Venus Remedies Limited has received approval from Drugs Controller General of India (DCGI) to conduct phase-III clinical trials of its cancer detection NCE (New Chemical Entity). After screening by IND committee for the investigational NCE VRP1620, DCGI has found clinical phase-I and phase II data satisfactory and consented for phase-III trials.
Dr Manu Chaudhary, director research, Venus Medicine Research Centre (VMRC) said that the 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 utilized to promote delivery of cancer detection contrast media to the site of tumours via blood stream.
It is a targeted delivery of diagnostic agent which enhances image quality to several 100 times allowing to differentiate a benign and malignant tumour and trace small sized ones. Currently, there is no technology for early detection of small sized solid tumour available globally and VRP1620 can help to stage tumours besides omitting false negatives, she added.
The company presented positive results of the investigational NCE, VRP1620 after completion of two pivotal phase I & II studies.
Considering this, the diagnostic use of VRP 1620 in detecting breast cancers better in routine X ray or screen film mammography is being explored in phase III study. A total of 220 subjects will be recruited at seven to eight centres spread across different zones of India. The company is about to start phase III clinical trial of this molecule as per International standards and GCP guidelines, said Dr Mufti Suhail Sayeed, sr vice president, VMRC.
Phase I study was completed successfully at the Postgraduate Institute of Medical Sciences (PGIMER), Chandigarh to find maximum tolerable dose levels in breast cancer in 2010. Later, in April 2011, after DCGI approval phase II study was conducted at multiple institutions including PGIMER, Chandigarh and Central India Cancer Research Institute, Nagpur, to establish the pharmacokinetic profile and preliminary efficacy. “Late stage diagnosis of breast cancer and solid tumours result in poor survival indices. Now VRP-1620 will let breast cancer patient to receive better therapeutic benefits,” said Dr Ajay Mehta, director, Central India Cancer Research Institute.
“The company would launch this NCE by last quarter of 2013 in India for the first time globally. This is our first-ever success in phase I and II and we look forward to meeting the otherwise unmet market need,” said Pawan Chaudhary, chairman and managing director, Venus Remedies Limited.