HSV529 リサーチグループからの返信

早速ですが、HS529リサーチグループから返信がありました！(*^^)v

本当に来るとは思っていなかったので、メールをチェックして、

　「へっ… (゜o゜)」

となってしまいました…。


返信の内容は、というと…

Our study for HSV529 (NIH protocol 13-I-0172) is only accepting participants who live within 60 miles of the NIH Clinical Center.

というものでして…、(ーー;)


最終的には、「National Institute of Health Clinical Center から60マイル以内に住む人」を対象としているようで、日本からの旅行者などは対象とはならないようです… (-"-)

ちょっと残念ですが… (p_-)


ちなみに、NIH の場所ですが、以下のG-MAPから確認できます！

結構、いい感じのところですよ…☆


https://www.google.co.jp/maps/place/National+Institute+of+Health+Critical+Care/@39.0009545,-77.1110183,10z/data=!4m5!1m2!2m1!1sNational+Institutes+of+Health+Clinical+Center,+Center+Drive,+Bethesda,+MD,+United+States!3m1!1s0x0:0x789308af1b72ff37



【以下、返信文】

Dear Zenigata:

Thank you for emailing the Office of Patient Recruitment at the National Institutes of Health (NIH) Clinical Center. We provide information about how to take part in clinical research studies here at the Clinical Center in Bethesda, Maryland.

Our study for HSV529 (NIH protocol 13-I-0172) is only accepting participants who live within 60 miles of the NIH Clinical Center.

To search for research studies at other organizations please visit http://clinicaltrials.gov. This website is continuously updated, so you may want to check it frequently to see if new studies have been added.

If you would like to read more about herpes simplex, please visit http://www.nlm.nih.gov/medlineplus/herpessimplex.html.

Thank you,

Office of Patient Recruitment
National Institutes of Health Clinical Center
Bethesda, MD 20892
Toll-Free 1-800-366-5165
TTY: 1-866-411-1010
Hours: Monday - Friday 8:30 a.m. – 3:30 p.m. (ET) except Federal holidays
Internet: http://clinicalcenter.nih.gov
Clinical Study Information: http://clinicalstudies.info.nih.gov

検討してみました結果… (^_-)-☆

少し前に、ご相談させていただいた、

　「FBに移行しようかなぁ…」

というお話ですが…、

やっぱり、ヤメにしました (*´з`)

　ちょっと投稿するのが楽になるかなぁ…

と思っただけなのですが、どこかいい所（もちろん、ここでも良いんですが…(#^^#)）ありましたら、また教えてください。

皆さんともご相談しながら、検討したいと思います。

HS529治験センターに問い合わせ…

先ほどの投稿のすぐ後…、ちょっと思い立って、HSV529の治験を実施しているNational Institutes of Health Clinical Center に…、

　「外国人旅行者でも参加可能でしょうか？」

という問い合わせメールを出してみました !(^^)!

出したばかりですので、もちろん返事はまだですが…、返信が来たらまたUPします☆


お楽しみに !(^^)!

スゴイねぇ！GEN-003 (*^^)v 症状とウィルスの排出を ↓

日曜だというのに、仕事に追われている銭型でございます… (-"-)

今日は、またもや仕事の合間に「ボーッ」とネットで探し物をしていたのですが、そうしたら！

　　「GEN-003 が Phase 1で、症状だけでなく、ウィルスの排出も抑制した」

という記事を見つけました！!(^^)!

色んなワクチン研究で、「発症期間が短くなった」、「症状が軽くなった」などの報告は良くあるのですが…、

　ウィルスの排出が51％少なくなった（つまり、49%＝半分以下）

というものは少ないように思います !(^^)!

