Counting my change
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GNVC in Play
$2.55
BIEL New Audited Annual Report (Inception thru 2008)
One step closer to OTCBB!!!
http://www.otcmarkets.com/otciq/ajax/showFinancialReportById.pdf?id=29235
http://www.otcmarkets.com/pink/quote/quote.jsp?symbol=biel#getFilings and go to filings
BIEL New Audited Filing (Inception thru 2008)
One step closer to OTCBB!!
http://www.otcmarkets.com/otciq/ajax/showFinancialReportById.pdf?id=29235
http://www.otcmarkets.com/pink/quote/quote.jsp?symbol=biel#getFilings and go to filings
IN PLAY..GenVec Announces Contract With The Department of Homeland Security
prnewswire
Press Release Source: GenVec, Inc. On Friday February 19, 2010, 7:24 am
GAITHERSBURG, Md., Feb. 19 /PRNewswire-FirstCall/ -- Today GenVec, Inc. (Nasdaq:GNVC - News) announced a new contract with the Department of Homeland Security (DHS) to continue the development of adenovector-based vaccines against foot-and-mouth disease (FMD) based on research and development done in collaboration with USDA-ARS and DHS S&T scientists at the Plum Island Animal Disease Center. Under this new agreement, GenVec will receive $3.8 million in program funding the first year and an additional $0.7 million if DHS exercises its renewal option under the contract. Â
Under this contract, GenVec will use its adenovector technology to develop additional FMD-serotype candidate vaccines. GenVec will also explore methods to increase the potency and simplify the production process of FMD vaccines developed under this contract as well as its previous contract with the DHS announced in 2007.
"This contract expands our ongoing efforts to develop adenovector-based FMD vaccines," said Dr. Paul Fischer, GenVec's President and Chief Executive Officer. "This new contract with the DHS will support new vaccine discovery and technology improvement for this important threat." Â
About GenVec
GenVec, Inc. is a biopharmaceutical company developing novel therapeutic drugs and vaccines. GenVec's lead product, TNFeradeâ?¢, is currently in a pivotal clinical study (PACT) in locally advanced pancreatic cancer. TNFerade has also been and is currently being evaluated for its potential use in the treatment of several other cancers, including esophageal cancer, rectal cancer, and head and neck cancer. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV, malaria, foot-and-mouth disease, respiratory syncytial virus (RSV), and HSV-2. Additional information about GenVec is available at www.genvec.com and in the company's various filings with the Securities and Exchange Commission.
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues and operating expenses, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Â GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Â Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by GenVec to secure and maintain relationships with collaborators; risks relating to the early stage of GenVec's product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of GenVec's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; and risks that we may lack the financial resources and access to capital to fund our operations. Â Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations, are contained in GenVec's filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Â These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements.
Investor Contact:
Media Contact:
GenVec, Inc.
Tiberend Strategic Advisors, Inc.
Danielle M. DiPirro
Andrew Mielach
(301) 944-1877
(212) 827-0020
ddipirro@genvec.com
amielach@tiberendstrategicadvisors.com
ANX over 20% in 30 min
ANX in Play!! up 13% on Heavy Volume
ANX up 13%
ANX in Play Volume rising hard
TDLP NEWS
Form 8-K for TRANSDEL PHARMACEUTICALS INC
18-Feb-2010
Change in Directors or Principal Officers, Financial Statements and
Item 5.02 Departure of Directors of Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
The Board of Directors (the "Board") of Transdel Pharmaceuticals, Inc. (the "Company") accepted the resignation of Dr. Juliet Singh as Chief Executive Officer of the Company and as a director on the Board, effective February 17, 2010. The Board appointed Jeffrey J. Abrams, M.D. as Chairman of the Board. The Board also appointed John T. Lomoro, the Company's current Chief Financial Officer, as acting Chief Executive Officer. Mr. Lomoro will also serve as the Company's principal executive officer.
In connection with Dr. Singh's resignation, the Company and Dr. Singh entered into a separation agreement that provides Dr. Singh with one year of continued salary in accordance with the terms of her existing employment agreement as well as the accelerated vesting of 300,000 stock options previously granted. In addition, Dr. Singh will have three years from the date of her resignation to exercise her vested options. The separation agreement also includes a mutual release of claims.
The Company and Dr. Singh also entered into a consulting agreement, which provides that Dr. Singh has agreed to provide consulting services to the Company at the direction of the Board. Dr. Singh will be entitled to $5,000 per month for her consulting services.
The press release issued by the Company on February 18, 2010 is furnished as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
99.1 Press Release, dated February 18, 2010.
TDLP NEWS
Form 8-K for TRANSDEL PHARMACEUTICALS INC
18-Feb-2010
Change in Directors or Principal Officers, Financial Statements and
Item 5.02 Departure of Directors of Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
The Board of Directors (the "Board") of Transdel Pharmaceuticals, Inc. (the "Company") accepted the resignation of Dr. Juliet Singh as Chief Executive Officer of the Company and as a director on the Board, effective February 17, 2010. The Board appointed Jeffrey J. Abrams, M.D. as Chairman of the Board. The Board also appointed John T. Lomoro, the Company's current Chief Financial Officer, as acting Chief Executive Officer. Mr. Lomoro will also serve as the Company's principal executive officer.
In connection with Dr. Singh's resignation, the Company and Dr. Singh entered into a separation agreement that provides Dr. Singh with one year of continued salary in accordance with the terms of her existing employment agreement as well as the accelerated vesting of 300,000 stock options previously granted. In addition, Dr. Singh will have three years from the date of her resignation to exercise her vested options. The separation agreement also includes a mutual release of claims.
