Cuba and lung cancer vaccine

[Jyoung20]

Here is the link to an article about a lung cancer vaccine available in Cuba.

I thought it was very interesting

http://www.msnbc.msn.com/id/25354060/

[CaroleHammett]

Thanks for the link, Jamie. Very interesting reading, particularly the part about Americans not being eligible to travel to Cuba to get the vaccine. (Maybe we should join together and charter a plane and get lung cancer publicity on our return when we all disembark vaccinated, but handcuffed by U.S. Customs officials! )

Actually, I googled the web to see if I could find an article with more details, such as whether it's efficacious for a particular type of lung cancer vs. all types, whether it's only recommended for particular stages, and also more details on the Cuban clinical trials themselves, but found nothing so far.

Of course, five months additional survival probably doesn't sound like much to most people, but for those of us battling lung cancer, it's a lifetime.

Thanks again, Jamie.

Carole

Life is not measured by the number of breaths we take, but by the moments that take our breath away.--the late, great George Carlin

[RandyW]

Medical services, even the most sophisticated, are provided free to Cuba’s 11.2 million people. But in the 1990s, Cuba opened its doors to health tourists, which means that foreigners could come to this Caribbean island nation to receive treatment with the vaccine.

CIM scientists told reporters on Tuesday that clinical trials in more than 400 patients with advanced lung cancer showed that CimaVax EGF has no serious side-effects, elicits an immune response and lengthens the lives of patients, as well as improving their quality of life.

The vaccine has undergone seven clinical trials in Cuba, Canada and the United Kingdom, and is presently being used in three further trials, two in Cuba and one in Malaysia. Gisela González, a CIM expert, said that trials are also due to start this year in China.

The vaccine consists of a protein, epidermal growth factor (EGF), combined with another protein that enhances the patient’s immune response against EGF. When EGF binds to its specific receptor on cell membranes, it triggers the cell proliferation mechanism, which is augmented in the case of tumours.

"Upon vaccination, the body produces antibodies that recognise and bind specifically to EGF, preventing the protein from binding to its receptor and initiating cell proliferation. As a result, tumour growth is slowed, to an extent that depends on each patient’s individual response," a press release said. González, who headed the project that began in 1992, said this is the first vaccine for lung cancer to be registered anywhere in the world. CimaVax EGF has been patented in Cuba, Canada, Japan, South Africa and the United States, among other countries.

The researcher said that sales of the vaccine abroad will be undertaken by different foreign companies through arrangement with Cuba. The Bioven company in Malaysia will cover the market in that country and the rest of Southeast Asia, while YM BioSciences of Canada may handle distribution in North America and Europe.

But the vaccine will continue to be produced in Cuban laboratories, said González, who added that exports will depend on the results of clinical assays and on obtaining registration of the vaccine in each and every interested country.

Special authorisation granted by the U.S. Treasury Department in 2004 permits distribution of the vaccine in the United States, but YM BioSciences needs to complete the clinical trials that were left unfinished due to the bankruptcy of U.S. firm CancerVac, the holder of the permit.

CIM scientists hope that the vaccine’s registration in Cuba will provide an incentive for carrying out the U.S. clinical trials, which are expected to cost about 20 million dollars.

A U.S. law passed in 2000 authorised sales of food to Cuba, despite the nearly half-decade U.S. embargo.

CIM and CIGB are part of the West Havana Scientific Pole, which includes the Finlay Institute of Serum and Vaccines, the Immunoassay Centre (CIE), the National Centre for Scientific Research (CNIC), and the National Bio-preparations Centre (BIOCEN).

These biotech centres carry out the complete product cycle, from R&D to marketing and assessing the impact on health. In total, the country has more than 120 scientific research centres, employing about 30,000 people.

Opened in 1994, CIM is devoted to manufacturing biopharmaceuticals for the treatment of cancer and other chronic, non-infectious diseases, to be used in the Cuban public health system. At the same time it endeavours to make its scientific and productive activities self-sufficient, and to make important contributions to the country’s economy.

Since the early 1980s, the government determined that biotechnology was a priority area for Cuba’s economic and social development. Its support for the sector was maintained even during the crisis of the 1990s, caused by the collapse of the Soviet Union, its main aid and trade partner.

