posted
Press Release Source: SIGA Technologies, Inc.
SIGA Passes Another Milestone with Smallpox Drug SIGA-246 Thursday November 9, 1:17 pm ET
NEW YORK--(BUSINESS WIRE)--SIGA Technologies, Inc. (NASDAQ: SIGA - News) announced today the successful results of two independent primate trials of its smallpox drug SIGA-246. Last month, SIGA announced that SIGA-246 provides complete protection against human smallpox virus in nonhuman primates. The current trials involve infection with high doses of monkeypox virus, which may be lethal in primates if left untreated. SIGA-246 again afforded complete protection against disease symptoms. As with the primate trial last month and the human safety trial announced earlier this year, the current trials also demonstrate that SIGA-246 should be safe as well as effective.
ADVERTISEMENT The first monkeypox virus study was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) and conducted at the Lovelace Respiratory Research Institute in Albuquerque, NM. In this study, all monkeys in the two groups receiving SIGA-246 (different dosages) were completely protected from disease.
The second study was conducted at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and was funded by the Department of Defense's Defense Threat Reduction Agency under the supervision of Dr. John Huggins, Chief of the Viral Therapeutics Branch. In the second study, two groups of nonhuman primates received SIGA-246 orally starting either one day post-infection or three days post-infection. Again both treatment groups were completely protected from disease.
"Taken together with the recent breakthrough results from the smallpox virus study, the data continue to support the use of SIGA-246 as the first drug available to prevent and treat disease caused by pathogenic poxviruses without significant side effects," said Dr. Dennis E. Hruby, Chief Scientific Officer of SIGA. He added, "These are very important results for two reasons. First, in many respects monkeypox infections in non-human primates are more aggressive than infection with smallpox virus (normally a human pathogen), so protection by SIGA-246 represents a higher hurdle. Second, SIGA will likely use SIGA-246's performance against monkeypox infection in monkeys, along with the results in all of the several animal species tested to date, to satisfy FDA's efficacy requirements, so success here bodes well."
SIGA previously announced that SIGA-246 has been shown to be safe to administer to humans as a once-a-day pill. SIGA-246 has also demonstrated 100% disease protection in several mouse models of infection, which results SIGA will use, along with results from additional tests yet to be completed, to fulfill the U.S. Food and Drug Administration's "Animal Efficacy Rule." In December 2005, the FDA granted "fast-track" status to SIGA-246.
The Department of Homeland Security has designated smallpox a "material threat" to our national security, so SIGA-246 will be eligible for purchase for the Strategic National Stockpile under Project Bioshield.
In addition to smallpox, SIGA has antiviral programs targeting other Category A viral pathogens, including arenaviruses (Lassa fever, Junin, Machupo, Guanarito, Sabia, and LCM), flaviruses (Dengue), and the filoviruses (Ebola and Marburg), each of which presents a substantial, unmet medical need.
About SIGA Technologies, Inc.
SIGA Technologies is applying viral and bacterial genomics and sophisticated computational modeling in the design and development of novel products for the prevention and treatment of serious infectious diseases, with an emphasis on products for biological warfare defense. SIGA is a leading company in the discovery of pharmaceutical agents to fight emerging pathogens. SIGA leverages its proprietary technologies through multiple strategic partners, including the National Institutes of Health and TransTech Pharma, Inc. For more information about SIGA, please visit SIGA's Web site at www.siga.com.
About the National Institute of Allergy and Infectious Diseases (NIAID)
NIAID, an institute within the U.S. National Institutes of Health, conducts and supports research to study the causes of allergic, immunologic and infectious diseases, and to develop better means of preventing, diagnosing and treating these illnesses. NIAID is headquartered in Bethesda, Maryland.
About the Defense Threat Reduction Agency
The Defense Threat Reduction Agency (DTRA) is an agency of the U.S. Department of Defense that safeguards America and its allies from weapons of mass destruction by providing capabilities to reduce, eliminate, and counter the threat, and mitigate its effects. DTRA headquarters is located at Fort Belvoir, Virginia, and it also operates field offices worldwide. The DTRA has identified an orthopox therapeutic as a critical need in its ongoing threat reduction efforts.
About the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)
USAMRIID, located at Fort Detrick, Maryland, is the lead medical research laboratory for the U.S. Biological Defense Research Program, and plays a critical role in national defense and in infectious disease research. The Institute's mission is to conduct basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Material Command.
The information contained in this press release does not necessarily reflect the position or policy of the U.S. government, and no official endorsement should be inferred.
