Innovative drugs for patients with breast cancer
1. What kind of activities does IRO perform within the NanoHer2Restore project?
This is a major research project for us and it is our goal to explore the efficacy of a newly proposed drug that combines two active ingredients (a receptor inhibitor and an antibody) using a nanoassembly as carrier. We performed toxicity studies in vitro as well as efficacy studies using 2D and 3D cell cultures as well as small rodents studied.
2. Nanostructure is a very modern concept. How does this apply in your research?
We are fortunate to work in partnership with researchers from "Petru Poni" Research Institute for Macromolecular Chemistry. They solved the task of producing a very small structure ~100nm that has the capacity to change its properties when exposed to acidic media. In our case we use the tumoral environment (acidic) to target delivery of chemotherapy directly in this type of tissue.
3. What is the innovation of this new drug?
We aim to selectively distribute the drug in tumoral tissue with little or no effect on normal structures. As an extra, the antibody attached to the nanostructures appears to increase its effectiveness against breat cancer tissue, including a very aggressive form - triple negative breast cancer.
4. How does that make a difference for patients with breast cancer?
One advantage refers to lowering the amplitude of side effects in treated patients. That is very significant as the majority of the problems with chemotherapy are generated by the indiscriminate treatment of both tumoral and healthy tissue. Another benefit is that a population previously unresponsive to a common drug (Herceptin) may benefit from this type of treatment with better quality of life and prolonged survival.
5. How much time is needed to bring a new, innovative drug on the market?
We do not have such complex experience, but certainly it takes many years of preclinical and clinical research. There is data that 10 years of research is a reasonable period, including clinical trials and validation with the international agencies.
6. What is the actual stage in the pathway of your proposed new drug?
We have done most of the toxicity studies and a significant amount of efficacy studies in preclinical settings. At this moment we will look for funds to upgrade the product such as to be able to access clinical studies. From this point onwards the process is more complex and is not really accessible for small players like us. Clinical testing is very expensive and needs a major infrastructure and that is what big pharma is doing. We need to present our data to such major investors and hope they will find our proposed mechanism as interesting.
7. Can you foresee the next step?
We are close to what we wanted to achieve, that is full characterisation of a new drug delivery mechanism. The level we aimed for is TLR4 from which point the drug should follow a more difficult and very expensive road map. We are in contact with representatives of big pharma and initial feedback is good. But we do not expect that such a negotiation will be very simple nor very quick.
8. Innovative drugs are generally more expensive?
Yes they are. Every new drug brought on the market is just the tip of the eisberg. A huge amount of money goes into research and a huge list of drugs start the competition of becoming a new innovatovative drug.A very small proportion appears interesting in the preclinical studies and a smaller fraction will become a new drug. All this enormous financial investment will be reflected in the price of a new, innovative drug.
9. Which are the risks of your new drug as compared with traditional alternatives?
We have not yet identified additional risks, but clinical studies aim to fully evaluate such problems. So, it is a bit too early to discuss this subject.
10. Who are the patients that might benefit from the new drug?
The whole project was designed for the treatment of women with breast cancer. I do not believe that is any more necessary to underline the importance of such a drug, as breast cancer is on the rise and new drugs are needed for cure and for better management of metastatic disease.
NanoHer2Restore Team - IRO Iasi