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Formulation could reduce toxicities of head and neck cancer chemoradiotherapy
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Researchers at Purdue University and Indiana University School of Medicine have developed a novel chemoradiotherapy formulation that could decrease treatment-associated adverse events among patients with advanced head and neck cancer.
Results from studies conducted in mice have laid the groundwork for a trial in humans.
“All previous commercial formulations are not optimized for releasing drugs directly at the tumor under radiation,” You-Yeon Won, PhD, professor at Davidson School of Chemical Engineering at Purdue University, said in a press release. “Our formulation provides more control on drug release and could also be applied to any type of solid tumor, such as those in the breast, prostate, lungs or the liver.”
HemOnc Today spoke with Won about this novel formulation and the timeline for when trials may be conducted in humans.
Question: Wh y is a formulation like this needed for this patient population?
Answer : Chemotherapy and radiotherapy both produce side effects. The combination of the two, therefore, involves many side effects. This results in exclusion of many patients, particularly those who are older or have certain other medical conditions. Our approach uses radiation-controlled drug release nanoparticle formulations to achieve maximum availability of the toxic chemotherapy drugs within the tumor and minimize the side effects of the drugs in normal tissue. This radiation-controlled drug release technology will enable patients with advanced solid tumors to achieve the benefits of chemoradiotherapy with reduced side effects. This approach has the potential to present a new therapeutic option for patients excluded from conventional chemoradiotherapy protocols.
Q: How does the novel therapy work?
A: Our formulation allows for adverse events associated with chemoradiotherapy to be minimized by encapsulating the drug within a specially designed radiation-degradable polymer capsule and injecting this directly into the patient’s tumor before normal radiotherapy. Current commercial chemotherapy formulations are not optimized for use in chemoradiotherapy treatments.
Q: What type of efficacy has been observed so far?
A: Preclinical efficacy studies, both in cell cultures and in mouse models of human head and neck cancer, confirmed that our radiation-controlled drug release formulation significantly enhances the cancer cell-killing effect of radiation. Histopathological analysis of organs from mice treated with our nano formulation in comparison with commercial off-the-shelf formulations suggest a significantly improved safety profile with our novel formulation.
Q: When will a trial be conducted in humans?
A: We are currently in the preclinical stage of research, but we hope to start clinical trials to validate the safety and efficacy among human patients within the next few years. Areas where further research is required toward this end include scale-up and optimization of nanoparticle manufacturing and understanding clearance mechanisms of our formulation in the human body. – by Jennifer Southall
Reference:
Misra R, et al. J Control Release. 2019;doi:10.1016/j.jconrel.2019.04.033.
For more information:
You-Yeon Won , PhD, can be reached at Purdue University, Forney Hall of Chemical Engineering, 480 Stadium Mall Drive, West Lafayette, IN 47907; email: yywon@ecn.purdue.edu.
Disclosure: Won reports no relevant financial disclosures.