All the nine clinical trials being conducted by the Central Drugs Research Institute (CDRI), Lucknow have shown much headway during the last one year which also witnessed the premier research organisation tying research pacts with at least five more partners on new drug discovery.
A research agreement was signed with DNDi, Geneva, for development of new chemotherapeutic agents for Human African Trypanosomiasis and another one in the area of Leishmaniasis is in the discussion stages. Ipca Laboratories, Mumbai, tied up with the institute for further development of compound 99/411, a promising synthetic substitute, developed at CDRI, as a preferable substitute to Artemisnin.
In collaboration with Ipca, toxicity studies on another anti-malarial candidate compound 97/78 were carried out and the compound was found to be safe. The phase I clinical trials of the same will be initiated soon at PGIMER, Chandigarh, sources in the CDRI said.
A collaborative agreement was signed with Duphar Interferan Limited, Mumbai, to further extend phase III clinical trials at different centres in respect of PICROLIV, a hepatoprotective agent. The institute received permission from Institutional Animal Ethics Committee and Committee on the Prevention, Control and Supervision on Experimental Animals for conducting 28 days toxicity studies, in respect of herbal medicament (for treatment of cerebral stroke) in Rhesus Monkey, in collaboration with Themis Medicare, Mumbai.
Besides extending consultation to Ranbaxy Labs to set up a facility for polypeptide synthesis at their R&D centre at Gurgaon, the CDRI during last year signed a material transfer agreement for providing pET28b CFP-10 expression vector with Indian Immunological Limited, Hyderabad for the development of diagnostic kits for tuberculosis in animals.
"A novel formulation of compound 80/574 (a hypolipidaemic) with atorvastatin, which exhibited better synergistic lipid lowering activity, continued to be of interest to Cadila Pharma. Discussions with several large pharma companies are near finalization for collaborative development of a synthetic molecule 99/373 (anti-resorptive), CDR- 134D123 (antidiabetic and antidyslipedmic), Centchroman (non-steroidal female contraceptive) and Bacopa monniera extract (memory enhancer)", according to its annual report.
The clinical studies continued on nine candidate products, which are in different phases of drug development. Drugs Controller General of India (DCGI) cleared CONSAP, a contraceptive cream of herbal origin, for human use. This product is expected to be extremely beneficial in the family planning endeavour as it has good contraceptive efficacy, product acceptability by women and is devoid of any undesirable side effects.
Multicentric clinical trials for efficacy of Arteether (blood schizonticidal) in 235 children suffering from P. falciparum malaria concluded at 5 centres and the dossier is under submission to DCGI. Safety evaluations in G6-PD deficient cases in respect of the compound 80/83 (anti-relapse antimalarial) were conducted in Thailand. It was observed that its safety profile was better than primaquine. Phase III clinical trials continued on Picroliv (hepatoprotective) and 80/574 (hypolipidemic) and the data analysis is in progress. Pharmacokinetic and metabolic studies were undertaken on seven candidate products. Bio-analytical method development and pilot PK studies were undertaken on 4 anti-thrombotic compounds during the period, the annual report said.