記事の最後の方にも書いてあるのですが、まだ、Phase 1ですので、これから効果検証を目的とした Phase 2、より多くの人に対する安全性検証を目的とした Phase 3 を乗り越えていくには、まだまだ時間が必要です…。

ただ、このGEN-003にしろ、HSV529にしろ、新しいアプローチでのワクチン開発がどんどん進んでいるように思います。

今後の動きに、注目ですね ☆


http://www.admitonevip.com/herpes-cure-2014-new-discoveries-to-battle-the-infection/

Genocea Herpes Vaccine: GEN-003
Genocea Biosciences is one of the many institutions trying to develop a new way to deal with herpes. Although this prospect treatment is still not completed, results have been positive so far. Say hello to herpes cure 2014, the GEN-003.
The leading candidate to battle genital herpes is GEN-003. This new vaccine is designed to lessen the duration and the intensity of the symptoms of the disease. Not only that, it also aims to regulate the transmission of the virus. It also aims to reduce viral shedding which is how the virus gets easily contracted. This protein subunit vaccine is expected to respond well with the immune system.
The vaccine is known to contain antigens that are have demonstrated resistance against the disease and reduced the duration of the symptoms and viral shedding. Clinical trials are now being made to see if the vaccine will work. In the Phase 1 clinical trial conducted by Genocea, there are 143 participants. All participants had HSV-2.

How Does It Work
The vaccine works by working on the T cells. It activates these cells so that they can better handle the outbreaks of the virus. The vaccine will enable the T cells to quickly identify and take down the infection before it can actually reach the surface of the skin. Because of that, the immune system is quicker when dealing with the virus.

How is the Vaccine Given
GEN-003 is administered to the participants by injections, 3 injections in series to be particular. Booster shots are also given at certain times to make sure that the vaccine is active. The vaccine may not take out the virus but it definitely is a good alternative than taking anti-viral drugs every now and then.

Results
The first clinical trial for the vaccine has been successful. GEN-003 shows promising results for the treatment of herpes. There was a significant reduction seen in the viral shedding by 51%. With this reduction, the chance of transmitting herpes to sexual partners would lessen.
With the success of the Phase 1 clinical trial, GEN-003 will enter the Phase 2 hoping that it bears positive results. The first phase is normally conducted to volunteers. It aims to determine the side effects and other factors.
Since Phase 1 was a success, Phase 2 begins which will focus most especially on the efficiency of the vaccine. The participants will be compared to another set of participants taking another treatment. This phase normally lasts for 2 years.
The third phase follows with an estimated duration of 3 years. This will tackle more on the safety of the vaccine. Various populations will be studied to cater other factors. Different dosages will be tested too.
The arrival of this herpes cure 2014, the GEN-003, gives much hope to those who suffer from the disease. The path to reaching the goal is still far but as long as there is perseverance, one can always triumph.

再生医療の会社がHSV2ワクチンを開発中！(^^♪

やらなきゃいけないことはたんまりあるんですが…、何となくボーっとしながら調べてみると、…

いろんな情報があるもんですね (^_-)-☆

今回、偶然に探し当てたのが、

Admedusという再生医療の会社がHSV2のワクチンを開発しており、フェーズ1の臨床実験で好成績を収めた

というものでした (^^♪

Admedusという会社はオーストラリアにあるようで、ホームページを見ると、心臓弁膜症の治療に使うためのバイオシートを作成しているようです。そのバイオシートを使った治療成績は結構良いようで、そこそこ有名な会社のようです。

オーストラリアと言えば、HSV2のワクチン作成で有名な Professor Ian Frazer と研究チームがいるわけで…、今回のこの Admedus も、Frazer博士が開発したテクノロジーを基にワクチンの開発を進めているとのことです。

私も専門家ではないので全く分りませんが … (*_*;


　「心臓弁膜症で使うバイオシート」
　「HSV2のワクチン作成」


この二つの間にはどのような関係性があるのでしょう？？？

記事を読んでみて、ちょっとだけ疑問に思いました (*´з`)


まぁ、いろんなところが研究を進めているということで、頼もしいことです！


Admedus' HSV-2 therapeutic vaccine achieves primary endpoint in Phase 1 trial

http://www.news-medical.net/news/20140203/Admedus-HSV-2-therapeutic-vaccine-achieves-primary-endpoint-in-Phase-1-trial.aspx

Admedus (ASX: AHZ) today announced that interim study results on its Phase 1 trial of a therapeutic vaccine for Herpes Simplex Virus (HSV-2) have shown that it achieved the primary endpoint of the study by being safe in the study subjects. In addition, the study has also shown that the vaccine was able to generate a T-cell response.

