Drug implants containing enzalutamide and methods of use thereof

Inventors

Rairkar, Maithili • Desai, Pujan • Schuler, Carlos • Hall, Keith • Munster, Pamela • Maroney, John • Thomas, Scott

Assignees

University of California San Diego UCSD • Alessa Therapeutics Inc

Abstract

Provided herein are drug implants comprising enzalutamide for the treatment of disease in a subject. In some cases, the drug implant may comprise a polymer matrix and enzalutamide disposed therein. Additionally provided are methods for manufacturing the drug implants and methods of treating diseases with the implants. In some cases, the drug implant may be used for the treatment of a proliferative disease of the prostate.

Core Innovation

A drug implant is provided that includes a biocompatible, non-biodegradable polymer matrix and enzalutamide dispersed in the biocompatible, non-biodegradable polymer matrix. The enzalutamide is incorporated throughout the non-biodegradable polymer matrix rather than being in a biodegradable or erodible form, and the implant is configured to deliver enzalutamide in a sustained manner based on the dispersion state and the interaction with the polymer matrix.

The implant is defined by performance and material constraints that relate to enzalutamide release and retention. In particular, the implant is characterized by in vitro cumulative release behavior under an in vitro model, and by a quantified fraction of enzalutamide remaining after implantation. Additional dependent features constrain polymer hardness, thermal processing relationships between enzalutamide melting temperature and polymer molding or curing temperatures, and optionally ultrasound visibility for placement in target tissue.

The disclosed system is directed to treating prostate proliferative diseases using an enzalutamide drug implant. The implant and delivery concepts are described for deployment into prostate tissue, including transperineal or catheter or needle delivery concepts with ultrasound guidance, and the document also describes manufacturing approaches for forming the implant from a polymer matrix with enzalutamide dispersed therein.

Claims Coverage

The independent claim covers a drug implant with two core inventive elements: a biocompatible, non-biodegradable polymer matrix and enzalutamide dispersed in that matrix. The claim set further defines release and retention behavior, mechanical hardness, thermal processing compatibility, and optionally ultrasound visibility for placement.

Overall, the claim coverage centers on an enzalutamide drug implant where enzalutamide is dispersed in a biocompatible, non-biodegradable polymer matrix, and it further defines release and retention performance, mechanical hardness, thermal processing compatibility, and optionally ultrasound visibility.

Stated Advantages

Documented Applications