Gibson Oncology Initiates Phase 2 Trial for Glioblastoma Drug LMP744
Miami-based Gibson Oncology, a private pharmaceutical company, has commenced Phase 2 clinical trials for its compound LMP744, investigating it as a potential treatment for first-time recurrent glioblastoma patients.
The company's strategic focus is on developing small molecules designed to offer dual-action inhibition of topoisomerase 1 and reduce the overexpression of the cMYC oncogene.
Phase 2 Trial Design: Assessing Tumor Regression and Patient Outcomes
The primary objective of the Phase 2 study is to assess tumor regression in patients with recurrent glioblastoma. Secondary objectives are comprehensive, aiming to provide a holistic view of the drug's impact:
- Evaluating progression-free survival.
- Analyzing biological changes in glioblastoma tissues before and after treatment.
- Monitoring self-reported quality of life.
- Observing overall survival.
Approximately 40 patients with first-time recurrent glioblastoma will participate in the trial. Participants will initially receive a daily one-hour infusion of LMP744 for five consecutive days. Biological analyses of brain tissues will be conducted both before and after this initial treatment period.
If initial biological results are favorable, treatment will extend for 12 cycles, each comprising five days of treatment followed by 23 days without treatment.
Understanding Glioblastoma and the Promise of LMP744
Glioblastomas are aggressive malignant tumors found in the brain or spinal cord, known for their rapid growth and invasion of nearby tissues. Standard treatments typically involve surgery, radiation, and chemotherapy. The average life expectancy post-diagnosis has remained around 15-18 months for the past three decades. For patients experiencing glioblastoma recurrence, the outlook is even grimmer, with life expectancy approximately six to nine months and very limited treatment options.
LMP744's Phase 2 protocol received approval from the Food and Drug Administration (FDA), followed by the National Institutes of Health's (NIH) approval for the trials. This advancement comes after successful completion of Phase 1 studies.
In two Phase 1 human trials involving over 40 heavily pretreated, advanced-stage cancer patients, LMP744 demonstrated good tolerability. Results from Phase 1 included two patients with at least a 30% reduction in tumor size, and 35% of patients whose tumors did not increase in size for up to 18 months.
Related Research: Expanding the Pipeline with LMP400
Gibson Oncology is also actively investigating LMP400, another clinical-stage compound and an analogue of LMP744, in collaboration with Dr. Matthew Waitkus at Duke University. LMP400 is being explored for its potential to treat high-grade gliomas resistant to other therapies.
A key feature of LMP400 is its design to be less susceptible to efflux from cancer cells, potentially overcoming common drug resistance mechanisms. Like LMP744, it also exhibits dual action against topoisomerase 1 and cMYC overexpression.
Both LMP744 and LMP400 have received extensive intellectual property protection and orphan drug designations. LMP400 additionally holds pediatric designation, highlighting its potential in a vulnerable patient population.
Origins at Purdue University
Both LMP744 and LMP400 originated from a research team at Purdue University, led by Mark Cushman. Cushman now serves as Gibson Oncology's chief scientific officer, founder, and board member. The drugs were initially disclosed to Purdue Innovates Office of Technology Commercialization, which successfully secured patents for the compounds from the United States Patent and Trademark Office.