A novel drug, BMX-001, is under investigation for its potential to alleviate the harsh side effects associated with radiation and chemotherapy treatments in patients with anal and rectal cancers. Led by radiation oncologist Chi Lin, MD, PhD, the clinical trials are showing encouraging early results.
Protecting Healthy Tissue
BMX-001 is designed to protect normal tissue from radiation-induced damage without compromising the effectiveness of cancer treatments. "BMX-001 is a drug that can protect normal tissue from radiation-induced damage while not protecting cancer cells in chemo and radiation therapy patients," Dr. Lin explained. "In the lab, we have seen that it's actually enhancing the chemo and radiation killing of cancer cells."
The trials primarily aim to reduce the severe side effects of radiation treatment for anal and rectal cancers, including diarrhea, skin breakdown, and urinary discomfort, as well as long-term effects such as rectal bleeding and pain.
Encouraging Early Data
Initial data from the anal cancer trial, which has enrolled 21 of the planned 24 patients, are promising. Dr. Lin reported a significant reduction in severe toxicity (Grade 3 or above), with only 14% of patients experiencing such effects, compared to historical data showing rates of 21% to 36%.
Rectal Cancer Trial
The rectal cancer trial, initiated last year, aims to enroll 56 patients. Participants are randomized to receive either standard treatment or standard treatment plus BMX-001. The trial is investigating whether BMX-001 can mitigate the side effects of total neoadjuvant therapy, the current standard approach for rectal cancer, which combines chemotherapy and radiation before surgery.
Multidisciplinary Approach
The research exemplifies a multidisciplinary approach, integrating radiation therapy, chemotherapy, and surgery. Dr. Lin highlighted the importance of this collaborative effort, stating, "For a lot of tumors, we need all three things. We work with surgeons and medical oncologists. A lot of chemo and radiation done prior to surgery is trying to help surgeons do a better job."
Translational Research
This study represents translational medicine, bridging laboratory discoveries with patient care. Dr. Lin collaborates with UNMC researcher Rebecca Oberley-Deegan, PhD, sharing clinical samples and data to further understand the drug’s mechanisms. "We are translating the lab science to benefit the patient in the clinic," Dr. Lin noted.
The potential applications of BMX-001 may extend beyond rectal and anal cancers, possibly benefiting patients with prostate or gynecological cancers in the pelvic area, though separate clinical trials would be required to confirm this.
Patient Participation
Dr. Lin emphasized the importance of patient participation in these trials. "We hope patients will consider being part of this research," she said.
