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Chinsangaram J.,SIGA Technologies | Honeychurch K.M.,SIGA Technologies | Tyavanagimatt S.R.,SIGA Technologies | Leeds J.M.,SIGA Technologies | And 14 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2012

ST-246 is being evaluated as a treatment for pathogenic orthopoxvirus infections in humans. To this end, a phase 2, doubleblind, randomized, placebo-controlled, multicenter trial was conducted to assess the safety, tolerability, and pharmacokinetics (PK) of ST-246 when administered as a single daily oral dose (400 mg or 600 mg) for 14 days in fed adult volunteers. ST-246 was safe and well tolerated, with no deaths or serious adverse events reported during the study. There was a low incidence of treatment- emergent adverse events (TEAEs), the most common of which were mild nausea and headache. There were no clinically significant results from laboratory assessments, vital sign measurements, physical examinations, or electrocardiograms. The PK and dose proportionality of ST-246 were determined. The PK analysis showed that steady state was achieved by day 5 for the ST-246 400-mg treatment group and by day 6 for the 600-mg group. The dose proportionality analysis showed that the 400- and 600-mg ratio of dose-normalized peak drug concentration in plasma (C max) and relative exposure for each dosing interval (AUC τ) ranged from 80% to 85%. However, the 90% confidence intervals did not include 1.0, so dose proportionality could not be concluded. Overall, ST-246 was shown to be safe, and the PK was predictable. These results support further testing of ST-246 in a multicenter pivotal clinical safety study for licensure application. Copyright © 2012, American Society for Microbiology. All Rights Reserved.


Chinsangaram J.,SIGA Technologies | Honeychurch K.M.,SIGA Technologies | Tyavanagimatt S.R.,SIGA Technologies | Bolken T.C.,SIGA Technologies | And 11 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2012

ST-246, a novel compound that inhibits egress of orthopoxvirus from mammalian cells, is being tested as a treatment for pathogenic orthopoxvirus infections in humans. This phase I, double-blind, randomized, crossover, exploratory study was conducted to compare the pharmacokinetics (PK) of a single daily 400-mg oral dose of ST-246 polymorph form I versus polymorph formVadministered to fed, healthy human volunteers. Both forms appeared to be well tolerated, with no serious adverse events. The order of administration of the two forms had no effect on the results of the PK analyses. Form I and formVboth exhibited comparable plasma concentration versus time profiles, but complete bioequivalence between the two forms was not found. Maximum drug concentration (C max) met the bioequivalence criteria, as the 90% confidence interval (CI) was 80.6 to 96.9%. However, the area under the concentration-time curve from time zero to time t (AUC 0-t) and AUC 0-∞ did not meet the bioequivalence criteria (CIs of 67.8 to 91.0% and 73.9 to 104.7%, respectively). The extent of absorption of form I, as defined by AUC 0-∞, was 11.7% lower than that of form V. Since ST-246 form I is more thermostable than form V, form I was selected for further development and use in all future studies. Copyright © 2012, American Society for Microbiology. All Rights Reserved.


News Article | November 23, 2016
Site: www.newsmaker.com.au

MarketStudyReport.com adds “Biodefense Market Size By Product (Anthrax, Small Pox, Botulism, Radiation/ Nuclear), Industry Analysis Report, Regional Outlook (U.S., Canada, U.K, Germany, China, Japan, Mexico, Brazil, South Africa), Application Potential, Price Trends, Competitive Market Share & Forecast, 2016-2024” new report to its research database. The report spread across 82 pages with table and figures in it. Global Biodefense Market size contribution was $9.8 billion for 2015 with CAGR of 6.91% predicted to be registered for forecast timeline. Rising bioterrorism threat and government support against bioterrorism are main aspects that are predicted to promote industry expansion in future. Many government legislations like project bioshield offers nations with counter measures against chemical, radiological, nuclear and biological attack. U.S. Biodefense Market Size, by Product, 2012 ? 2024 (USD Million) Project bioshield assures accessibility of next generation medical countermeasures against smallpox and anthrax agents. Main goal of the project is creating funding authority to build next generation counter measures, make innovative research & development programs and create a body like FDA (Food & Drug Administration) that can effectively use treatments in case of emergencies. All these factors are predicted to drive global biodefense industry trends.Furthermore, enhanced alertness displayed by public health organizations by investing in biodefense technology, skilled persons and materials along with heavy government support as well as funding from private & public sectors are predicted to contribute towards global biodefense market growth. Product Trends Global biodefense industry is segmented into products like botulism, anthrax, nuclear/radiation and small pox. Anthrax product segment contributed about 31.6% to global biodefense market share for 2015 and is projected to surpass revenue of $4.21 billion by end of forecast timeframe. The reason for segment growth can be credited to the fact that bacillus anthracis is identified as greatest priority in biodefense study and positioned among 9 agents in A class according to CDC (Centers for Disease Control and Prevention) classification. Further, government projects like BioShield, BARDA (Biomedical Advanced Research and Development Authority) and Joint Program Executive Office-Chemical and Biological Defenses offer large funding and vaccine doses against anthrax. All these factors are predicted to propel segment growth in future. Radiation segment is predicted to record higher CAGR during forecast timeline. Rapid increase in research & development activities owing to outbreak of Ebola virus and possible use of the virus as bio weapon is projected to promote segment growth. Regional Trends Global biodefense market is segmented into geographical locations like APAC, Latin America, Europe, MEA and North America. North America biodefense industry dominated the global industry by accounting for highest regional revenue share for 2015. It contributed about $8.91 billion in terms of revenue for this year. U.S. biodefense market share led the regional industry for 2015 in terms of revenue. The growth of the industry in U.S. cane be credited to factors like large scale funding for biodefense activities and government support. Europe biodefense market is anticipated to register maximum CAGR of 11.41% during forecast timeline. UK?s ministry of defense contributed highest regional industry share for 2012 by providing funds worth $75.67 million for defense & civilian research. Competitive Trends Key industry participants profiled in the report include Emergent Biosolutions, SIGA Technologies, Ichor Medical Systems Incorporation, PharmaAthene, Cleveland BioLabs Incorporation, Achaogen, Alnylam Pharmaceuticals, Xoma Corporation, Dynavax Technologies Incorporation, Elusys Therapeutics, DynPort Vaccine Company LLC, Bavarian Nordic and Nanotherapeutics Incorporation. To receive personalized assistance, write to us @ [email protected] with the report title in the subject line along with your questions or call us at +1 866-764-2150