Forward-looking Statements
This Press Release contains or implies certain "forward-looking statements'' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the efficacy of potential products, the timelines for bringing such products to market and the availability of funding sources for continued development of such products. Forward-looking statements are based on management's estimates, assumptions and projections, and are subject to uncertainties, many of which are beyond the control of SIGA. Actual results may differ materially from those anticipated in any forward-looking statement. Factors that may cause such differences include the risks that (a) potential products that appear promising to SIGA or its collaborators cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (b) SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products, (c) SIGA may not be able to obtain anticipated funding for its development projects or other needed funding, (d) SIGA may not be able to secure funding from anticipated government contracts and grants, (e) SIGA may not be able to secure or enforce adequate legal protection, including patent protection for its products and (f) regulatory approval for SIGA's products may require further or additional testing that will delay or prevent approval. More detailed information about SIGA and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this Press Release, is set forth in SIGA's filings with the Securities and Exchange Commission, including SIGA's Annual Report on Form 10-K for the fiscal year ended December 31, 2005, and in other documents that SIGA has filed with the Commission. SIGA urges investors and security holders to read those documents free of charge at the Commission's Web site at http://www.sec.gov. Interested parties may also obtain those documents free of charge from SIGA. Forward-looking statements speak only as to the date they are made, and, except for any obligation under the U.S. federal securities laws, SIGA undertakes no obligation to publicly update any forward-looking statement as a result of new information, future events or otherwise.
Contact:
SIGA Technologies, Inc. Thomas N. Konatich, 212-672-9100 Chief Financial Officer & Acting CEO
Source: SIGA Technologies, Inc.
-------------------- Best Regards and Good Trading Posts: 239 | From: Florida City, FL | Registered: Jul 2006
| IP: Logged |
AP Siga: Studies Show Smallpox Drug Is Safe Thursday November 9, 2:41 pm ET Siga Pharamceuticals Says 2 Federal Studies Show Smallpox Drug Is Safe and Effective
NEW YORK (AP) -- Biotechnology company Siga Technologies Inc. said Thursday results from two independent studies of its smallpox drug show that it is safe and effective. The trials were conducted by the National Institute of Allergy and Infectious Diseases and the U.S. Army Medical Research Institute of Infectious Diseases. They focused on primates that had high levels of monkeypox infection, which can be fatal if left untreated. In both studies, the subjects were completely protected from the disease.
The study validates a previous study, the company said, in which the drug candidate provided complete protection against human smallpox in non-human primates.
Studies have shown that the treatment drug is safe to administer to humans in a once-a-day pill form. The drug, called Siga-246, has been granted Fast-Track status by the Food and Drug Administration.
Shares of Siga rose 14 cents, or 3.8 percent, to $4.03 in afternoon trading on the Nasdaq. The stock has traded between 86 cents and $5.50 over the last 52 weeks.
-------------------- "Great Day for Up!"....Dr. Seuss Posts: 3387 | Registered: Mar 2006
| IP: Logged |
posted
Press Release Source: SIGA Technologies, Inc.
SIGA Announces $2.3 Million in New Contracts with the U.S. Air Force Friday November 10, 7:30 am ET
NEW YORK--(BUSINESS WIRE)--SIGA Technologies, Inc. (NASDAQ: SIGA - News) today announced receipt of two contracts from the U.S. Air Force for a total of $2.3 million. SIGA received a one-year, $1.4 million contract with the Air Force Medical Service for the development of counter-measures against important potential biowarfare pathogens, the Dengue viruses, and other water-related viral agents. SIGA also received a one-year, $900,000 contract to aid the USAF Special Operations Command (USAFSOC) in its development of specific anti-viral agents, focusing on orthopoxvirus targets distinct from the target that is the focus of SIGA-246, the Company's lead smallpox drug.
ADVERTISEMENT Click here to find out more! "We appreciate the opportunity to continue the development of these critical biological defense capabilities with our colleagues from the Air Force," said Dr. Dennis E. Hruby, Chief Scientific Officer of SIGA.
Dengue fever and Dengue hemorrhagic fever are acute febrile mosquito-borne diseases caused by one of four closely related virus serotypes of the genus Flaviviridae. The two diseases affect tens of millions of people worldwide every year and present a biodefense threat in the U.S. Currently, there is no approved drug or vaccine against Dengue, leaving troops vulnerable overseas and in areas affected by flooding.
SIGA recently announced a breakthrough in its SIGA-246 program with the successful completion of a preliminary primate trial in which the drug completely prevented smallpox disease.
About SIGA Technologies, Inc.
SIGA Technologies is applying viral and bacterial genomics and sophisticated computational modeling in the design and development of novel products for the prevention and treatment of serious infectious diseases, with an emphasis on products for biological warfare defense. SIGA believes that it is a leader in the development of pharmaceutical agents and vaccines to fight potential biowarfare pathogens. In addition to smallpox, SIGA has antiviral programs targeting other Category A pathogens, including arenaviruses (Lassa fever, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis), dengue virus, and the filoviruses (Ebola and Marburg).
