Oasmia Pharmaceutical AB, a developer of a new generation of drugs within human and veterinary oncology, announced that its next anti-cancer drug Docecal, has been approved for clinical clients and patient recruitment will commence in January 2016.

Docecal is a nanoparticle and water soluble formulation of docetaxel, one of the most commonly used anti-cancer substances in oncology today, in combination with the company’s patented technology XR-17. Docetaxel is the most active substance in the cytostatic Taxotere, marketed by the global healthcare provider Sanofi-Aventis. Prior to the patent expiration in 2010, Sanofi-Aventis executed $3 billion in Taxotere sales 2009. Taxotere has continued to perform, generating sales of $350 million in 2014, clearly demonstrating market demand for the product.

Taxotere is used either as mono therapy or in combination with other anti-cancer medicine in the treatment of prostate cancer, breast cancer, lung cancer, gastric cancer and head and neck cancer. The product is a formulation of docetaxel and Polysorbate 80, a water soluble emulsifier made of polyethoxylated sorbitan and oleic acid. By comparison, Oasmia’s product Docecal is solvent free and requires no pre-treatment, leading the company to believe its technology represents a significant upgrade over products like Taxotere that are already established within the oncology market.

“This approval to commence clinical trials is a significant step forward for the company, as this product is of highest priority to reach the market as soon as possible,” said Julian Aleksov, executive chairman of Oasmia. “Docecal possesses tremendous potential within the human oncology market that has already exceeded $100 billion in sales in 2015 and could reach $147 billion by 2018. We believe this market opportunity, when coupled with recent advancements and sales of Paclical, position the company to capture significant share of the market.”

“We are excited to conduct the first clinical studies with this very important product, one that I am confident will showcase the results we expect from cancer treatment using Docecal,” said Margareta Eriksson, head of clinical development for Oasmia.

“We believe this combination of docetaxel and Oasmia’s patented XR-17 technology has the potential to overcome many difficulties faced by patients treated by Taxotere, thus improving their overall quality of life.”

Clinical trials with Docecal are scheduled to begin in January 2016.