According to official sources, 38 new products were registered in this cutting-edge scientific field in 2007, and in the same year biotechnology became the country’s second most valuable export category after nickel.

Exports from CIGB alone have reached over 340 million dollars since their début, supplying countries in Latin America, Africa, Oceania, Asia and Europe. (END/2008)

[CaroleHammett]

Randy:

Thanks so much for locating and posting the additional information on both this treatment and Cuban and U.S. policies. Very interesting (and thought-provoking).

Carole

Life is not measured by the number of breaths we take, but by the moments that take our breath away.--the late, great George Carlin

[Barb73]

Dear Jamie, Carole, and Randy,

I woke up this morning to the information about the new vaccine, and wondered what it all might mean.

Needless to say, I arrived here to find many more particulars about it.

Increase in survival time (even 4-5 mos.) can be time to be alive to be able to receive possibly even another arriving on the conveyor belt from the cancer drug pipeline.

Those survival times usually indicate median numbers which indicate that there would be longer survivals and possibly lower. Anyway, I am sure we will be hearing more about this vaccine, and those who will be taking it.

It's a good day when we see that research continues and survivors may survive longer.

Meanwhile, it is encouraging to me that they are still "working on it."

Barbara

[RandyW]

Right on the Head baby Every day is another day closer!

[Barb73]

Here is another article (MSNBC) about the Cuban vaccine:

http://worldblog.msnbc.msn.com/archive/ ... 72063.aspx

[CaroleHammett]

Thanks, Barb.

This article definitely contains new information (which is why I went ahead and pasted it in fully below). Re the new info:

1. The survival figures are much higher by far than anything I saw coming out of the recent ASCO conference:

"Those given the vaccine lived on average 11.47 months compared to 5.33 months for terminal patients treated with only chemotherapy and/or radiation. In the best case scenarios, some fortunate patients lived for up to 18.53 months while taking the new vaccine, compared to other patients who lived for just 7.55 months while undergoing conventional treatment."

2. The drug's benefits aren't just extended survival, but increased quality of life:

"Patients breathe easier, experience less fatigue, less pain and increased appetite."

3. And if one needed no other reason to consider "vacationing" in Cuba this year, there is this:

"While testing has been approved by the U.S. government, clinical studies may not begin for at least two years."

Good Gawd! The worms would be done with me before the U.S. even started Phase I, let alone completed Phase III!

I do wonder why they won't discuss side effects, and would also be interested in any stats comparing survival in squamous cell vs. adenocarcinoma, but in the meantime, I'm off to check the expiration date on my passport.

Carole

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Cuba develops 'breakthrough' cancer drug Posted: Friday, June 27, 2008 11:07 AM

Filed Under: Havana, Cuba

By Mary Murray, NBC News Havana Bureau Chief

HAVANA – A Cuban Scientific Research Institute just patented a promising new drug that it says helps terminal lung cancer patients live longer.

In some cases, the drug known as CimaVax EGF extended the lives of participants in the treatment trials by close to a year.

CimaVax EGF, is classified as a therapeutic vaccine, because it is composed of modified proteins that help the body recognize and destroy cancer cells for those already suffering from lung cancer. It does not prevent lung cancer.

"It is the first lung cancer vaccine to be patented in the world," said Dr. Gisela Gonzalez, head of the team that researched and developed the drug through testing with hundreds of patients over 16 years.

She did point out that other countries are working on similar vaccines, but that they are still in the development stage.

Gonzalez cautioned that while it is "not a miracle drug," she does believe it is a "breakthrough in treating terminally ill patients."

While the research team would not identify any side effects of CimaVax EFG, Gonzalez claims it has numerous advantages over traditional treatments alone. Patients breathe easier, experience less fatigue, less pain and increased appetite. It is administered in conjunction with conventional treatments of chemo and radiotherapy.

CimaVax EGF is undergoing testing in other countries.

After Cuba concluded the Phase One study that determined safe dosage and the best way to administer the vaccine, Phase Two trials started in Cuba, Canada and England, said Gonzalez. This August additional ones begin in China and Peru. Already the vaccine is being registered in Malaysia for sale in Europe.

While testing has been approved by the U.S. government, clinical studies may not begin for at least two years.

