'I Thought It Was a Miracle' – Clinical Trial Works Wonders for Markey Patient

LEXINGTON, Ky. (Sept. 17, 2019) — Despite the leaps and advances made in cancer treatments over the past few decades, sometimes patients still discover that they’ve exhausted all other available options.

Tollesboro resident Jenn Highfield was far younger than most when she was diagnosed with colon cancer. With a strong family history of the disease – her father had been diagnosed with colon cancer at age 40 – she had been getting colonoscopies since age 30, decades before the recommended age of 50. Those screens ended up being a lifesaver: when she was just 38 years old, her doctor found a cancerous polyp.

After a consultation with one oncologist, Jenn sought a second opinion at the University of Kentucky Markey Cancer Center. A flurry of treatments followed: chemotherapy in pill form at Markey, and Monday-through-Friday radiation treatments at a hospital in Maysville that was closer to home. A resection of her cancer, performed by UK surgeon Dr. Sandra Beck. Then more chemotherapy, this time an infusion, that left her sick and weak.

Still, her cancer spread. Her liver, lungs and lymph nodes became affected. She had a liver ablation, a lung resection, and more radiation to a lymph node in her chest that couldn’t be removed.

Despite all this, her cancer refused to back down. With all current options exhausted, her oncologist, Dr. Aju Mathew, suggested she explore hospice care.

But Jenn and her husband, Tyrome, wanted to search for more possibilities. They drove to Nashville for a second opinion, where doctors told her the same thing. Then, they trekked seven hours to Chicago, hoping for another opportunity there.

Same answer: nothing new to try.

One night back home, Jenn became incredibly sick, reeling from pain related to her disease. Tyrome rushed her to the UK Chandler Hospital Emergency Department from their home in Tollesboro – a 90-minute drive on small country highways. After she was admitted, her case caught the attention of Markey oncologist Dr. John Villano.

Villano, who serves as the medical director for Markey’s Precision Medicine Clinic, came to Jenn with something she hadn’t seen in a long time – hope. Through the Clinic, Villano was opening up an arm of a clinical trial to test the efficacy of a brand new chemotherapy drug known as BXQ-350.

“The trial had just opened, and she was a candidate because all other therapies had failed and her cancer was still progressing,” Villano said. “She was a little hesitant at first, but she liked the option.”

The Precision Medicine Clinic opened last year at Markey Cancer Center, increasing patient access to phase I and phase II clinical trials, commonly known as “early phase” clinical trials. In other words, these trials provide patients an opportunity to try promising new drugs that are not yet FDA-approved. When patients are enrolled in phase I trials, they are often among the first people to receive a promising new drug or treatment. Phase II trials build on the information gathered in a phase I trial and often compare its efficacy with the current standard treatment for that specific cancer.

Manufactured by the Kentucky pharmaceutical company Bexion, BXQ-350 had never been investigated in humans before. Villano had 25 openings for the phase I trial at UK, and Jenn became the first to enroll.

BXQ-350 is administered via infusion, and Jenn initially came to the Precision Medicine Clinic every weekday for her treatment. After the first month, she was tapered down to returning monthly for the infusion.

Her health improved dramatically in those first few weeks – partly, she says, because this new drug is far less toxic to her system.

“The other types of chemo I’ve had were the typical, ‘I can’t eat, I’m nauseous, I’m tired,’” she said. “With this drug, I feel like I’m back to normal – I feel like I did before I had cancer.”

But BXQ-350 did more than just improve her symptoms and overall quality of life. While the drug was given to patients who have a variety of solid cancer types, those with primary colorectal cancer have responded the most favorably to the drug, and Jenn has had the most remarkable results of all.

Villano says that as of right now, Jenn is in remission, showing no evidence of the disease that had been spreading throughout her body.

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Sitting in a treatment bay at the Precision Medicine Clinic, Jenn and Tyrome are in good spirits. She’s wearing soft, fuzzy five-toed socks to keep her feet warm, and has a blanket in her lap because she often naps during her treatment. Tyrome has gone to retrieve snacks for their long wait – a typical appointment takes about four hours, including the time for lab work, allowing the specialty pharmacy to mix the drug, and then receiving the 45-minute infusion.

It’s late August, and she and Tyrome are about to become empty-nesters – in just a few days, they’re moving their son into a dorm at Shawnee State University. It’s an exciting but bittersweet moment for both; and Jenn quietly comments that at one time, she thought she wouldn’t be around to see him graduate from high school.

For Tyrome, one of the most difficult moments of their ordeal – the emergency trip to UK’s ED – turned out to be a blessing in disguise.

“The best thing that happened to us was her getting sick and going to the ED,” he says. “Because it got us to this trial.”

Even though the trial is now closed at UK, Jenn will continue to receive the monthly infusions both because of her amazing progress and because she’s not experiencing toxicity from the drug. Having access to the trial so much closer to home has been a happy bonus for the Highfields, who say they don’t mind the monthly drive to Lexington for Jenn’s infusion – especially compared to the much longer journeys they made to seek treatment outside of Kentucky. And that’s precisely the reason the Precision Medicine Clinic exists, says Villano.

“Our goal is to have these types of clinical trials right here at Markey,” he said. “It saves our patients from spending valuable resources to travel out of the state for care.”

As Kentucky’s only National Cancer Institute-designated cancer center, clinical research is at the heart of Markey’s mission. Right now, the cancer center has 113 open trials and 48 more in preparations to launch. Forty-four of those open studies and 14 of the upcoming studies are early phase trials run through the Precision Medicine Clinic specifically. And as Markey faculty learn more about the genetics behind Kentucky’s most devastating cancers from Molecular Tumor Board data, new trials will be designed to target those specific mutations – and hopefully, lead future patients like Jenn to newer, more effective treatments.

For the healthcare team inside the Precision Medicine Clinic, it ultimately comes down to being able to make a difference for patients when they thought all their other options had been exhausted. Witnessing a patient like Jenn experience such a breakthrough in treatment is humbling, Villano says.

“It reaffirms why you’re in the field,” he said. “It inspires you and makes it all worthwhile.”

And for many patients who agree to participate in clinical trials at the Precision Medicine Clinic, it’s about getting not just a second chance, but perhaps a third or fourth chance at a treatment that will work.

When her dose of BXQ-350 arrives from the pharmacy – a nondescript, transparent fluid in a clear bag – Jenn and Tyrome are holding hands and watching as clinic nurse Renee Rainey hangs the medicine to prepare the infusion. They weren’t sure what to expect when Jenn agreed to be among the first humans to try this new drug, but they couldn’t be happier with the results.

“I thought it was a miracle,” Tyrome says.

Jenn smiles. “It was for me.”

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Bexion Pharmaceuticals, Inc. did not contribute to this article. As noted on Bexion's website, BXQ-350 is in the early stage of clinical testing and the evaluation of efficacy and safety is not yet complete. Consistent with FDA regulations, the results of current and future clinical studies will be submitted for review by the FDA. The FDA determines whether drug candidates demonstrate adequate efficacy and safety to warrant formal approval for use in the treatment of disease.