University of Hyderabad (UoH) in collaboration with National institute of Nutrition (NIN) and IKP Knowledge Park in Hyderabad have successfully completed pre-clinical studies for temozolomide an anti cancer drug in animal models.

During the past two years UoH, NIN and IKP Knowledge Park have formed a research collaboration to conduct clinical trials for an anticancer drug. During their trials during the past two years all the three institutes have successfully culminated and came out with positive preclinical trials for temozolomide anti cancer drug which can be used for treating brain tumor. According to scientists, the animal model studies for the drug have been quite promising and very soon they will be going for further tests on humans to find the efficacy and safety aspects of the drug.

So far, temozolomide is the only drug approved for brain tumor, known as glioblastom multiforme in scientific term. The stability of this otherwise potent chemotherapy is compromised due to degradation in storage and shelf handling, causing dark brown discoloration of the drug powder. This problem is more acute in the hot and humid tropical zone IV countries of the world, including Asia, Far East and Latin America.

The research group of Prof Ashwini Nangia at School of Chemistry, UoH developed stable pharmaceutical co-crystal of temozolomide which overcomes the discoloration problem to give a stable, improved crystalline form of the drug. Then in collaboration with the laboratory of Dr Dinesh Kumar, Scientist ‘E’ (Deputy Director) & Coordinator, Preclinical Toxicology at NIN, they tested the stable temozolomide co-crystal with the reference drug in animal models to establish bioequivalence and bioavailability and drug transport.

The temozolomide co-crystal is 100-110 per cent efficacious compared to the parent drug, the allowed range for bioequivalence being 80-120 per cent. Additionally, pharmacokinetic parameters and hematology and drug metabolism and half life for the stable temozolomide co-crystal are equal to or better than the pure drug. As a last confirmation, they showed that the active drug species is released from the stable co-crystal and was detected in rat brain tissue. In vitro data on human glioblastoma cell lines for temozolomide co-crystal carried out at Life Science Incubator in IKP are equally positive.

This collaborative project is a success story of the Knowledge-to-Equity programme of the Ministry of Science and Technology as part of which academic discoveries get a platform for drug translation to the market in PPP model.

This pre clinical research project was part-funded by Department of Biotechnology under BIPP-BIRAC scheme to Crystalin Research, a start-up R&D venture founded by Dr Nangia in 2010 at Technology Business Incubator on UOH campus.