Biomarck Pharmaceuticals has completed patient enrolment in a Phase II trial evaluating the safety and efficacy of BIO-11006 in comparison with standard of care (SOC) alone and with SOC for the treatment of Stage IV non-small cell lung cancer (NSCLC).
The randomised trial has enrolled 60 patients currently receiving pemetrexed and carboplatin as SOC, but who will not undergo curative surgery, radiation, or immunotherapy.
It will be carried out at ten clinical centres in India as part of an investigational new drug (IND) application approved by both the US Food and Drug Administration (FDA) and Indian FDA.
Patients will be split equally into two treatment arms of 30 subjects each as part of the trial.
The first arm will receive aerosolised 125mg BIO-11006 using Pari eFlow nebuliser in combination with SOC chemotherapy, while the second arm will be treated with SOC chemotherapy only.
Both groups will receive treatment for a period of three months, followed by a nine-month survival follow-up period.
The trial’s primary efficacy endpoint is progression-free survival (PFS) at three months, while its secondary efficacy endpoints include response rate (RR) at three months, overall survival (OS), and patient body weight maintenance at 12 months.
Initial results from the trial are expected to be available by March next year.
Biomarck Pharmaceuticals said in a statement: “In-vivo studies have shown BIO-11006 can inhibit NSCLC metastases and reduce tumour size in several animal species.
“Those treated with BIO-11006 also did not lose weight over the treatment period. This study is intended to give an initial confirmation of these findings in a clinical setting.”
End-stage NSCLC is a fatal disease with a poor prognosis and quality of life.