Cancer vaccine research – how close are we to real cures for cancer?

How far along is cancer vaccine research development?

According to this morning’s NHK TV Asaichi programme, Tokyo University research in cancer vaccine is the furthest and most advanced stage of all research. They have had positive results and seen 100% regression of cancers in their clinical experiments on human patients for various types of cancer including lung cancer and brain tumours. However, it was admitted that a lot more research needed to be done on the type of meds to be used, delivery methods to cancerous cells or tumours in different parts of the body, etc, etc.

However, a perusal of online news on the state of cancer vaccine research suggests that the Israelis appear to be at the most advanced state of research.

Source: The Asaichi programme website:

メインテーマ驚き!がんワクチン治療最前線

専門家ゲスト:中村祐輔さん(東京大学医科学研究所 ヒトゲノム解析センター 教授)
ゲスト:内藤剛志さん(俳優)、城之内早苗さん(演歌歌手)
リポーター:内藤裕子アナウンサー

出演者の関連情報はこちら

日本人の2人に1人がかかると言われる“がん”。これまでのおもな治療法は外科手術、抗がん剤、放射線の3つですが、番組では、最近注目されている「がんワクチン治療」の最前線に迫りました。患者自身の免疫力を高め、がん細胞を攻撃するもので、副作用が少なく、月に数回通院して注射を受けるだけという利便性があります。日本では臨床試験の段階ですが、その効果に救われる人も出てきています。すい臓がんでもう治療法がないと言われたものの、肝臓に転移した腫瘍が消え、家族旅行を楽しめるまでに回復した30代の主婦。余命2か月と言われ抗がん剤治療を始めたものの副作用で投与を止めざるをえず、絶望のふちをさまよったが、症状が改善した40代の男性など、がんワクチン治療の体験者を紹介。その驚きの可能性から治療費など課題まで、がんワクチンの全貌をお伝えしました。

「がんワクチン」とは?

ワクチンというと、インフルエンザやBCG、最近では子宮頸(けい)がんなど病気を“予防”するものが知られていますが、今回ご紹介したのは“治療”するワクチン。自分の持つ免疫能力を活性化させ、がん細胞を攻撃します。副作用が少なく、延命効果が認められるのが特徴です。
このワクチンの中に入っているのは、『ペプチド』と言われるタンパク質の断片。『ペプチド』はがん細胞の表面に角のように出ているもので、これが治療に大きく役立っています。

そもそも私たちの体は、ウィルスなどの異物が侵入すると・・・

監視役として働く「樹状細胞」が異変を察知、その特徴を記憶

攻撃役として働く「キラーT細胞」に異物の特徴を伝達

「キラーT細胞」がウィルスに侵された細胞を攻撃

この一連の流れが、私たちの体を守るいわゆる“免疫”です。

では、私たちの体ががんに侵されると・・・

がん細胞も異物ですが、非常に早いスピードで際限なく広がるため、「キラーT細胞」の数が足らず攻撃しきれません。

そこで『ペプチド』が大量に入った「がんワクチン」を投与すると・・・

「樹状細胞」はペプチドが大量に入ってきたことを異常事態だととらえ

「キラーT細胞」に警告

「キラーT細胞」も異常事態に反応、自ら数を増やしパワーアップしてがん細胞を攻撃

「がんワクチン」の臨床研究に参加するには

臨床研究に参加する条件

がんワクチンはまだ承認されていません。
受けるには臨床研究に参加するという方法がありますが、さまざまな条件があります。また、誰にでも効果が認められているというわけではありません。

≪臨床研究 参加の条件≫
・がんの種類
・進行度
・白血球の型・数
・リンパ球の数
・治療歴
・期間・人数

臨床研究が行われている病院の問い合わせ先

(1) VTR「すい臓がんの女性が受けたワクチン」、「ぼうこうがんの女性が再発予防のために受けたワクチン」はこちら

東京大学医科学研究所ヒトゲノム解析センター 中村祐輔研究室
ホームページ:http://www.ims.u-tokyo.ac.jp/nakamura/
(トップページに病院一覧が貼り付けてあります。)
電話:03-3443-8111(代表)

