GLEN MARK RECIEVES USFDA CLEARENCE FOR CONDUCTING CLINICAL TRIAL FOR ANTI MYLOMMA DRUGS.

As per the company sources,they have received approval from USFDA for conducting clinical trial for new drug for Anti myeloma. This is Glenmark’s second investigational new drug from its immuno-oncology portfolio to enter clinical trials. USFDA have given clearance to Glenmark Pharmaceuticals’ investigational new drug application to initiate a phase 1 study that will evaluate GBR 1342 for treatment of patients with previously treated multiple myeloma.GBR 1342 is designed to activate the patient's immune system by redirecting immune cells towards tumor tissue, which may lead to targeted destruction of tumors. It is based on Glenmark's proprietary BEAT® (Bispecific Engagement by Antibodies based on the T cell receptor) technology platform.

“This is an exciting time for Glenmark as our flagship biotechnology platform and antibody science are beginning to become a reality for patients, now that we have a second oncology candidate entering clinical trials,” Kurt Stoeckli, president and chief scientific officer at Glenmark Pharmaceuticals, said in a company-issued press release. “ there is still significant development ahead, these steps signify that Glenmark’s investment in discovery and development of biologics is rapidly progressing.”

The study will be conducted in two parts.Teh first part is a dose escalation to determine the safety profile and maximum tolerable dose; the second is an expansion cohort treated at maximum tolerable dose to further investigate the safety profile and preliminary efficacy of GBR 1342.

As per company sources,GBR 1342 is also being considered for the treatment of other malignancies.