Jenn Highfield was diagnosed with colon cancer at 38.  Wisely securing a second option at University of Kentucky (UK) Markey Cancer Center, a flurry of treatments followed from chemotherapy to radiation treatments at a clinic closer to home. After a resection of her cancer was performed again by UK, additional chemotherapy treatments commenced. Yet the cancer spread further now to liver, lungs and lymph nodes. Ultimately her case caught the attention of UK Markey oncologist Dr. John Villano, medical director for Markey’s Precision Medicine Clinic, and after that first meeting Jenn felt something different—hope. Dr. Villano was opening up an arm of a clinical trial to test the efficacy of an investigational chemotherapy drug called BXQ-350.

The Study

As it turns out, the objective of the first-in-man study Jenn entered, sponsored by Bexion Pharmaceuticals, Inc., is to characterize the safety profile and determine the maximum tolerate dose (MTD) of BXQ-350, when given as a single agent at escalating doses, according to the investigational product (IP) related dose-limiting toxicities (DLTs) in patients with advanced solid tumors. Secondarily, their objective was to assess the preliminary antitumor activity of BXQ-350 in solid tumors and recurrent high grade gliomas.

Dr. Villano reported to UKNow that “The trial had just opened, and she (Jenn) was a candidate because all other therapies had failed and the cancer was still progressing.” The doctor continued, “She was a little hesitant, but she liked the option.”

The Markey Cancer Center Precision Cancer Clinic

The Precision Medicine Clinic opened last year, which helped increase patient access to Phase I and Phase II clinical trials—known as “early phase” trials. Jenn Highfield is one of the beneficiaries of this opening as she was one of the first people to receive the investigational drug BXQ-350.

What is BXQ-350

Manufactured by Kentucky’s emerging biopharma venture BexionBXQ-350 is a first-in-man drug. Dr. Villano had 25 openings for the Phase I trial at UK Markey and Jenn was the very first to enroll. Administered via infusion, Jenn came to the Precision Medicine Clinic every weekday for the treatment. Her health improved dramatically in the first few weeks. She believes strongly that because the drug is far less toxic to her system, she felt it make a big difference in the early days of the study.

A Near Miracle

However BXQ-350 did much more than just improve symptoms and quality of life—patients have responded favorably and Jenn’s response has been near miraculous. Dr. Villano reports that Jenn is now in remission and there is no evidence that the disease is spreading.

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.

Who is Bexion Pharmaceuticals, Inc.

Bexion Pharmaceuticals Inc. is developing innovative cures for cancer. Founded in 2006 when technology was licensed from Cincinnati Children’s Hospital Medical Center, Bexion has developed a first-in-class biologic, BXQ-350, with a novel mechanism of action for targeting and eliminating tumor cells. Mechanism of action studies support potential efficacy across a broad range of tumors, while minimizing “off-target” effects.

Bexion’s leadership, including the founders, Drs. Ray Takigiku (CEO/President) and Kevin Xu (VP), have significant experience in drug discovery, development, and market support of pharmaceuticals. They are supported by team members with advanced degrees in science and business, and multiple “best of breed” consultants and collaborators in toxicology, regulatory affairs, manufacturing, and clinical research.

The National Cancer Institute (NCI) has awarded Bexion funding through three Phase I Small Business Innovation Research (SBIR) grants, 1 Phase II SBIR grant, and a Phase II Bridge grant to study cancer. The Company has been able to leverage these funds to attract significant private investment capital.

In July 2016, Bexion received FDA Clearance for the first Clinical Trial using BXQ-350 (IND 113203) to dose patients with cancer. Patients have been dosed at the University of Cincinnati Barrett Cancer Center, the University of New Mexico Cancer Center, University of Kentucky Markey Cancer Center, and the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James).

Lead Research/Investigator

Dr. John Villano 

Call to Action: What an amazing story proving the potential of clinical research as a care option. We consider physicians such as Dr. Villano and their staff the heroes of healthcare. Should you or a loved one have a major cancer diagnosis, consider clinical trials in your area—they can save a life.

Source: University of Kentucky

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