The study (OAS-04-01) was a tolerance and pharmacokinetic study where the dose for Apealea (paclitaxel micellar) was determined. This phase I study was conducted at two clinics in Sweden located in Lund and Umeå between 2004 and 2007. The 34 patients included in the study had different forms of refractory cancers with solid tumours. The detailed pharmacokinetic results together with the tolerance assessments have been summarized in a manuscript that is now being published in the peer-review journal “Advances in Therapy” (https://link.springer.com/article/10.1007/s12325-019-00909-6).
-As Apealea was recently approved within EU, it is of great importance to share its available clinical data to the scientific and clinical community. Publishing our study data in a peer-reviewed journal, as an open access publication, provides a channel to reach this broad audience, says Mikael Asp, CEO
For more information, please contact:
Nina Heldring, Head of Clinical Development
Tel: +46 18 50 54 40
Notes to editors:
Apealea is a macrogolglycerol ricinoleate- and albumin-free formulation of the well-known cytostatic paclitaxel combined with Oasmia’s excipient technology XR-17. Paclitaxel is one of the most widely used anticancer substances and other formulations are approved as treatment of a variety of cancers such as lung cancer, breast cancer, pancreatic cancer and ovarian cancer. Apealea consists of a freeze-dried powder, which is dissolved prior to intravenous infusion.
The most common clinically significant adverse reactions associated with the use of Apealea are neutropenia, gastrointestinal disorders, peripheral neuropathy, arthralgia/myalgia, and infusion site reactions.
About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops, manufactures, markets and sells new generations of drugs in the field of human and veterinary oncology. The company’s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatic which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. The company’s product development is based on its proprietary in-house research and company patents. Oasmia is listed on NASDAQ Capital Markets (OASM.US), Frankfurt Stock Exchange (OMAX.GR, ISIN SE0000722365) and NASDAQ Stockholm (OASM.ST).