The dosing of study subjects was completed in December 2013 and further analysis of the data in still ongoing. Admedus anticipates providing further study data later in the year.

“This is an encouraging result for the core vaccine technology and provides us with the basis for not only progressing the Herpes therapeutic vaccine program, but also preparing the Human Papillomavirus vaccine for initial clinical studies as a therapeutic against HPV and Cervical Cancer” said Admedus CEO Mr Lee Rodne.

The core technology is based on Professor Ian Frazer and his team’s work over the last 10 years. The technology looks at stimulating the immune response to enable a patient to fight against diseases.

“The results are very encouraging and we believe we should progress these programs forward” said Professor Ian Frazer.

“Once we complete our analysis the team will be looking to take this program into a second clinical study in patients infected with the Herpes virus”.

Currently there is no cure for Herpes and incidence is high. The US CDC estimates that 1 in 6 people in the USA between the age of 14 and 49 have contracted the infection. There is currently no cure for Herpes Simplex 2 infection.

ちょっと、ご相談なんですが… (´・ω・`)

House of Herpesians、Facebookに移転しようかとも考えているんですが、みなさん、どう思われますか？たぶん、実名でFBに登録されている方もいらっしゃると思うので、「おっ、良いかも！」と思う反面、「やめたほうがいいかなぁ…」とも考えております… (´・ω・`)

良かったら、ご意見をお聞かせくださいませ… (#^^#)

Vical の秘密兵器？Vaxfectin

ちょっとドタバタしてしまいまして、更新が遅れてしまいました… (*_*;

スミマセン (*´з`)


どうやら、Vicalさんが VaxfectinというHSV2に特化した新薬の治験に入ったようですね！(^^♪

うれしい限りです！

ちょっと出たばかりなので、ざぁっと感じで読んだ限りでは…、

1. VaxfectinはHSV2に特化した「治療薬」で、
2. 性器ヘルペス患者からのウイルス排出にも効果が期待！

ということのようです (^^♪

Vaicalさんは製薬会社の名前で個人的にはよく聞くんですが…、世界ランク５０位には入っていないんですね… (´・ω・`)

下記リンク参照
http://www.currentpartnering.com/insight/top-50-pharma/


ちなみに、日本の製薬会社では…、

• 武田製薬
• アステラス製薬
• 第一三共
• 大塚製薬
• エイザイ
• 三菱田辺
• 共和発酵
• シオノギ

が入ってるみたいですね！

個人的には、ポカリをよく飲むので…、


　「大塚、頑張れぇぇぇつ！」


と言いたいところです (^^)/

まぁ、いずれにしても、Phase 2の第一段階ですからね、先は長いですが、是非とも実現を期待したいところです！

Vical Incorporated (NASDAQ:VICL) Initiated The Phase-1/2 Trial Of Its Vaxfectin

http://nysepost.com/vical-incorporated-nasdaqvicl-initiated-the-phase-12-trial-of-its-vaxfectin-38572

Boston, MA, 01/27/2014 (nysepost) - Recently, Vical Incorporated (NASDAQ:VICL) announced that the company had initiated the  Phase-1/2 trial of its  Vaxfectin™-formulated therapeutic-vaccine used for herpes simplex virus type-2 (HSV-2), which is a cause of genital-herpes, in almost 156 subjects. This randomized, placebo-controlled, double-blind trial will evaluate the tolerability, safety and the efficacy in the otherwise healthy HSV-2-infected patients who are aged 18-50 years at 6 key United States’ clinical sites.

Vice President for Vaccine Research at Vice President of Vaccine Research, Larry Smith said that the initiation of this particular trial represents another milestone for the company. This trial is specifically-designed to demonstrate he reductions in rate of HSV-2 that has been shed from the individuals suffering from symptomatic genital herpes. A therapeutic vaccine might  be an ideal approach to reduce viral shedding due to its  ability to harness the immune-system in controlling HSV-2, potentially freeing the subjects from daily, life- long antiviral drug-usage.