The Company and Dr. Singh also entered into a consulting agreement, which provides that Dr. Singh has agreed to provide consulting services to the Company at the direction of the Board. Dr. Singh will be entitled to $5,000 per month for her consulting services.
The press release issued by the Company on February 18, 2010 is furnished as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
99.1 Press Release, dated February 18, 2010.
Here is the e-mail I mentioned:
Thank you for your interest in Nature’s Peak Company and products. We appreciate your patience with us in responding to your requests/inquiries.
We are working on our E-News portion of our website and will inform you when it is complete. Fresh product samples should be ready for shipment in early March, 2010. Could you please verify your shipping address for us again, we did not receive the city, state and zip code information previously.
To also help us better serve you better, please tell us if you are a distributor/retail store, direct consumer, or just interested in obtaining information on our company.
Also, please let us know if you are already a stockholder in our company.
Thank you again for your interest,
Jeri Tjon
Customer Service
Nature’s Peak
343 Soquel Ave.
Santa Cruz, CA. 95062
800-628-7325
I would hope, the last spot on the Balancing Act is March 5th.I would assume they would want to keep the momentum going following these segments.March seems to be the common denominator
....we will see.
For what it is worth,I received an e-mail about 2-3 weeks ago from Natures Peak customer service in response to me ordering product on-line. They responded that samples would be available in March and to e-mail back my info.I have been trying to gather more information from Robert,but no answer. With every message I am asking him to update us in a PR.
Check out CTIC's New and Added Institutional Holdings on ...Pretty impressive.
http://www.mffais.com/ctic
The Float is 215.45M
NVLT - New Institutional Holdings
http://www.mffais.com/nvlt.ob
NVLT New Institutional Holdings
http://www.mffais.com/nvlt.ob
New BIEL Interview with CEO Andy Whelan
February 16, 2010 – Update on BioElectronics Corp. (BIEL)
by Joe on February 16, 2010
February 16, 2010 – Update on BioElectronics Corp. (BIEL)
This weekend we had the opportunity to sit down with Andy Whelan, CEO of BioElectronics for an update on corporate and business activities. Over the past few weeks we have assembled a list of questions from investors. Below, Mr. Whelan provides answers to these questions.
Question – What is the status of the audit? And why is it taking so long to complete?
Mr. Whelan: First of all, let me reiterate that this was a completely voluntary audit on our part. It is simply something we did not have to do. Second, I want to make sure that everyone understands that completing an audit is not an easy task. We have a very limited staff at BioElectronics and the completion of this audit caused us to have two professional staff members almost completely off-line for two full months. We, of course, are very happy to have most of this process behind us.
The audit was started at the end of October with the process running for several months. Over the last few weeks the audit team did a lot of additional checking of their work to ensure complete accuracy. This was clearly a very thorough audit. Many full audits take between 60 and 90 days, so considering the audit did not get fully under way until the end of October, it was completed relatively on time. I can appreciate, however that our investors wanted to see the results sooner rather than later.
Late last week we received the report from the audit team, which raised no new issues. It covers the Company’s operations through the year ending 2008. Additionally, the auditor conducted a full financial review up through the September quarter of 2009. This is normal operating procedure for auditing firms as full audits typically correspond to full operating fiscal years. In the case of BioElectronics, we have a December year end, which means the next audit period will end on December 31, 2009. We have already advised the auditor to proceed with completion of the full audit period for full year 2009. With that said, I want to emphasize that a full financial review by the auditing firm up through the third quarter of 2009 has been conducted. We are very happy with the results.
Question: What is the status of moving off the Pink Sheets?
Mr. Whelan: The completion of the audit and financial review offers us increased flexibility on several fronts. Upon completion of the full audit for 2009, we will be able to invoke one of several strategies relative to the trading of BioElectronics shares. We think we have come up with several innovative strategies, but at this time it is not really appropriate for us to publicly announce these. We certainly understand the need to do something in this area and were working hard toward a resolution. Stay tuned for developments as our strategy moves forward.
Question: We have heard rumors there are some major product upgrades in the works. What can you tell us relative to this area?
Mr. Whelan: We are very excited about a major product upgrade that is in the final stages. One of the issues with our ActiPatch Therapy product has always been just how to attach the product to the body. As most of you know, last year we were awarded a groundbreaking patent for PEMF products that are attached to the skin. The specific methodology for attachment has continuously been refined over the past few years and now we think we are on the verge of another major upgrade. We are now well past the testing phase and moving into the manufacturing phase of a new wrap that holds the technology against the body. This upgraded product utilizes a much stronger fabric that not only allows for better adhesion against the skin, but at the same time is much more flexible, while being significantly more durable. We now have full product samples in house and we are quickly moving all manufacturing to this new wrap technology. We feel strongly this is a significant product upgrade for ActiPatch.
We have also made some major product improvements to the Allay Menstrual Therapy product and packaging. The product now includes several replaceable soft, fabric sleeves. This will enable a woman to frequently change the sleeve while still maintaining cost effectiveness. We believe this is also a significant upgrade to our product line. The Allay products being shipped in support of our new Latin America marketing campaign will include this upgrade.
While we have been making modifications to the existing product, our product managers have also been working on an entirely new back pain product. We have designed a very elegant product specific to back pain. It is a very high quality belt that contains small pockets that will enable our core technology to be specifically placed directly over the site of back pain. We have always said that the back pain market is the single largest market for us and we believe this new product could be a huge winner for us allowing us to compete for shelf space next to some of the big back pain brands within the grocery and drug chain stores. We are very excited about this new break through product offering, which we hope to formally announce and show to investors very soon.
Question: What is the status of Latin American marketing campaign?
