One of the most common malignant tumors that afflicts the urinary system is non-muscle invasive bladder cancer, the most superficial one that has not reached the internal muscle of the organ. This malignant tumor represents 70% of cases of urinary tract diseases and is considered by the World Health Organization (WHO) to be the ninth most common neoplasm in the world. To assess the severity of the problem, data from the WHO indicate that in 2018 alone, 550 new cases were diagnosed in the world, affecting mainly elderly people.
Today, the most common treatment for this type of cancer that does not invade the muscular layer of the bladder is surgery to scrape the tumor, followed by treatment with a vaccine based on Bacillus Calmette-Guérin, better known as ONCO BCG and also used as the basis of the tuberculosis prevention vaccine, to prevent the tumor from returning and/or progressing.
However, according to professor Wagner Fávaro from the Institute of Biology at the State University of Campinas (IB Unicamp), there are two problems with this conventional treatment: first, that approximately 70% of patients who underwent it had a relapse and were forced to undergo the same treatment and , in more severe cases or a new relapse, undergoing bladder removal followed by chemotherapy, which has a failure rate of 80% of cases and with side effects.
“The treatment is very aggressive because bladder cancer mostly occurs after the sixth decade of life. And normally this population has a lot of comorbidity, that is, they tend to have more diseases or changes that occur throughout their lives, such as hypertension and diabetes, which make it impossible to remove the organ or, due to comorbidity, 90% of patients end up having side effects. collateral to the treatment of ONCO BCG and with no therapeutic perspective.”, explains Fávaro about the risk in the conventional treatment of this tumor.
The second problem for this type of treatment is the worldwide lack of supply of BCG-based medicines, the only Brazilian laboratory that exclusively produced this medicine was banned in 2019 by the National Health Surveillance Agency (Anvisa) for not complying with technical requirements for good practices for the production of medicines.
OncoTherad: a treatment alternative
In this scenario and after 13 years of research into urogenital carcinogenesis, Fávaro in partnership with professor Nelson Durán from the Chemistry Institute (IQ Unicamp) developed a new, less aggressive medicine called OncoTherad, whose brand and patent were protected by the Unicamp Innovation Agency for the University.
It is a nanodrug, a completely synthetic molecule produced in the laboratory, which, when used in treatment with intramuscular applications, stimulates the immune system to fight the tumor, with a success rate of 88,5% for animals and 80% in animals. humans, as the professor detailed about the development and results of the medicine.
“We started all development in animals (mouse, rat and rabbit). We then evolved into a veterinary clinical trial in dogs that spontaneously presented with bladder cancer. It is worth mentioning that the treatment of bladder cancer for dogs is terrible and very restricted, with survival of around 161 days with traditional treatment. We have treated more than 30 dogs with 88,5% tumor reduction from animals that have been alive for more than 542 days. It’s a huge gain in terms of survival and quality of life for these animals.”, details Fávaro.
After the positive results in animals and with the authorization of the Unicamp ethics committee, clinical trials evolved for people whose traditional treatment had failed and were without therapeutic prospects. “We have 30 patients that we have been following for two years. Of those 30 patients, we had an 80% success rate. In other words, we had 24 patients whose tumor did not return and 6 patients who had a recurrence. However, in the cases that recurred, we found recurrence to a much lesser degree than when these patients started treatment with OncoTherad.”, celebrates Fávaro with the results obtained.
The clinical trial took place in partnership with the Paulínia Municipal Hospital, in the interior of São Paulo, where there is a Urology and Immunotherapy Outpatient Clinic, as the medicine falls into the immunotherapy category by stimulating the immune system.
New steps for the medicine to go to market
The next step to obtain authorization from Anvisa and Food and Drug Administration (FDA), regulatory bodies in Brazil and the United States respectively, which guarantee the safety and efficacy of the medicine to be able to go to market are the results of multinational multicenter clinical trials.
This means that the same protocol used with patients at the Paulínia Municipal Hospital must be applied in other centers inside and outside Brazil. To continue with these trials, the researchers founded a Unicamp spin-off company called CND Pharma, which in 2019 licensed the OncoTherad patent and brand to produce the drug for veterinary and human use.
“Now, together with the company, there will be a scaling of the production of the medicine so that the necessary volume can be obtained for application in both the veterinary and human fields. Only then will it be possible to proceed with the multicenter clinical trial.”, comments the researcher about the new phase before obtaining authorization from regulatory bodies that will enable the nanodrug to reach the national and international market.
Published article originally on the Inova Unicamp Innovation Agency website.