(2) VTR「小細胞肺がんの男性が受けたワクチン」はこちら

久留米大学病院 がんワクチン外来事務局
ホームページ:http://www.med.kurume-u.ac.jp/med/immun/F/
電話:0942-31-7975

■注意■
「がんワクチン」についてインターネットなどで検索するとさまざまなサイトにつながり、誰でもすぐ受けられるように感じます。しかし、がんワクチンは日本ではまだ承認されておらず、その効果を確かめる臨床試験の段階です。がんワクチンを希望する方は、そのことを十分考慮する必要があります。

久留米大学病院「がんワクチン外来」

2009年4月に「がんワクチン外来」を設けて以来、手術や抗がん剤、放射線などで効果がなく、もう治療法がないと言われた患者を中心に年間300人近くが受診しています。外来と言ってもがんワクチンはまだ承認されていないため、ワクチン投与を希望する患者は臨床研究に参加するという形になり、ワクチン代の一部を負担することになります。また、主治医からの紹介状が必要で、抗がん剤や放射線など標準治療で効果がある方はその治療を優先し、がんワクチンは補助的に併用するよう勧めています。
ここの特徴は、31種類のペプチドのうち、効果が高いと考えられるペプチドを最高4種類同時に投与することで、どのペプチドにするかは、血液検査で患者の状況を調べて決めます。そのため『テーラーメイドペプチドワクチン』と呼ばれています。

問い合わせは上記 久留米大学病院「がんワクチン外来事務局」へ
※ワクチン投与を希望する場合は大学の臨床研究に参加するという形になり、ワクチン代の一部を負担することになります。
1回投与ごとに10万円弱
≪例≫
・1クール目 6回投与で約58万円(初回の血液検査代込み)
・2クール目 6回投与で約50万円
※金額は久留米大学がんワクチン外来ホームページ:より

なお、悪性脳腫瘍については現在厚生労働省の科学研究費で研究が進められているため、条件の合う方はワクチン代の負担はありません。また、前立腺がん(ホルモン療法が効かなくなり、内臓機能低下で抗がん剤が使えない場合など)については高度医療に認められており、公的医療保険との併用が可能です。

がんワクチンは再発の予防にも

がんワクチンは、もう治療法がないと言われた末期のがんだけでなく、手術後の再発予防にも効果があると考えられ研究が進んでいます。それは「がん細胞」とそれを攻撃する「キラーT細胞」の数の問題です。手術直後、がん細胞が少ない時にがんワクチンを打ち、あらかじめキラーT細胞にがんの目印『ペプチド』を覚えさせておけば、再発を防げるのではないかと考えています。

がんワクチンの実用化

薬は、大学などによる「臨床研究」、製薬会社が患者に投与し効果や安全性を調べる「治験」、国が審査をして「承認」という道を経て実用化されます。現在、日本国内で実用化に向けて動き出したがんワクチンを表にまとめました。もっとも進んでいるものは、治験の第3段階を終了しており、早ければ今年か来年には日本初のがんワクチンが実用化される見込みです。

≪臨床研究・治験進捗状況≫

・すい臓A、すい臓B・・・東京大学医科学研究所ヒトゲノム解析センター 中村祐輔研究室にお問い合わせください。
・肺A・・・グラクソ・スミスクライン株式会社が開発
・肺B・・・メルクセローノ株式会社が開発
・悪性脳腫瘍、前立腺・・・久留米大学 がんワクチン外来にお問い合わせください。
・胆道、ぼうこう、食道A・・・東京大学医科学研究所ヒトゲノム解析センター 中村祐輔研究室にお問い合わせください。
・食道B・・・株式会社イミュノフロンティアが開発
・骨髄異形性症候群・・・中外製薬株式会社、大日本住友製薬株式会社が共同で開発
・大腸、肝臓・・・東京大学医科学研究所ヒトゲノム解析センター 中村祐輔研究室にお問い合わせください。

VTRに登場した病院

「すい臓がんの30代女性」のVTRで、ワクチンの臨床研究を行っていた病院

※現在、すい臓がんの臨床研究は行っていません。
千葉徳州会病院
ホームページ:http://www.chibatoku.or.jp/
電話:047-466-7111(代表)
(問い合わせをする場合は「がんワクチン療法について」と伝えてください。)

「小細胞肺がんの40代男性」のVTRで、ワクチンの臨床研究を行っていた病院

久留米大学病院 がんワクチン外来事務局
ホームページ:http://www.med.kurume-u.ac.jp/med/immun/F/
電話:0942-31-7975

「ぼうこうがんの70代女性」のVTRで、再発予防を目的としたワクチンの臨床研究を行っていた病院

※現在、ぼうこうがん再発予防の臨床研究参加者の募集は行っていません。
岩手医科大学付属病院
ホームページ:http://www.iwate-med.ac.jp/hospital/
電話:019-651-5111(代表)

***

.