Mr. Whelan: The Latin American operation is taking a little bit longer than expected to get off the ground. It has clearly been a lot of work on our part, but we think we are now ready to launch. I was in Miami less than two weeks ago meeting with our marketing partner for the operation and was very impressed with what has been completed. We are very happy with the television spot to introduce the Allay product to Latin America and we are expecting to begin testing over the next week or so. As is normal in this type of campaign, we will probably make a few minor modifications using information from the tests and then began full launch. We are very excited about this product introduction launch and will closely be monitoring this rollout as it occurs.
Question: What is the update relative to other international marketing initiatives?
Mr. Whelan: There is a tremendous amount of marketing activity within the international markets. I was recently in China meeting with our distribution partner, local government officials and television executives. We are currently working on introducing the Allay product to the country.
As many of you know, we also have a major initiative in the works to penetrate the Japanese market. In this endeavor we have partnered with a new publicly traded company that will be bringing both ActiPatch and Allay into Japan. This deal resulted in the largest single order we have ever received.
We also recently launched a major infomercial program expansion in the country of Turkey for the ActiPatch and Allay products, which is backed by orders totaling more than $1 million in 2010. We are also very close to our ActiPatch launch in Canada. The television spots we had planned to run in Canada needed some minor regulatory modifications. These modifications are currently underway. All of these new international initiatives augment our existing distribution agreements in other parts of the world.
Question: In one of your last press releases a comment was made about strengthening the balance sheet. Please explain.
Mr. Whelan: We are very proud of what we have been able to accomplish relative to our balance sheet. Over the past year, we retired all of the convertible debt that was very unfavorable to the Company and we have paid virtually all of the Company’s other debts. The recent large orders we received at the end of the fourth quarter allowed us to further strengthen the balance sheet by paying the debt down even further. We believe our year end 2009 balance sheet will show some very strong financial ratios – certainly significantly stronger than the vast majority of companies our size – we think we are in very good shape.
Question: What is the update relative to FDA clearance for ActiPatch and Allay?
Mr. Whelan: FDA is still in process of reviewing our 510K submissions. Additionally, we recently applied for reclassification from Class III to Class II. This application is also currently under review at FDA. In our last meeting with FDA personnel it was suggested by them that BioElectronics might want to file a different type of application called a PMA. While receiving clearance under PMA (Pre-Marketing Approval) would likely offer us some additional protections against would be competitors, it’s a much more exhaustive process. While we have indicated we will be filing a PMA application, it may not be necessary after all. All of this is in a bit of a state of flux right now, but it should be sorted out more thoroughly as we have additional correspondence with FDA over the next few weeks. The easiest thing for us is still OTC clearance under 510K, which will allow us to market our products on store shelves within the U.S. – but as I indicated, we will know more over the next few weeks as additional correspondence with FDA personnel takes place.
We think the bottom line relative to FDA is that while the process has not been pain-free for us and we have not been on an easy regulatory clearance path, we believe clearance will be granted. We have sold over 200,000 ActiPatch’s worldwide without a single safety complaint. The devices have helped thousands upon thousands receive effective pain relief. We have conducted several IRB supervised clinical studies that have proven both the safety and efficacy of the Allay and ActiPatch devices. Navigating through the FDA is difficult, but we believe we will be successful in gaining clearance.
New BIEL Interview with CEO Andy Whelan
February 16, 2010 – Update on BioElectronics Corp. (BIEL)
by Joe on February 16, 2010
February 16, 2010 – Update on BioElectronics Corp. (BIEL)
This weekend we had the opportunity to sit down with Andy Whelan, CEO of BioElectronics for an update on corporate and business activities. Over the past few weeks we have assembled a list of questions from investors. Below, Mr. Whelan provides answers to these questions.
Question – What is the status of the audit? And why is it taking so long to complete?
Mr. Whelan: First of all, let me reiterate that this was a completely voluntary audit on our part. It is simply something we did not have to do. Second, I want to make sure that everyone understands that completing an audit is not an easy task. We have a very limited staff at BioElectronics and the completion of this audit caused us to have two professional staff members almost completely off-line for two full months. We, of course, are very happy to have most of this process behind us.
The audit was started at the end of October with the process running for several months. Over the last few weeks the audit team did a lot of additional checking of their work to ensure complete accuracy. This was clearly a very thorough audit. Many full audits take between 60 and 90 days, so considering the audit did not get fully under way until the end of October, it was completed relatively on time. I can appreciate, however that our investors wanted to see the results sooner rather than later.
Late last week we received the report from the audit team, which raised no new issues. It covers the Company’s operations through the year ending 2008. Additionally, the auditor conducted a full financial review up through the September quarter of 2009. This is normal operating procedure for auditing firms as full audits typically correspond to full operating fiscal years. In the case of BioElectronics, we have a December year end, which means the next audit period will end on December 31, 2009. We have already advised the auditor to proceed with completion of the full audit period for full year 2009. With that said, I want to emphasize that a full financial review by the auditing firm up through the third quarter of 2009 has been conducted. We are very happy with the results.
Question: What is the status of moving off the Pink Sheets?
Mr. Whelan: The completion of the audit and financial review offers us increased flexibility on several fronts. Upon completion of the full audit for 2009, we will be able to invoke one of several strategies relative to the trading of BioElectronics shares. We think we have come up with several innovative strategies, but at this time it is not really appropriate for us to publicly announce these. We certainly understand the need to do something in this area and were working hard toward a resolution. Stay tuned for developments as our strategy moves forward.
Question: We have heard rumors there are some major product upgrades in the works. What can you tell us relative to this area?
