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UTHSC’s drug candidate for advanced prostate cancer goes to first clinical trial

A drug candidate developed by researchers on the University of Tennessee Health Science Center for advanced metastatic castration-resistant prostate cancer is now in its first clinical trial.

Ramesh Narayanan, PhD, deputy director of the Center for Cancer Research and the Muirhead Endowed Professor within the College of Medicine at UTHSC, and Duane Miller, PhD, Professor Emeritus within the Department of Pharmaceutical Sciences at UTHSC, have worked for greater than a decade on therapies involving the hormone receptors that influence cancer progression. Their drug candidate, a molecule designed as a treatment for advanced metastatic prostate cancer, is now in its first clinical trial.



This can be a very, very rare occurrence. In the event you take all the tutorial researchers in the US, probably only an insignificant percent would have the posh or the privilege of taking a drug all the best way from concept to clinical trial.”

Ramesh Narayanan, PhD, Deputy Director of the Center for Cancer Research and the Muirhead Endowed Professor within the College of Medicine at UTHSC

Biopharmaceutical company Oncternal Therapeutics, Inc., holds the license for the drug candidate, an androgen (male hormone) receptor inhibitor dubbed ONCT-534, developed at UTHSC by Drs. Narayanan and Miller. On October 5, the corporate announced the primary patient had received ONCT-534. On October 26, Oncternal disclosed that the FDA granted fast-track designation for ONCT-534, which could potentially speed up the clinical development process.

“In the event you take a look at prostate cancer, more often than not it occurs in patients over 40, and about 60% are over 60,” Dr. Miller said. “And it seems that black men have the next incidence, like 70% of the diagnoses, than white men.”

“We felt that there’s a significant need for this patient population,” Dr. Narayanan said.

Existing treatments for prostate cancer goal androgens, extending survival for many patients. Nonetheless, roughly 30 percent of tumors don’t respond, and patients who initially respond often develop resistance.

“Enzalutamide is generally the drug that is chosen to provide to men,” Dr. Miller explained. “With time, it just doesn’t work, and we tried to work out what is going on on there.”

One among the first reasons for treatment failure or relapse is a mutation of the receptor protein for androgens. Enzalutamide works on one area of the receptor.

ONCT-534 is a dual-action androgen receptor inhibitor that has shown activity in prostate cancer models against unmutated and mutated androgen receptors. The research on the drug candidate has been funded by the National Cancer Institute, Oncternal, and GTx Inc., the corporate that became Oncternal.

“It looks like our drug is a really strong candidate for treating these patients who’ve relapsed from current treatment options,” Dr. Narayanan says. “It might potentially have the chance to increase the survival.”

Drs. Narayanan and Miller are collaborators on several projects, including the preclinical development of a molecule to treat Kennedy’s Disease, a rare progressive neurodegenerative disease in younger men. Dr. Miller and his team are accountable for the chemistry, designing the molecules and testing and refining the structure. Dr. Narayanan and his team do the pharmacological testing to see how they perform within the lab.

Because the licensee for ONCT-534, Oncternal has handled the lengthy process resulting in FDA approval for clinical trials that may test safety, efficacy, and at last, the way it compares against current standard treatments. Passing all three hurdles could advance a drug to market someday.

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