Pharma major Venus Remedies Ltd today said that it has got an approval from the Drugs Controller General of India (DCGI) to conduct Phase-III clinical trials of its cancer detection New Chemical Entity (NCE) which will involve an investment of $1 million.
The company intends to roll out the NCE by the last quarter of 2013 in domestic and global markets.
“After thorough screening by the IND committee for the investigational New Chemical Entity VRP1620, DCGI has found clinical Phase-I and Phase II data satisfactory and thus granted permission to conduct Phase-III clinical trials on the molecule which is for early cancer detection,” the company said in a statement.
“This NCE is based on selective tumour targeting because tumour-infiltrating blood vessels deviate morphologically and biochemically from normal vessels. VRP1620 specifically increases tumour blood flow and this property has been utilised to promote the delivery of cancer detection contrast media to the site of tumours via blood stream,” said Manu Chaudhary, Director Research, Venus Medicine Research Centre, which is a part of Venus Remedies.
“We can also differentiate between benign and malignant tumour because of its property to enhance the image quality and very small-sized tumours can also be traced,” she said while claiming that as of now, there is no such technology for early detection of small-sized solid tumours available in the market across the globe.
Chaudhary said in Phase-III (of clinical trials), $one million will be spent. About the cost of the diagnostic kit, the company claimed that the product would be affordable to common man.
“It is difficult to judge the exact cost-effectiveness as no competitive therapy is there but definitely keeping in view the benefits of removing false positives, late detections and staging of cancer, it will be quite economical,” she said.