Ahead of the whole planet
Russia will become the first country in the world to sell a cancer vaccine. A small pharmacological company Antigenics announced on Tuesday that Russian regulatory authorities have approved Oncophage for sale. Reuters notes that this is the first time that a drug that has not been tested in the country of production, in this case in the United States, where Antigenics failed to complete a series of tests, receives approval in Russia.
In a statement, Antigenics said that the company hopes to receive the approval of the European authorities by the end of this year, and the drug will be ready for sale in Russia this summer.
Oncophage has been tested as a vaccine to prevent relapses of kidney cancer, more precisely from hypernephroma – its most common variety. The vaccine is not used to prevent the disease itself. The basis for the vaccine is an extract from the cancer tissues of the patient himself, and from this point of view, Antigenics offers a new, individualized approach in pharmacology. The strength of the drug, says Antigenics, is its targeted effect on cancer cells, which distinguishes it from other methods of fighting the disease. Moreover, renal tumors are less susceptible to radiation and chemotherapy than other types of cancer.
The company failed to complete the last stage of testing the vaccine on patients with kidney cancer, which made it impossible to obtain permission to use the vaccine in the United States in the near future. In Russia, the drug has been tested since the summer of 2007 – as part of the third stage of testing. A significant part of the control group was from Russia – 172 out of 604 patients. At the same time, about 70% were in the subgroup where the prognosis of the subsequent operation was better than that of all the others.
An incomplete study showed that in patients with kidney cancer, in whom the probability of recurrence was minimal, Oncophage extended the remission period by 45%, on average by 1.8 years, compared with the control group. According to the data of the third phase of clinical trials, the use of Oncophage can increase the life expectancy of patients by 45% without signs of relapse of the disease. During 17 months of follow-up, 13 people (8.2%) died in the group of patients receiving Oncophage, while 25 people (14.0%) died in the group of patients taking placebo.
In the USA, these data turned out to be insufficient, since the American regulator – the US Food and Drug Administration, the FDA – considers the effect of drugs on everyone suffering from the disease, and Oncophage has shown effectiveness mainly in cases of moderate severity. Accordingly, the effectiveness "sprayed" on the entire group was insufficient for the approval of the vaccine on the American market.
Currently, the use of a vaccine for the treatment of brain cancer is being studied.
Kidney cancer in RussiaNo data on this type of cancer has been published in Russia for a long time.
The latest report of the International Agency for Research on Cancer is dated 2004. According to these data, 16,329 new cases of kidney cancer were recorded in Russia, 10,872 patients died, and 90% of cases of kidney cancer are hypernephroma, from relapses of which the new drug is designed to help.
The head of Antigenics Garo Armen claims that the vaccine can be very effective in a quarter of cases, and bring noticeable relief to half of patients. He estimated the market volume at $ 200 million, and the prospects for selling Oncophage as "moderate". At the same time, Armen regards Russia as a key market that will allow Antigenics to begin conquering the whole of Europe.
"The USA is guided by statistical dogma, not scientific and clinical criteria," the head of the firm complains. – This is not a mistake of the FDA, it is a feature of the whole system, and the agency alone cannot change the approach. Although the will to do so is present. It turned out that there is less bureaucracy in Russia (in this matter), although it still remains a laborious process. The key difference is that you are involved in an almost continuous dialogue – unlike the (American) situation with formal letters and responses coming in 30 or 60 days," Armen says.
Armen told PharmaTimes: the main difficulty is that the drug helps at a relatively early stage, when doctors usually resort either to surgery or outpatient observation, and therefore a lot of explanatory work among specialists will have to be done.
How the vaccine worksOncophage (formerly HSPPC–96) is an individual vaccine aimed at preventing cancer recurrence with minimal side effects.
Cancer tissues of the patient are used for its manufacture, so it is obvious that it cannot be used for the prevention of the disease.
The tissues are removed during a surgical operation, and within a day they are delivered to the company's factory in Massachusetts, where they are used to make a vaccine. The tissues are needed in order to isolate the characteristic "fingerprints" of cancer cells and antigens that will awaken the patient's immune responses to his cancer cells. The injection of the vaccine stimulates the immune system to attack cancer cells with a certain "fingerprint", the company's website says.
The patient receives the vaccine at his disposal four to eight weeks after the operation, which gives time to recover. In the first month, Oncophage injections are followed weekly, then – by injection a week later.
The vaccine has been tested on more than 750 patients around the world, and not only on kidney cancer sufferers. Currently, the University of California is studying the effects of the vaccine on brain cancer patients. "Oncophage is inspired above all by its potential – it can be long–term effective against all types of cancer, and can save hundreds of billions of dollars in healthcare systems around the world," Armen says.
referenceHypernephroma (Hypernephroma), Grawitz Tumour, renal Cell carcinoma (Renal Cell Carcinoma) is a malignant tumor of renal cells; its name is due to the fact that it resembles the adrenal gland in its structure, and previously it was believed that it affects the adrenal glands.
Hypernephroma can develop asymptomatically in the human body for several years before its first symptoms appear, which include: fever, pain in the lumbar region and the presence of blood in the urine.
The treatment is surgical, but these tumors can form a second time.
The spread of tumor cells occurs through the bloodstream; often their proliferation can be observed along the renal vein. Secondary growths of renal cell carcinoma, usually occurring in the lungs, have a characteristic appearance, resembling a cannonball.
This type of tumor is relatively insensitive to the effects of radiation therapy and cytotoxic drugs, but it can be treated with hormones such as progestogens and testosterone.
Portal "Eternal youth" www.vechnayamolodost.ru
08.04.2008