Mr. Whelan: We are very excited about a major product upgrade that is in the final stages. One of the issues with our ActiPatch Therapy product has always been just how to attach the product to the body. As most of you know, last year we were awarded a groundbreaking patent for PEMF products that are attached to the skin. The specific methodology for attachment has continuously been refined over the past few years and now we think we are on the verge of another major upgrade. We are now well past the testing phase and moving into the manufacturing phase of a new wrap that holds the technology against the body. This upgraded product utilizes a much stronger fabric that not only allows for better adhesion against the skin, but at the same time is much more flexible, while being significantly more durable. We now have full product samples in house and we are quickly moving all manufacturing to this new wrap technology. We feel strongly this is a significant product upgrade for ActiPatch.
We have also made some major product improvements to the Allay Menstrual Therapy product and packaging. The product now includes several replaceable soft, fabric sleeves. This will enable a woman to frequently change the sleeve while still maintaining cost effectiveness. We believe this is also a significant upgrade to our product line. The Allay products being shipped in support of our new Latin America marketing campaign will include this upgrade.
While we have been making modifications to the existing product, our product managers have also been working on an entirely new back pain product. We have designed a very elegant product specific to back pain. It is a very high quality belt that contains small pockets that will enable our core technology to be specifically placed directly over the site of back pain. We have always said that the back pain market is the single largest market for us and we believe this new product could be a huge winner for us allowing us to compete for shelf space next to some of the big back pain brands within the grocery and drug chain stores. We are very excited about this new break through product offering, which we hope to formally announce and show to investors very soon.
Question: What is the status of Latin American marketing campaign?
Mr. Whelan: The Latin American operation is taking a little bit longer than expected to get off the ground. It has clearly been a lot of work on our part, but we think we are now ready to launch. I was in Miami less than two weeks ago meeting with our marketing partner for the operation and was very impressed with what has been completed. We are very happy with the television spot to introduce the Allay product to Latin America and we are expecting to begin testing over the next week or so. As is normal in this type of campaign, we will probably make a few minor modifications using information from the tests and then began full launch. We are very excited about this product introduction launch and will closely be monitoring this rollout as it occurs.
Question: What is the update relative to other international marketing initiatives?
Mr. Whelan: There is a tremendous amount of marketing activity within the international markets. I was recently in China meeting with our distribution partner, local government officials and television executives. We are currently working on introducing the Allay product to the country.
As many of you know, we also have a major initiative in the works to penetrate the Japanese market. In this endeavor we have partnered with a new publicly traded company that will be bringing both ActiPatch and Allay into Japan. This deal resulted in the largest single order we have ever received.
We also recently launched a major infomercial program expansion in the country of Turkey for the ActiPatch and Allay products, which is backed by orders totaling more than $1 million in 2010. We are also very close to our ActiPatch launch in Canada. The television spots we had planned to run in Canada needed some minor regulatory modifications. These modifications are currently underway. All of these new international initiatives augment our existing distribution agreements in other parts of the world.
Question: In one of your last press releases a comment was made about strengthening the balance sheet. Please explain.
Mr. Whelan: We are very proud of what we have been able to accomplish relative to our balance sheet. Over the past year, we retired all of the convertible debt that was very unfavorable to the Company and we have paid virtually all of the Company’s other debts. The recent large orders we received at the end of the fourth quarter allowed us to further strengthen the balance sheet by paying the debt down even further. We believe our year end 2009 balance sheet will show some very strong financial ratios – certainly significantly stronger than the vast majority of companies our size – we think we are in very good shape.
Question: What is the update relative to FDA clearance for ActiPatch and Allay?
Mr. Whelan: FDA is still in process of reviewing our 510K submissions. Additionally, we recently applied for reclassification from Class III to Class II. This application is also currently under review at FDA. In our last meeting with FDA personnel it was suggested by them that BioElectronics might want to file a different type of application called a PMA. While receiving clearance under PMA (Pre-Marketing Approval) would likely offer us some additional protections against would be competitors, it’s a much more exhaustive process. While we have indicated we will be filing a PMA application, it may not be necessary after all. All of this is in a bit of a state of flux right now, but it should be sorted out more thoroughly as we have additional correspondence with FDA over the next few weeks. The easiest thing for us is still OTC clearance under 510K, which will allow us to market our products on store shelves within the U.S. – but as I indicated, we will know more over the next few weeks as additional correspondence with FDA personnel takes place.
We think the bottom line relative to FDA is that while the process has not been pain-free for us and we have not been on an easy regulatory clearance path, we believe clearance will be granted. We have sold over 200,000 ActiPatch’s worldwide without a single safety complaint. The devices have helped thousands upon thousands receive effective pain relief. We have conducted several IRB supervised clinical studies that have proven both the safety and efficacy of the Allay and ActiPatch devices. Navigating through the FDA is difficult, but we believe we will be successful in gaining clearance.
Been trying no contact yet.
CombinatoRx Announces Extension of Exalgo™ Extended-Release Tablets PDUFA Date to March 1, 2010
February 16, 2010 4:01 PM ET
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Stocks mentioned in this article
CombinatoRx Inc (CRXX) Stock Quote, Chart, News, Add to Watchlist
Business WireAll Business Wire news
CombinatoRx, Incorporated CRXX today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for review of the Exalgo™ (hydromorphone HCl) extended-release tablets New Drug Application (NDA) from Monday, February 22, 2010 to Monday, March 1, 2010 due to federal government closings.
The U.S. rights to Exalgo tablets were acquired from Neuromed by Mallinckrodt Inc., a Covidien company, in June, 2009. Neuromed acquired the U.S. marketing rights to Exalgo tablets from ALZA Corporation in April 2007 and was responsible for clinical development and regulatory filings. Covidien is responsible for all commercialization activities for Exalgo in the U.S., including marketing, sales and all post-approval FDA regulatory filings, and will now own the intellectual property for the product. ALZA is responsible for manufacturing, packaging and supply of the product. CombinatoRx and Neuromed merged on December 21, 2009.
