University of Oxford. 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; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time, and risk of failure of conducting clinical trials; HEAT Study data is subject to further verification and review by the HEAT Study Data Management Committee; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses or the possible failure to make such acquisitions or licenses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Celsion's periodic reports and prospectuses filed with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement forward- looking statements that become untrue because of subsequent events, new information or otherwise.
Investor Contact
Jeffrey W. Church
Senior Vice President and
Chief Financial Officer
609-482-2455
jchurch@celsion.com
SOURCE Celsion Corporation
/Web site: http://www.celsion.com
(END) Dow Jones Newswires
01-27-14 0800ET
Copyright 2014, Dow Jones and Company, Inc. News Provided by Acquire Media Corporation
CLSN-big news out--elsion Corporation Announces Updated Overall Survival Results from Phase III HEAT Study of ThermoDox(R) in Primary Liver Cancer
Latest Data from Large Subgroup of Patients Shows that the Combination of ThermoDox(R) and Optimized RFA Provides a Statistically Significant Survival Improvement of Over 50%
Provides Basis for Further Development of ThermoDox(R) in HCC Patients
PR Newswire
LAWRENCEVILLE, N.J., Jan. 27, 2014
LAWRENCEVILLE, N.J., Jan. 27, 2014 /PRNewswire/ -- Celsion Corporation ( NASDAQ: CLSN) today announced that the latest overall survival data from its post-hoc analysis of results from the Company's Phase III HEAT Study of ThermoDox(R), Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radio frequency ablation (RFA), supports the continued clinical development of ThermoDox(R) in a prospective pivotal Phase III Study, subject to regulatory review and agreement. This analysis followed the announcement on January 31, 2013, that the HEAT Study did not meet its primary endpoint, progression-free survival (PFS). As provided for in the HEAT Study's Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), the Company continues to follow patients for overall survival, the secondary endpoint of the Study. Data from four quarterly reviews of overall survival have been evaluated since the announcement of top line PFS data.
Data from the updated HEAT Study analysis suggests that ThermoDox(R) may significantly improve overall survival, compared to control, in patients whose lesions undergo RFA treatment for 45 minutes or more. These findings apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients (41% of the patients in the HEAT Study). Updated OS data from this subgroup of patients is summarized below:
-- In the patient subgroup treated in the ThermoDox(R) arm, whose RFA
procedure lasted longer than 45 minutes (285 patients or 63% of single
lesion patients) clinical results indicate a 55% improvement in overall
survival, a Hazard Ratio of 0.64 (95% CI 0.41 -- 1.00) and a P-value =
0.0495. Median overall survival for this subgroup has not yet been
reached.
-- In contrast, the patient subgroup treated with ThermoDox(R) whose RFA
procedure lasted less than 45 minutes in duration (167 patients or 37% of
single lesion patients) indicated a Hazard Ratio of 1.12 (95% CI 0.68 --
1.86) and a P-value = 0.66. Median overall survival for this subgroup
has not yet been reached.
-- The Hazard Ratios reported above warrants additional clinical development
and should be viewed with caution since they are based on a retrospective
analysis and the HEAT Study has not reached its median point for overall
survival analysis. Celsion will continue to follow patients in the HEAT
Study to the secondary endpoint, overall survival, and will update the
subgroup analysis based on RFA heating duration.
"The HEAT Study post-hoc data is compelling. The combination of ThermoDox(R) and an optimized RFA treatment appears to have a significant improvement in overall survival in HCC patients," stated Dr. Nicholas Borys, Celsion's Chief Medical Officer. "While this conclusion is reached based on a post-hoc evaluation, it is nonetheless supported by the consistency of the data seen over a one year follow-up period, and by what is now a statistically significant outcome for overall survival. Our investigators are convinced that RFA can and should be optimized in future trials."
The HEAT Study and prior post-hoc analyses were presented at three medical conferences in 2013, including the World Conference on Interventional Oncology in May; the European Conference on Interventional Oncology in June and the International Liver Cancer Association Annual Conference in September. Presentations were made by some of the most highly recognized liver cancer researchers and key HEAT Study investigators. Quarterly overall survival data analyses have been conducted with the full support of these researchers and clinical investigators.
Additionally, Celsion has been consulting with its clinical advisors, regulatory and expert statistician consultants and the FDA regarding the study design and statistical plan for its proposed pivotal Phase III clinical trial. The Company anticipates initiating a multicenter global trial in the first half of 2014.
"These data continue to support our strong interest in ThermoDox(R) and its potential as a first line treatment for a significant percentage of the world's 750,000 newly diagnosed HCC patients," noted Michael H. Tardugno, Celsion's President and Chief Executive Officer. "In addition to the FDA, the Company is pursuing regulatory approval of its new Phase III clinical trial in multiple countries, particularly those where HCC's prevalence represents an important health issue. In parallel with this effort, we are recruiting key CRO partners to initiate the Study rapidly following regulatory agency agreement. With our strong financial resources and the support of the global HCC community, we are confident in our ability to conduct a timely and cash efficient pivotal program."
About Celsion Corporation
Celsion is dedicated to the development and commercialization of innovative cancer drugs, including tumor-targeting treatments using focused heat energy in combination with heat-activated liposomal drug technology. Celsion has research, license or commercialization agreements with leading institutions, including the National Institutes of Health, Duke University Medical Center, University of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the Kyungpook National University Hospital, the Beijing Cancer Hospital and the University of Oxford. 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; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time, and risk of failure of conducting clinical trials; HEAT Study data is subject to further verification and review by the HEAT Study Data Management Committee; the need for Celsion to evaluate its future development plans; possible acquisitions or licenses of other technologies, assets or businesses or the possible failure to make such acquisitions or licenses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Celsion's periodic reports and prospectuses filed with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement forward- looking statements that become untrue because of subsequent events, new information or otherwise.
Investor Contact
Jeffrey W. Church
Senior Vice President and
Chief Financial Officer
609-482-2455
jchurch@celsion.com
SOURCE Celsion Corporation
/Web site: http://www.celsion.com
(END) Dow Jones Newswires
01-27-14 0800ET
Copyright 2014, Dow Jones and Company, Inc. News Provided by Acquire Media Corporation
NM-shipper-cash distribution of .4425 announced-not hit wires yet-for holders FEB 10th. payable 14th.
.I just see it on Schwab trader??
anyone confirm this? was thinking of buying--thanks
NM-shipper-cash distribution of .4425 announced-not hit wires yet-for holders FEB 10th. payable 14th.
.I just see it on Schwab trader??
anyone confirm this? was thinking of buying--thanks