For patients
Frequently asked questions
As opposed to radiation and surgery chemotherapy affects the entire body. This will often lead to undesired side-effects, at many times serious. However, the development of new methods of treatment is in progress, today both the palliative care and the possibility to cure different forms of cancer have improved considerably. Problems with relapses, metastasis and development of resistance still remain. Therefore there is great need for new, improved and effective drug formulations with minimized side-effects in order to enhance the quality of life during treatment.
Oasmia's new drug candidate Paclical® (along with three other drug formulations being developed) will provide new improved solutions for attending cancer patients compared with existing alternatives. Oasmia has recently closed a phase I/II clinical trial on patients with solid malignant tumours for which no standard palliative therapy was available.
A comprehensive phase III clinical study in patients with ovarian cancer will commence early in 2008.
What is Paclical®?
Paclical® is a new formulation of paclitaxel, the active substance in the most effective and common cancer drugs today.
How does treatment with Paclical® differs from existing cancer treatments?
An essential feature regarding Paclical® is the new excipient making the active ingredient paclitaxel water soluble. This new excipient will not lead to hypersensitivity reactions as comparable other drugs with paclitaxel used today leads to. This means that premedication is not necessary leading to the use of short infusion times.
How does Paclical® work?
Paclitaxel belongs to a family of cytostatics called taxanes. Like paclitaxel, taxanes in general inhibits the growth and division of cancer cells by affecting central structures important for the survival of the cells.
What are the advantages of Paclical®?
No premedication
Higher doses tolerated
Short infusion times
No hypersensitivity reactions
Is Paclical® available on the market today?
At present Paclical® is in an advanced phase of clinical testing (phase III) which results will form the base for a registration of the drug candidate.
What is a clinical trial?
A drug candidate must undergo extensive testing and be approved by regulatory agencies before marketing. After the initial pre-clinical research and development in order to ascertain the safety for human use the candidates enter different clinical phases.
Phase I - The aim is to determine the basic drug safety and determine how the drug affects the body. Usually 20-80 persons are enrolled.
Phase II - The aim is to determine the drug efficacy and the dose response relationship. Usually 100-200 persons are enrolled.
Phase III - The aim is to determine and to verify effectiveness and safety in a larger population with focus on regulatory approval issues. Two hundred up to thousands of patients can be enrolled at this stage.
Phase IV - Phase IV trials commence after regulatory approval and marketing. The aim is collect data concerning safety and unexpected adverse events not seen in the earlier trials. In this phase new indications, new formulations or other extra-clinical benefits can also be implemented.
What is a tumour?
A tumour is a growth formed because of a permanent change in a cells internal regulation resulting in uncontrolled growth of cells. Tumours often occur locally and can often be either benign or malignant.
What is the difference between a benign and malignant tumour?
A benign tumour does not spread. If the tumour is malignant it can spread in the body forming metastases or secondary tumours in other tissues and organs. Even if a tumour does not give rise to metastasis it can be locally very aggressive and destroy the surrounding tissues.
What is cancer?
When a tumour is diagnosed as benign it is not called cancer. If the tumour instead is diagnosed as malignant, it is called cancer. It can be difficult to distinguish between the two variants. Sometimes both terms are used synonymously, which is not entirely correct.
