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Asp2151 Japan update help?

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House of Herpesians
7 hours ago, sdl35 said:

The translated page I read said it was for shingles. Is this correct?

@sdl35

The Web page I quoted referred to the drug as the one for simple shingles. I double checked other web pages of the Amenolief trials (both in English and Japanese) and confirmed that the drug was tested both for shingles and HSV1 & 2.

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LucyLevi

That would make sense as aciclovir treats both shingles and HSV but in different doses

Lucy

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moialbalushi
40 minutes ago, House of Herpesians said:

@dont quit!17

I'm happy to know that the news I posted made you feel happy!!

In case of Oka VZV vaccine, I heard that it took more than 10 or 15 years the FDA approved it. This may be because the FDA is really careful for the live vaccines for the fear the vaccine may spread the disease in the country. However, considering Amenolief is a drug that successfully completed the all required trials in the US, FDA will approve it quite soon if Astellas/Maruho sells the drug there.

I don't think it appropriate to contact Maruho before the drug is finally approved by the Ministry. After the drug is formally approved by the government, you can email Maruho/Astellas about their sales in the US. If you think you need my help, please contact me (^^)/

I have texted them and they said it will approved only in Japan at the beggining.

And they will see after that.

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Mackie82

When it will be approved in Japan ?  

Edited by Mackie82
Wrong message

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dont quit!17
8 hours ago, House of Herpesians said:

@dont quit!17

I'm happy to know that the news I posted made you feel happy!!

In case of Oka VZV vaccine, I heard that it took more than 10 or 15 years the FDA approved it. This may be because the FDA is really careful for the live vaccines for the fear the vaccine may spread the disease in the country. However, considering Amenolief is a drug that successfully completed the all required trials in the US, FDA will approve it quite soon if Astellas/Maruho sells the drug there.

I don't think it appropriate to contact Maruho before the drug is finally approved by the Ministry. After the drug is formally approved by the government, you can email Maruho/Astellas about their sales in the US. If you think you need my help, please contact me (^^)/

Yes. I'm looking forward to their trial results. I recall reading that gabapentin took 6-8 years to get approval and now hopefully this won't take that long or longer. 

Here is an article from Japanese drug maker Mitsubishi for an ALS drug. It states:

http://www.fiercepharma.com/pharma-asia/mitsubishi-tanabe-eyes-u-s-approval-next-june-for-als-therapy-edaravone

"Japanese drugmaker Mitsubishi Tanabe is hoping to end a drought in the U.S. for new medicines that can treat the devastating neurodegenerative disease amyotrophic lateral sclerosis.

The FDA has kicked off its review of Mitsubishi's edaravone, setting up a possible approval in June 2017."

This article is from 09/2016. It appears that it could take approximately 1 year for possible approval. I realize that these are different types of drugs but it is exciting because in itself this drug is pretty much a functional cure. And then we can further supplement with Genoceas vaccine which will probably be approved by 2020.

I agree maybe after we get news of approval we can contact Maruho. Thank you my friend. I had a rough week and appreciate your feedback.

Edited by dont quit!17

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moialbalushi
4 hours ago, dont quit!17 said:

Yes. I'm looking forward to their trial results. I recall reading that gabapentin took 6-8 years to get approval and now hopefully this won't take that long or longer. 

Here is an article from Japanese drug maker Mitsubishi for an ALS drug. It states:

http://www.fiercepharma.com/pharma-asia/mitsubishi-tanabe-eyes-u-s-approval-next-june-for-als-therapy-edaravone

"Japanese drugmaker Mitsubishi Tanabe is hoping to end a drought in the U.S. for new medicines that can treat the devastating neurodegenerative disease amyotrophic lateral sclerosis.

The FDA has kicked off its review of Mitsubishi's edaravone, setting up a possible approval in June 2017."

This article is from 09/2016. It appears that it could take approximately 1 year for possible approval. I realize that these are different types of drugs but it is exciting because in itself this drug is pretty much a functional cure. And then we can further supplement with Genoceas vaccine which will probably be approved by 2020.

I agree maybe after we get news of approval we can contact Maruho. Thank you my friend. I had a rough week and appreciate your feedback.

What do they mean by Kicked off buddy ? Can you explain plz ? I texted the company and they said it will be approved in Japan first.

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SOH1987

Kicked off means started. So they started their review 9/2016, and it could be approved in June 2017.

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valleynovascotia

So this isn't for herpes

Edited by valleynovascotia

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dont quit!17
1 hour ago, moialbalushi said:

What do they mean by Kicked off buddy ? Can you explain plz ? I texted the company and they said it will be approved in Japan first.

That is in regards to another drug for ALS from Japan. What I was getting at was for that particular drug it would take about a year to get FDA approval. That drug is already approved in Japan.

