Biomarck Begins Phase 2 Trial of Lung Cancer Drug
Durham-based Biomarck Pharmaceuticals, a portfolio company of the North Carolina Biotechnology Center, has launched a Phase 2 clinical trial of a potential therapy for treating advanced non-small cell lung cancer (NSCLC).
The study at 10 sites in India will evaluate the safety and efficacy of Biomarck’s novel, patented protein inhibitor, a peptide denoted as BIO-11006, the company said in a news release. The study will compare standard of care therapy -- a combination of the chemotherapy drugs pemetrexed and carboplatin -- to standard of care plus BIO-11006.
“The initiation of this clinical study represents a significant milestone for Biomarck as we progress to clinically develop our patented portfolio in diseases, such as non-small cell lung cancer, that cause significant morbidity and mortality,” said Dr. Brian Dickson, Biomarck's chief executive officer. “This represents a first-in-class therapy."
Despite recent treatment advances including immunotherapy, the five-year survival rate for advanced NSCLC remains disappointingly low, Dickson said.
New therapy seeks to reduce side effects
“These immunotherapeutic agents have significant side effects, and quality of life remains a critical issue to both patients and their treating oncologists,” he said.
In animal studies BIO-11006 reduced primary tumor size, prevented the development of secondary tumors and acted synergistically with other chemotherapeutic agents, Dickson said.
The side effect profile in over 200 patients in previous clinical studies “demonstrated an encouraging safety database where only cough and headache were more common than placebo,” he said. “Furthermore, animals with NSCLC treated with BIO-11006 did not lose weight whereas those untreated lost 30 percent body weight within three weeks.”
The study is a controlled randomized clinical trial. The primary endpoint is progression-free survival at three months. Overall survival and body weight are secondary endpoints.
BIO-11006 inhibits the MARCKS protein, which has been shown to be involved in cell division and movement. BIO-11006 targets cancer cells but does not affect normal cells.
BIO-11006 is part of Biomarck’s portfolio of over 100 patented peptides that inhibit the phosphorylation of the MARCKS protein, a primary mediator of inflammation involved in respiratory disease and cancer progression. Phosphorylation is the addition of a phosphate group to a protein that can change the shape and function of the protein.
Biomarck, a 2002 spinout of N.C. State University, received two loans from the Biotech Center totaling $165,000 that helped the company attract federal research grants and equity capital. The company’s technology is based on the research of Kenneth Adler, Ph.D., a professor of cell biology at NCSU whose lab demonstrated inhibition of the MARCKS protein.