For more information about SIGA, please visit SIGA's Web site at www.siga.com.
Forward-looking Statements
This Press Release contains or implies certain "forward-looking statements'' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the efficacy of potential products, the timelines for bringing such products to market and the availability of funding sources for continued development of such products. Forward-looking statements are based on management's estimates, assumptions and projections, and are subject to uncertainties, many of which are beyond the control of SIGA. Actual results may differ materially from those anticipated in any forward-looking statement. Factors that may cause such differences include the risks that (a) potential products that appear promising to SIGA or its collaborators cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (b) SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products, (c) SIGA may not be able to obtain anticipated funding for its development projects or other needed funding, (d) SIGA may not be able to secure funding from anticipated government contracts and grants, (e) SIGA may not be able to secure or enforce adequate legal protection, including patent protection for its products and (f) regulatory approval for SIGA's products may require further or additional testing that will delay or prevent approval. More detailed information about SIGA and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this Press Release, is set forth in SIGA's filings with the Securities and Exchange Commission, including SIGA's Annual Report on Form 10-K for the fiscal year ended December 31, 2005, and in other documents that SIGA has filed with the Commission. SIGA urges investors and security holders to read those documents free of charge at the Commission's Web site at http://www.sec.gov. Interested parties may also obtain those documents free of charge from SIGA. Forward-looking statements speak only as to the date they are made, and, except for any obligation under the U.S. federal securities laws, SIGA undertakes no obligation to publicly update any forward-looking statement as a result of new information, future events or otherwise.
Contact:
SIGA Technologies, Inc. Mr. Tom Konatich, 212-672-9100 CFO/Acting CEO
Source: SIGA Technologies, Inc.
-------------------- Best Regards and Good Trading Posts: 239 | From: Florida City, FL | Registered: Jul 2006
| IP: Logged |
posted
That SIGA 1.4m contract was out over a week ago, they just took their sweet time PRing it. It was nice to play it twice. Posts: 83 | Registered: May 2006
| IP: Logged |
By Althea Chang TheStreet.com Staff Reporter 11/10/2006 2:56 PM EST
Siga Technologies (SIGA - commentary - Cramer's Take - Rating), a developer of antiviral medications, said it has received contracts from the Air Force worth $2.3 million. Under one contract valued at $1.4 million, Siga will develop counter-measures against potential biowarfare pathogens, the Dengue viruses and water-related viral agents for the Air Force Medical Service.
The company also received a one-year contract worth $900,000 to aid the Air Force Special Operations Command in developing antiviral agents.
Dengue fever and Dengue hemorrhagic fever are serious mosquito-borne diseases for which there are no approved drugs or vaccines. As a result, U.S. troops are vulnerable overseas and in areas affected by flooding, Siga says.
Shares were up 6.3% to $4.21 Friday.
-------------------- "Great Day for Up!"....Dr. Seuss Posts: 3387 | Registered: Mar 2006
| IP: Logged |
FDA Approves Orphan Drug Designation for SIGA's Smallpox Drug, SIGA-246 2:30 p.m. 12/20/2006 Provided by
The Designation is for Both Treatment and Prevention of Smallpox NEW YORK, Dec 20, 2006 (BUSINESS WIRE) -- SIGA Technologies, Inc. (SIGA) announced today that the Office of Orphan Products Development (OOPD) of the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to SIGA-246, SIGA's smallpox drug, for the prevention and treatment of smallpox. In December 2005, the FDA awarded SIGA-246 fast track status to expedite the drug's review.
Orphan Drug designation will entitle SIGA to seven years of marketing exclusivity in the United States if SIGA-246 becomes the first drug of its kind to obtain marketing approval from the FDA. Historically, the approval time for orphan products as a group has been considerably shorter than the approval time for other drugs.
"This is an important step in bringing SIGA-246 to market. The drug has made significant progress since the approval of its Investigational New Drug application just a year ago. In July 2006, we successfully completed the first planned human clinical safety trial, and, in October, the drug demonstrated 100% protection against human smallpox virus in a primate trial. We believe that SIGA-246 holds great promise and will be the first drug available to prevent and treat the disease without significant side effects," said Dr. Dennis E. Hruby, Chief Scientific Officer of SIGA.
Smallpox has been designated by the Department of Homeland Security as a "material threat" to our national security, qualifying SIGA -246 for purchase for the Strategic National Stockpile under Project Bioshield. Currently, there is no effective and safe smallpox therapy available without the risk of significant complications, and the U.S. government has expressed strong interest in the development of novel smallpox therapies. Existing techniques to prevent or ameliorate smallpox have unacceptably high rates of complications, including encephalitis, myocarditis and death, and can take days or weeks to confer protection.
