Oasmia’s docetaxel micellar formulation is designed to improve the solubility of docetaxel without solubility enhancers and avoid the mandatory use of steroid pre-medication
Uppsala, Sweden, 21 April 2021 –
Bone metastases in advanced prostate cancer are common and cause bone fragility. During the long course of the disease, corticosteroids are used, and corticosteroid premedication is mandatory with solvent-based docetaxel. High-dose steroid use is known to change the bone metabolism and further increase the fragility risk in these patients. Bone fractures impact patients’ quality of life and may also reduce survival time.
Oasmia’s Docetaxel micellar is a solvent-free formulation of docetaxel to avoid the need for solubility enhancers and mandatory high-dose steroid premedication while providing an effective treatment option. Docetaxel is approved for a wide range of solid malignancies and is a standard of care for advanced prostate cancer.
The SAKK 67/20 trial (NCT04629781) is an open-label, multicenter, single-stage Phase 1b trial at major hospitals in
Prostate cancer is a significant and increasingly prevalent health problem worldwide and is the leading cause of male cancer deaths.
SAKK is a non-profit organization, which has been conducting clinical trials in oncology since 1965. Its primary objective is to research new cancer therapies, to develop existing treatments further and to improve the chances of a cure for patients with cancer.
Professor Markus Jörger, President Project Group Developmental Therapeutics, at
SAKK commented: “We approached Oasmia about collaborating on a clinical trial in advanced prostate cancer using Docetaxel micellar as we saw the potential to remove pre-treatment with corticosteroids, thereby greatly reducing the incidence of adverse events such as bone fractures and other skeletal related events. We are optimistic that Docetaxel micellar could provide a much-needed treatment option for patients with advanced prostate cancer.”
Commenting on the clinical trial approval,
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About
Oasmia is a specialty pharma company dedicated to improving the lives of patients by enhancing the intravenous delivery of established and novel drugs in significant diseases, including cancer. Product development is based on Oasmia’s proprietary drug delivery platforms which can be applied to medicines used in many therapeutic areas, to develop water soluble formulations of drugs that currently require chemical solubilizers for dissolution. The first product approved using this technology is Apealea® (paclitaxel micellar). Apealea has received market authorization in the
About SAKK
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