Pluristem Therapeutics Inc. (NASDAQ:PSTI) recently announced that the U.S. FDA gave a nod to its Phase III trial design for its PLX-PAD stem cell treatment for CLI or critical limb ischemia. By June 2017, the company hopes to enrol the required number of patients for this year’s study. The unique thing about this trial is that the company will enrol 250 patients, which the company believes, will get it marketing approval through biologics license application.
An important change in the Biotech industry
Pluristem Therapeutics Inc. has proven that even the smaller companies come with a tendency of their independent research and clinical trials. As of now, we have seen a trend where majority of the costs for these kinds of clinical developments are sourced from either big companies, or the smaller ones are never able to launch their drugs in the market independently.
The cost of enrolling patients is often so high that the smaller biotechnology companies end up giving up. The bigger companies enjoy the licensing deals, which are good enough to make them richer and bigger. But now, it is becoming possible for the smaller companies to start off their own researches.
With the number of enrolling patients as high as 250, there are chances that the company may also go for the approval from European regulators, EMA.
Pluristem Therapeutics Inc.’s important research
Company’s research for CLI is important since the problem is said to affect as many as 12% adult people in the U.S. alone. The disease can be attributed to people’s lifestyle, with major reasons being diabetes, obesity and heavy smoking. At present, the cost of treatment of this disease per patients comes up to be a whopping $50,000, approximately. Every year, a patient requires a month of hospitalization.
Importance of clinical data for the company
It is the data, which will play a paramount role here. The company would definitely want a successful end result. In fact, we believe that the research would be so important for the company that it would not be waiting for its primary endpoint. Instead, it would be looking for the progress in patients, for each week, each month. The week after week progress through the collected data will be of much importance to the company.