Venus gets Phase III nod for cancer detection NCE
Venus Remedies Limited, an Indian multinational research based progressive pharma company, announced that it has received approval from Drugs Controller General, India (DCGI) to conduct Phase-III Clinical Trials of its cancer detection NCE (New Chemical Entity).
After thorough screening by 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.
The molecule is for early cancer detection and this leap towards successful Phase III will make Venus pioneers among the companies working and providing innovative solution for cancer detection.
Dr Manu Chaudhary, Director Research, Venus Medicine Research Centre (VMRC), said, "This NCE is based on selective tumor targeting because tumor-infiltrating blood vessels deviate morphologically and biochemically from normal vessels.
"VRP1620 specifically increases tumor blood flow and this property has been utilized to promote delivery of cancer detection contrast media to the site of tumors via blood stream.''
It is a targeted delivery of diagnostic agent which enhances image quality to several 100 times, thus making it clearly differentiated.
"We can also differentiate between benign and malignant tumor because of its property to enhance image quality and very small sized tumors can also be traced.
"As of now, there is no such technology for early detection of small sized solid tumor available in the market across the globe and secondly, VRP1620 will help us in staging of tumors. Our technology omits false negatives," she said.
Venus presented positive results of the investigational NCE, VRP1620 after completion of meticulously planned, managed, executed and analyzed two pivotal Phase I and II Clinical Trials.
An increase of 17.31pc in tumor vessel diameter was reported compared to baseline, 12-15 minutes after drug administration of VRP-1620 at dose levels 0.8 and #956;g / Kg body weight.
Corresponding to this increase in tumor vessel diameter, there was a decrease in RI (resistive index) 7.15pc . These changes indicate an increase in tumor blood perfusion causing the contrast media to deeply penetrate, creating a better tumor silhouette.
Adding to this, Dr Mufti Suhail Sayeed, Sr Vice President, VMRC, informed that previous studies have well established that VRP 1620 a highly selective ETB receptor agonist enhances breast tumor perfusion.
Combination of ETB receptor agonist VRP 1620 with standard chemo/radio-therapeutic agent significantly increases their effectiveness in selective tumor targeting.
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 7-8 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.
Venus Remedies had successfully completed Phase I study at Postgraduate Institute of Medical Sciences (PGIMER) Chandigarh conducted to find maximum tolerable dose levels in breast cancer patients in third quarter of 2010.
Later, in April 2011, after DCGI approval Phase II study of this molecule was conducted at multiple institutions throughout India including PGIMER, Chandigarh and Central India Cancer Research Institute, Nagpur, Maharashtra to establish the pharmacokinetic profile and preliminary efficacy of the drug.
"Late stage diagnosis of breast cancer and solid tumors in general are a major cause of decreasing survival indices in our country. A diagnostic product like VRP-1620 will surely go a long way in putting breast cancer patient ahead in time to receive better therapeutic benefits. I shall be looking forward to this novel drug performing in clinical practice," said Dr. Ajay Mehta, Director, Central India Cancer Research Institute.
In a recent report, the World Health Organisation (WHO) has warned that there will be a cancer patient in each household in India by 2020.
In India, the number of people suffering from cancer is expected to increase to 40 lakh by 2020, and the number of people dying of it each year is expected to rise to 11.5 lakh.
In more than 70pc of the cases cancer is not diagnosed at the advanced stages of the disease, which leads to a poor survival and high mortality rate.
This NCE has huge potential and will provide a cutting edge in timely detection of cancer and has tremendous need specially in under developed and developing countries.
"This technology can offer new ray of hope for early detection of breast cancer," said Dr Shyam Aggarwal, Medical Oncologist, Sir Gangaram Hospital, Delhi.
Venus is planning to launch this NCE by last quarter of 2013 in India for the first time globally.
"We are excited about this NCE molecule, as 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.
The global cancer market was worth USD 56.7billion in 2007, growing at 16.8 per cent over 2006, and is forecast to reach a value of USD 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 pharmaceutical market with a total global annual market for next generation cancer diagnostics of USD 776 million in 2010, and is growing at a compound annual growth rate (CAGR) of 47pc , to reach a forecast market size of USD 5.3 billion in 2015.