Leeds J.M.,SIGA Technologies | Fenneteau F.,Pharsight | Gosselin N.H.,Pharsight | Mouksassi M.-S.,Pharsight | And 10 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2013

Although smallpox has been eradicated, the United States government considers it a "material threat" and has funded the discovery and development of potential therapeutic compounds. As reported here, the human efficacious dose for one of these compounds, ST-246, was determined using efficacy studies in nonhuman primates (NHPs), together with pharmacokinetic and pharmacodynamic analysis that predicted the appropriate dose and exposure levels to provide therapeutic benefit in humans. The efficacy analysis combined the data from studies conducted at three separate facilities that evaluated treatment following infection with a closely related virus, monkeypox virus (MPXV), in a total of 96 NHPs. The effect of infection on ST-246 pharmacokinetics in NHPs was applied to humans using population pharmacokinetic models. Exposure at the selected human dose of 600 mg is more than 4-fold higher than the lowest efficacious dose in NHPs and is predicted to provide protection to more than 95% of the population. Copyright © 2013, American Society for Microbiology.


News Article | November 30, 2016
Site: www.newsmaker.com.au

The report provides comprehensive information on the therapeutics under development for Poxviridae Infections, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers  the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Poxviridae Infections and features dormant and discontinued projects. The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. Complete report on Poxviridae Infections - Pipeline Review, H2 2016 addition with 30 market data tables and 13 figures, spread across 96  pages http://www.reportsnreports.com/reports/703647-poxviridae-infections-pipeline-review-h2-2016.html This report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis (plague + small pox) vaccine, 24a, BA-368, brincidofovir CEL-1000, CJ-40011, imatinib mesylate, Monoclonal Antibodies for Infectious Disease, Monoclonal Antibody for Smallpox, nilotinib , NN-001, PL-801, SCV-305, Small Molecules for Molluscum Contagiosum,z small pox vaccine, tecovirimat , varicella hyperimmune globulins, VIR-001, VP-100 Bavarian Nordic A/S, BioFactura, CEL-SCI Corporation, Chimerix, China Biologic Products, CJ HealthCare Corp., EpiVax, N & N Pharmaceuticals Inc, SIGA Technologies, akeda Pharmaceutical Company Limited, Tonix Pharmaceuticals Holding Corp., Verrica Pharmaceuticals Inc., Inquire before buying for this report


Sandoz K.M.,Oregon State University | Eriksen S.G.,Oregon State University | Jeffrey B.M.,Oregon State University | Suchland R.J.,University of Washington | And 4 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2012

A novel and quantitative high-throughput screening approach was explored as a tool for the identification of novel compounds that inhibit chlamydial growth in mammalian cells. The assay is based on accumulation of a fluorescent marker by intracellular chlamydiae. Its utility was demonstrated by screening 42,000 chemically defined compounds against Chlamydia caviae GPIC. This analysis led to the identification of 40 primary-hit compounds. Five of these compounds were nontoxic to host cells and had similar activities against both C. caviae GPIC and Chlamydia trachomatis. The inhibitory activity of one of the compounds, (3-methoxyphenyl)-(4,4,7-trimethyl-4,5-dihydro-1H-[1,2]dithiolo[3,4-C] quinolin-1-ylidene)amine (MDQA), was chlamydia specific and was selected for further study. Selection for resistance to MDQA led to the generation of three independent resistant clones of C. trachomatis. Amino acid changes in SecY, a protein involved in Sec-dependent secretion in Gram-negative bacteria, were associated with the resistance phenotype. The amino acids changed in each of the resistant mutants are located in the predicted central channel of a SecY crystal structure, based on the known structure of Thermus thermophilus SecY. These experiments model a process that can be used for the discovery of antichlamydial, anti-intracellular, or antibacterial compounds and has led to the identification of compounds that may have utility in both antibiotic discovery and furthering our understanding of chlamydial biology. Copyright © 2012, American Society for Microbiology. All Rights Reserved.


