Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Microcap & Penny Stocks : Rat dog micro-cap picks... -- Ignore unavailable to you. Want to Upgrade?

To: Bucky Katt who wrote (37562)	4/5/2008 2:24:42 PM
From: Baton	Respond to of 48461

You gotta like this WHO report on ST 246. The last two news items were slow outa the gate and I did add a bit more yesterday morning. If it pulls back under 2.50-60. I'll likely add more. I have over 60K shares, so I'm already loaded and then some. $10+ would just about put me in primo retirement mode ala ice cold marguaritas and red-hot senoritas for life. If AVII ever hits, style would improve. Baton who.int 9. ST-246: drug development and human clinical safety studies 9.1 Dr Dennis Hruby presented recent progress on the development of an antiviral drug, ST-246 (SIGA Technologies Inc.). The development of ST-246 has been possible as part of the research agenda authorized by this Committee. The research has led to the identification of a compound that suppressed orthopoxvirus growth in vitro and is active in treating orthopoxvirus infections in animal models. ST-246 is an orally available, non toxic compound that is stable at room temperature. It has been used recently in a clinical case of eczema vaccinatum (see below). Initial dose ranging clinical studies are now in progress and it is anticipated that pivotal safety studies for regulatory approval will be undertaken. Studies in animal models have suggested that the drug levels needed to achieve therapeutic benefit can be achieved easily in humans with the proposed 14 day treatment protocol. 9.2 The Advisory Committee was informed that a pharmaceutical company (Albemarle) will undertake large scale synthesis of ST-246. This could ultimately allow a production capacity of roughly 25 million doses, and three small scale Good Manufacturing Practice (GMP) pilot lots have already been completed. Administration formats – capsules for daily oral administration, suspension preparations etc. – are being explored. Stability studies indicated that the compound is stable for 2 years at WHO Advisory Committee on Variola Virus Research Report of the Ninth Meeting, Geneva, Switzerland, 29-30 November 2007 5 room temperature and tests for longer-term stability are ongoing. Data on animal efficacy in different models, at different doses and at different times of administration, have been submitted to the United States Food and Drug Administration (FDA) as part of an Investigational New Drug (IND) submission. 9.3 The Advisory Committee was very encouraged by the findings presented and noted that funding from several agencies was being used to support this research. The Committee was also informed that results with ST-246 were sufficiently promising that small amounts of the drug were being stockpiled by the company for emergency, compassionate use. Work is in progress to determine if ST-246 can be used in immunocompromised individuals and pregnant women. 10. ST-246: animal efficacy studies 10.1 Dr John Huggins gave a brief overview of efficacy studies of ST-246. Based on activity in other multiple small animal models, oral ST-246 was evaluated in the Variola viruscynomolgous monkey model of lesional smallpox that bears some resemblance to human disease. 10.2 The placebo group demonstrated typical disease with > 1250 pox lesions and 33% mortality. Oral gavage with ST-246 began 24 hours after infection, when all tissues showed extensive infection. Disease progression was halted, with no significant clinical or laboratory abnormalities. Virus levels in blood did not increase over pretreatment levels and virus was cleared in 6 days, versus 16 days for an alternate antiviral drug, cidofovir, based on historical data. 10.3 ST-246 was then evaluated using a monkeypox virus/cynomolgous monkey model. The placebo treated group demonstrated typical disease with > 1500 pox lesions and 100% mortality. Oral gavage treatment with ST-246 began 1 day after infection, when all tissues showed extensive infection. This treatment halted disease progression and no significant clinical or laboratory abnormalities were recorded. 10.4 Dose seeking studies of oral treatment of cynomolgous monkeys infected with a uniformly lethal dose of monkeypox virus were initiated 3 days after infection when primates showed signs of clinical disease and 1/3 had typical poxvirus lesions, i.e. a point when a clinical diagnosis could easily be made. At this time viral replication had progressed to the point that all organs had high viral burdens. All doses (300 to 3 mg/kg) resulted in protection from death. ST-246 treatment also reduced lesion formation and viral load significantly, with no obvious toxicity. Ongoing ascending multiple dose human clinical studies, designed to establish the human dose, and similar pharmacokinetic studies in cynomolgous monkeys, indicate that the human dose that provides the same drug exposure as the primate dose of 30 mg/kg is achievable, and that this dose is 10-fold higher than that required to protect primates. 10.5 ST-246 is orally bioavailable with excellent pharmacokinetic parameters. Preclinical development is complete and the United States FDA has granted an IND, Fast-Track status and Orphan Drug Designation. Human clinical studies with ST-246 are underway and New Drug Application (NDA)-enabling studies are in progress. Ongoing clinical studies show that ST-246 appears safe and well-tolerated when administered orally as a single dose to healthy normal volunteers in a fasted (500 to 2000 mg) or non-fasted WHO Advisory Committee on Variola Virus Research Report of the Ninth Meeting, Geneva, Switzerland, 29-30 November 2007 6 (1000 mg) state. Human twenty-one day dosing studies are nearing completion at oral doses of 250, 400 and 800 mg/day in fed adults. 10.6 It was noted that ST-246 might be used to treat some smallpox vaccine adverse reactions, and that with CMX100 (the oral lipid conjugate prodrug of cidofovir), the requirement of having two drugs that inhibit Variola virus replication by acting on different targets could be satisfied. Continued attention is also being paid to analogues of Gleevac/imatinib (Gleevec®, Glivec®), a tyrosine kinase inhibitor, for its potential in treating smallpox. 10.7 The Committee noted that additional assessments of antiviral agents in non-human primate models of smallpox, under Good Laboratory Practice conditions, are limited by the availability of BSL-4 containment facilities.