Sepsis is a life threatening condition which is caused when a localized infection or its components breaks physical and immune barriers to enter into systemic circulation. It slowly builds into a multi-functional disorder which involves exaggerated inflammatory mediators, immune system suppression, and disrupted coagulation. This results in multi-organ failure culminating into respiratory, renal, hepatic, circulatory systems failure and ultimately death. Mr O. P. Singh, President – Sales and Marketing, Cadila Pharmaceuticals talks about Sepsivac, an innovation set to revolutionize Sepsis management.
“Sepsis affect more than 30 million people worldwide every year, potentially leading to 6 million deaths*. 1 out of 10 deaths associated with pregnancy and childbirth is due to maternal sepsis with over 95% of deaths due to maternal sepsis occurring in lower and middle-income countries*. In India, 1 in 4 patients in ICUs suffer from severe sepsis and around 34% succumb to this disease.
Scientists and researchers, for years, have been working towards finding a treatment option for this threatening disease. History is full of products which failed in clinical trial settings, and none of the agents showed any significant survival benefit in sepsis. Taking the challenge of venturing into newer therapeutic areas and continuously innovating for unmet needs, Cadila Pharmaceuticals took up the challenge to develop a product to treat sepsis.
Cadila Pharmaceuticals, first, participated in a sepsis program under a public-private partnership initiative by New Millennium Indian Technology Leadership Initiative (NMITLI), CSIR. The activities were closely monitored by NMITLI committee where our product, Sepsivac, was able to show 40% survival benefit in a very tough pre-clinical model of sepsis. This initial survival benefit was the driving force for the whole Cadila team to work towards finding a clinical benefit.
With a strong pre-clinical evidence, phase II A clinical trials were initiated for 72 patients suffering from gram negative sepsis. Intra-dermal dose of 0.3 ml Sepsivac was administered for 3 days and was able to show a huge improvement in the SOFA (Sequential Organ Function Assessment) score and faster recovery of organ functions.
With the increased belief in the treatment, phase II B clinical trials were initiated for 200 patients suffering from sepsis due to suspected gram negative infection. The trial achieved the primary endpoint of reducing 28 day mortality associated with sepsis. Overall, the use of Sepsivac in sepsis contributed to significant reduction in days of mechanical ventilation, ICU and hospital length of stay, lower incidence of SOFA score, in addition to potential survival benefit. Taken together, all the evidences suggested potential benefit of Mw (Mycobacterium w) use in sepsis.
The clinical benefit can be attributed to multiple mechanisms of actions offered by Sepsivac. It is a dual potent immunomodulator that stimulates immune system by regulating multiple pathways. The modulation of immune cells boosts the cell mediated immunity and balances out the aggravated non-specific immune component. Thus, it counteracts bad inflammation and alleviates suppressed component of immune system.
All the hard work of the team finally culminated into success when DCGI acknowledged the potential of the product and gave the approvals for the treatment of sepsis due to gram negative infection.
Sepsis is a deadly condition. It takes an unprecedented toll on everyone around a sepsis patient. Our focus through this innovative approach remains to provide care and reduce the suffering of our patients. As an organization we keep on working towards finding treatment solutions so that the doctors can have the best options available when fighting such deadly diseases.”
Disclaimer: This article contains medical information and should not be treated as advice. If you have any specific questions about any medical matter, you should consult your doctor or other professional healthcare provider.