FAQs - the FDA approval and other moments...
Has FDA approved this cancer vaccine?
Today, to register the vaccine RESAN, it is necessary to conduct clinical trials for each type of tumors, against which the vaccine works. For example, in order to under go clinical trials of the vaccine against prostate cancer according to the standards of GCP, The Cancer Research Institute allots 450 000 $ for a 3 year- grant. That means, for holding clinical trials of vaccine in concern with breast cancer we need another 450 000 $, and for ovary cancer 450 000 $ more and so on for each other types of tumors.
Annually The Cancer Research Institute finances altogether 3 projects on clinical trials of anticancer vaccines. SRE RESAN did submit all the necessary documents to The Cancer Research Institute (681 Fifth Avenue New York, NY 10022-4209) for the grant of 15 April 2001 round to hold the clinical trials of vaccine RESAN. After 4 months the project was rejected with an explanation that CRI was in shortage of finance.
In fact, in spite of the excessive demands in the cancer treatment, the FDA has not approved any cancer vaccines for use as a standard treatment so far.
Can a single vaccine (RESAN) be effective against many different tumors?
In many people may arise the question: how could a single vaccine may be effective in such broad types of tumors? They think that usually one vaccine can work against only one type of disease. Such point of view is not always correct. For example, in 2000 the European Agency for the Evaluation of Medical Products – EMA has approved an administration of a new vaccine – Hexavac® elaborated by the company PASTEUR MERIEUX MSD. This combined vaccine is used for preventing a group of infections – diphtheria, tetanus, hooping-cough, poliomyelitis, hepatitis and hemophilic infection type b. In this way the vaccine works against 6 different infections and is released at a dose of 0.5 ml ready for injections.
Moreover, the immune system is capable to response against thousand different antigens at a time, therefore there is nothing supernatural that the vaccine RESAN helps to develop the immune answer against 40 different tumor antigens.
Would the NEW immunotherapy replace the traditional chemo or radiotherapy?
Today unfortunately the traditional methods- chemo and radiotherapy still dominate in the field of cancer treatment. But as time passes we move forward and the controversy between the supporters and opponents of the immunological aspects in the genesis and treatment of the malignant tumors is already out of subject for further discussion, as it was the dispute with rather narrow minded, conservative and bureaucratic opponents. What so ever, it is not meant that one should rush to a conclusion and immediately hand over all the former methods of cancer treatment into archive, on the other hand, it is absolutely not correct to convert them into an authoritative doctrines. Taking into account those numerous factors which define the successes in treatment and prevention of relapses of malignant tumors, it is absolutely fare to diametrically oppose, beforehand, the obvious out-of-date, palliative and little promising traditional medical programs turning into a standard harsh pattern scheme of modern cancer treatment.
More about the problems of tradional methods...
Can the resan vaccine help stage 4 rhabdomyosarcoma?
The comment for CancerHelp UK
- We are not propose RESAN immunotherapy as the method of monotherapy for cancer of stage 4, including rhabdomyosarcoma.
The indications for RESAN vaccine treatment are 1 and 2 grades of cancer, and if the total volume of the tumor tissue is not more that define size in dependence of tumor histology.
- CancerHelp UK dsribes the traditional (which are recommended by official medical institutions) rhabdomyosarcoma’s methods of treatment. Naturally, in 2002 none of vaccines have been registered all over the world. So, the immunotherapy of tumors is not the topic of discussion with the authors of article - they do not understand the problem in general.
- RESAN company is not cooperating in 2002 and now with none of Mexican clinics. As we know, there were a number of clinics along northern Mexican border in 2002 , where the alternative methods of late cancer stages treatment have been administrated. It is forced practice, because the system of drug registration in FDA of USA is almost completely blockade the manufacturers from European and other countries in USA inner market. In fact it is possible to registered and market only the drugs which produced in USA mainly big affiliated with FDA companies.
- RESAN vaccine has not been tested in clinical trials in National Cancer Institute of the USA, - it is the statement of authors of the article. Yes. But the authors are not remembering that there are a number of such organizations in the world.
- In many people may arise the question: how could a single vaccine may be effective in such broad types of tumors? The authors do not understand that RESAN vaccine is fundamentally differ from auto vaccines which work against only one type of disease. So wide spectrum of RESAN action is caused by special composition of xenogeneic tumor antigen imitators, the detail mechanism of vaccine action has been described early. The actiion of vaccine is confirmed by clinical tests. The example of European combined vaccine with wide spectrum of action see here.
- We are wanted to underline once more that the article has been written in 2002 (first we have read the article just this time) and after that has been not revised. (Copyright Cancer Research UK 2002, Cancer Research UK Charity Number 1089464).