For Medical Professionals

1. Major (Ongoing) research projects

 Project TitleFunding sourceDate commenced
As PI
(Investigator generated)
Pharmacogenetic study of commonly used anti-cancer drugs: implication of ADME gene polymorphisms in the treatment of Indian cancer patientsICMR8th Feb, 2017
Development of new cancer chemotherapeuticsBARC3rd October, 2016
To assess in vivo toxicity of Ayurvedic formulations to be used as adjunct treatment for A) Triple Negative Breast Cancer patients and B) BRCA 1/2 positive Breast cancer patientsIntegrated Cancer Treatment & Research Centre, Wagholi, Pune11th April, 2016
To study the utility of Therapeutic drug monitoring of Sunitinib in Patients of metastatic Renal Cell CarcinomaIntramural23rd July 2015
Modulation of late lung tissue response of pneumonitis and/or fibrosis in mice folowing throsic irradiation by the oral supplimenation with 3’-3’ diselenodipropionic acid (DSePA)BARC23rd April, 2015
An open label, non-randomized, single dose, parallel, bioequivalence study of two formulations of Erlotinib (Innovator - Tarceva and generic - Tyrokinin) or Gefitinib (Innovator - Iressa and generic - Xefta) in adult non-small cell lung cancer (NSCLC) patients with non-squamous histology, who have undergone atleast one previous chemotherapyIndustry supported02nd Feb 2015
To study the radioprotective effects of a lectin in normal tissues and tumor cells and its mechanism of action using athymic nude mice, SCID mice and Nrf2 knockout miceBARC19th December, 2014
CSF Distribution of High Dose Versus Standard dose Geftinib and Erlotinib in lung cancer patients with brain metastasesIntramuralMay 29, 2014
Targeting deacetylases and methyltransferases to improve outcomes after allogeneic bone marrow transplantation in chemo-conditioning based murine model of acute graft versus host diseaseIntramural and DBT14 March, 2014
Population pharmacokinetics and pharmacogenetics study of 6-mercaptopurine in adult patients with acute lymphoblastic leukemiaTerry fox Foundation2 Nov, 2012
As Co-PI / Co-IDevelopment of a mathematical model to predict the occurrence of recurrent grade 2 or grade 3 Hand Foot Skin Reaction requiring dose modification in patients with either metastatic Renal Cell Carcinoma or unresectable Hepato Cellular Carcinoma receiving standard dose of Sorafenib.Terry fox foundationJanuary 27, 2016
A Prospective, open label, non randomized, cohort study of Paclitaxel pharmacokinetics in women with different Body Mass Index undergoing chemotherapy for breast and ovarian cancerIntramuralJanuary 02, 2014
(Completed this year)
Tobacco related biomarkers in head and neck squamous cell carcinomaUniversity of MinnesotaJuly 4, 2013
Development of prophylactic and therapeutic radioprotective treatment regimen for hematopoietic injury using chlorophyllin

Board of Research in Nuclear Sciences (BRNS)Dec 2011
Bioactivity Studies of Metallic Nanoparticles.Office of Principal Scientific Advisor to the Govt. of India.May 2011
A prospective, open label, randomized, active control, parallel design, comparative pharmacokinetics study of intramuscular pegaspargase (Hamsyl®) of Gennova Biopharmaceuticals Ltd versus intramuscular Oncaspar® in pediatric patients with relapsed cases of Acute Lymphoblastic Leukemia (ALL)Study code- EM-002’Gennova Biopharmaceuticals Ltd26th January 2016
Protocol No. RLS/0314/020- A two stage, randomized, multicentric, open label, multiple dose, two-treatment, two sequence, two-period, crossover, steady state bioequivalence study of test Nilutamide 150 Mg tablets (from EirGen Pharma Ltd.,Ireland) with reference Nilandron 150 mg tablets of Sanofiaventis U.S. LLC in prostate cancer patients under fasting condition.Reliance Life Sciences28th August 2015
(Completed this year)
A Phase I Clinical Study to evaluate the safety, pharmacokinetics and anti-tumor activity of NRC- 2694-A in patients with advanced Solid Malignancies.Natco Pharma05 Feb, 2014

