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Venus Remedies completes Phase I & II clinical trials of Tumatrek (VRP1620)

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Announcement Corporate
Last Updated : Jan 20 2013 | 2:02 AM IST

Tumatrek, a unique and cost effective diagnostic tool for cancer can also detect malignancy even through a simple X-ray

Venus Remedies Limited, a leading research based pharma MNC 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 of the company told, “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 Center (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 tumors. “Phase III will be completed this year only and product will be ready for market launch in early 2012.” Dr. 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, Govt. 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 tumor vessel. An increase of 17.31 per cent in tumor vessel diameter was observed compared to baseline 12-15 minutes after drug administration of VRP-1620 at dose levels 0.8 ?g / Kg body weight. Corresponding to this increase in tumor vessel diameter there was a decrease in RI (resistive index) 7.15 per cent. These changes indicate an increase in tumor blood perfusion causing the contrast media to deeply penetrate, creating a better tumor 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.

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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. 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 specially in under developed and developing countries.

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 center and competent staff of more than 1500 experts.

The global cancer market was worth $56.7billion 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 pharmaceutical market. The Indian Oncology Market is estimated to be about Rs 7,000 to 8,000 million. It has been indicated that the oncology market in India has been 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 dollars, is nearly 20 per cent higher than heart disease, the second leading cause of economic loss ($753 billion).

Oncology is prime area of focus in research, manufacturing and marketing others being Cephalosporins, Carbapenems, Cardiovascular, Pre-Filled Syringes and other specialty injectables.

About Venus Remedies Ltd.:
Venus Remedies Ltd is research and development driven pharmaceutical manufacturing company. Among the top 50 Indian Pharma companies of India, the company has outpaced most Indian pharmaceutical companies in its growth and value creation over the past few years.

Driven by a top class team of managers and motivators this organization is counted as one of the most professional companies of India and a preferred place for top innovators and managers to join the bandwagon of the globally significant Indian Pharma industry.

Venus Remedies Ltd is BSE & NSE listed company with turnover of 310 crores (FY 2010) is present in 60 regulated and semi-regulated countries, actively exporting to more than 20 countries.

The company has two manufacturing locations in India and one in Germany. Venus is top class manufacturer of Oncological and Cephalosporin Injectable products following EU-GMP norms for all is activities.

Venus has a broad range of products catering to critical care segment in parenterals like cephalosporins, carbapenems and oncology drugs in lyophilized form, infusions and small volume parenterals.

The research team of Venus has proved itself to be a power house of innovation by filing many international patents for sophisticated formulations of anti-biotics and oncological therapeutics.

In May 2010 Venus has won Gold medal for the best innovation under the India Innovation Growth Program 2010 organized by FICCI, Department of Science and Technology Govt. of India, Lockheed Martin Corporation, IC2 Institute at the University of Texas and Indo-US Science &Technology Forum. Having won this award company will be assisted by US-based Lockheed Martin Foundation and the University of Texas to commercialise its advanced wound care product Ampucare in the US market.

Venus Remedies is aiming to create intellectual property wealth of one billion US dollar.

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First Published: Apr 27 2011 | 7:24 PM IST

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