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Possible Breakthrough for AIDS Cure
kryonD writes "Researchers believe they have found a new compound that could finally kill the HIV/AIDS virus, not just slow it down as current treatments do. While most of the community is still hesitant to comment on this until it passes peer review, initial results show that their method attacks and kills ALL variations of the virus. A fast track through the FDA could have one of the world's leading problems licked in less than a decade."
Although the scientist doing this work stated, "we would like to formally show this before making any claims that would cause unwanted hype" and the "few AIDS research luminaries" mentioned in the article are not willing to comment this early, it looks like there may already be some interest in Ceragenix Pharmaceuticals' OTC stock which closed at 3.67--up a healthy 122.42% today.
" Further, the compounds appear to have few limits on how they are delivered to patients. Although early indications are for application of CSAs with an ointment or cream, pills or injections may also be developed - if the compound gets to market. "
this actually makes perfect sense considering the economics and regulatory hurdles of FDA clinical trials. *
for a topical NDA (New Drug Application), the costs of a full trial is in the range of 5K-10K per patient. for NDAs that are injected or ingested, the costs are an order of magnitude higher.
furthermore, clinical trials have four steps. pre-clinical, phase 1, phase 2 and phase 3. at each stage, the chances of the trial failing increases quite significantly, resulting in major financial losses. in other words, if the company spends $300M to bring a drug to phase 3 but fails at that stage, the entire cost is completely sunk.
for ingested or injected, the risks of failing at a later stage are much higher than topical drugs. in fact, 1 in 5 drugs that reach phase 3 pass.
considering that the article states that the product is both an anti-viral and anti-fungal agent, there are many applications in the topical space from warts to foot fungus. my guess is that the pharma company will try to quickly bring the drug to market as a topical for these areas due to the above reasons while preparing for clinical trials for HIV/AIDS in parallel.
*the numbers used here are conjected, but scale is about right.
As for the blood-brain barrier: the barrier is made by what are called "glia cells." Or more specifically, astrocytes, a type of glia cells. The lipid membranes of these cells only allow certain molecules that are lipid soluble (non-polar) to enter the brain barrier. That is why when you add only one acetyl group to morphine, it becomes heroin and can act on the brain simply because it is non-polar enough to pass through the barrier. Most anti-viral drugs can indeed get through this barrier. Even if that were not the case though, HIV is a blood pathogen and circulation in and out of the brain would likely be enough to contact all HIV molecules with the anti-viral medication. How else would today's HIV cocktails work? HIV does NOT camp out and slowly kill neurons. At all. It cannot attack neurons. Only t-cells. When enough of your t-cells are attacked and killed, you get AIDS.
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You definitely would NOT mention it to the press if you wanted to get published in a top journal like Nature, Science, or Proceedings of the National Academy of Sciences. They have strict restrictions against talking to the press before the work is accepted and published. If you feel like ignoring these restrictions, then these journals can and will yank your paper. See, for instance http://www.nature.com/nature/authors/policy/embarg o.html.