Proprietary Doxorubicin Formulation Increases Survival and Safety Over Free Doxorubicin and Doxil

Doxorubicin (DOX) is a commonly used anticancer chemo drug, and its clinical use is associated with dose-limiting cardiotoxicity. It is used to treat a wide variety of cancers including leukemia, bone and Karposi sarcomas, multiple myeloma, and ovarian, breast, kidney, endometrial, liver and gastric cancers. Despite being a generic, the market for liposomal DOX (e.g., Doxil®) was over $800 million in 2015 and is expected to grow to $1.4 billion by 2024. The market for a more effective and safer alternative could be significantly larger.

A research team from SUNY Upstate researchers has created a new DOX formulation using its proprietary nanocarriers that both reduces DOX's toxicity and improves its anti-tumor activity. These nanocarriers are characterized by their ultra-high drug loading capacity (equal amounts by weight of doxorubicin and polymer), sustained drug release with reduced initial burst release (20% or less), optimal particle sizes (20~40 nm) for passive tumor targeting, and low toxicity - mice were able to tolerate a 2 to 2.5 higher dose of Upstate's proprietary formulation than either clinically approved free DOX or the PEGylated liposomal nanoformulation Doxil®. Moreover, despite causing less weight loss and cardiac and kidney toxicity than both free DOX and Doxil®, Upstate's formulations remained as potent as free DOX over 72 hours in vitro incubation (Doxil's IC50 was 5-10 times that of both free DOX and Upstate's formulation). Upstate's formulation demonstrated excellent passive tumor targeting and drug accumulation in mice bearing tumor xenografts, e.g. Raji lymphoma, MDA-MB-231 breast cancer, and SKOV3 ovarian cancer. In particular, significant tumor growth inhibition (almost none) and prolonged survival were observed in mice bearing SKOV3 ovarian cancer xenograft treated with Upstate's formulations; indeed none of the mice treated with Upstate's formulation died from due to tumor growth during the 100 days after the final drug administration (days 0, 4, 8).

Upstate's proprietary new doxorubicin formulation offers the opportunity for a company to offer a branded alternative to the generic doxorubicin formulations currently available which is not only safer but also more effective.

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