The company’s lead human product paclical successfully meets primary objective in pivotal phase III clinical study.
The data show that Paclical, which has orphan designation for epithelial ovarian cancer in the EU and in the US, met the pre-defined requirement of non-inferiority compared with Taxol.
The Phase III open, randomized, multi-centre study, which included in total 789 patients, was designed to compare the efficacy and safety between Paclical and Taxol, which is also a paclitaxel-based product. Both Paclical and Taxol were administered in combination with carboplatin.
Paclitaxel in combination with carboplatin, or any other platinum containing compound, has emerged as a standard in a first line setting in patients with epithelial ovarian cancer, and is used also as second line treatment, providing the patient had a response time of at least 6 months. These patients are defined as platinum sensitive.
The period from randomization to relapse or death (PFS) becomes shorter with the number of relapses, and hence treatment periods, that the patient goes through. A study comparing the period of the first PFS with the second showed a difference of 7 months, 17.8 compared to 10.8 months (ref 1).
The study showed a PFS period of 10.3 months for Paclical + carboplatin compared to 10.1 months for Taxol + carboplatin. The result corresponds well with literature data from studies in platinum sensitive patients in second line treatment, e.g. 10.8 months (ref 1) and 9.4 months (ref 2).
“We are very excited by these results. Our patented XR-17 technology increases the solubility of the well-known cytostatic paclitaxel without the use of toxic solvents, which we believe facilitates the ease of administration and allows for higher doses than some of the other existing products on the market. We are pursuing a strategy to replace the use of these products in treating multiple types of cancer”, commented Julian Aleksov, CEO and President of Oasmia.