By a News Reporter-Staff News Editor at Health & Medicine Week -- Researchers detail new data in DNA Research. According to news reporting from Hyderabad, India, by NewsRx journalists, research stated, "Pre-clinical toxicology evaluation of biotechnology products is a challenge to the toxicologist. The present investigation is an attempt to evaluate the safety profile of the first indigenously developed recombinant DNA anti-rabies vaccine [DRV (100 ?g)] and combination rabies vaccine [CRV (100 ?g DRV and 1.25 IU of cell culture-derived inactivated rabies virus vaccine)], which are intended for clinical use by intramuscular route in Rhesus monkeys."
The news correspondents obtained a quote from the research from the National Institute of Nutrition, "As per the regulatory requirements, the study was designed for acute (single dose -14 days), sub-chronic (repeat dose -28 days) and chronic (intended clinical dose -120 days) toxicity tests using three dose levels, viz. therapeutic, average (2x therapeutic dose) and highest dose (10 x therapeutic dose) exposure in monkeys. The selection of the model i.e. monkey was based on affinity and rapid higher antibody response during the efficacy studies. An attempt was made to evaluate all parameters which included physical, physiological, clinical, haematological and histopathological profiles of all target organs, as well as Tiers I, II, III immunotoxicity parameters. In acute toxicity there was no mortality in spite of exposing the monkeys to 10XDRV. In sub chronic and chronic toxicity studies there were no abnormalities in physical, physiological, neurological, clinical parameters, after administration of test compound in intended and 10 times of clinical dosage schedule of DRV and CRV under the experimental conditions. Clinical chemistry, haematology, organ weights and histopathology studies were essentially unremarkable except the presence of residual DNA in femtogram level at site of injection in animal which received 10X DRV in chronic toxicity study. No Observational Adverse Effects Level (NOAEL) of DRV is 1000 ug/dose (10 times of therapeutic dose) if administered on 0, 4, 7, 14, 28 th day."
According to the news reporters, the research concluded: "The information generated by this study not only draws attention to the need for national and international regulatory agencies in formulating guidelines for pre-clinical safety evaluation of biotech products but also facilitates the development of biopharmaceuticals as safe potential therapeutic agents."
For more information on this research see: Pre-clinical toxicity & immunobiological evaluation of DNA rabies vaccine & combination rabies vaccine in rhesus monkeys (Macaca mulatta). The Indian Journal of Medical Research, 2013;137(6):1072-88. The Indian Journal of Medical Research can be contacted at: Indian Council Medical RES, PO Box 4911 Ansari Nagar, New Delhi 110029, India (see also DNA Research).
Our news journalists report that additional information may be obtained by contacting B.D. Kumar, National Institute of Nutrition (ICMR), Hyderabad, India. Additional authors for this research include P.U. Kumar, T.P. Krishna, S. Kalyanasundaram, P. Suresh, V. Jagadeesan, S. Hariharan, A.N. Naidu, K. Krishnaswamy, P.N. Rangarajan, V.A. Srinivasan, G.S. Reddy and B. Sesikeran.
Publisher contact information for the The Indian Journal of Medical Research is: Indian Council Medical RES, PO Box 4911 Ansari Nagar, New Delhi 110029, India.
Keywords for this news article include: Asia, India, Hyderabad, Viral DNA, DNA Research.
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