Taclantis™ is a novel formulation of paclitaxel developed with SPARC’s proprietary NanotectonTM technology.
Paclitaxel is one of the most widely used cytotoxic agent and is approved for the treatment of Breast cancer, Ovarian cancer, Non Small Cell Lung cancer and Pancreatic cancer.
Taclantis™ is cremophor free and Human Serum Albumin free formulation. Cremophor containing paclitaxel formulations are associated with high incidence of hypersensitivity reactions and are required to be administered slowly and with high dose steroids and anti-histamines as pre-medication. The absence of a biologic protein has advantages such as easier preparation (minimal foaming inside the vial upon reconstitution) and storage (reduced risk for microbial contamination). In addition, it eliminates potential risk of viral/prion transmission from human blood products.
Taclantis™ offers several advantages over available paclitaxel formulations
- Quick and easy "One Step" dilution and infusion preparation
- Shorter infusion time (30 min)
- Significantly higher MTD dose
- No Premedication
- Linear pharmacokinetic profile
- Storage at ambient temperatures
Taclantis™ is currently approved and marketed in India under the trade name Bevetex® by Sun Pharmaceutical Industries Ltd.
SPARC had received US FDA guidance for filing the product under 505 (b) (2) pathway by establishing bio-equivalence of Taclantis™ to Abraxane®. In the pivotal BE study; PICS was bioequivalent to Abraxane® in patients with locally recurrent or metastatic breast cancer.