ANNUAL REPORT - Department of Biotechnology

in fermenter as compared to the flask. Animal studies
have began with GLP produced VLPs with or without
APCs as per the co-development agreement with
M/s Nicolas Piramal Pvt Ltd., Mumbai. VLPs were
provided in batches to ACTREC, Mumbai for
assessing VLP induced immune response in mice
using different routes. It is expected that animal
studies would be completed soon. Work on
therapeutic aspects is also be studied at AIIMS, New
Delhi.
For developing immunological assays for assessing
the immune responses to the indigenously
developed HPV vaccine, C57BL/6 and Balb/c mice
were immunized via intra-peritoneal route to study
the lymphocyte responses to the vaccine. Studies
are in progress to analyse different immunization
schedules and analyse antigenic specific functions in
control and immunised mice.
Cohort Development by AIIMS, New Delhi is going
on. The sample size for the study on HPV vaccine
trial site preparation has been calculated to be 2000
women based on the assumption that there will be a
20% prevalence of HPV infection in the population of
married women aged 16-24 years and that 50% of
them will be positive for HPV 16/18. Govindpuri
slums have been selected as the study site where a
support services set up for examination of patients.
Enumeration process has started, a database was
created based on the enumeration forms and a list of
all the eligible women in the age group of 16-24 years
generated. Pre enrollment and enrollment forms,
consent form and information Sheet as well as food
frequency questionnaire were designed and identity
cards printed for all recruited women. Samples for
Zinc testing on serum are being stored at present. Sri
Ram Institute in Delhi University has agreed to
collaborate in processing the samples. Follow up has
been done on 76 women so far.
Cervical cancer and Toll-like receptors (TLR) and
Notch induced oncogenesis:
The study on “TLR expression profile in langerhans
and Dendritic cells in invasive cervical cancer,
cervical intraepithelial neoplasia and chronic
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cervicitis” is being carried out at KMIO, Bangalore to
assess the inherent immunity to HPV and to study the
role of t-reg cells.
Major progress had been achieved in terms of
validation of the role of Notch signaling in human
epithelial oncogenesis and defining the pathway that
may serve as therapeutic targets.
Curcumin Cancer Clinical trials: The department
has taken an initiative to start clinical trial using a
common herb, Curcumin for various cancers. As a
follow up of a brainstorming in May, 2005, proposals
were invited and funded to objectively study the effect
of curcumin in Oral pre-cancerous lesions/OSMF;
Head & Neck cancer; and cervical cancer. A herbal
TM
formulation, BASANT for clearance of early cervical
lesions associated with HPV is also being
investigated. As the bio-availability of curcumin is
poor, different formulation that have shown enhanced
bio-availability in animal models would be procured in
bulk from a vendor/drug suppliers after ensuring
quality control and physico-chemical uniformity. A
comparative bio-availability studies on different
formulation of Curcumin is being done at DIPSAR,
New Delhi. Four groups involved in the trials are :
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Pre-cancer lesions and Oral Sub mucous
Fibrosis- Co-ordinating centre - AIMS, Kochi ;
Participating centers: Tata Memorial Hospital,
Mumbai; RGCBT and RCC, Trivandrum;
AIMS, Kochi; RDCH and CDRF,Chennai
Head and neck cancer- Co-ordinating centre,
AIIMS, New Delhi and Participating centers:
AIIMS, New Delhi; HIMS, Dehradoon
Cervical cancer: Co-ordinating centre- AIIMS,
New Delhi and Participating centers: AIIMS,
New Delhi; TMC, Mumbai.
Basant for the Cervical Cancer- Early lesions
associated with HPV infection (BASANT
formulation, Co-ordinating centre - ICPO,
Noida and Participating Centers: ICPO,
Noida; TRF, New Delhi; TMC, Mumbai; CNCI,
Kolkata.
Research and Development