Yaky Yanay, President and Co-CEO of Pluristem Therapeutics (NASDAQ: PSTI), addressed a group interested in learning about the Israeli developer of cell therapy.The lunchtime discussion was sponsored by the South Florida chapter of Americans for a Safe Israel (AFSI) andtook place at a kosher restaurant in Miami Beach on Wednesday, July 19th.Several members of AFSI were given a tour of the Pluristem plant in the MATAM Industrial Park in Israel during their May mission, and were excited to hear him again.
Yanay began his talk with the fact that while we have doubled life expectancy in the last 150 years, “there is a significant decrease in quality of life as we age. The current standards of care allow the body to live longer, but not always better.” Our current health systems, and the financial costs of this population, especially in the healthcare realm, are becoming an increasing drain on governments and economies.
According to Yanay, elderly people are hospitalized for too long per incident and suffer from chronic ailments far too often; they are consuming drugs for much longer than recommended by physicians and many lose mobility.
Pluristem’s cell therapy products, derived from placenta from C-sections, are designed to treat patients by stimulating their bodies’ own regenerative mechanisms.The treatment is off-the-shelf and needs no tissue matching, making it significantly less expensive and considerably more convenient than other treatments.
Yanay held up a small vial to show the attendees and said, “In this vial there are over 100,000,000 (one hundred million) stem cells. From one placenta, Pluristem can manufacture as many as 20,000 treatments. Our cell therapy treatment and regenerative medicine in general works by secreting proteins supporting the healing process. We help the body heal itself.”
Tobias Winkler, a physician at Charite, Germany’s largest university hospital, said Pluristem’s cell therapy could prove effective in treating any number of challenges associated with immunological stress regularly experienced by the elderly. He explained that the human body is constantly regenerating itself to ward off diseases and combat injuries. Since older people’s regenerative systems have generally been eroded due to this process, it has fewer beneficial cells to fight off these attacks, leading to less effective regeneration in the elderly. Thus, this treatment could be a game-changer.
“We urgently need to regenerate better,” said Winkler. “I think the potential of these cells to help in the regeneration process is really promising.”
Another promising application of the therapy, currently in testing, is an injection which seems to help tissue exposed to radiation, from radiation treatments, or even from a catastrophic situation such as a nuclear plant meltdown or by use of a nuclear-tipped missile. Acute Radiation Syndrome (ARS), results from bodily exposure to extreme doses of radiation.
The injected cells secrete growth hormones, and can be used even before ARS has been diagnosed, according to Dr. Arik Eisenkraft, Pluristem’s director of homeland security.
If the U.S. Department of Health and Human Services funds the next step — which Pluristem is waiting to hear about — the treatment will move into a large trial in non-human primates. The trial is essentially equivalent to a late-stage trial in humans, Eisenkraft said. (A human trial can’t ethically be performed because it involves radiation.)
Should everything go as planned, an approval decision from the Food and Drug Administration could be expected somewhere around late 2018, he said. Still, when it comes to radiation damage, PLX-R18 won’t help with everything. The treatment doesn’t address radioactive materials like radioactive dust, which can also harm human health, for example.
“We also must acknowledge our limits,” Eisenkraft said. “Probably there will be victims we won’t be able to help, unfortunately… But at least those that we can help will benefit from this technology and this advanced medical treatment.”
“Having a widely available, universally tolerable, effective and low-cost treatment for ARS wouldhelp in our defense of civilians and defuse the threats posed by rogue nations such as North Korea and Iran.”, said Carol Flatto, South Florida chapter chair of Americans For a Safe Israel