About CombinatoRx
CombinatoRx, Incorporated (CRXX) develops novel drug candidates with a focus on the treatment of pain and inflammation. The company applies its combination drug discovery capabilities and its selective ion-channel modulation platform to generate innovative therapeutics. To learn more about CombinatoRx, please visit www.combinatorx.com.
Forward-Looking Statement:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning CombinatoRx, the product candidate Exalgo™, the timing of FDA action regarding the NDA for Exalgo, the CombinatoRx drug discovery technologies, and the business plans of CombinatoRx. These forward-looking statements about future expectations, plans and prospects of CombinatoRx involve significant risks, uncertainties and assumptions, including risks related to the ability of CombinatoRx or Mallinckrodt to obtain regulatory approval for the sale and marketing of the Exalgo™ product candidate, the ability of Mallinckrodt to successfully market Exalgo™ if approved by the FDA, the unproven nature of the CombinatoRx drug discovery technologies, the Company's ability to obtain additional financing or funding for its research and development and those other risks that can be found in the "Risk Factors" section beginning on page 31 of CombinatoRx's Form S-4 Registration Statement filed in connection with its merger with Neuromed (File No. 333-161146) on file with the Securities and Exchange Commission and the other reports that CombinatoRx periodically files with the Securities and Exchange Commission. Actual results may differ materially from those CombinatoRx contemplated by these forward-looking statements. These forward looking statements reflect management’s current views and CombinatoRx does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.
(c) 2010 CombinatoRx, Incorporated. All rights reserved.
CombinatoRx, Incorporated
Justin Renz, 617-301-7575
Senior Vice President, CFO
JRenz@combinatorx.com
or
Gina Nugent, 617-460-3579
gnugent@combinatorx.com
Copyright 2010 Business Wire
CombinatoRx Announces Extension of Exalgo™ Extended-Release Tablets PDUFA Date to March 1, 2010
February 16, 2010 4:01 PM ET
advertisement
Stocks mentioned in this article
CombinatoRx Inc (CRXX) Stock Quote, Chart, News, Add to Watchlist
Business WireAll Business Wire news
CombinatoRx, Incorporated CRXX today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for review of the Exalgo™ (hydromorphone HCl) extended-release tablets New Drug Application (NDA) from Monday, February 22, 2010 to Monday, March 1, 2010 due to federal government closings.
The U.S. rights to Exalgo tablets were acquired from Neuromed by Mallinckrodt Inc., a Covidien company, in June, 2009. Neuromed acquired the U.S. marketing rights to Exalgo tablets from ALZA Corporation in April 2007 and was responsible for clinical development and regulatory filings. Covidien is responsible for all commercialization activities for Exalgo in the U.S., including marketing, sales and all post-approval FDA regulatory filings, and will now own the intellectual property for the product. ALZA is responsible for manufacturing, packaging and supply of the product. CombinatoRx and Neuromed merged on December 21, 2009.
About CombinatoRx
CombinatoRx, Incorporated (CRXX) develops novel drug candidates with a focus on the treatment of pain and inflammation. The company applies its combination drug discovery capabilities and its selective ion-channel modulation platform to generate innovative therapeutics. To learn more about CombinatoRx, please visit www.combinatorx.com.
Forward-Looking Statement:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning CombinatoRx, the product candidate Exalgo™, the timing of FDA action regarding the NDA for Exalgo, the CombinatoRx drug discovery technologies, and the business plans of CombinatoRx. These forward-looking statements about future expectations, plans and prospects of CombinatoRx involve significant risks, uncertainties and assumptions, including risks related to the ability of CombinatoRx or Mallinckrodt to obtain regulatory approval for the sale and marketing of the Exalgo™ product candidate, the ability of Mallinckrodt to successfully market Exalgo™ if approved by the FDA, the unproven nature of the CombinatoRx drug discovery technologies, the Company's ability to obtain additional financing or funding for its research and development and those other risks that can be found in the "Risk Factors" section beginning on page 31 of CombinatoRx's Form S-4 Registration Statement filed in connection with its merger with Neuromed (File No. 333-161146) on file with the Securities and Exchange Commission and the other reports that CombinatoRx periodically files with the Securities and Exchange Commission. Actual results may differ materially from those CombinatoRx contemplated by these forward-looking statements. These forward looking statements reflect management’s current views and CombinatoRx does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.
(c) 2010 CombinatoRx, Incorporated. All rights reserved.
CombinatoRx, Incorporated
Justin Renz, 617-301-7575
Senior Vice President, CFO
JRenz@combinatorx.com
or
Gina Nugent, 617-460-3579
gnugent@combinatorx.com
Copyright 2010 Business Wire
CRXX in Play $1.37
GNVC - Looking Strong Pre-Market $2.15
The BIEL audit covers through 2008 with the financial review covering through Q3 2009
BIEL Audit should come out this week,according to my DD
APPA AH moving strong $2.08
I agree Sheff....CCCP has a ton of knowledge and brings in amazing DD and insight!
It's Rally time for crxx.
CRXX on a great AH move $1.26
Cell Therapeutics, Inc. (CTI) Decreases Net Loss by 42% in 2009
prnewswire
Companies:
o Cell Therapeutics, Inc.
Press Release Source: Cell Therapeutics, Inc. On Thursday February 11, 2010, 1:30 am EST
SEATTLE, Feb. 11 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today reported recent accomplishments and financial results for the fourth quarter and year ended December 31, 2009.