The Phase-1/2 trial is a critical step towards development of a product that limits the viral shedding but might also reduce symptomatic genital-herpes lesions and virus transmission said Smith. HSV-2 is a sexually-transmitted virus which is the main cause of a recurrent genital herpes. Around 1 out of 6 six individuals aged 15-49 years globally is chronically infected by the HSV-2 virus. HSV-2 infections are very persistent and can eventually result in debilitating genital-lesions. Periodic virus-shedding places sexual partners at a risk of infection. The presence of the HSV-2 genital lesions significantly raises the risk of acquiring this HIV-1 virus from any HIV-infected sexual partners. There is still no approved-vaccine for HSV-2.

Vical Incorporated (NASDAQ:VICL) researches & develops bio pharma products that are based on the company’s patented DNA-delivery technologies for prevention and the treatment of various serious/ life-threatening diseases. Potential applications of Vical Incorporated (NASDAQ:VICL)’s DNA-delivery technology include DNA-vaccines for cancer or infectious diseases.

AIC316 （Pritelivir）、治験中断の原因とは…

ちょっと時間が空いてしまいましたが…、すみません…。<m(__)m>

仕事が立て込んでしまい、

　　＼(゜ロ＼)ココハドコ? (／ロ゜)／アタシハダアレ?

という感じになっておりましたので…。はい… (^_^;)


今日は、ちょっと偶然に見つけた記事を紹介したいと思います！

それは、以前から紹介していた、AIC316（製造名：Pritelivir）に関する情報です。


Pritelivir は、ドイツの製薬会社 AiCuris が開発を進めている HAV2 をターゲットとした新薬なのですが、これまでの薬品（Zovirax, Famvir and Valtrex）とは異なる機能を持っており、特に、

　　「HSV2 ウィルスの体外排出を抑えることができる」

という点では、他の３薬には見られないもののようです！


以下の引用文の中で、

The study, funded by German drug maker AiCuris, included 156 adults with HSV-2 infections. They were randomly assigned to one of five groups. One group received placebo pills, while the other four took different doses of pritelivir. 

Over 28 days, patients on the highest drug dose (75 milligrams a day) showed the biggest effects. They had viral shedding on only 2 percent of those days, versus almost 17 percent in the placebo group. Another group, which received a once-a-week 400 mg dose, also showed a significant drop in viral shedding.

という部分が、治験結果に関して述べているのですが、この部分はと言いますと…

1. 実験では156名の大人が参加した
2. 実験時間は28日間
3. プラセボ（偽薬）グループを１つ、Pritelivir を投与したグループを、薬品の濃度に合わせて4グループ作り、治験を行った
4. その結果としては、以下のようであったとのことです…

• 最も濃度が高かったグループ（78ミリグラム/日）が最も高い効果を示した
• プラセボグループが、実験期間中（28日間）の約17％（約 4.76日）でウイルスの排出が認められたのに対し、上記のグループでは、わずか2％（約 0.56日）であった。
• 週１回 400ミリグラムの投与を受けたグループでも、有意にウイルス排出期間が少なくなっていた

この記事を見た時、思わず…

　　「えっ、治験が再開されたの？」 ＼(◎o◎)／！

と思ったのですが、実はそういうわけではないようでして…。


どうやら、FDAが治験をストップしている理由が、

Further clinical trials of the drug are on hold right now. Last May, the U.S. Food and Drug Administration suspended the work after research in monkeys showed some unexpected blood and skin abnormalities.

It's not clear why, Ward said. "We haven't seen those effects in humans," she said.

ということらしく、動物実験で予期しなかった異常（血液と皮膚における異常）が見つかったことが原因となり、「治験お預け」となっているようです… (-_-)

先の人間を対象とした治験では、全くそのような影響は出なかったようなのですが…、こればかりは仕方がないですかね… (－－〆)


早く、再開して欲しいものです…。



By Amy Norton

HealthDay Reporter

WEDNESDAY, Jan. 15, 2014 (HealthDay News) -- An experimental drug could eventually offer a new treatment option for genital herpes, a common and incurable sexually transmitted infection, researchers report.

