Pritelivir (aic316) Phase ll study Fast Track in the making ?!?!? Let me know your thoughts.

[whiteshadowcgb]

"Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need"

 

MY THOUGHT: There haven’t been any new treatments in the last how many years? With 2200 new daily cases it is time we start taking preventative measures and also find treatment for those already affected.

 

"Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one."

 

MY THOUGHT: This disease has caused havoc among young teens and college aged students. We need to find a way to STOP it. The disease itself may not be “life threatening” in itself but it surely leads to serious problems ( depression, suicide, neonatal herpes, the risk of HIV becomes 3-5 times more likely) Sexual education just isn’t enough these days and MOST of the Dr.’s I have seen when first being diagnosed didn’t “think” I had HSVII and clearly stated

“you would know, you would have sores, feel REALLY ill” (not my case) In addition, the standard STD check doesn’t include testing for HSV.

 

****So I have to ask, “who/what is protecting us and our children”*****

 

Any drug being developed as a treatment or preventative measure for a disease that does not have a current therapy is labelled as an unmet need. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as:

• Showing superior effectiveness

• Avoiding serious side effects of an available treatment

• Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome

• Decreasing a clinically significant toxicity of an accepted treatment

A drug that receives Fast Track designation is eligible for some or all of the following:

• More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval

• More frequent written correspondence from FDA about such things as the design of the proposed clinical trials

• Eligibility for FDA Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit

• Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA

• Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status

 

MY THOUGHT:

With all this being said and AIC316 doing another Phase II Study (which they didn’t need to do) I am HOPING and PRAYING that after this study they find that AIC316 is indeed superior to Valtrex and AiCuris will apply for a FAST TRACK. Am I being to optomistic? I hope not. AiCuris isn’t “new” to the fast process. Their AIC246 received fast track approval. So maybe there is “reason” they are conducting this phase to truly show that AIC316 is superior.

 

Any thoughts?

 

 

[bonafiderarity]

Woah. I'm hoping this is true too. any knowledge as to why they did another phase II? And I've never heard of aicuris. I know aic316 was the former name of pritelivir but what's aic246?

[whiteshadowcgb]

aic246 ----It's a drug they made and got it fast track approval for it. This current study that are doing isn't required by the FDA so I was wondering why they are doing it. The trial is basically comparing the two drugs. So deep in my pea sized brain I was wonering "why" then I little light bulb a 10th of the size of my pea brain came on and said "hey" maybe there is more to than we are being told and they are doing this so they can show significant superior results that AIC316 is in fact a better drug and should be fast tracked. I don't know, just a thought. Was wondering what others thought about idea.

[mr_hopp]

It's interesting how much attention has been on a cure for as long as herpes stigma was first invented to sell medication (see the "inventing herpes" blog article below) ... I totally get it, don't get me wrong, that I understand why people would want to be cured of feeling shame and stigma. But if there is more attention on a cure than living your life happy and self-accepting NOW, then we're missing something. We're overstepping the moment. Check out the following articles:

http://herpeslife.com/herpes-cure/

http://herpeslife.com/the-key-to-being-happy-with-herpes-give-up-hope

http://herpeslife.com/inventing-herpes/

[HereComesTheSun]

I just don't know how to accept this as a forever thing... I don't know how to live happily now with it always, always weighing me down... Blah. I'm sad and lonely always and just wish they'd cure this thing so I could get my funny/ worry free life and self back... :( that's alllllll....

[mr_hopp]

Notice how you're making a decision in what you just said. That is your self-fulfilling prophecy. And I have compassion for that belief because I thought the same way when I got herpes. But here's the truth: Herpes as a virus in your body is the only thing that is forever. Herpes doesn't immediately mean sadness, aloneness, etc. You are believing all of those things will come with it forever. It's not fair to you to believe that. It's not fair to your future. But it's your choice. And it's a process of recognizing that on a deep level. The home study course that's coming out in the next few months will help to shift this perspective in a deep way.

http://herpeslife.com/herpes-forum/discussion/1180/interested-in-an-h-opp-home-study-experience/p1

[chadwick34]

If a 5 month old can catch it from a condom in a motel I would assume fast would never be fast enough. Acyclovir has been know to cause liver kidney and pancreatic failure over time. Valtrex will probably end up the same.

 

[mr_hopp]

Chadwick, where did you hear that about a 5 month old catching herpes from a condom in a motel? I've never heard that, and I don't want to be spreading false facts here. As far as I've ever heard, the only way to spread herpes is skin-to-skin contact. As far as the Acyclovir being linked to kidney and pancreatic failure, can you provide where you've heard that, too? WebMD says kidney failure is a rare side effect:

http://www.webmd.com/drugs/drug-941-Acyclovir+Oral.aspx?drugid=941&drugname=Acyclovir+Oral&pagenumber=6