The Phase Two studies that were conducted in Cuba and elsewhere took a look at how much longer patients lived with CimaVax EGF as compared to other treatments. Those given the vaccine lived on average 11.47 months compared to 5.33 months for terminal patients treated with only chemotherapy and/or radiation. In the best case scenarios, some fortunate patients lived for up to 18.53 months while taking the new vaccine, compared to other patients who lived for just 7.55 months while undergoing conventional treatment.

Given those clinical results, Cuba started Phase Three studies in the hope that CimaVax EGF could become the new standard of care in treating end stage lung cancer.

About 4,500 new cases of lung cancer are diagnosed annually in Cuba while the disease claims over 1.3 million deaths worldwide annually, with the highest rates in the United States, Canada and Europe.

Across the globe, lungs are the most common site of fatal cancers for both women and men. Lung cancer generally affects people over 50 who have a history of smoking, although other risk factors include exposure to second hand tobacco smoke or pollutant emissions from cars or factories.

CimaVax EGF could also prove effective in slowing other cancers, believes Dr. Tania Crombet, the team’s chief clinical researcher at Havana’s Center for Molecular Immunology. She said that researchers have begun testing CimaVax EGF’s effectiveness against breast, prostate, uterus and pancreas cancers.

Crombet also said CimaVax EGF is now available in Cuban hospitals for any patient, regardless of nationality. "We can market the vaccine in Cuba and receive patients from outside."

And that could mean an influx of fresh, hard currency for the struggling island’s economy.

With more than 7,000 scientists dedicated to researching new drugs, Cuba has one of the most sophisticated biotech industries in the developing world. Last year the country earned $350 million from exporting 180 different medicines.

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Submitted by Carole from http://worldblog.msnbc.msn.com/archive/ ... 72063.aspx

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[Joe B]

OK we need tp push BIG time for fast tracking this and getting studies intiated pronto !!!!

Lungevity-- You want a cause -- THIS IS IT !!

[Welthy]

Here are two links to Dr. West's comments at CancerGRACE.org on CimaVax EGF:

Dated April 16, 2008 - http://cancergrace.org/lung/2008/04/16/ ... ine-trial/

Dated June 29, 2008 with above link embedded in response: http://cancergrace.org/lung/2008/04/16/ ... ine-trial/

[CaroleHammett]

Hi, all.

Still trying to play catch up from my 5 day "hall pass," but I must confess this Cuba thing is really getting to me.

I'm with Joe all the way on this one. What can Lungevity do to help get us this vaccine? (Or what can we do to help Lungevity get us this vaccine?)

As I posted earlier, the results of this study are far and away better than anything to come out of the June ASCO conference; and quite frankly (like so many of us here), I do not have time to waste... about which I'll be posting more later, but in the meantime, I remain:

Carole the Queen of Procrastination

PS Great to be back!

[Joe B]

I am investigating participating in a study with the HIH/ NCI in Bethesda, MD

It is a phase II study with the "Hyper-Acute" lung cancer vaccine. It is for NSCLC ad You have to be off chemotherapy for 4 weeks, and cannot have any more than 2 previous regimes of chemo.

Here is the link;

http://bethesdatrials.cancer.gov/clinical-research/search_detail.aspx?ProtocolID=NCI-04-C-0049

[CaroleHammett]

Thanks so much for posting clinical trial link, Joe.

I just checked it out and, unfortunately, struck out on two counts (in addition to my original cisplatin/etoposide/docetaxel, I've had Tarceva and Alimta therapies, plus I'm on prednisone (corticosteroid)).

In the meantime, however, my passport's still not expired.

Good luck!

Carole

[Joe B]

Hang in there Carole. These vaccines are close and pressure is going to build to make them available. If this vaccine doesnt work for me, I may be going to Cuba myself !!

The other option is to try to pursue Stimuvax (BLP25) on a compassionate use basis through the established protocols with the FDA.

If you have asite near you participating in the phase III trials (check the Listings with the NCI) then they are already administering the vaccinations, and if you can get the oncologist there to plead your case it might work.

Joe B

[CaroleHammett]

Thanks, Joe.

I think(?) I checked out Stimuvax and wasn't eligible , but will have to check again due to brain drain!

Carole

PS I wonder if we can get group discount to Cuba!