Uppsala, Sweden, 2011-10-03 08:35 CEST (GLOBE NEWSWIRE) --
Since 2009, Oasmia has performed a comparative Phase III study on patients with ovarian cancer. The enrolment of the predetermined 650 patients is now complete. The next step for the company is to evaluate when survival data from the study can be analyzed, as data cannot be obtained until the patient is deceased. Furthermore, the number of patients required in order to obtain data within reasonable time will be investigated.
- We are very pleased with the completion of enrolment. It is an important milestone for Oasmia’s clinical development program. Survival data is important information for physicians when they decide how to treat a patient. Survival data significantly improves the prospects for Paclical®, says Margareta Eriksson, Vice President Clinical Development of Oasmia.
In the study, the patients were treated with either Paclical® in the dose 250 mg/m2 or with Taxol® in the dose 175 mg/m2. Patients treated with Taxol® were also premedicated according to clinical practice to counteract adverse effects associated with Taxol®. The infusion time for Paclical® was one hour and the corresponding time for Taxol® was three hours. Both pharmaceuticals were combined with carboplatin.
In August 2011, the company published an interim analysis of 400 patients in total and the results showed that Paclical® met the clinical endpoint of non-inferiority compared to Taxol®.
About Paclical®
With the retinoid based unique platform XR-17, Oasmia has managed to develop a water soluble formulation of paclitaxel that does not require premedication. The formulation also has an improved side effect profile compared to Taxol®. The main indications are ovarian cancer and lung cancer.
About ovarian cancer
Ovarian cancer is a disease with few and unspecific symptoms at its early stages, therefore difficult to detect. Unlike certain other cancer diseases the number of patients diagnosed with ovarian cancer increases every year. 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 Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops a new generation of drugs within human and veterinary oncology. The product development aims to manufacture novel formulations based on well-established cytostatics which, in comparison with current alternatives, show improved properties, a reduced side-effect profile and an expanded therapeutic area. The product development is based on in-house research within nanotechnology and company patents. The company was registered in 1999 and is located in Uppsala, Sweden.
Maria Lundén, Head of Public Relations, Oasmia Pharmaceutical AB.
E-mail: press@oasmia.com Phone: +46 (0) 18 50 54 40.
German contacts: Dr. Sönke Knop, Peggy Kropmanns, edicto GmbH, Frankfurt, Germany. E-Mail: oasmia@edicto.de, Phone: +49 (0) 69 90 55 05 51.
Information is also available at www.oasmia.com www.nasdaqomxnordic.com www.boerse-frankfurt.de
