The ongoing international multicentre Phase III study with Paclical® conducted by Oasmia Pharmaceutical, Uppsala, Sweden, has triggered a large interest and commitment among participating physicians in Europe. The study comprises 75 clinics in 17 different countries. Altogether 650 women with ovarian cancer will participate in the study. In the study Paclical® is compared to the well-known pharmaceutical Taxol®. The results of the two treatments will be evaluated with respect to effect and side-effects. Half of the women will be treated with Paclical® and the other half will be treated with Taxol®. Both Paclical® and Taxol® will be administered in combination with carboplatin; another cytotoxic agent and part of the standard treatment for ovarian cancer used today. The aim of the study is to show better effect and a diminished risk of side-effects, especially hypersensitivity reactions. Therefore Paclical® is administered in a higher dose than Taxol®. The patients are treated in six cycles and have a six month follow up period. The inclusion of patients is estimated to be completed in 2009. Paclical® has several advantages compared to Taxol®, foremost due to the absence of the excipient Cremophor EL® which is linked to serious side effects. The need for a better treatment and improved quality of life for this group of patients is immense. Paclical® have previously been granted an Orphan Drug designation by the European Medicines Agency EMEA. The designation gives Paclical® market exclusivity in the EU on the indication for 10 years when the product candidate receives a market authorization. About Ovarian cancer Ovarian cancer is a disease with few and unspecific symptoms at its early stages, and is difficult to detect. The numbers of patients that are diagnosed are increasing on a yearly basis. Ovarian cancer is most often diagnosed in women over 50 years of age, but younger women are also affected. The annual incidence of new diagnosed cases is approximately 125 000 women in EU alone. About Paclical® With the retinoid based unique platform XR-17, Oasmia has managed to produce a water soluble formulation of Paclitaxel (Paclical®), that does not require premedication and abolish Cremophor® EL related side effects. The main indication is ovarian cancer. Other planned indications are lung cancer (NSLC) and malignant melanoma. About Oasmia Oasmia Pharmaceutical AB develops second and third generation cancer drugs based on nanotechnology for human and veterinary use. The broad portfolio is focused on oncology and contains several promising products in clinical and pre-clinical phase. Oasmia cooperates with leading universities and other biotech companies to discover and optimize substances with a favourable safety profile and better efficacy. The company was founded in 1998 and is based in Uppsala, Sweden. For more information, please contact: Maria Lundén, Head of Public Relations, Oasmia Pharmaceutical AB. E-mail: press@oasmia.com Phone: +46 (0) 18 50 54 40. Information is also available at www.ngm.se and www.oasmia.com
Oasmia Pharmaceutical's international multicentre Phase III study on ovarian cancer generates great interest across Europe
| Source: Oasmia Pharmaceutical AB