Australian researches say it has the potential to significantly increase the lifespan and survival rates of cancer patients
Australian biopharmaceutical company Bionomics has initiated a Phase 1 trial of its stem cell drug following acceptance of an investigational new drug (IND) application by the US Food & Drug Administration last year.
The 15-month trial of BNC101, said by Bionomics' Chief Executive Deborah Rathjen to be an important milestone for the business, will involve up to 60 patients.
'We’ve got data that shows BNC101 could potentially be used in other cancers such as pancreatic, breast and lung, so we do believe there is broad applicability,' she said.
As part of the trial, Adelaide-based Bionomics will be evaluating response rates to treatment; looking at overall survival and looking at other measures which indicate that BNC101 is prolonging the disease-free period using a measure called progression-free survival.
BNC101 is a highly specific monoclonal antibody to LGR5 and will target cancer stem cells by blocking key stem cell survival signals downstream of LGR5. In the trial, BNC101 will be used in combination with standard-of-care chemotherapy to inhibit cancer stem cell activity and/or directly eliminate cancer stem cells. As a result, BNC101 is proposed to significantly increase the duration of response and survival compared with current standard-of-care therapies for colorectal cancer.
'It’s a very innovative approach to cancer treatment in targeting these cancer stem cells, which are the seeds of cancer, but we believe it has a lot of potential in the treatment of cancer,' Dr Rathjen said.
Bionomics will be looking to form a strategic licensing deal with a global pharmaceutical company on BNC101 as the firm moves through the current clinical trial so BNC101 has the resources required to fast-track its development.
Dr Rathjen said it typically took 5–7 years from the first clinical trial before a drug was commercially available and could be prescribed by doctors.
In 2015, the US Centers for Disease Control and Prevention estimated that there were about 133,000 new cases of metastatic colorectal cancer in the US alone.
The current five-year survival rate for metastatic colorectal cancer patients is about 11% with a median overall survival span for metastatic colorectal cancer ranging from approximately 20 to 30 months. The global market for metastatic colorectal cancer treatments is predicted to grow to US$9.4bn by 2020.