Cancer Vaccine Reaches Final Clinical Trials ‘(PCWorld    Nov 22, 2011 )

A cancer vaccine has just entered “Phase III” clinical trials at Jerusalem’s Hadassah University Medical Center. If the vaccine passes this phase, the drug will go to the appropriate regulatory authorities in countries around the world. After passing regulatory review, the drug would be able to enter the drug market within a matter of about 6 years from now.

The vaccine, called ImMucin, is produced by Vaxil BioTherapeutics, a clinical-stage company (so called because all of its products are in the early stages of development and testing and not yet ready for the market). ImMusin is synthetically derived from the MUC1 protein, which Vaxil says is associated with more than 90% of solid tumor cancers and a number of non-solid tumors.

According to the company, ImMucin is designed to work by stimulating the patient’s immune system to selectively target tumor cells. Vaxil says that the preclinical studies have shown ImMucin to induce a stronger immunity against MUC1 compard with other MUC1-derived derived vaccines.

The company says that ImMucin is designed to tell the body which cells to attack, by enhancing the immune system so that it can track down and destroy the cancer. Julian Levy, the CEO of Vaxil, told United With Israel, “the body knows something is not quite right but the immune system doesn’t know how to protect itself against the tumor like it does against an infection or virus. This is because cancer cells are the body’s own cells gone wrong.”

ImMucin will be tested on a large number of patients (hundreds to thousands of individuals) in the Phase 3 trials. If the drug proves successful in trials and pases each country’s regulations (the FDA in the US), it may then go on the market in that country. After it reaches the market, there are two more phases to evaluate the long-term effects on patients and to further integrate it into widespread public treatment.

Breakthrough: Israel is Developing Cancer Vaccine | United with Israel

Vaxil’s groundbreaking therapeutic vaccine, developed in Israel, could keep about 90 percent of cancers from coming back 

in a breakthrough development, the Israeli company Vaxil BioTherapeutics has formulated a therapeutic cancer vaccine, now in clinical trials at Hadassah University Medical Center in Jerusalem

Cancer Vaccine Significantly Reduces Tumor Size 13 Dec 2011An experimental cancer vaccine has been found to reduce tumor size by an average of 80%, researchers from the Mayo Clinic and the University of Georgia reported inProceedings of the National Academy of Sciences. In their animal experiment, mouse models that mimic most human pancreatic and breast cancer cases had dramatic reductions in tumor size – even among those that had not responded to standard treatments.

Tumors that share the same distinct carbohydrate signature may be especially treatable with this new vaccine, say the authors. This includes various cancers such as colorectal, ovarian, breast, pancreatic and some others. Sugars on the surface proteins of cancerous cells are different from those in healthy cells, the authors explain. For several years, researchers have sought ways of getting the immune system to identify the differences and target the cancer cells only, leaving the healthy ones alone. However, this is not easy, because cancer cells start off in the patient’s own body, and his/her immune system does not see them as foreign or pathogenic, and does not attack them.
Study co-author, Sandra Gendler, developed some unique mice for this experiment. Tumors in mice overexpress MUC1, a type of protein, on the surface of their cells. The surface of MUC1 found in tumors has a unique, shorter set of carbohydrates (this is not the case with carbohydrates on the surface of healthy cells).

Gendler said:

“This is the first time that a vaccine has been developed that trains the immune system to distinguish and kill cancer cells based on their different sugar structures on proteins such as MUC1. We are especially excited about the fact that MUC1 was recently recognized by the National Cancer Institute as one of the three most important tumor proteins for vaccine development.”

MUC1 was found to exist in over 70% of all lethal cancer

Scroll down to the bottom of page to see the other countries’  various types of cancer vaccine research, at various stages.

