Good preparation is pivotal for a good clinical trial

ANSWERED BY PETER BUHL JENSEN, CEO, TOPOTARGET A/S

Published in Medicon Valley Drug and Device Development Guide, June 2005

 

COMPANY TopoTarget A/S

FOUNDED 2000

LOCATION Copenhagen (HQ), UK and Germany

NUMBER OF EMPLOYEES 60

 

TopoTarget is a research-based biopharmaceutical company whose objective is to develop and market novel pharmaceuticals and to identify new indications for existing compounds. TopoTarget is developing new approaches, with the overall aim of improving cancer treatment.

 

1) How many products does TopoTarget have in preclinical and clinical development?

TopoTarget has two target drug platforms:

> topoisomerases

> histone deacetylase inhibitors (HDACi)

 

Within these two fields TopoTarget has five drugs under clinical development.

 

The most advanced is Savene for extravasation: a product we plan to market ourselves in Europe. This product utilizes our topoisomerase technology as does a further product, currently in phase I, which aims to target chemotherapy at metastases in the brain.

 

With HDACi we are starting phase II clinical trials on basal cell carcinoma and acne and, in collaboration with the American company CuraGen and the National Cancer Institute, we are developing second-generation HDACi. Phase I trials started in late 2003 on the treatment of multiple myeloma with our product candidate PXD101, which was discovered in our Oxford UK facilities, and entered phase II in Europe in February 2005.

 

In addition the company has in-licensed two products, for both of which phase I trials have been completed.

> Endovion has been developed in collaboration with NeuroSearch. It is an ion channel blocker that appears to increase the efficacy of an existing brain tumour anticancer agent.

> Zemab is an antibody fragment linked to a toxic substance. Recently published results demonstrated responses in some patients when the product was injected directly into the tumours.

 

TopoTarget’s preclinical pipeline includes new candidates attacking the above targets in addition to HSP90, E2F and DUBS.

 

2) What good advice can you give on how to prepare non-clinical and clinical trials?

Good preparation is pivotal for a good clinical trial. TopoTarget seeks advice from high performing clinicians within the field and from skilled experienced regulatory professionals. Money here is well spent.

 

3) In what processes did you seek external expert assistance (consultancy)?

During the growth of the company, it has become increasingly clear that the assistance of external experts is useful at all levels except for the decision making process itself.

 

4) Based on your experience, are there particular criteria for selecting external expert assistance that you would recommend?

We would recommend always asking for a track record within the specific area where assistance is sought and ensuring that the external expert has sufficient time and resources to conduct the required services.

 

5) Please mention processes or events that were more demanding in terms of time and money than you initially expected?

This can be found in many fields of the company’s development: business development is more demanding than we expected; manufacturing is demanding; as is logistics and the regulatory process.

 

6) Based on your experience, where are the cost and time saving opportunities?

Plan – seek advice but do as much as you can yourself as this way the company’s internal expertise is developed. Obtain external help for bottlenecks and key problems.

 

7) How far will you go with your lead compound/product?

We are currently building our own European sales force aimed at niche oncology markets.