Mumbai-based Actis Biologics Pvt Ltd, the biotech research and technology incubator company, is expecting approval to initiate phase-III studies of its potential anti-sense speciality product, Angiozyme, for colon cancer in India shortly. The company is trying to raise funds to the tune of USD 400 million for business expansion and research both in India and Malaysia.
Actis has already filed application for approval from the Drug Controller General of India for clinical trials in 150 patients across 16 sites in the country to test Angiozyme. It is also negotiating with its parent company in US - Actis Biologics Inc (ABI) - to obtain the trial material, according to P N Venugopalan, president, Actis Biologics.
Plans are to purchase almost 4.5 kg of trial material available with the US firm by negotiating price when compared to the USD 16 million cost estimated to acquire the material from open market. The negotiations will be made based on the equity sharing deal with ABI. Actis will also receive monetary support from the Department of Science and Technology amounting Rs 17.5 crore, provided the company incur the same amount for the phase-III studies, he revealed.
"The product is currently at late stage development and we expect to initiate the phase-III clinical trials in next 12 weeks in India. The data of human studies in India will be submitted to the US regulator to make the filing processes in US easier," said Venugopalan.
Angiozyme, a novel platform technology based on nucleic acid technology developed by the company's Ribozyme platform division, primarily targets colorectal cancer and secondly on lung and prostrate cancer also with a potential to have its effect on age-related macular degeneration (AMD), glioblastoma and for obesity.
The concerns for the product with the US, Canadian drug regulatory authorities are kept alive and the company can save cost of human trials in these countries with the support of clinical trial data from India, he added. The Swiss-based Avastin is one of the most popular products developed to treat colorectal cancer, at present.
Besides, Actis' Vascular Fusion Factor 2 (VFF2) yeast-mammalian cell culture technology to increase the production of protein eight times from the normal rate of protein product in human body through increasing body mass of the particular cell to accelerate activities, will hit the market early next financial year. The technology can be used in production of a wide range of biotech drugs including interferon and erythropoietin (EPO).
At present, clones for streptokinases and growth hormones has been prepared in the Mumbai R&D facility and a pilot plant to manufacture the technology in a wider scale has to be set up before applying for commercial rights with the drug regulators. The company will set up the pilot plant with an investment of about Rs 10 crore in next six months in Mumbai, informed Venugopalan.
The company's strategy is to develop biopharmaceutical products for unmet needs in the leveraging resources through collaborative relationships that allow further discoveries and basic research to simultaneously be conducted in academic laboratories.