More information and readings:

Earlier via 2011 Vaccine Weekly via NewsRx.com:

Investigators publish new data in the report “A phase I study of vaccination with NY-ESO-1f peptide mixed with Picibanil OK-432 and Montanide ISA-51 in patients with cancers expressing the NY-ESO-1 antigen. ‘We conducted a phase I clinical trial of a cancer vaccine using a 20-mer NY-ESO-1f peptide (NY-ESO-1 91-110) that includes multiple epitopes recognized by antibodies, and CD4 and CD8 T cells. Ten patients were immunized with 600 g of NY-ESO-1f peptide mixed with 0.2 KE Picibanil OK-432 and 1.25 ml Montanide ISA-51,” scientists writing in the International Journal of Cancer Journal International Du Cancer report (see also Cancer Vaccines).

“Primary end points of the study were safety and immune response. Subcutaneous injection of the NY-ESO-1f peptide vaccine was well tolerated. Vaccine-related adverse events observed were fever (Grade 1), injection-site reaction (Grade 1 or 2) and induration (Grade 2). Vaccination with the NY-ESO-1f peptide resulted in an increase or induction of NY-ESO-1 antibody responses in nine of ten patients. The sera reacted with recombinant NY-ESO-1 whole protein as well as the NY-ESO-1f peptide. An increase in CD4 and CD8 T cell responses was observed in nine of ten patients. Vaccine-induced CD4 and CD8 T cells responded to NY-ESO-1 91-108 in all patients with various HLA types with a less frequent response to neighboring peptides. The findings indicate that the 20-mer NY-ESO-1f peptide includes multiple epitopes recognized by CD4 and CD8 T cells with distinct specificity. Of ten patients, two with lung cancer and one with esophageal cancer showed stable disease,” wrote K. Kakimi and colleagues, University of Tokyo Hospital.

The researchers concluded: “Our study shows that the NY-ESO-1f peptide vaccine was well tolerated and elicited humoral, CD4 and CD8 T cell responses in immunized patients.”

Kakimi and colleagues published their study in International Journal of Cancer Journal International Du Cancer(A phase I study of vaccination with NY-ESO-1f peptide mixed with Picibanil OK-432 and Montanide ISA-51 in patients with cancers expressing the NY-ESO-1 antigen. International Journal of Cancer Journal International Du Cancer, 2011;129(12):2836-46).

Additional information can be obtained by contacting K. Kakimi, Dept. of Immunotherapeutics, University of Tokyo Hospital, Tokyo, Japan

::

Research being conducted by the University of Tokyo Hospital’s Department of Immunotherapeutics: A phase I study of cancer vaccine with NY-ESO-1 overlapping peptides in patients with advanced cancers expressing NY-ESO-1 antigen and Clinical study on safety and efficacy of adoptive transfer of autologous gamma/delta T lymphocytes in patients with non-small cell lung cancer.

Ongoing clinical trials on patients with breast cancer; and on patients with renal cancer (Two of the four patients are currently alive 58 and 40 months after the initial vaccination with low-dose interleukin-2. Results suggest that GVAX substantially enhanced the antitumor cellular and humoral immune responses, which might have contributed to the relatively long survival times of our patients in the present study); on patients with colorectal cancer

Where cancer vaccine research and clinical trials are being undertaken – see Cancer Research Institute page.

A publication on Japanese cancer vaccine research:  Cancer vaccine: new research by Nathan Elliot (Nova Science Publishers)

Phase II cancer vaccination trial with multiple peptides derived from novel oncoantigens against advanced esophageal cancer  Conclusions: The OS in patients having all of three peptide-specific CTL responses indicated much better prognosis (OS=7.5 month) compared to that in the other patients. The phase II cancer vaccine therapy demonstrated the promising survival benefit as well as good immunogenicity, and, therefore, warrants further clinical studies.

Cancer vaccine shows early promise/ Researchers at the Center for Cancer Research, the National Cancer Institute and the National Institutes of Health tested a vaccine called Panvac

On April 14, 2009, Dendreon Corporation announced that their Phase III clinical trial of Provenge, a cancer vaccine designed to treat prostate cancer, had demonstrated an increase in survival.