Review of 2009 Key Accomplishments and Targeted 2010 Milestones
* Pixantrone New Drug Application ("NDA") for relapsed/refractory aggressive non-Hodgkin's lymphoma filed with the U.S. Food and Drug Administration (the "FDA") and accepted for review in 2009. The FDA established Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.
* Initiated a Marketing Authorization Application ("MAA") for pixantrone in Europe in 2009 and received Orphan Drug Designation by the European Medicines Agency. CTI expects to file a Marketing Authorization Application in mid-2010.
* Phase II clinical data on OPAXIO demonstrated high rates of pathologic complete remissions for treatment of patients with advanced esophageal cancer paving way for potential registration trial as radiation sensitizer. CTI expects to meet with the FDA in the first half of 2010 to discuss a potential registration trial for OPAXIO as a radiation sensitizer.
* Decreased debt in 2009 by $57.4 million through exchanges and eliminated all of outstanding preferred stock.
* Added in 2009 to the Russell 2000, 3000 and Global Indices as well as the Nasdaq Global Biotechnology Index.
* Adopted Shareholder Rights Plan designed to deter coercive takeover tactics, and to prevent an acquirer from gaining control of CTI without offering a fair price to all of CTI's shareholders.
* Received net proceeds of $136 million in 2009 through sale of Zevalin and investments by institutions to fund operations and decrease debt.
"In 2009 we focused on streamlining our operations, improving our balance sheet and supporting our late stage product to position us for the potential commercialization of a CTI product," stated James A. Bianco, M.D., CEO of CTI. "We look forward to presenting the benefit-risk pixantrone data to the Oncologic Drugs Advisory Committee at the meeting which is being rescheduled especially in light of the completion of the updated study overall survival results."
Financial Results
For the quarter ended December 31, 2009, total net operating expenses were approximately $26.2 million, compared to $11.2 million for the same period in 2008. The increase in total net operating expenses was mainly a result of a non-cash equity based compensation expense of $11.7 million for the quarter ended December 31, 2009 and a $9.4 million gain on the sale of Zevalin to a 50/50 owned joint venture with Spectrum that was recognized in the quarter ended December 31, 2008. Research and development expenses decreased by 15% to $7.3 million compared to $8.6 million for the same period in 2008. Net loss attributable to common shareholders decreased by 34% to $27.4 million ($0.05 per share), compared to a net loss attributable to common shareholders of $41.3 million ($0.52 per share) for the same period in 2008. The decrease in net loss for the quarter ended December 31, 2009 is mainly a result of the decrease in expenses associated with financings for the quarter ended December 31, 2009 compared to the expenses associated with financings incurred in the same period in 2008.
For the year ended December 31, 2009, total net operating expenses decreased to $81.6 million, compared to $88.7 million for the same period in 2008. Research and development expenses decreased by 42% to $30.2 million compared to $51.6 million for the same period in 2008. Net loss attributable to common shareholders decreased 42% to $116.8 million ($0.25 per share), compared to a net loss attributable to shareholders of $202.9 million ($7.00 per share) for the same period in 2008. The decrease in net loss for the year ended December, 31, 2009 compared to the same period in 2008 is mainly the result of a decrease in research and development expenses and expenses associated with financings.
CTI had approximately $37.8 million in cash, cash equivalents and securities available-for-sale as of December 31, 2009. This does not include approximately $28.2 million in net proceeds, the Company received in January 2010 in connection with a registered offering of preferred stock and warrants.
Conference Call Information
On Thursday, February 11, 2010, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific, members of CTI's management team will host a conference call to discuss CTI's 2009 fourth quarter and year end achievements and financial results.
Conference Call Numbers
Thursday, February 11, 2010
8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time
1-877-941-6009 (US Participants)
1-480-629-9770 (International)
Call-back numbers for post-listening available at 11:30 a.m. Eastern:
1-800-406-7325 (US Participants)
1-303-590-3030 (International)
Passcode: 4199432
Live audio webcast at www.celltherapeutics.com will be archived for post-call listening approximately two hours after call ends.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.celltherapeutics.com.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI's securities. Specifically, the risks and uncertainties include statements about CTI's ability to continue to reduce CTI's operating expenses, CTI's ability to continue to raise capital as needed to fund CTI's operations, the development of pixantrone, OPAXIO and brostallicin, which include risks associated with preclinical and clinical developments in the biopharmaceutical industry, in general, and with pixantrone, OPAXIO and brostallicin, in particular, including, without limitation, the potential failure of these product candidates to prove safe and effective for the treatment of ovarian cancer, esophageal cancer, non-Hodgkin's lymphoma and sarcoma or to achieve market acceptance for such treatments, the possibility that FDA approval is not granted for pixantrone at all, the possibility that CTI does not file an MAA, that the potential registration trial for OPAXIO does not occur, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling pixantrone, OPAXIO and brostallicin, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission, including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter CTI's forward-looking statements whether as a result of new information, future events, or otherwise
Cell Therapeutics, Inc. (CTI) Decreases Net Loss by 42% in 2009
prnewswire
Companies:
o Cell Therapeutics, Inc.
Press Release Source: Cell Therapeutics, Inc. On Thursday February 11, 2010, 1:30 am EST
SEATTLE, Feb. 11 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today reported recent accomplishments and financial results for the fourth quarter and year ended December 31, 2009.
Review of 2009 Key Accomplishments and Targeted 2010 Milestones
* Pixantrone New Drug Application ("NDA") for relapsed/refractory aggressive non-Hodgkin's lymphoma filed with the U.S. Food and Drug Administration (the "FDA") and accepted for review in 2009. The FDA established Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.
