Venus Remedies, a leading research based pharma, has successfully completed phase I & II clinical trial for VRP1620, a cancer detection molecule. The clinical study has shown excellent results in detection of breast cancer. With this drug detection of breast cancer would be possible even with a simple X-ray using dye and the sensitivity of other detection devices such as coloured doppler, PET would be increased several times.
On the occasion Dr Manu Chaudhary, research director, said, “VRP 1620 (Tumatrek) is a unique and cost effective diagnostic tool for cancer which can also detect malignancy even through X-ray. It can detect cancer at lesser cost and at primary stage itself.” By detection of cancer at early stage it can increase the cure rate. Scientists believe that after phase III trials of this product VRP-1620 may also help in locating proliferation of cancer site. There are lots of opportunities where the usage of this product can be extrapolated for the benefit of humanity.
A team of scientists from Venus Medicines Research Centre (VMRC), R&D wing of the company, were working for past couple of years on a novel peptide VRP 1620, which is highly selective ETB receptor agonist and is involved in selective vasodilation in solid tumours. “Phase III will be completed this year only and product will be ready for market launch in early 2012,” Chaudhary added.
Venus Remedies has completed and submitted the report of phase I & II study on breast cancer patients for VRP 1620 after due permission from IND Committee and DCGI, Government of India. Phase I was conducted at the prestigious Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh to find the maximum tolerable dose. Later phase II clinical study was conducted at multiple institutions throughout India including PGIMER, Chandigarh and Central India Cancer Research Institute, Nagpur, Maharashtra.
This clinical study documented the pharmacokinetic profile and appropriate dose range for the drug. It also described the efficacy for its use as a diagnostic agent for breast cancer. The efficacy was gauged by observing increase in diameter and the corresponding change in resistive index of tumour vessel. An increase of 17.31 per cent in tumour vessel diameter was observed compared to baseline 12-15 minutes after drug administration of VRP-1620 at dose levels 0.8 µg / Kg body weight. Corresponding to this increase in tumour vessel diameter there was a decrease in RI (resistive index) 7.15 per cent. These changes indicate an increase in tumour blood perfusion causing the contrast media to deeply penetrate, creating a better tumour silhouette.
Tolerability of VRP 1620 was also assessed by the investigators and subjects at the end of study treatment period, which showed that the product is well tolerated.
From past two decades Venus Remedies Limited, has worked to discover, develop and commercialise medications to advance the care of patients suffering from life-threatening diseases in areas of met and unmet medical need. Headquartered in Panchkula, India, the company has made huge expansion and made its presence in 6 continents, operations spanning in more than 60 countries, 3 manufacturing facilities, 11 overseas offices, 1 R&D centre and competent staff of more than 1500 experts.