ALMATY – Kazakh scientists have developed a new pharmacological agent (FS-1) for the treatment of multi-drug-resistant tuberculosis.
Microbial resistance to drugs has long been of concern to scientists. Nevertheless, over the last 50 years, no new anti-tuberculosis drugs have been made. Therefore, the new agent developed by Kazakh scientists is important. Its importance is confirmed by the fact that the pharmaceutical industry in the former Soviet Union produces mainly generics, while original products are imported from abroad.
The agent was developed under a programme called, Development of New Anti-Infective Drugs, which is done under the auspices of the Scientific Centre of the Ministry of Industry and New Technologies. Professor and doctor Murat Kulmanov leads the project and says that FS-1 is an original anti-tuberculosis drug and that they had been working on it for many years.
“The first preclinical test was held with laboratory animals and the result was a 100-percent recovery. The second phase was conducted with human volunteers and also yielded excellent results. The Ministry of Healthcare granted us two clinical bases in Almaty and Karaganda where we began direct treatment of patients and found the most effective therapeutic dose. The main thing is that treatment with our drug is short and does not cause relapse,” Kulmanov said.
Upon completion of each phase of clinical trials that confirmed the alleged properties of FS-1, namely its low toxicity and high efficacy in the treatment of multi-drug-resistant tuberculosis of the lungs, the scientists prepared a detailed report for the health department. Moreover, preliminary calculations, according to Kulmanov, showed the use of FS-1 in the treatment of tuberculosis can reduce costs up to one million tenge (US$5,494) per person.
After successful completion of phase two, the scientists applied to the Ministry of Healthcare for accelerated registration of the new drug following the third stage of testing. It should be noted that there is a worldwide practice of allowing expedited registration of drugs after the third round of testing when the ailment is life threatening. However, the process has stalled. Despite the apparent success, the Ministry of Healthcare has still not considered the issue, citing a lack of standards and practices for such cases.
In President Nursultan Nazarbayev’s most recent state-of-the-nation address, he said increasing Kazakhstan’s scientific capacity will help create a knowledge-based economy. “In this area, we should improve legislation on venture financing, protection of intellectual property and support for research and innovation, as well as the commercialisation of research,” said the President.
According to scientists, Kazakhstan is at least one year behind the U.S., which already has started to introduce its new anti-tuberculosis drug Sirturo in American clinics, which U.S.-based, phase two clinical trials have shown to have side effects, including fatal heart failure. Nevertheless, the United States has registered the new drug.
Today, Kazakh experts are negotiating with various international manufacturers and are discussing the most favourable conditions for Kazakhstan. Kazakhstan must complete the third phase of clinical tests with its foreign partners in their countries and register FS-1. Only then will Kazakhstan be able to patent the drug as intellectual property abroad.