Drug approval process for ovarian cancer

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Published: 15 Nov 2012
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Prof Maria Paolo Costi – University of Modena, Italy

Prof Maria Paolo Costi talks to ecancer at the 4th EUTROC meeting in Liverpool, UK about new drug developments and the main issues surrounding the drug approval process for ovarian cancer.


Prof Costi highlights work being done on folate receptors and their role in ovarian cancer; in particular, a project discussed at the meeting on candidate drugs targeting this receptor and the difficulty of advancing these drugs to the clinical stages.

4th EUTROC, Liverpool, UK

Drug approval process for ovarian cancer

Professor Maria Paolo Costi – University of Modena, Italy

I was chairing the poster session and presenting one poster, one communication on our work that is dealing with the folate receptor role in ovarian cancer. In particular the project is devoted to the discovery of drugs, candidate drugs, targeting the folate receptor. This was one of the works that was presented there, then other work was focussed on glycols that are inserted present in the outside of the cell membrane of ovarian cancer. This is a pretty new topic, the presenter was discussing about the fact that this could be a specific molecular recognition element with respect to healthy cancer cells, ovarian cells. So in principle it is possible to discriminate between ovarian cancer cells and normal ovarian cells, analysing these glycols outside the cell membrane.

Another important topic was related to CDK6 kinase and this seems to be an important new drug target for a PD compound that is now in a phase I clinical trial and the clinical trial against ovarian cancer is starting very soon. So the general idea is that there are many candidate drugs, a number of candidate drugs, a good number of candidate drugs targeting the ovarian cancer diseases but still the pathology is not concrete, a cure to this cancer type has not been discovered yet. The efforts are in a good number, a high number, of clinical trials that try to use the best existing anti-cancer drugs directed to ovarian cancer in order to improve the overall survival and to do the best for the patient, to improve the overall survival and the progression and, at the end, the survival of patients to this difficult disease.

So my role in particular, my expertise, is focussed on medicinal chemistry, mostly, and translational research. So my personal effort is trying to develop new anti-cancer drugs but keeping a strong connection with clinical research and trying to adopt clinical research information to optimise the basic research on new drugs. So this is something that is not so easy to achieve because this requires a strong network between the chemistry department, biology department and hospitals and clinical research departments. So that would be something as a perspective to achieve. We are, at Modena, we are trying to realise this since now.

What are the problems in developing these new drugs?

There is more than one problem, I think. The first is that usually medicinal chemists are trying to discover anti-cancer drugs in general so that means that they try to discover some compounds and some drugs that can hit, let’s say, breast cancer, lung cancer and other cancer types. This is, in principle, very important but in practice this approach forgets that each cancer type is different from another, so one cancer type is different from another one. Also let’s say the performance of the drug can be different and this is the case for ovarian cancer, for example, that we have some chemotherapeutic drugs that can work pretty well, very well with colorectal cancer, for example, and for lung cancer but cannot work at all or maybe not in a good way, in an optimal way, against ovarian cancer. So this means that medicinal chemists have to change their perspective to try to focus on specific cancer, considering the biology of that cancer type and trying to use information coming from the biologist and from the clinical research in order to make the progression from the discovery phase to the pre-clinical to the final pre-clinical phase straightforward and more rational and more logical, as much as we can because it’s a very long process and very difficult.

I think that another problem is related to the delivery of the drug. Very often we focus, and medicinal chemists mostly focus on the potency of the drug and the delivery of the drug is… that means the way to bring the drug from the outside, from the outside of the body, inside to the specific target inside the tumour. This, the way to do that, sometimes is not considered as important as it should be. Recently more attention is being devoted to this particular step that is the pharmaceutical research, more than the discovery and the development. It has been shown that instead it’s very critical to the success of the drug in the clinic and phase I, for example, and phase II and so on. So this is another aspect that we need to consider, let’s say, earlier in our drug development effort.

So basically the specificity of the tumour, the delivery system that allows us to take the drug from the outside of the body to the target inside the body; there are other aspects but of course these can be considered some of the most important ones