May 7 2014
Azaya Therapeutics, Inc., a clinical-stage oncology company developing safer and more effective cancer treatments through its nanotechnology platform, announced a collaboration with the University of Chicago, in Chicago, Illinois.
The research will be conducted at the University of Chicago Ludwig Center for Metastasis Research by investigators Stephen J. Kron MD-PhD and Ralph R. Weichselbaum MD. The researchers hope to develop a new application for the investigational drug ATI-1123, a proprietary formulation of the chemotherapy agent docetaxel, commonly known as Taxotere, manufactured using Azaya’s patented Protein Stabilized Liposomes™ (PSL) process. The goal is to determine whether a low, clinically safe dose of radiation can significantly enhance delivery of ATI-1123 to experimental tumors in laboratory mice. The study will also document the effects of radiation on docetaxel accumulation in the irradiated tumors, and examine whether the combination leads to greater inhibition of tumor growth. This work may serve as a model for future clinical studies in cancer patients undergoing radiation therapy.
“The outcome of this study could lead to a new treatment option for cancer patients in which our ATI-1123 liposomal docetaxel could provide a powerful means to improve the benefits of radiotherapy,” said Mike Dwyer, the President and CEO of Azaya. “Given the established safety of ATI-1123 on its own, we plan to test this combination in cancer patients if the results of the animal study are promising.”
While many chemotherapy drugs are highly effective, their use is often limited by their toxicity. Liposomes have long been considered attractive as a means to help direct chemotherapy to tumors without increasing uptake in normal tissue. Since the tumor-supporting blood vessels lack the tightly bound cells of healthy vasculature, blood components can leak into tumors. This mechanism, called the enhanced permeability and retention (EPR) effect, is how liposomes leave the bloodstream and reach tumors, where they can release the encapsulated chemotherapeutic agent.
Recent studies at the University of Chicago demonstrate that delivery of liposomal chemotherapy to tumors can be further enhanced after radiation, leading to increased drug accumulation and greater effects on tumor cells. Researchers now hope to apply their method to ATI-1123 liposomal docetaxel.
More than half of all cancer patients receive radiotherapy during the course of their disease. Using the radiation to direct liposomal drugs to tumors could improve the benefits of treatment to these patients. Docetaxel is an ideal choice for the radiation-targeted liposome delivery strategy because it’s a highly effective drug and is commonly combined with radiation therapy in treatment of cancer. However, the toxicity of Taxotere can lead to early discontinuation of therapy, preventing patients from fully benefitting from the therapy. Due to its liposomal encapsulation, ATI-1123 has the potential for both reduced toxicity and increased cancer therapeutic uptake at the tumor, which could be enhanced further when combined with radiation.
About Azaya Therapeutics
Azaya Therapeutics, Inc. is a clinical-stage oncology company focused on developing more effective cancer treatments through its novel nanotechnology platform. Azaya’s patented Protein Stabilized Liposomes™ (PSL) platform allows for high-dose delivery of potent cytotoxics with potentially lower side effects. Azaya’s lead compound, ATI-1123, is a novel liposomal encapsulation of docetaxel. ATI-1123 has completed a FDA-approved Phase I clinical trial in solid tumor patients. Results included evidence of clinical benefit in 82% of the patients with an improved safety profile. Azaya has entered into a licensing agreement with CANbridge Life Sciences, of Beijing, China, to develop ATI-1123 for markets in China, Taiwan and South Korea.
Azaya’s other product, ATI-0918, is a generic formulation of DOXIL®/CAELYX®. ATI-0918 is in an FDA-approved bioequivalency clinical trial in comparison with DOXIL/CAELYX in women with ovarian cancer. On the basis of this trial and various in vitro tests, the company will apply for market approval in both the United States and Europe.
Azaya Therapeutics, Inc. is privately held and located in San Antonio, Texas.