GRAND RAPIDS — Saint Mary’s Mercy Medical Center has been named one of 12 research sites for phase II of TransMolecular Inc.’s study of a scorpion venom derivative to aid in the radiation treatment of advanced cancer.
Alabama-based TransMolecular is a privately held biotechnology company committed to discovering, developing and commercializing novel and proprietary products to diagnose and treat diseases having inadequate pharmaceutical alternatives, including cancer and pain.
Most notably, it is developing a product pipeline based on a small peptide derived from scorpion venom that could be useful in treating a wide variety of cancers.
Saint Mary’s will participate in the second phase of a multiple-dose study of one such product, 131I-TM-601, a radiopharmaceutical containing a synthetic version of chlorotoxin, a substance derived from scorpion venom.
Chlorotoxin, or TM-601, specifically seeks out and binds to a receptor expressed on tumor cells, but not on normal cells. Through this, TM-601 acts as a guidance system to deliver a radioactive payload to its target, precisely killing the tumor cells and minimizing collateral damage to normal cells.
“On the strength of the results of our phase I/II data that showed good safety and tolerability, we are very excited to advance this program into phase II development,” stated Lyle Hohnke, TransMolecular chairman and acting CEO. “We are proud to be working on a product that could fill a need for safe, more effective treatment for those who suffer from this devastating disease.”
The Phase II study will be conducted in two parts, both involving adult patients with recurrent high-grade glioma. Glioma is a highly invasive cancer of the brain and spinal cord that is resistant to both surgical and adjuvant therapies. Of the 36,000 primary brain tumors reported nationally each year, more than 17,000 are high-grade gliomas.
About half of these patients die within the first year, according to the American Cancer Society.
The first sequence is an open-label dose escalation, multi-dose study. Four cohorts of patients will be treated postoperatively at escalating dose levels until the Maximum Practical Dose (MPD) is reached or until determination of the Maximum Tolerated Dose (MTD).
After the MPD or MTD is reached, this dose will be expanded in the second trial sequence.
The second trial sequence is an open-label, randomized study in a larger group of patients. Patients will receive either a three- or six-dose treatment cycle at the previously determined MPD or MTD to evaluate the safety, time-to-disease progression and survival rates after treatment.
TransMolecular anticipates that in the first sequence of the study, three patients will be enrolled in each dose cohort. An additional group of three patients may be enrolled at a given dose based on safety. In the second sequence, a total of 54 patients will be randomized in two equal groups treated with either one cycle of three or one cycle of six repeat doses of intracavitary 131I-TM-601.
131I-TM-601 has received Orphan Drug and Fast Track Development Program status from the FDA.
Other research sites include the City of Hope National Medical Center, Duarte, Calif.; Florida Hospital, Orlando, Fla; Northwestern University, Evanston, Ill.; Saint Louis University, St. Louis, Mo.; and University of Alabama at Birmingham, Birmingham, Ala.