2) Publications in last 4 years
a) Pubmed Publications

Sl. No.AuthorsTitleJournal/Vol./Page/Year
2016-17
1.Anupama S, Laha P, Sharma M, Pathak K, Bane S, Ingle AD, Gota V, Kalraiya RD, Yu LG, Rhodes JM, Swamy BM, Inamdar SR.Pharmacokinetics, biodistribution and antitumour effects of Sclerotium rolfsii lectin in mice.Oncol Rep. 2017 Apr 3. doi: 10.3892/or.2017.5545.
2.Kavathiya K, Gurjar M, Patil A, Naik M, Noronha V, Joshi A, Gota V, Prabhash K. (Corresponding author – Gota V)A Comparative Pharmacokinetic Study of 2 Pemetrexed Formulations in Indian Adult Chemonaive Patients With Adenocarcinoma Stage III/IV Non-Small Cell Lung Cancer.Clin Pharmacol Drug Dev. 2017 Mar 29. doi: 10.1002/cpdd.347.
3.Khariwala SS, Garg A, Stepanov I, Gupta PC, Ahluwalia JS, Gota V, Chaturvedi P.Point-of-Sale Tobacco Advertising Remains Prominent in Mumbai, India.Tob Regul Sci. 2016 Jul;2(3):230-238.
4.Kulkarni P, Karanam A, Gurjar M, Dhoble S, Naik AB, Vidhun BH, Gota V. (Corresponding author – Gota V)Effect of various anticoagulants on the bioanalysis of drugs in rat blood: implication for pharmacokinetic studies of anticancer drugs.Springerplus. 2016 Dec 20;5(1):2102.
5.Pantziarka P, Hutchinson L, André N, Benzekry S, Bertolini F, Bhattacharjee A, Chiplunkar S, Duda DG, Gota V, Gupta S, Joshi A, Kannan S, Kerbel R, Kieran M, Palazzo A, Parikh A, Pasquier E, Patil V, Prabhash K, Shaked Y, Sholler GS, Sterba J, Waxman DJ, Banavali S.Next generation metronomic chemotherapy-report from the Fifth Biennial International Metronomic and Anti-angiogenic Therapy Meeting, 6-8 May 2016, Mumbai.Ecancermedicalscience. 2016 Nov 2;10:689. eCollection 2016.
6.GuhaSarkar S, Pathak K, Sudhalkar N, More P, Goda JS, Gota V, Banerjee R.Synergistic locoregional chemoradiotherapy using a composite liposome-in-gel system as an injectable drug depot.Int J Nanomedicine. 2016 Dec 1;11:6435-6448. eCollection 2016.
7.Kameswaran M, Gota V, Ambade R, Gupta S, Dash A.Preparation and preclinical evaluation of 131 I-trastuzumab for breast cancer.J Labelled Comp Radiopharm. 2017 Jan;60(1):12-19.
8.Gota V, Chinnaswamy G, Vora T, Rath S, Yadav A, Gurjar M, Veal G, Kurkure P. (Corresponding author – Gota V)Pharmacokinetics and pharmacogenetics of 13-cis retinoic acid in Indian high-risk neuroblastoma patients.Cancer Chemother Pharmacol. 2016 Oct;78(4):763-8.
9.Chavare A, Chowdari P, Ghosh S, Pawar P, Patkar M, Dakave S, Gota V, Chaudhari P, Chiplunkar SV, Kane S, Suresh AK, Bellare J.Safety and bioactivity studies of Jasad Bhasma and its in-process intermediate in Swiss mice.J Ethnopharmacol. 2017 Feb 2;197:73-86.
10.Gota V, Karanam A, Rath S, Yadav A, Tembhare P, Subramanian P, Sengar M, Nair R, Menon H. (Corresponding author – Gota V)Population pharmacokinetics of Reditux™, a biosimilar Rituximab, in diffuse large B-cell lymphoma.Cancer Chemother Pharmacol. 2016 Aug;78(2):353-9.
11.Joshi H, Marulkar K, Gota V, Ramaa CS.Hydroxy Cinnamic Acid Derivatives as Partial PPARγ agonists: In Silico Studies, Synthesis and Biological Characterization Against Chronic Myeloid Leukemia Cell Line (K562).Anticancer Agents Med Chem. 2016 Jun 6. [Epub ahead of print]
12.Patere SN, Pathak PO, Kumar Shukla A, Singh RK, Kumar Dubey V, Mehta MJ, Patil AG, Gota V, Nagarsenker MS.Surface-Modified Liposomal Formulation of Amphotericin B: In vitro Evaluation of Potential Against Visceral Leishmaniasis.AAPS PharmSciTech. 2017 Apr;18(3):710-720.
2015-16
13.Goda JS, Pachpor T, Basu T, Chopra S, Gota VTargeting the AKT pathway: Repositioning HIV protease inhibitors as radiosensitizers.Indian J Med Res. 2016 Feb;143:145-59.