About SIGA Technologies, Inc.
SIGA Technologies is applying viral and bacterial genomics and sophisticated computational modeling in the design and development of novel products for the prevention and treatment of serious infectious diseases, with an emphasis on products for biological warfare defense. SIGA believes that it is a leader in the development of pharmaceutical agents and vaccines to fight potential biowarfare pathogens. In addition to smallpox, SIGA has antiviral programs targeting other Category A pathogens, including arenaviruses (Lassa fever, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis), dengue virus, and the filoviruses (Ebola and Marburg). SIGA's product development programs also emphasize the increasingly serious problem of drug resistant bacteria.
For more information about SIGA, please visit SIGA's Web site at www.siga.com .
Forward-looking Statements
This Press Release contains or implies certain "forward-looking statements'' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the efficacy of potential products, the timelines for bringing such products to market and the availability of funding sources for continued development of such products. Forward-looking statements are based on management's estimates, assumptions and projections, and are subject to uncertainties, many of which are beyond the control of SIGA. Actual results may differ materially from those anticipated in any forward-looking statement. Factors that may cause such differences include the risks that (a) potential products that appear promising to SIGA or its collaborators cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (b) SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products, (c) SIGA may not be able to obtain anticipated funding for its development projects or other needed funding, (d) SIGA may not be able to secure funding from anticipated government contracts and grants, (e) SIGA may not be able to secure or enforce adequate legal protection, including patent protection for its products and (f) regulatory approval for SIGA's products may require further or additional testing that will delay or prevent approval. More detailed information about SIGA and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this Press Release, is set forth in SIGA's filings with the Securities and Exchange Commission, including SIGA's Annual Report on Form 10-K for the fiscal year ended December 31, 2005, and in other documents that SIGA has filed with the Commission. SIGA urges investors and security holders to read those documents free of charge at the Commission's Web site at http://www.sec.gov . Interested parties may also obtain those documents free of charge from SIGA. Forward-looking statements speak only as to the date they are made, and, except for any obligation under the U.S. federal securities laws, SIGA undertakes no obligation to publicly update any forward-looking statement as a result of new information, future events or otherwise.
SIGA Technologies, Inc. Tom Konatich, 212-672-9100 Chief Financial Officer & Acting CEO
Copyright Business Wire 2006 ********************************************************************** As of Saturday, 12-16-2006 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated an UPTREND on 09-27-2005 for SIGA * $1.25. For more information on Comtex SmarTrend Alert, contact your market data provider or go to www.CSTADirect.com SmarTrend is a registered trademark of Comtex News Network, Inc. Copyright 2004-2006 Comtex News Network, Inc. All rights reserved.
-------------------- "Great Day for Up!"....Dr. Seuss Posts: 3387 | Registered: Mar 2006
| IP: Logged |
"Orphan Drug designation will entitle SIGA to seven years of marketing exclusivity in the United States if SIGA-246 becomes the first drug of its kind to obtain marketing approval from the FDA. Historically, the approval time for orphan products as a group has been considerably shorter than the approval time for other drugs. "
The DOD sees small pox as a major threat, that means huge contracts would be awarded if this thing pulls through. In the short term, Repo is dead on, look for a gap tomorrow but then look to flip. These things almost always come back to earth.
-------------------- Success is having the time and money to enjoy all of life's wonders... Posts: 2083 | Registered: Nov 2005
| IP: Logged |
$4's tomorrow though Orphan drug status isn't that big a deal..... day traders will whack this for tomorrow at least.... and it moves easy..... maybe $5 tomorrow in at 3.58 wasn't quick enough can't sell till tomorrow or my acct will get marked as a daytrader.... damn
Posts: 1835 | From: Boston, MA | Registered: Sep 2004
| IP: Logged |
posted
keep posting I shut off my acct! I can't watch cause I can't sell I hope 3:45 it rockets It should nothing else is doing great today
Posts: 1835 | From: Boston, MA | Registered: Sep 2004
| IP: Logged |
posted
pick em low, this thing is going to fly, that news was very big and a lot of people know it. This is not your average daytraders making this fly, over 6 million shares traded already, that's big money coming in and we're still moving up 4.16 now. $5 is very possible IMO today
-------------------- Success is having the time and money to enjoy all of life's wonders... Posts: 2083 | Registered: Nov 2005
| IP: Logged |
posted
AH.... I see it was above $4 before anyway.... it should easily hold that......
Posts: 1835 | From: Boston, MA | Registered: Sep 2004
| IP: Logged |
UBBFriend: Email this page to someone!
Printer-friendly view of this topic
![[Smile]](smile.gif)
![[Mad]](mad.gif)
![[Big Grin]](biggrin.gif)