In a small study, researchers found that the drug -- called pritelivir -- substantially curbed "viral shedding" in people with genital herpes. That means it decreased the amount of time the virus was active and potentially transmissible to patients' sexual partners.

The findings, reported in the Jan. 16 issue of the New England Journal of Medicine, are based on 156 patients followed for just four weeks. Experts cautioned that the study is preliminary and offers a "proof of concept."

Still, they said, the results are important because pritelivir is the first in a new class of drugs that works differently than existing medications for genital herpes. The hope is that pritelivir will be better at preventing transmission of the virus.

"There was a fairly dramatic decrease in the probability of viral shedding in this study," said Dr. Richard Whitley, an infectious disease expert at the University of Alabama at Birmingham.

There is still a lot of research to be done, said Whitley, who wrote an editorial published with the study. But he said it's good news that drugs that work in new ways are under development.

"We're at the beginning of a new era" in genital herpes treatment, Whitley said.

Genital herpes is caused by the herpes simplex virus -- usually the strain known as HSV-2. It's a common disease: An estimated 16 percent of Americans aged 14 to 49 have an HSV-2 infection, according to the U.S. Centers for Disease Control and Prevention.

The infection may cause painful sores around the genitals, rectum or mouth. But, more often, it causes no symptoms or only mild ones, which means most people with HSV are unaware they're infected.

HSV can be dangerous, however. If it's passed from a mother to a newborn, the infection can be fatal. In rare cases, HSV invades the brain and triggers potentially deadly inflammation.

There is no cure for genital herpes. Once a person is infected, HSV hides out in nerve cells and reactivates periodically -- sometimes causing symptoms, sometimes not. Currently, three medications can treat symptoms, and -- if taken daily -- suppress new symptom outbreaks: acyclovir (brand name Zovirax), famciclovir (Famvir) and valacyclovir (Valtrex).

Even with that daily treatment, there is still viral shedding and the drugs cut HSV transmission by only about half, said Dr. Anna Wald, lead researcher on the new study.

"Clearly, we'd like to do better," said Wald, a professor of allergy and infectious disease at the University of Washington, in Seattle.

Acyclovir, the oldest of the existing drugs, was developed in the 1980s. All three medications had a big impact on managing genital herpes when they came out, said Dr. Lawrence Stanberry, an infectious disease expert at Columbia University Medical Center/NewYork-Presbyterian Hospital, in New York City.

Stanberry agreed, however, that the drugs fall short when it comes to preventing HSV transmission. Plus, he said, doctors are seeing some viral resistance to acyclovir in patients with compromised immune systems, such as people with HIV.

The ultimate hope is to develop drugs that eliminate dormant HSV from the nerve cells, said Stanberry, who was not involved in the new study.

"But we don't have anything like that," he said. "And [pritelivir] is not it either."

"[But] it's exciting that there's a new class of drugs," Stanberry said. "This has the potential to improve treatment."

The study, funded by German drug maker AiCuris, included 156 adults with HSV-2 infections. They were randomly assigned to one of five groups. One group received placebo pills, while the other four took different doses of pritelivir.

Over 28 days, patients on the highest drug dose (75 milligrams a day) showed the biggest effects. They had viral shedding on only 2 percent of those days, versus almost 17 percent in the placebo group. Another group, which received a once-a-week 400 mg dose, also showed a significant drop in viral shedding.

That's important, Stanberry said, because if a once-weekly drug dose were effective, that would make treatment more convenient.

There were no significant side effects from the medication, according to the researchers. But, Ward said, the study was small and short-term, so the safety question needs more investigation.

Further clinical trials of the drug are on hold right now. Last May, the U.S. Food and Drug Administration suspended the work after research in monkeys showed some unexpected blood and skin abnormalities.

It's not clear why, Ward said. "We haven't seen those effects in humans," she said.

More information

The U.S. Centers for Disease Control and Prevention has more on genital herpes.

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