Hopefully that would be the case for Amenamevir (asp2151). Imagine if this gets approved in Japan this year (2017) and we have it here FDA approved within 3-5 years. That would be heaven sent. 

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MoniqueLow
48 minutes ago, dont quit!17 said:

That is in regards to another drug for ALS from Japan. What I was getting at was for that particular drug it would take about a year to get FDA approval. That drug is already approved in Japan.

Hopefully that would be the case for Amenamevir (asp2151). Imagine if this gets approved in Japan this year (2017) and we have it here FDA approved within 3-5 years. That would be heaven sent. 

Thank you very much. If it's good, I may go to Japan for it. I wanted to visit it anyway :-)

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fugazi1

Guys I am super lost on this particular drug (its hard to keep up haha). What exactly is this particular  drug and is it exclusively focused on HSV? If anybody could briefly summarize I would appreciate that. And yes I would also happily use this as an excuse to take the trip I have always wanted to take to Japan. That would be amazing!

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dont quit!17
48 minutes ago, fugazi1 said:

Guys I am super lost on this particular drug (its hard to keep up haha). What exactly is this particular  drug and is it exclusively focused on HSV? If anybody could briefly summarize I would appreciate that. And yes I would also happily use this as an excuse to take the trip I have always wanted to take to Japan. That would be amazing!

There are some links up above. This drug Amenamevir is in a drug class named helicase primase inhibitor. This drug class (HPI) is the same as Pritelivir which reduced shedding at approximately >95% in previous clinical trials. There is a link provided up above with more information. If not do a simple google for Pritelivir. 

Fortunately for us we have a Japanese forum member who announced that Maruho/Astellas who is manufacturing Amenamevir is going to release final clinical results at the end of this month which is exciting news. All 3 phase clinical trials have been done already in Japan but Maruho has given very limited information in the last couple of years. Personally Im looking forward to this results. 

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fugazi1
58 minutes ago, dont quit!17 said:

There are some links up above. This drug Amenamevir is in a drug class named helicase primase inhibitor. This drug class (HPI) is the same as Pritelivir which reduced shedding at approximately >95% in previous clinical trials. There is a link provided up above with more information. If not do a simple google for Pritelivir. 

Fortunately for us we have a Japanese forum member who announced that Maruho/Astellas who is manufacturing Amenamevir is going to release final clinical results at the end of this month which is exciting news. All 3 phase clinical trials have been done already in Japan but Maruho has given very limited information in the last couple of years. Personally Im looking forward to this results. 

Thank you, that is great. I am surprised there isn't more hype around this. I'm guessing it is because it is being developed in Japan and there has not been much published regarding clinical trials. At best, how do you think this drug might affect sufferers of hsv
 

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valleynovascotia

so can someone address if this is for herpes and what happened to pritlever if it reduced shedding by 95 percent then thats almost a therapeutic vaccine imagine if it was combined with valkltrex that would almost be a cure.

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dont quit!17
53 minutes ago, fugazi1 said:

Thank you, that is great. I am surprised there isn't more hype around this. I'm guessing it is because it is being developed in Japan and there has not been much published regarding clinical trials. At best, how do you think this drug might affect sufferers of hsv
 

Well best case scenario would be that Maruho brings Amenamevir to the states with a sense of urgency. If that is the case within a few years we could possibly have Genoceas therapeutic vaccine available as well as this HPI medication. In combination Gen-003 vaccine+ HPI (Amenamevir) would probably lead to NO shedding thus a functional cure.

So if you are asking me how it could possibly affect us? I would say it would affect me fucking GREAT! (not being sarcastic). No worries of transmission, less insecurities when I'm around attractive people and a peace of mind.

I would love to have this available up until the whole CRISPR thing gets figured out.

*Please Lord, let this be available.

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House of Herpesians
30 minutes ago, fugazi1 said:

Thank you, that is great. I am surprised there isn't more hype around this. I'm guessing it is because it is being developed in Japan and there has not been much published regarding clinical trials. At best, how do you think this drug might affect sufferers of hsv
 

@fugazi1

I quickly checked the publications about ASP2151 on PubMed, the most famous academic database in medical field, and found following 10 articles that have been published on academic journals:

1.
ASP2151, a novel helicase-primase inhibitor, possesses antiviral activity against varicella-zoster virus and herpes simplex virus types 1 and 2.
Chono K, Katsumata K, Kontani T, Kobayashi M, Sudo K, Yokota T, Konno K, Shimizu Y, Suzuki H.
J Antimicrob Chemother. 2010 Aug;65(8):1733-41. doi: 10.1093/jac/dkq198. Epub 2010 Jun 9.