* Initiated a Marketing Authorization Application ("MAA") for pixantrone in Europe in 2009 and received Orphan Drug Designation by the European Medicines Agency. CTI expects to file a Marketing Authorization Application in mid-2010.
* Phase II clinical data on OPAXIO demonstrated high rates of pathologic complete remissions for treatment of patients with advanced esophageal cancer paving way for potential registration trial as radiation sensitizer. CTI expects to meet with the FDA in the first half of 2010 to discuss a potential registration trial for OPAXIO as a radiation sensitizer.
* Decreased debt in 2009 by $57.4 million through exchanges and eliminated all of outstanding preferred stock.
* Added in 2009 to the Russell 2000, 3000 and Global Indices as well as the Nasdaq Global Biotechnology Index.
* Adopted Shareholder Rights Plan designed to deter coercive takeover tactics, and to prevent an acquirer from gaining control of CTI without offering a fair price to all of CTI's shareholders.
* Received net proceeds of $136 million in 2009 through sale of Zevalin and investments by institutions to fund operations and decrease debt.
"In 2009 we focused on streamlining our operations, improving our balance sheet and supporting our late stage product to position us for the potential commercialization of a CTI product," stated James A. Bianco, M.D., CEO of CTI. "We look forward to presenting the benefit-risk pixantrone data to the Oncologic Drugs Advisory Committee at the meeting which is being rescheduled especially in light of the completion of the updated study overall survival results."
Financial Results
For the quarter ended December 31, 2009, total net operating expenses were approximately $26.2 million, compared to $11.2 million for the same period in 2008. The increase in total net operating expenses was mainly a result of a non-cash equity based compensation expense of $11.7 million for the quarter ended December 31, 2009 and a $9.4 million gain on the sale of Zevalin to a 50/50 owned joint venture with Spectrum that was recognized in the quarter ended December 31, 2008. Research and development expenses decreased by 15% to $7.3 million compared to $8.6 million for the same period in 2008. Net loss attributable to common shareholders decreased by 34% to $27.4 million ($0.05 per share), compared to a net loss attributable to common shareholders of $41.3 million ($0.52 per share) for the same period in 2008. The decrease in net loss for the quarter ended December 31, 2009 is mainly a result of the decrease in expenses associated with financings for the quarter ended December 31, 2009 compared to the expenses associated with financings incurred in the same period in 2008.
For the year ended December 31, 2009, total net operating expenses decreased to $81.6 million, compared to $88.7 million for the same period in 2008. Research and development expenses decreased by 42% to $30.2 million compared to $51.6 million for the same period in 2008. Net loss attributable to common shareholders decreased 42% to $116.8 million ($0.25 per share), compared to a net loss attributable to shareholders of $202.9 million ($7.00 per share) for the same period in 2008. The decrease in net loss for the year ended December, 31, 2009 compared to the same period in 2008 is mainly the result of a decrease in research and development expenses and expenses associated with financings.
CTI had approximately $37.8 million in cash, cash equivalents and securities available-for-sale as of December 31, 2009. This does not include approximately $28.2 million in net proceeds, the Company received in January 2010 in connection with a registered offering of preferred stock and warrants.
Conference Call Information
On Thursday, February 11, 2010, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific, members of CTI's management team will host a conference call to discuss CTI's 2009 fourth quarter and year end achievements and financial results.
Conference Call Numbers
Thursday, February 11, 2010
8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time
1-877-941-6009 (US Participants)
1-480-629-9770 (International)
Call-back numbers for post-listening available at 11:30 a.m. Eastern:
1-800-406-7325 (US Participants)
1-303-590-3030 (International)
Passcode: 4199432
Live audio webcast at www.celltherapeutics.com will be archived for post-call listening approximately two hours after call ends.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.celltherapeutics.com.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI's securities. Specifically, the risks and uncertainties include statements about CTI's ability to continue to reduce CTI's operating expenses, CTI's ability to continue to raise capital as needed to fund CTI's operations, the development of pixantrone, OPAXIO and brostallicin, which include risks associated with preclinical and clinical developments in the biopharmaceutical industry, in general, and with pixantrone, OPAXIO and brostallicin, in particular, including, without limitation, the potential failure of these product candidates to prove safe and effective for the treatment of ovarian cancer, esophageal cancer, non-Hodgkin's lymphoma and sarcoma or to achieve market acceptance for such treatments, the possibility that FDA approval is not granted for pixantrone at all, the possibility that CTI does not file an MAA, that the potential registration trial for OPAXIO does not occur, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling pixantrone, OPAXIO and brostallicin, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission, including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter CTI's forward-looking statements whether as a result of new information, future events, or otherwise
A Snow Day for...CTIC
FDA Postpones Oncologic Drugs Advisory Committee Meeting to Review Pixantrone Due to Severe Weather Conditions
prnewswire
Companies:
o Cell Therapeutics, Inc.
Press Release Source: Cell Therapeutics, Inc. On Tuesday February 9, 2010, 1:30 am EST
SEATTLE, Feb. 9 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the United States Food and Drug Administration (the "FDA") informed CTI that due to severe weather conditions in the Washington, D.C. area, the FDA is postponing the Oncologic Drugs Advisory Committee ("ODAC") meeting that was to be held on Wednesday, February 10, 2010 to discuss the pixantrone New Drug Application ("NDA"). The FDA indicated that it intends to reschedule the meeting as soon as the FDA can determine a schedule that will allow them to reconvene the advisory panel.
This meeting is an open public forum for the presentation and discussion of safety and efficacy information contained in the pixantrone NDA for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL).
