Venus Remedies receives DCGI nod to conduct Phase-111 clinical trials of cancer detection NCE

05 Dec 2012 Evaluate

Venus Remedies has received approval from Drugs Controller General, India (DCGI) to conduct Phase-111 clinical trials of its cancer detection new chemical entity (NCE). After thorough screening by IND committee for the investigational NCE VRP1620, DCGI has found Clinical Phase-1 and Phase-11 data satisfactory and thus granted permission to conduct Phase-111 clinical trials on the molecule. The molecule is for early cancer detection and this leap towards successful Phase-111 will make the company pioneers among the companies working and providing innovative solution for cancer detection.

Venus Remedies has presented positive results of the investigational NCE VRP1620 after completion of meticulously planned, managed, executed and analyzed two pivotal Phase-1 & Phase-11 clinical trials. The company is planning to launch this NCE by last quarter of 2013 in India for the first time globally.

Venus Remedies had successfully completed Phase-1 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-11 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.

Venus Remedies is a pharmaceutical manufacturing company. The company provides formulations in area of antibiotics and oncological therapeutics. The company has two manufacturing facilities located in India and Germany. It manufactures Oncological and Cefelosporine Injectable products.

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