2.
Effect of ASP2151, a herpesvirus helicase-primase inhibitor, in a guinea pig model of genital herpes.
Katsumata K, Chono K, Sudo K, Shimizu Y, Kontani T, Suzuki H.
Molecules. 2011 Aug 25;16(9):7210-23. doi: 10.3390/molecules16097210.


3.
Efficacy of ASP2151, a helicase-primase inhibitor, against thymidine kinase-deficient herpes simplex virus type 2 infection in vitro and in vivo.
Himaki T, Masui Y, Chono K, Daikoku T, Takemoto M, Haixia B, Okuda T, Suzuki H, Shiraki K.
Antiviral Res. 2012 Feb;93(2):301-4. doi: 10.1016/j.antiviral.2011.11.015. Epub 2011 Dec 4.

4.
ASP2151 for the treatment of genital herpes: a randomized, double-blind, placebo- and valacyclovir-controlled, dose-finding study.
Tyring S, Wald A, Zadeikis N, Dhadda S, Takenouchi K, Rorig R.
J Infect Dis. 2012 Apr 1;205(7):1100-10. doi: 10.1093/infdis/jis019. Epub 2012 Feb 20.


5.
Susceptibility of herpes simplex virus isolated from genital herpes lesions to ASP2151, a novel helicase-primase inhibitor.
Katsumata K, Weinberg A, Chono K, Takakura S, Kontani T, Suzuki H.
Antimicrob Agents Chemother. 2012 Jul;56(7):3587-91. doi: 10.1128/AAC.00133-12. Epub 2012 Apr 23.

6.
Synergistic activity of amenamevir (ASP2151) with nucleoside analogs against herpes simplex virus types 1 and 2 and varicella-zoster virus.
Chono K, Katsumata K, Suzuki H, Shiraki K.
Antiviral Res. 2013 Feb;97(2):154-60. doi: 10.1016/j.antiviral.2012.12.006. Epub 2012 Dec 20.


7.
Pharmacokinetics and pharmacodynamics of ASP2151, a helicase-primase inhibitor, in a murine model of herpes simplex virus infection.
Katsumata K, Chono K, Kato K, Ohtsu Y, Takakura S, Kontani T, Suzuki H.
Antimicrob Agents Chemother. 2013 Mar;57(3):1339-46. doi: 10.1128/AAC.01803-12. Epub 2012 Dec 28.


8.
Statistical analysis of Amenamevir (ASP2151) between pharmacokinetics and clinical efficacies with non-linear effect model for the treatment of genital herpes.
Takada A, Katashima M, Kaibara A, Sawamoto T, Zhang W, Keirns J.
Clin Pharmacol Drug Dev. 2014 Sep;3(5):365-70. doi: 10.1002/cpdd.108. Epub 2014 Feb 17.


9.
Regulated bioanalysis of conformers - A case study with ASP2151 in dog plasma and urine.
Ohtsu Y, Otsuka S, Nakamura T, Noguchi K.
J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Aug 1;997:56-63. doi: 10.1016/j.jchromb.2015.05.028. Epub 2015 May 28.


10.
Profile of anti-herpetic action of ASP2151 (amenamevir) as a helicase-primase inhibitor.
Yajima M, Yamada H, Takemoto M, Daikoku T, Yoshida Y, Long T, Okuda T, Shiraki K.
Antiviral Res. 2017 Mar;139:95-101. doi: 10.1016/j.antiviral.2016.12.008. Epub 2016 Dec 24.

Since I'm not a professional in the field of virology, I believe I'm not a right person to answer your question, but as an individual suffering HSV2, I DO HOPE the drug give us positive effects.

21 minutes ago, valleynovascotia said:

so can someone address if this is for herpes and what happened to pritlever if it reduced shedding by 95 percent then thats almost a therapeutic vaccine imagine if it was combined with valkltrex that would almost be a cure.

@valleynovascotia

Amenalief will be surely effective for HSV, since it is developed to combat the disease. A pharmacy said we can use the drug with Valtrex. I'm not sure how the release of Amenalief will affect the development of other drugs...

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fugazi1
2 hours ago, dont quit!17 said:

Well best case scenario would be that Maruho brings Amenamevir to the states with a sense of urgency. If that is the case within a few years we could possibly have Genoceas therapeutic vaccine available as well as this HPI medication. In combination Gen-003 vaccine+ HPI (Amenamevir) would probably lead to NO shedding thus a functional cure.

So if you are asking me how it could possibly affect us? I would say it would affect me fucking GREAT! (not being sarcastic). No worries of transmission, less insecurities when I'm around attractive people and a peace of mind.

I would love to have this available up until the whole CRISPR thing gets figured out.

*Please Lord, let this be available.