14.S Gulia, V Gota, Sangita D Kumar, Sudeep GuptaAcute renal failure secondary to ingestion of alternative medication in a patient with breast cancer.J Cancer Res Ther. 2015 Oct-Dec;11(4):1006-8.
15.Gota V, Divatia JV.Off-label use of drugs: An evil or a necessity?Indian J Anaesth. 2015 Nov;59(11):767-68.
16.Gota V, Goda JS, Doshi K, Patil A, Sunderajan S, Kumar K, Varne M, Kunwar A, Jain VK, Priyadarshini I.Biodistribution and Pharmacokinetic Study of 3,3' Diseleno Dipropionic Acid (DSePA), A Synthetic Radioprotector, in Mice.Eur J Drug Metab Pharmacokinet. 2015 Oct 7.
17.Gambhir L, Checker R, Sharma D, Thoh M, Patil A, Degani M, Gota V, Sandur SK.Thiol dependent NF-κB suppression and inhibition of T-cell mediated adaptive immune responses by a naturally occurring steroidal lactone Withaferin A.Toxicol Appl Pharmacol. 2015 Dec 1;289(2):297-312.
18.Kameswaran M, Pandey U, Dhakan C, Pathak K, Gota V, Vimalnath KV, Dash A, Samuel G.Synthesis and Preclinical Evaluation of 177Lu-CHX-A"-DTPA-Rituximab as a Radioimmunotherapeutic Agent for Non-Hodgkin's Lymphoma.Cancer Biother Radiopharm. 2015 Jun 11.
19.Suryavanshi S, Sharma D, Checker R, Thoh M, Gota V, Sandur SK, Sainis KB.Amelioration of radiation-induced hematopoietic syndrome by an antioxidant chlorophyllin through increased stem cell activity and modulation of hematopoiesis.Free Radic Biol Med. 2015 Apr 11;85:56-70
2014-15
20.Gota VS, Patial P.Toward better quality of anticancer generics in India.Indian J Cancer. 2014 July-September;51(3):366-368.
21.Nagraj J, Chatterjee S, Pal T, Sakpal AS, Gota V, Ramaa CS, Ray P.A novel series of di-fluorinated propanedione derivatives synergistically augment paclitaxel mediated caspase 3 activation in ovarian cancer cells.J Cancer Res Ther. 2014 Jul-Sep;10(3):701-9.
22.Patel K, Patil A, Mehta M, Gota V, Vavia POral delivery of paclitaxel nanocrystal (PNC) with a dual Pgp-CYP3A4 inhibitor: preparation, characterization and antitumor activity.Int J Pharm. 2014 Sep 10;472(1-2):214-23.
23.Gota V, Kavathiya K, Doshi K, Gurjar M, Damodaran SE, Noronha V, Joshi A, Prabhash K.High plasma exposure to pemetrexed leads to severe hyponatremia in patients with advanced non small cell lung cancer receiving pemetrexed-platinum doublet chemotherapy.Cancer Manag Res. 2014 Jun 4;6:261-5.
24.Gota V, Patial P.Towards Better Quality of Anticancer Generics in India.Indian J Cancer. 2014 July-September;51(3):366-368.
2013-14
25.Arora B, Gota V, Menon H, Sengar M, Nair R, Patial P, Banavali SD.Therapeutic drug monitoring for imatinib: Current status and Indian experience.Indian J Med Paediatr Oncol. 2013 Jul;34(3):224-8.
26.Patel K, Patil A, Mehta M, Gota V, Vavia P.Medium chain triglyceride (MCT) rich, paclitaxel loaded self nanoemulsifying preconcentrate (PSNP): a safe and efficacious alternative to Taxol.J Biomed Nanotechnol. 2013 Dec;9(12):1996-2006.

b) Non Pubmed Publications

AuthorsTitleJournal/Book./Page/Year
P Gota, A Adegoke, M. Gurjar, S Singh, M. Nandave, L. Hingorani and V GotaComparison of the metabolic stability of Solid Lipid Boswellia Serrata Particles versus plain Boswellia Serrata Extract in human hepatocytes (hhl-17)IJPCBS 2016, 6(1), 22-27
Rath S, Nathani A, Patel D, Kulkarni P, Gota VStatus of technology transfer in India – the much needed magic remedyCurrent Science. 2014;106(8):1058-60.
Book Chapter
Jayant Goda & Vikram GotaClinical perspectives of nanotechnology in cancer management: Cancer imaging and therapy.

In: Nanotechnology: Diagnosis and treatment of cancers. Chapter # 13, Pp 253-68. Narosa Publishing House 2012

3) Drug development 

The department is involved with various groups for drug development. The following drugs are being development.

Name of the drugIndication CollaoratorStatus/contribution
Diselenopropionic acid (DSePA)RadioprotectorBARCDose ranging efficacy study is completed in mouse model of radiation pneumonitis. Evaluation of tumor protection in xenograft models is underway.
Paclitaxel loaded – Liposome-in-gel (injectable in-situ drug depot)RadiosensitizerProf. Rinti Banerjee, IIT-BPreclinical PK, tumor distribution, toxicity and efficacy studies done. Manuscript published. Patent to be filed.
Withaferin-AGVHD prophylaxis-GVHD model developed successfully. Preliminary pharmacology studies demonstrate withaferin’s ability to modulate immune system. Mechanistic studies are underway.

4) Quality of generics

Two important studies were conducted and published related to quality of generics and biosimilars demonstrating comparable pharmacokinetics of generic pemetrexed with Alimta (Refer publication # 2) and a biosimilar rituximab with MabThera (Refer publication # 10). These studies firmly established the quality of selected Indian generics and their interchangeability with the innovators. This is an important area of research because it instills confidence in the generic brands among oncologists leading to substantial cost saving and reduction in out-of-pocket expenditure for the patients. At the same time it was also demonstrated that some of the generic brands of L-asparaginase and peg-asparaginase are inferior to the innovators (unpublished data) and cannot be used interchangeably. The data was submitted to the Department of Medical Oncology who in turn has urged the generic manufacturers to improve the quality of their products. Based on these findings, I have also proposed a study to evaluate the quality of generic formulations of selected drugs which are part of the essential drug list in oncology.