PubMed | SIGA Technologies
Type: Comparative Study | Journal: PloS one | Year: 2011

ST-246 is an antiviral, orally bioavailable small molecule in clinical development for treatment of orthopoxvirus infections. An intravenous (i.v.) formulation may be required for some hospitalized patients who are unable to take oral medication. An i.v. formulation has been evaluated in three species previously used in evaluation of both efficacy and toxicology of the oral formulation.The pharmacokinetics of ST-246 after i.v. infusions in mice, rabbits and nonhuman primates (NHP) were compared to those obtained after oral administration. Ten minute i.v. infusions of ST-246 at doses of 3, 10, 30, and 75 mg/kg in mice produced peak plasma concentrations ranging from 16.9 to 238 g/mL. Elimination appeared predominately first-order and exposure dose-proportional up to 30 mg/kg. Short i.v. infusions (5 to 15 minutes) in rabbits resulted in rapid distribution followed by slower elimination. Intravenous infusions in NHP were conducted at doses of 1 to 30 mg/kg. The length of single infusions in NHP ranged from 4 to 6 hours. The pharmacokinetics and tolerability for the two highest doses were evaluated when administered as two equivalent 4 hour infusions initiated 12 hours apart. Terminal elimination half-lives in all species for oral and i.v. infusions were similar. Dose-limiting central nervous system effects were identified in all three species and appeared related to high C(max) plasma concentrations. These effects were eliminated using slower i.v. infusions.Pharmacokinetic profiles after i.v. infusion compared to those observed after oral administration demonstrated the necessity of longer i.v. infusions to (1) mimic the plasma exposure observed after oral administration and (2) avoid C(max) associated toxicity. Shorter infusions at higher doses in NHP resulted in decreased clearance, suggesting saturated distribution or elimination. Elimination half-lives in all species were similar between oral and i.v. administration. The administration of ST-246 was well tolerated as a slow i.v. infusion.


PubMed | SIGA Technologies
Type: Clinical Trial, Phase I | Journal: Antimicrobial agents and chemotherapy | Year: 2012

ST-246, a novel compound that inhibits egress of orthopoxvirus from mammalian cells, is being tested as a treatment for pathogenic orthopoxvirus infections in humans. This phase I, double-blind, randomized, crossover, exploratory study was conducted to compare the pharmacokinetics (PK) of a single daily 400-mg oral dose of ST-246 polymorph form I versus polymorph form V administered to fed, healthy human volunteers. Both forms appeared to be well tolerated, with no serious adverse events. The order of administration of the two forms had no effect on the results of the PK analyses. Form I and form V both exhibited comparable plasma concentration versus time profiles, but complete bioequivalence between the two forms was not found. Maximum drug concentration (C(max)) met the bioequivalence criteria, as the 90% confidence interval (CI) was 80.6 to 96.9%. However, the area under the concentration-time curve from time zero to time t (AUC(0-t)) and AUC(0-) did not meet the bioequivalence criteria (CIs of 67.8 to 91.0% and 73.9 to 104.7%, respectively). The extent of absorption of form I, as defined by AUC(0-), was 11.7% lower than that of form V. Since ST-246 form I is more thermostable than form V, form I was selected for further development and use in all future studies.


PubMed | SIGA Technologies
Type: Journal Article | Journal: Antimicrobial agents and chemotherapy | Year: 2013

Although smallpox has been eradicated, the United States government considers it a material threat and has funded the discovery and development of potential therapeutic compounds. As reported here, the human efficacious dose for one of these compounds, ST-246, was determined using efficacy studies in nonhuman primates (NHPs), together with pharmacokinetic and pharmacodynamic analysis that predicted the appropriate dose and exposure levels to provide therapeutic benefit in humans. The efficacy analysis combined the data from studies conducted at three separate facilities that evaluated treatment following infection with a closely related virus, monkeypox virus (MPXV), in a total of 96 NHPs. The effect of infection on ST-246 pharmacokinetics in NHPs was applied to humans using population pharmacokinetic models. Exposure at the selected human dose of 600 mg is more than 4-fold higher than the lowest efficacious dose in NHPs and is predicted to provide protection to more than 95% of the population.


News Article | November 16, 2016
Site: www.prnewswire.com

ANNAPOLIS, Md., Nov. 16, 2016 /PRNewswire/ -- PharmAthene, Inc. (NYSE MKT: PIP), a biodefense company developing medical countermeasures against anthrax, today received a final payment from SIGA Technologies, Inc. of $83.9 million which fully satisfies the judgment owed to PharmAthene. In...

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