Could This Be The End Of Cancer? Dec 12, 2011  U of Washington

On April 8, 2008, New York-based company Antigenics announced that it had received approval for the first therapeutic cancer vaccine in Russia. It is the first approval by a regulatory body of a cancer immunotherapy. The treatment, Oncophage, increased recurrence-free survival by a little more than a year according to the results of a phase III clinical trial. The approval is for a subset of kidney cancer patients who are at intermediate risk for disease recurrence. It awaits approval in the US and EU.[8] but will need a new trial for FDA approval.

Cancer-vaccine-shows-promise “A doctor injects a cancer patient with a mass-produced compound; the drug teaches the patient’s own antibodies and white blood cells how to attack cancerous tumors throughout the body. The tumors disappear. That is the promising scenario suggested bya new cancer vaccine developed by a University of Georgia researcher. Now in animal trials, the glycopeptide is among a new family of treatments that could change medicine. And as the foundation of a potential vaccine factory in Georgia or elsewhere, it’s also an example of the university’s effort to turn research into industry.

“Our vice president of research David Lee puts an emphasis on taking discoveries and translating products into companies,” said J. Michael Pierce, director of the UGA Cancer Center. Next in line is an attempt to raise the several million dollars needed to stage clinical trials of the compound, said researcher Geert-Jan Boons, developer of the vaccine. “To go from a mouse to a compound on the market will take seven years,” he said. Boons, Franklin professor of chemistry in UGA’s Complex Carbohydrate Research Center, collaborated on the project with Sandra Gendler at the Mayo Clinic’s Arizona facility. The treatment, called MUC1 tripartite immunotherapy, was shown to reduce tumors in mice by 80 percent or more. Boons said the compound has been used to treat breast cancer but also should be effective treatment for prostate cancer, pancreatic cancer and lung cancer. The efforts at the University of Georgia are possible because of the state’s cancer research infrastructure, an apparatus that grew appreciably with the creation of the Georgia Cancer Coalition in the late 1990s. Then-Gov. Roy Barnes insisted that Georgians shouldn’t have to leave the state to receive advanced treatment. ”

Top Japanese Scientist leaving government post to move to the University of Chicago Medical Center (IGSB, January 9, 2012)

Death of Japanese teen is the fifth case in the world of a death after injection with Cervarix, a cervical cancer vaccine approved for use in Australia…   Teen dies after taking cervical cancer vaccine 09/13/2011 

A 14-year-old girl died two days after being injected with Cervarix, a cervical cancer vaccine, the Ministry of Health, Labor and Welfare said on Sept. 12.

The junior high school girl’s death in July was the first fatality reported in Japan upon taking Cervarix.

However, the ministry said that it is not possible to recognize the pharmaceutical made by Britain’s GlaxoSmithKline P.L.C. as being directly responsible for her death.

A ministry report said the girl received a vaccine shot on July 28 and was found with her heart stopped and confirmed dead on July 30. The girl had a history of heart disease and it is believed the precise cause of her death stemmed from an irregular heartbeat.

Cervarix was first approved for use in Australia in May 2007 and went on sale in Japan from December 2009. An estimated 2.48 million women in Japan have been vaccinated against cervical cancer by using the drug.

The girl’s death soon after using Cervarix is the fifth such case reported around the world. None of these cases has directly linked the drug to causing death.

This news comes on the back of the following initiatives:

UPDATE 1-Japan panel backs Glaxo cervical cancer vaccine | Reuters |  Anti-cervical cancer vaccine to be put on sale in Japan by year-end | |  Cost-effectiveness analysis of prophylactic cervical cancer vaccination in Japanese women Vaccinating a 12-year-old cohort was predicted to reduce CC incidence and deaths from CC by 73%. These clinical effects were associated with an incremental cost-effectiveness ratio of yen1.8 million per quality-adjusted life year gained. The incremental cost-effectiveness ratio of vaccinating all 10- to 45-year-old women was yen2.8 million per quality-adjusted life year.

The Lancet: On the communication gap between researchers and the mass media. Emotive media reports have amplified people’s distrust in medicine, and have widened the communication gap between medical professionals and patients. Japan recently experienced a case of a misleading media report about a cancer vaccine clinical trial which had a great impact on cancer patients.

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