Sun Pharmaceutical Industries Ltd and includes its subsidiaries and/or associate companies) has announced that it has received approval from the Drugs Controller General of India (DCGI) to initiate a clinical trial with Nafamostat Mesilate in Covid-19 patients. Nafamostat is approved in Japan for improvement of acute symptoms of pancreatitis and treatment of Disseminated Intravascular Coagulation (DIC).
The Centre for Cellular and Molecular Biology (CCMB) has established stable cultures of coronavirus (SARS-CoV-2) from patients’ samples. Virologists at CCMB have isolated infectious viruses from several isolates. The ability to culture the virus in lab enables CCMB to work towards vaccine development and testing of potential drugs to fight COVID-19.
Novel coronavirus enters human cell by binding with the ACE-2 receptor on the cell surface. Not all cells have ACE-2 receptors. Human epithelial cells in the respiratory tract copiously express ACE-2 receptors, causing respiratory disease in the infected patient. However, we cannot grow human epithelial cells in lab. “Currently, primary epithelial cells generated from human origins do not grow for many generations in labs, which is key to culturing viruses continuously. At the same time, the labs that are growing the virus need an ‘immortal’ cell line”, says Dr Krishnan H Harshan, Principal Scientist, CCMB. They use Vero cells (kidney epithelial cell lines from green African monkey), which express ACE-2 proteins and carry a cell division that allows them to proliferate indefinitely.
But why cultivate a dreadful germ? If we culture a large amount of the virus and inactivate them, then it can be used as inactivated virus vaccine. Once we inject the inactivated virus, the human immune system triggers the production of germ-specific antibodies. One can inactivate the virus by heat or chemical means. The inactivated virus can trigger antibody response, but does not infect and make us sick as they cannot reproduce.
“Currently, primary epithelial cells generated from human origins do not grow for many generations in labs, which is key to culturing viruses continuously. At the same time, the labs that are growing the virus need an ‘immortal’ cell line”
For the development of antibodies or antidots, virus cultures are important. Inactivated viruses can trigger antibody response in other mammalian hosts in addition to humans. Various such hosts are currently under test for their efficiency of antibody response. Such antibodies generated in these non-human hosts can be purified, processed and collected. The antibodies can be used as therapeutic intervention for patients suffering from the infection. Such antibodies can trigger antiviral response upon injection into humans and have the potential of limiting the infection. Administering antibodies does not provide immunity like a vaccine does, but can be considered as anti-dotes against the virus.
These cultures may also be helpful in the process of drug screening. Potential drugs can be tested against the virus in a test-tube for their efficacy.
“Using the Vero cell lines to grow the coronavirus, CCMB is now in a position to isolate and maintain viral strains from different regions. We are working towards producing viruses in huge quantities that can be inactivated, and used in vaccine development and antibody production for therapeutic purposes”, says CCMB Director, Dr Rakesh Mishra. CCMB has also started testing potential drugs with other partners such as the Defence Research Development Organisation (DRDO) using this viral culture.
“We hope that such systems are replicated at multiple research institutes and private companies to become a useful resource in the fight against this pandemic as well as for future preparedness”, said Dr Mishra.
- India Science Wire
Roche announced European Medicines Agency (EMA) approval of a new, shorter two-hour OCREVUS® (ocrelizumab) infusion time, dosed twice yearly, for relapsing or primary progressive multiple sclerosis (MS). The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).
“The approval of a shorter, two-hour infusion time for OCREVUS in Europe, dosed twice yearly, will further improve the treatment experience for patients while also increasing capacity in healthcare systems,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “With more than 160,000 people treated with OCREVUS globally, a shorter infusion may assist both patients and healthcare providers to reach the ultimate goal of slowing disease progression in MS.’’
The approval is based on data from the randomised, double-blind ENSEMBLE PLUS study, which showed comparable frequency and severity of infusion-related reactions (IRRs) for a two-hour OCREVUS infusion time vs. the conventional 3.5-hour time in patients with relapsing-remitting MS (RRMS) (289 patients shorter infusion; 291 conventional infusion). The first dose was administered per the approved dosing schedule (two 300 mg intravenous (IV) infusions separated by two weeks) and the second or later doses (600 mg IV infusion) were administered over a shorter, two-hour time.
The primary endpoint of this study was the proportion of patients with IRRs following the first randomised 600 mg infusion (frequency/severity assessed during and 24-hours post infusion). The frequency of IRRs was comparable between those who received the two-hour infusion (24.6%) and those who received the 3.5-hour infusion (23.1%). The majority of IRRs were mild or moderate, and more than 98% resolved in both groups without complication. No IRRs were life-threatening, serious or fatal. No patients discontinued the study due to an IRR and no new safety signals were detected.
As previously communicated, the U.S. Food and Drug Administration accepted a supplemental Biologics License Application for a two-hour OCREVUS infusion time and is expected to make a decision by 14 December 2020.
With rapidly growing real-world experience and more than 160,000 patients treated globally, OCREVUS has twice-yearly (six-monthly) dosing and is the first and only therapy approved for RMS (including relapsing-remitting MS (RRMS) and active, or relapsing, secondary progressive MS, in addition to clinically isolated syndrome in the U.S.) and primary progressive MS (PPMS). OCREVUS is approved in 90 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland and the European Union.
Eminence Business Media organized the Pharma GMP, GCP & Quality Management Webinar on May 14th-15th, 2020.
Loss of smell (anosmia) and changes in taste (dysgeusia) were strongly associated with SARS-CoV-2, according to a Canadian study published in CMAJ (Canadian Medical Association Journal).
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