According to its usual practice the FDA has posted on its website briefing documents for the ODAC meeting that will be held to discuss the pixantrone NDA. The briefing information can be accessed on the FDA website at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/ucm195226.htm
"We are pleased with the time that the FDA has invested in connection with its review of our application for pixantrone. We believe that many of the key issues they identified are addressed in our own briefing material which is now publically available as well," said James A. Bianco, M.D., CEO of Cell Therapeutics. "We are disappointed that the meeting was not able to take place as originally scheduled but understand that the severe weather conditions made travel safety an issue. We look forward to the ODAC meeting where our lymphoma expert physicians will discuss the clinical benefits of pixantrone with the advisory panel."
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of the securities of CTI. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory, aggressive NHL as determined by the FDA (including ODAC), that the FDA may postpone the ODAC meeting again, that CTI's briefing materials do not address all of the key issues the FDA may have with the pixantrone NDA, CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
F: 206.272.4434
E: deramian@ctiseattle.com
www.celltherapeutics.com/press_room
Investors Contact:
Ed Bell
T: 206.272.4345
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
www.celltherapeutics.com/investors
Weather Delay...CTIC
FDA Postpones Oncologic Drugs Advisory Committee Meeting to Review Pixantrone Due to Severe Weather Conditions
prnewswire
Companies:
o Cell Therapeutics, Inc.
Press Release Source: Cell Therapeutics, Inc. On Tuesday February 9, 2010, 1:30 am EST
SEATTLE, Feb. 9 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the United States Food and Drug Administration (the "FDA") informed CTI that due to severe weather conditions in the Washington, D.C. area, the FDA is postponing the Oncologic Drugs Advisory Committee ("ODAC") meeting that was to be held on Wednesday, February 10, 2010 to discuss the pixantrone New Drug Application ("NDA"). The FDA indicated that it intends to reschedule the meeting as soon as the FDA can determine a schedule that will allow them to reconvene the advisory panel.
This meeting is an open public forum for the presentation and discussion of safety and efficacy information contained in the pixantrone NDA for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL).
According to its usual practice the FDA has posted on its website briefing documents for the ODAC meeting that will be held to discuss the pixantrone NDA. The briefing information can be accessed on the FDA website at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/ucm195226.htm
"We are pleased with the time that the FDA has invested in connection with its review of our application for pixantrone. We believe that many of the key issues they identified are addressed in our own briefing material which is now publically available as well," said James A. Bianco, M.D., CEO of Cell Therapeutics. "We are disappointed that the meeting was not able to take place as originally scheduled but understand that the severe weather conditions made travel safety an issue. We look forward to the ODAC meeting where our lymphoma expert physicians will discuss the clinical benefits of pixantrone with the advisory panel."
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of the securities of CTI. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory, aggressive NHL as determined by the FDA (including ODAC), that the FDA may postpone the ODAC meeting again, that CTI's briefing materials do not address all of the key issues the FDA may have with the pixantrone NDA, CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
F: 206.272.4434
E: deramian@ctiseattle.com
www.celltherapeutics.com/press_room
Investors Contact:
Ed Bell
T: 206.272.4345
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
www.celltherapeutics.com/investors
HEB Still Going Strong...News
New Animal Model for Evaluating Antiviral Agents Against the SARS Virus Indicates Potential Effect of Ampligen(R), an Experimental Therapeutic
Independent University Researchers Find Ampligen(R) "Fully Protective" in Study
globenewswire
Companies:
o Hemispherx Biopharma, Inc.
Press Release Source: Hemispherx Biopharma, Inc. On Monday February 8, 2010, 8:45 am
PHILADELPHIA, Feb. 8, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company") reported a recent study, published in the December 20th issue of Virology (2009) by a consortium of researchers at Utah State University and the University of North Carolina, on a newly developed animal model of severe acute respiratory disease syndrome (SARS) which, according to the authors, " ... largely mimicked human disease". SARS emerged in 2002 in the Guangdong province of Southern China as a new infectious respiratory disease characterized by influenza-like symptoms with a very high mortality rate. The researchers characterized and adapted a new strain of the SARS virus (SARS-CoV) to mice that was 100% lethal and was associated with the overproduction of cytokines and severe lung pathology (Day CW, et al. Virology, 395:210-222, 2009).
Multiple agents with purported antiviral activity were evaluated for activity in this unique mouse model of the human disease, including Ampligen® (Poly I : Poly C12U), ribavirin (a commercially available antiviral with multiple modes of action for certain respiratory diseases) and other experimental agents. The researchers found that, uniquely among the agents tested, Ampligen®, an experimental therapeutic, " ... protected against death and gross damage to the lungs in the presence of lethal SARS-CoV" and was associated with a reduction in IL-6 concentration in which high levels of the cytokine correlated with the mortality of SARS-CoV infection. Mortality was high, under the conditions tested, for all the other antiviral agents examined, including ribavirin, that have previously been used extensively in humans with SARS without definitive evidence of efficacy (Stockman LJ, et al. PLoS Med 3 (9),e 343).
To date, there are no approved agents for treating SARS. Animal experiments do not necessarily predict safety or efficacy in man. Encouraged by these results, Hemispherx is now in discussions with Chinese clinical research organizations to institute clinical antiviral programs in China.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon LDO. Ampligen® represents experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes agents for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties, including, but not limited to, the risk that the results of the animal studies are not representative of the safety or efficacy profile of Ampligen® when used as a treatment in humans and the risk that we are not able to come to an agreement to institute a clinical antiviral program in China or elsewhere in connection with the use of Ampligen® as a treatment for SARS. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen® and Alferon® LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection® do not imply that the product will ever be specifically approved commercially for these other treatment indications.
Contact:
Hemispherx Biopharma, Inc.
Investor Contact:
Dianne Will
518-398-6222
ir@hemispherx.net
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