Immunomodulatory agents from natural products


 

Principal Investigator : Shakti N Upadhyay

Project Associates/Assistants
Raman P Yadav
Ramakrishna Hegde
Harpreet Kaur
Seema Bhatnagar
Alok Bharti
Raghvendra Rao
Nidhi Srivastava
Rashmi Singh (till Oct 2000)
Swati Bhattacharya (till Dec 2000)
Pujya Agarwal
Sunaina Kaul

Collaborators
S P Bajaj, Safdarjung Hospital, New Delhi
M Furmanova, Warsaw Med Acad, Poland
Akhilesh Tyagi, Delhi Univ, New Delhi

Immunomodulatory therapy, which relates to stimulation or suppression of immune response of the host, is now being recognized as an alternative to conventional chemotherapy for a variety of diseased conditions, especially when host’s defense mechanisms have to be activated under the conditions of impaired immune responsiveness or when a selective immunosuppression has to be induced in situations like auto-immune disorders, allergic reactions and organ transplantation. Since natural products, especially the plants used in the Indian traditional medicine, are the potential source of such immunomodulatory compounds, this project aims at evaluating the compounds isolated from such plants for both immunopotentiating and immunosuppressive activity with a view to developing leads for new therapeutic products.

In order to develop new therapeutic strategy, the work is being carried out to identify plant derived molecules that i) inhibit the expression of LPL by macrophages, ii) inhibit the LPL enzyme activity, iii) inhibit expression of ICAM-1 on the endothelial surface, and iv) inhibit pancreatic lipase activity. The project aims at i) identification and isolation of immunopotentiating compounds from natural products based on their stimulatory effect on the macrophage effector functions and ability to induce Th 1/Th2 response, ii) identification and isolation of anti-inflammatory/immunosuppressive/anti-atherosclerotic compounds from natural products based on their inhibitory effect on the enzymes involved in the signal transduction of immunological/inflammatory stimuli, and iii) evaluation of the therapeutic potential of the immunomodulatory molecules using appropriate animal models.

NII-60

As mentioned last year, technical information and commercial rights related to NII-60 were transferred to Gufic Biosciences Limited, Mumbai, who have filed an application with the Drug Controller of India to initiate clinical trials for prevention of septic shock in burn patients. In the mean time, a collaborative work was initiated with the Safdarjung Hospital, New Delhi to carry out evaluation of immunological status of burn patients. Following ethical clearance obtained from appropriate hospital authorities, blood samples were collected from burn patients immediately upon arrival at the burn emergency unit and subsequent blood samples were collected on alternate days, till discharge or survival of the patients. Serum samples were analyzed for various immunological markers, including cytokines and proliferative response of peripheral blood leukocytes to PHA, LPS, tetanus toxoid and PPD. The result on some of the parameters showed interesting correlation or distinction between survivor and non-survivors. While IL-6, IL-10 levels were higher in survivors, TGF-b was found to be higher in non-survivors. Similarly, proliferative response of peripheral lymphocytes gradually increased in survivors on subsequent days, it remained low in non-survivors. These parameters will be considered during the clinical trials with NII-60.

NII-60 was further evaluated for LPS binding/neutralization property. NII-60 interacted with different types of LPS obtained from E.coli, Shigella flexneri, Pseudomonas aeruginosa and Salmonella typhimurium with same intensity. This data suggests that NII-60 binds to a common interaction centre present in all types of LPS, most likely the phosphorylated anionic lipid A moiety. The interaction of NII-60 was quantitatively assayed by fluorescent method. The interaction of NII-60 with LPS was established as ionic, as the relative binding intensity decreased from 100% to 32.20 % in Polymyxin B displacement reaction at equimolar concentration. Though this interaction was established at all pH, the maximum binding was observed at pH 7.2 indicating its potential as LPS antagonist at physiological pH. The neutralizing effect of NII-60 was further demonstrated in Limulus gelation assay. To confirm the interaction of NII-60 with LPS in intact microorganisms, the lysozyme mediated outer membrane permeabilization was evaluated in E.coli and compared with known cationic membrane permeabilizer polymyxin B at same concentration. Interestingly NII-60 was also found to enhance the lysozyme mediated membrane permealization in E.coli, like polymyxin-B.

NII-18

A water-soluble salt of NII-18 has been prepared which retained the biological activity. The inhibitory effect of this purified NII-18 was also investigated against lipoprotein lipase and was found to be reversible which follows the competitive inhibition kinetics pattern at IC50 1mM. Inhibition of NII-18 was observed at alkaline pH whereas there is no effect or only slight inhibitory effect at acidic pH. Ligands such as Mg++, Ca++, Cu++ reversed the inhibitory effect of NII-18, whereas Zn+ and glucose maintained the inhibitory effect of NII-18 on lipoprotein lipase. Interestingly high glucose concentration (10mM) sustains and increases the inhibitory effect of NII-18 for longer time.

