UPPSALA, Sweden—Oasmia Pharmaceutical AB, a developer of a new generation of drugs within human and veterinary oncology, announced today the topline findings from a head-to-head comparison study of its lead human cancer product Paclical and Celgene’s Abraxane, which show similar pharmacokinetic (PK) profiles. The study was conducted in women with metastatic breast cancer.
One of the key findings is that Paclical reportedly has nearly identical concentration curves of both total and unbound paclitaxel as Abraxane following intravenous infusion of 260mg/m2, suggesting the two drugs have the same efficacy.
The comparison study also noted that Paclical is water-soluble and solvent-free, thus increasing the solubility of paclitaxel, and it suggested that Paclical enables higher doses.
“We believe our technology is superior to that of Abraxane because it increases the solubility of paclitaxel in water,” commented Margareta Eriksson, vice president of clinical development at Oasmia Pharmaceutical. “The benefits of using our treatment over those currently available on the market are simple: Paclical enables higher doses, shortens infusion time, eliminates the need for premedication and improves the safety profile for patients.”
Oasmia believes these data strengthen its position in terms of growth among competitors within the pharmaceutical oncology sector, including Sorrento Therapeutics Inc. and Celgene. Sorrento Therapeutics has recently expanded its Cynviloq strategy into multiple cancer indications, potentially receiving over $1 billion in compensation for rights; further, Abraxane was acquired for $2.9 billion by Celgene Corporation.
Paclical is a water-soluble formulation of Oasmia’s patented non-toxic XR-17 technology and paclitaxel, one of the most widely used anticancer substances which is included in the standard treatment of a variety of cancers such as lung cancer, breast cancer and ovarian cancer. Paclical consists of a freeze-dried powder that is dissolved in conventional solution for infusion, and it has orphan drug designation in the European Union and the United States.
Abraxane was developed as a Cremophor-free product containing paclitaxel suspended in human albumin. Because Abraxane contains no Cremophor EL solvent, its recommended dosing enables the delivery of 50 percent more paclitaxel compared to Taxol while maintaining a similar safety profile, and requires no routine premedication to prevent hypersensitivity reactions or the immediate allergic effects that often prevent or limit treatment. Like Abraxane, Paclical is free of Cremophor EL, but unlike Abraxane, Paclical does not contain human albumin.
“We are excited about these preliminary results because they demonstrate that Paclical has the potential to be just as effective in treating women with advanced breast cancer as Abraxane, which is the current market leader in this category within the United States,” said Julian Aleksov, executive chairman of Oasmia Pharmaceutical. “We remain committed to generating awareness and adoption of Paclical in the United States in order to help patients fight breast cancer, and we believe the findings from this study represent a big step forward in helping us achieve that goal.”
Breast cancer remains a huge threat to women in the United States, the company notes, citing recent data that about one in eight women (or approximately 12 percent) in the United States alone will develop invasive breast cancer over the course of her lifetime, and it is estimated that just in this year, there will be 231,840 new cases of invasive breast cancer among women in the United States, along with 60,290 new non-invasive cases.
These statistics underscore an increasing market opportunity for treatments of this disease, Oasmia notes. According to new forecasts from IMS Health, the increased use of targeted therapies, along with a greater uptake of branded drugs and rising incidence population, will cause the breast cancer therapeutics market value to grow from a value of $9.8 billion in 2013 to $18.2 billion by 2023.