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® differ 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 do. 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 inhibit the growth and division of cancer cells by affecting central structures important for the survival of the cells.
What are the advantages of Paclical®?
Higher doses tolerated
Short infusion times
No hypersensitivity reactions
Is Paclical® available on the market today?
Paclical® is currently in an advanced phase of clinical testing (Phase III), from which the 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, which is used 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 to 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 due to a permanent alteration in a cell's internal regulation system, resulting in uncontrolled and unbalanced growth of cells. Tumours can either be locally situated or spread throughout the tissues of the body. Tumours can be either malignant or benign.
What is cancer?
Malignant tumours are cancerous while benign tumours are not. These two terms are often mistakenly used synonymously as the distinction between the two can be difficult.
What is the difference between a malignant and a benign tumour?
A malignant tumour has the ability to spread in the body and form metastases or secondary tumours. Even if a tumour does not cause metastases it can be very aggressive, affecting and destroying surrounding tissues. A benign tumour, however, does not spread.