Edible vaccine: expression of antigenic determinants of Vibrio cholerae in tobacco or tomato and evaluation of their immunological potential

The aim of this study was to express cholera toxin B subunit (ctxB) in tomato and tobacco and to determine its immunologic potential. In this collaborative project, the construction of ctxB gene is being carried out by CBT, Delhi and IMTECH, Chandigarh, and expression of the antigens in plants is being carried out at the University of Delhi, South Campus; immunological studies are being done at NII.

Initial experiments were carried out to check whether CT-4A is immunogenic or not by intra-dermal immunizations. CT-4A immunized animals showed significantly higher cholera toxin specific IgG in their serum as compared to those immunized with untransformed plant from the 2nd bleed onwards. Cholera toxin B was used as the positive control. However it showed the presence of CT-specific IgG from the 1st bleed onwards only.

T cell proliferation studies were carried out in these same groups of animals. The group immunized with untransformed tobacco leaf extract showed normal proliferation to Con-A, LPS and anti-CD3. However, animals immunized with CT-4A and CTB showed selective suppression of T cells in Con-A and anti-CD3 treated cells. The activity of LPS stimulated cells were similar in all three groups of animals.

Cytokine analysis was done on the supernatants generated by the in vitro stimulation of the splenocytes isolated from these different groups of animals. The cytokines that were studied are IL-10, IL-12 and TNF-a. Cholera toxin induced IL-10 production. However the amount produced was significantly higher in CT-4A and CTB immunized groups. Addition of Con-A and anti-CD3 reduced this amount. However LPS failed to show any suppressive or synergistic action on the cytokine production levels. IL-12 and TNF-a production was suppressed in CT-4A and CTB immunized groups and addition of in vitro cholera toxin in the culture suppressed it even further. When the experiment was repeated this trend was maintained.

Mice were orally immunized with the same antigen. Then these groups of mice were divided into 2 groups. In group (i) peyers patches were taken out and stimulated in vitro with cholera toxin, and in group (ii) these animals were given cholera holotoxin orally and were sacrificed after 24 hours. In these animals also studies were done in peyer’s patches. Unstimulated cells were used as control. The studies included estimation of CT-specific IgA and cytokine levels in the culture supernatants. The experiments shows that only in CTB immunized group there was a significant enhancement in the level of CT-specific IgA following oral challenge. However the CT-4A immunized animals failed to induce significant CT-specific IgA following either in vitro or oral challenge. The IL-10 also showed similar profile, whereas IL-12 and TNF-a levels were very low.

Publications

Original peer-reviewed articles

1.   Furmanova M, Gajdzis-Kuls D, Ruszowska J, Czamocki Z, Obidoska G, Sadowska A, Rekha Rani and Upadhyay SN (2001) In vitro propagation of Withania somnifera and isolation of withanolides with immunosuppressive activity. Planta Medica (in press).

2.   Yadav RP and Upadhyay SN (2001) Environmental CO2 inversely regulates lipase-phospholipase production by Aspergillous species. Ind J Microbiol (in press).

3.   Agarwal Pujya, Yadav RP and Upadhyay SN (2001) Growth medium for differentiation of pathogenic from non-pathogenic aspergilli. J Med Microbiol (in press).

Reviews/Proceedings

1.     Yadav RP, Agarwal Pujya and Upadhyay SN (2001) Microbial lipases: Tool for drug discovery. J Sci Indus Res 59:977-987.

Patents

1.   Upadhyay SN, Wali N and Sarma DNK (2000) A novel process for the preparation of mangiferin. and a composition used for the prevention/treatment of parasitic diseases. Indian patent # 183,778 granted in Apr 2000.

2.   Upadhyay SN, Sarma DNK, Saraswathi NK, Wali N, Dhawan S and Yadav RP (2000) A novel process for isolation of berberine from berberine containing plant material. Indian patent # 184,685 granted in Sep 2000.

3.   Upadhyay SN, Sarma DNK, Wali N, Saraswathi NK and Dhawan S (2000) Method for suppressing allogenic immune response for prevention/treatment of graft-vs-host disease or graft rejection. US patent application # 08/789,464 granted in Oct 2000.

4.   Upadhyay SN and Madan V (2001) Method for ex vivo expansion of hematopoietic cells. US patent application # 09/339,759 granted in Mar 2001.