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09 july 2010: FDA Approves Beech Tree Labs' Oral Herpes IND Application

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Cool!!!

I've never heard of it until now, but it definitely sounds very interesting!!!

http://www.beechtreelabs.com/productdevelopment/candidates/herpes

Product Candidate Description

This single molecule has been used by Beech Tree's physicians and veterinarians to address all herpes infections of man and animals. Diseases responding to this approach include herpes simplex types I and II, herpes zoster (chickenpox), shingles, infectious mononucleosis, cytomegalovirus, and Bell’s palsy. Also, herpes infections of dogs and horses also respond quickly.

With a third of the world’s human population expected to suffer a herpes infection this year, the market for a safe product that can be used at the same dose for any such infection is extraordinary.

Laboratory Status

In vitro work conducted by company scientists has show results suggesting that this product inhibits re-assembly of virus particles after infection of cells and virus uncoating. Confirmatory work has yet to be completed. On-going genomics studies are revealing mechanism of action.

Clinical Status

Anecdotal experience by practitioners in the Beech Tree Labs' network indicate that this product candidate induces responses quickly and completely. No adverse effects have been reported.

Path Forward

An IND application focusing on recurrent oral herpes has been approved by the FDA.

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So what is it and when will it be available? Is it a pill that you take?

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IND means that the FDA gave green light to phase 1 clinical testing. Here's how the clinical trials work:

http://www.coolerheadsblog.com/Clinical%20Trial%20Process.jpg

Phase 1-3 trials take 5 years on average, though they may take up to 10 years in some cases. After that it takes the NDA about 2 years to review the product and after it is approved, it usually takes something like one or two years for the company to start manufacturing it. So in the idealistic scenario the product could enter the market in 3 or 4 years (clinical trials phases 1-3 may in some cases take only 2 years and it may sometimes take the NDA only 2 months to review the product). But realistically speaking, if everything goes well, we could have the product on market in 9, maybe 10 years.

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Thanks for posting. Is there any way to stay updated on when they might be conducting clinical trials and such?

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so this seems to be the closest thing to a cure? if i am mistaken? bloom is not even in pre clinical yet.

so should we focus on this instead of bloom or bavi? just throwing a suggestion out there!

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so this seems to be the closest thing to a cure? if i am mistaken? bloom is not even in pre clinical yet.

so should we focus on this instead of bloom or bavi? just throwing a suggestion out there!

Bloom is in pre-clinical trials, in fact in the last stage of pre-clinicals. After trying the ribozyme in a rabbit model (which is what we raised the cash for) he will have to do some toxicology studies and then he'll apply for IND with the FDA. This stuff is ahead of Bloom, but only slightly (IND has been approved, but so far no phase 1 trials have started) and since very little info has been released on it, we don't know whether it is just another treatment or an actual cure. Bavi on the other hand is in stage 2 and when it reaches the market, it will be possible to have it prescribed by a doc off-label. We should continue working closely with Bloom and keep in touch with Peregrine, but at the same time we should contact Beech Tree Labs and figure out more about their product and the ways we could help. Do they have the funding they need? Did pharma companies express interest in their product? How does their product work? It would be good if Living contacted them, but unfortunately he got banned and an organized group of individuals can't work properly without contact with the president. Who else would have the guts to make a phonecall to a researcher or a pharma company and speak on behalf of the HCC as well as hundreds of millions of HSV sufferers worldwide? Many people on this forum are lazy just to write a stupid e-mail!

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