In a bid to achieve self-sufficiency in clinical development and move forward with indigenous pharmaceutical agents, the Indian Council of Medical Research (ICMR) on Saturday announced the formalisation of a memorandum of agreement (MoA) with multiple sponsors to advance first-in-human phase 1 trials for four promising molecules.
A human clinical trial is a type of trial in which a new drug, procedure, or treatment is tested in humans for the first time. Human studies are conducted after the new treatment has been tested in laboratory and animal studies and are usually conducted as Phase 1 clinical trials.
Under its Phase 1 clinical trial network, ICMR will partner with Hyderabad-based Indian Immunologicals to develop a vaccine against Zika virus, a mosquito-borne viral infection. It will also coordinate with Bengaluru-based Mynvax for a trial of a seasonal flu vaccine.
The leading clinical research organisation will carry out collaborative research on a small molecule for multiple myeloma (a type of blood cancer affecting plasma cells) with Bengaluru-based Aurigene Oncology.
ICMR has also signed a pact with Navi Mumbai-based ImmunoACT to conduct a breakthrough study of CAR-T cell therapy for a new indication of chronic lymphocytic leukemia (a type of cancer affecting the bone marrow and blood).
The ICMR network for Phase 1 clinical trials consists of four institutions strategically located across India: King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College (KEMH and SGSMC) in Mumbai, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) in Navi Mumbai, SRM Medical College Hospital and Research Centre in Kattankulathur, Tamil Nadu, and Postgraduate Institute of Medical Education and Research (PGIMER) in Chandigarh.
“These institutes will be supported by a Central Coordination Unit at the ICMR headquarters in New Delhi,” the agency said.
ICMR officials added that this network is designed to build and enhance India’s capacity to conduct early phase clinical trials, supported by robust infrastructure and dedicated manpower at each trial site, ensuring smooth and effective operations.
According to sources, ICMR will fund the costs of Phase 1 clinical trials, including costs related to conduct, investigations and monitoring of clinical trials.
Speaking about the transformative potential of the project, Dr Rajiv Bahl, Secretary, Department of Health Research (DHR) and Director General, ICMR, said the collaboration reflects our commitment to promoting clinical research in India through strategic public-private partnerships.
“Establishing an infrastructure for Phase 1 clinical trials is a key component to foster the development of indigenous molecules and cutting-edge treatments. Our vision is to further expand this network, ensuring that India continues to lead the way in developing innovative and affordable healthcare solutions,” he added.
First published: September 14, 2024 | 16:06 IS
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