As you can read at the link above, the treatment recommended for adverse reactions by the United States Military, while not specifically referencing ST-246, mentioned cidofovir which may be used in certain situations. As the article reads, "Neither drug is currently licensed for this purpose... ...each would be administered under the investigational new drug program (IND)."
I contacted MILVAC today and faxed them a copy of musher's post "SBIR results report ST-246" and amin's post "So cool! vaccine given in combination with ST-246". So they would hopefully update their website on the SMALLPOX VACCINATION PROGRAM of the military to specifically mention ST-246 as an investigational new drug (IND) used to reduce the adverse reactions of the smallpox vaccinations.
VIG is also FDA approved. The article, while recently updated is outdated on the topic of smallpox and vaccinia treatment.
It *should* mention ST246 as an emergency treatment option under IND rules. Perhaps we should inform the military of the new treatment option?
Also if you check the dosing instructions for VIG you see an increasing dose recommendation up to 1 ml/kg if a response is not obtained at the initial dosage level. Not a very good effectiveness profile.
We know that these treatments aren't effective enough.
Both Cidofovir and Vaccinia Immune Globulin were used unsuccessfuly in the case of eczema vaccinatum back in march 2007.
The VIG had been studied since 1994 and was used in clinical practice in the 1950's. In August 2002 NIAID awarded a grant to Cangene for the development of VIG as a treatment for adverse reactions to smallpox vaccination. The new biologic application was submitted Sept. 2, 2004. The FDA approved the product in May of 2005, taking approximately 32 months.
Siga received its grant in Oct. 2006. A similar timeline would put NDA applicaton in the fall of 2008 and FDA approval in spring of 2009.
ST-246 has *fast track* designation which allows for a rolling review of the NDA, allowing Siga to submit data as the study trial progresses. The time line through FDA application is expediated via assistance from CDER. Although the last hurdle is the lrg cohort completed we may even see this time line finished earlier.
Although VIG has had an extended 5yr. contract with the CDC, & earlier fast track, the operative phrase *could provide for future orders* says it all. No definate resolve. Given the stability and shelf life of any of these *poor* alternatives 246 will be *shooed in* soon. So far the NIH, CDC and FDA are very familiar with and pleased with ST-246's performance and no other treatment offers the safety, cure effectiveness and relative cost.
This military website confirms the NEW application for ST-246 referred to in the NIH article referred to in the message board note "So cool,vaccine given in combination with ST-246. Check it out!!!!
info site needs to be updated...pretty dated info. ST-246 has already submitted IND, and I believe a 2nd one again last month. Working on NDA for FDA. Cidofovir stowed in vials, although considerably less in cost/treatment$2,000+ compared to other treatments at the time of this info guide release such as VIG,$23,000-$25,000/patient it is still considerable more expensive than ST-246 pill form ever will be. As there has not been a RFI or RRP by DOD unit cost has not been made available but I believe Hruby's been working on this for the last several weeks. Not to forget mention 246 has no side effects and has been deemed safe in human testing 100x required levels.
Last few days of accumulation before the next upward lap. Continues till news.