Monday, May 23, 2011

Venus Remedies completes phase I & II trials of cancer molecule

 

Venus Remedies recently announced that it has successfully completed phase I and II clinical trials for VRP1620, Tumatrek, which could become a cost effective diagnostic tool for cancer. The clinical study has shown excellent results in detection of breast cancer. With this molecule, detection of breast cancer would be possible with a simple X-ray using dye and the sensitivity of other detection devices such as coloured doppler, PET would be increased several times.

Dr Manu Chaudhary, Research Director, Venus Remedies 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 a lower cost and at the primary stage itself.” Detection of cancer in the early stage can increase the cure rate and scientists believe that after phase III trials of this product VRP-1620 may also help in locating proliferation of cancer sites.

For the past few years, a team of scientists from Venus Medicines Research Center (VMRC), the R&D wing of the company, were working on a novel peptide VRP 1620, which is a highly selective ETB receptor agonist and is involved in selective vasodilation in solid tumours. “Phase III will be completed this year and the product will be ready for market launch in early 2012,” Chaudhary added.

Venus Remedies has completed and submitted the report of phase I and II study on breast cancer patients for VRP 1620 after due permission from the IND committee and DCGI, Government of India. Phase I was conducted at 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.

Cancer prevalence in India is estimated to be around 2.5 million, with over 8,00,000 new cases and 5,50,000 deaths occurring each year due to this disease. More than 70 per cent of the cases report for diagnostic and treatment services in the advanced stages of the disease, which has lead to a poor survival and high mortality rate. The product has huge potential in urban and semi urban belts where advanced technologies of cancer detection are not available. This technology will provide a cutting edge in timely detection of cancer and has tremendous need especially in under developed and developing countries.

The global cancer market was worth $56.7 billion in 2007, growing at 16.8 per cent over 2006, and is forecast to reach a value of $76.9 bn by 2013 representing a CAGR of 5.1per cent (2007-13). Oncology is one of the leading therapeutic categories in the global pharma market. The Indian oncology market is estimated to be about Rs 7,000 to 8,000 million, growing at a CAGR of more than 30 per cent in the last three years. The economic toll from cancer, estimated to be $895 billion, is nearly 20 per cent higher than heart disease, the second leading cause of economic loss ($753 billion).

 

Source: ExpressPharma

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