Wow this would be incredible indeed. Keeping my fingers crossed and looking forward to the upcoming results. Thanks for the helpful feedback!

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Hansje

I don't know the rules in Japan. Could a traveller/tourist with HSV2 buy this medication there? Also a large amount so as not to run out very soon? Or maybe being ordered from abroad with a prescription? Is anything known about the cost yet? 

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House of Herpesians

@Hansje

It may be quite difficult for a foreign traveler to buy a newly-approved drug WITHOUT doctor's prescription... Even for Japanese, doctor's prescription is necessary for the new drugs. Basically, a prescription issued in a foreign country will not be accepted in any pharmacy. Considering the English literacy of the Japanese pharmacists, only a few of them will be capable of reading it, though... Anyways, just wait and see until the result of the meeting comes out. Without the formal approval, we cannot get the drug for any means.

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Whyyyyy
7 minutes ago, House of Herpesians said:

@Hansje

It may be quite difficult for a foreign traveler to buy a newly-approved drug WITHOUT doctor's prescription... Even for Japanese, doctor's prescription is necessary for the new drugs. Basically, a prescription issued in a foreign country will not be accepted in any pharmacy. Considering the English literacy of the Japanese pharmacists, only a few of them will be capable of reading it, though... Anyways, just wait and see until the result of the meeting comes out. Without the formal approval, we cannot get the drug for any means.

Sorry if this has been stated already but when is the formal approval supposed to take place? Do we have any idea?

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House of Herpesians

The meeting will be held on May 30, so in a few days the result will come out. Following the result, the Ministry will make the final decision about the approval of the drug, but I'm not sure how quickly this process will be completed... At the quickest time schedule, the drug may be approved next week (But I'M NOT TOTALLY SURE about this...) As for how to import the drug from Japan, I have no ideas about that..., sorry... (^^;)

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Whyyyyy
11 minutes ago, House of Herpesians said:

The meeting will be held on May 30, so in a few days the result will come out. Following the result, the Ministry will make the final decision about the approval of the drug, but I'm not sure how quickly this process will be completed... At the quickest time schedule, the drug may be approved next week (But I'M NOT TOTALLY SURE about this...) As for how to import the drug from Japan, I have no ideas about that..., sorry... (^^;)

Thank you very much! 

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House of Herpesians

This may disappoint many readers of this forum....

I double checked the document showing the agenda of the meeting on May 30 and confirmed that Amenoleaf will be discussed there at the meeting. According to the document, the approval for the drug's production and sales will be SURELY discussed there, though no herpes-related words were used in the agenda. However, according some websites relating to the new drug approval, the meeting seems to discuss Amenolief as the new drug for shingling or simple HSV... Since I personally have no relation with pharmaceutical industry nor do I have such deep knowledge about pharmaceutical sciences, I have no ideas about how they will handle the topic in the meeting... If the meeting approves the drug as a new drug for simple HSV, including HSV2, that'll surely change our life...

Of course, I will let you know about the result of the meeting, but please also note the possibility that the drug is not approved for the treatment of HSV2...

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dont quit!17
3 hours ago, House of Herpesians said:

@Hansje

It may be quite difficult for a foreign traveler to buy a newly-approved drug WITHOUT doctor's prescription... Even for Japanese, doctor's prescription is necessary for the new drugs. Basically, a prescription issued in a foreign country will not be accepted in any pharmacy. Considering the English literacy of the Japanese pharmacists, only a few of them will be capable of reading it, though... Anyways, just wait and see until the result of the meeting comes out. Without the formal approval, we cannot get the drug for any means.

Dude keep us updated. I will send you a Starbucks gift card, lol. Really this is the best potential upcoming news. Better than RVX and Genoceas vaccines that is for sure. 

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dont quit!17
8 hours ago, House of Herpesians said:

This may disappoint many readers of this forum....

I double checked the document showing the agenda of the meeting on May 30 and confirmed that Amenoleaf will be discussed there at the meeting. According to the document, the approval for the drug's production and sales will be SURELY discussed there, though no herpes-related words were used in the agenda. However, according some websites relating to the new drug approval, the meeting seems to discuss Amenolief as the new drug for shingling or simple HSV... Since I personally have no relation with pharmaceutical industry nor do I have such deep knowledge about pharmaceutical sciences, I have no ideas about how they will handle the topic in the meeting... If the meeting approves the drug as a new drug for simple HSV, including HSV2, that'll surely change our life...

Of course, I will let you know about the result of the meeting, but please also note the possibility that the drug is not approved for the treatment of HSV2...

It should work for both viruses. similar to valtrex but far more superior. We will have to wait and see. This is a good product and I've actually considered moving my family to Japan, haha.

Edited by dont quit!17

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